socio-cultural and technological … univ dr toader elena/02_teza... · capitole și include...

SOCIO-CULTURAL AND TECHNOLOGICAL

CHALLENGES IN CURRENT MODELS OF

INTEGRATED BIOETHICS

- HABILITATION THESIS –

ELENA TOADER, MD, PhD

IAȘI - 2018

Elena TOADER HABILITATION THESIS

SOCIO-CULTURAL AND TECHNOLOGICAL

CHALLENGES IN CURRENT MODELS OF

INTEGRATED BIOETHICS


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Contents

SUMMARY ............................................................................................................................................... 5

REZUMAT ................................................................................................................................................. 7

INTRODUCTION ....................................................................................................................................... 9

1. THE MAIN ETHICAL AND LEGAL ISSUES IN MEDICAL PRACTICE .................................................... 15

1.1. Ethical and constitutional values reflected in medical law – related to national health system in

Romania ............................................................................................................................................. 15

1.2. Decisions in medical act – ethical and legal meaning ................................................................ 18

1.2.1. Ethical and legal aspects of informed consent in clinical practice and research ................ 18

1.2.2. Correct briefing in the procedure of obtaining informed consent – ethical and legal

aspects ........................................................................................................................................... 27

1.3. Ethical, legal and social aspects regarding medical liability ....................................................... 34

1.3.1. Social impact of digestive diseases from the ethical perspective ....................................... 34

1.3.2. Medical responsibility as moral and ethical foundation for the professional conduit ....... 38

1.3.3. Vulnerabilities in Medical Practice ...................................................................................... 43

2. ETHICAL ISSUES IN THE WAKE OF TECHNOLOGICAL PROGRESS ................................................... 48

2.1. Application of biomedical technologies – issues in modern bioethics ...................................... 50

2.1.1. Biomedical technologies – scientific progress and social perception ................................. 51

2.1.2. Biomedical technologies application in healthcare: bioethics implications and concerns . 53

2.1.3. Clinical Application of Telemedicine - Ethical and Legal Issues ........................................... 55

2.1.4. Mobile phone interventions in the healthcare of chronic diseases .................................... 60

2.1.5. Software Applications Integrated in the Management of the Patient with Chronic Liver

Disease .......................................................................................................................................... 64

2.2. Clinical simulations – a learning tool .......................................................................................... 68

2.2.1. Ethical values of the medical education .............................................................................. 68

2.2.2. Clinical Simulation – Efficacy and Tendency in Medical Technological Education .............. 71

2.2.3. Clinical simulations for learning medical skills: a work-based approach to simulators ...... 73

2.2.4. Puzzle method - the option to learn within the team ......................................................... 78

3. BIOETHICS INTEGRATION IN THE SOCIO-CULTURAL CONTEXT OF THE CONTEMPORARY MEDICAL

ACT ........................................................................................................................................................ 84

3.1. Social and Cultural Representation of The Migration of Romanian Doctors ............................. 84

3.1.1. Theoretical Background for the Analysis of the Doctors’ Migration ................................... 85

3.1.2. Patients and students on the migrating doctors – social and cultural significations .......... 86

3.1.3. How is perceived the migration of the doctors by patients and future doctors? ............... 87


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3.1.4. Migration of the doctors – similarities and differences ...................................................... 87

3.1.5. Study limits .......................................................................................................................... 88

3.2. Cross-Cultural Medical Education a Challenge for Migrating Physicians in the Globalization Era

........................................................................................................................................................... 88

3.2.1. Transnational skills in the van of medical education in a globalized world ........................ 89

3.3. Conscientious objection in the medical migration context: cultural interference ................... 93

3.3.2. Conscientious objection in the medical migration .............................................................. 94

3.3.3. Methods .............................................................................................................................. 95

3.3.4. Results ................................................................................................................................. 95

3.3.5. Discussions .......................................................................................................................... 96

4. PERSPECTIVES .................................................................................................................................. 100

4.1. Perspectives in teaching ........................................................................................................... 100

4.2. Perspectives in academic and clinical research ........................................................................ 100

4.3. Perspectives in basic research .................................................................................................. 101

5. REFERENCES .................................................................................................................................... 102


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SUMMARY

The habilitation dissertation, headed “SOCIO-CULTURAL AND TECHNOLOGICAL

CHALLENGES IN CURRENT MODELS OF INTEGRATED BIOETHICS” is structured in

4 chapters, dealing with my main professional achievements, after defending my PhD thesis.

The milestones defining the present work are summarized in the 3 main chapters of the thesis.

The brief description of my academic and professional progress can be found in the

introductory paragraph.

The perspectives to follow after defending the present thesis are pointed in chapter 4, and

emphasize the future projects to be approached.

Chapter 1 - The main ethical and legal issues in medical practice – illustrates:

- Ethical and constitutional values reflected in medical law – related to national health

system in Romania

- Decisions in medical act – ethical and legal meaning

- Ethical, legal and social aspects regarding medical liability

Chapter 2 - Ethical issues in the wake of technological progress- deals with:

- Application of biomedical technologies – issues in modern bioethics

- Clinical simulations – a learning tool

Chapter 3 - Bioethics integration in the socio-cultural context of the contemporary

medical act – is describing:

- Social and Cultural Representation of The Migration of Romanian Doctors

- Cross-Cultural Medical Education a Challenge for Migrating Physicians in the

Globalization Era

- Conscientious objection in the medical migration context: cultural interference

Capitol 4 headed Perspectives deals with the Future Directions and are organized in:

Teaching perspectives will involve continuous formation process and the required ethical

standards, proposal for mandatory courses on ethics and law related medical issues and also

for ethic concepts and norm integration within clinical and basic research storyline.

Academic and clinical research perspectives will follow approaches to ethic aspects

derived from multicultural impact role in medical practice, partnership projects, together

with other local/national Universities, professional associations, and projects for junior

doctors to integrate medical and ethical knowledge on medical students’ clinical stages.

In basic research, I will spot on three directions:

First direction will focus on ethical issues generated by AI and deep learning. This will be an

important way to consider ethical and legal aspects of the developing personalized medicine,

while deep learning and AI are playing an active role in patient selection for targeted

medicines.

Second direction focuses to approach the topic regarding human embryo genome editing.

Being permanently updated with the new technologies, their efficacy and safety level will

help me to offer new insights regarding applicable changes to ethical principles to be applied

in the next decade medical act.


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Third direction is pointing for the ethics involved in the fast progress regarding personalized

and individualized medicine. It is important to redefine not only the landmarks for the

personalized medicine ethics but also to modulate its principles in order to provide certain

flexibility. A flexible but firm ethical norm set will be able to educate practitioners in the light

of the technological progress to rise in the next decades (including practitioners and patients’

lifetime).


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REZUMAT

Teza de habilitare intitulată „PROVOCĂRI SOCIO-CULTURALE ȘI TEHNOLOGICE

ÎN CONTEXTUL MODELELOR BIOETICE INTEGRATE” este structurată în 4

capitole și include realizările profesionale ulterioare susținerii tezei de doctorat.

Punctele de reper ale prezentei lucrări sunt reprezentate de cele trei capitole principale ale

tezei.

Sumarul activității academice, clinice și de cercetare se regăsește în capitolul introductiv al

prezentei lucrări.

Perspectivele derivate din activitatea științifică reflectată în demersul editorial asociat tezei

sunt enunțate în capitolul 4.

Capitolul 1, intitulat Principalele aspecte etice și legale în practica medicală prezintă:

- Valori etice și constituționale reflectate în legislația medicală – referiri la sistemul

național medical din România;

- Decizia în actul medical – semnificații etice și legislative

- Aspecte etice, legale și sociale referitoare la responsabilitate și răspundere în actul

medical.

Capitolul 2, denumit – Probleme etice raportate la progresul tehnologic - prezintă:

- Probleme de bioetică modernă referitoare la aplicații ale biotehnolgiilor medicale

- Conceptul de simulare clinică – o metodă educațională.

Capitolul 3, intitulat – Integrarea bioeticii în contextul socio-cultural al actului medical

contemporan – descrie:

- Proiecția socio-culturală a migrării personalului medical din România;

- Educația medicală interculturală – o provocare pentru medicii emigranți într-o eră a

globalizării;

- Obiecția de conștiință în contextul migrării personalului medical – interferențe

culturale.

Capitolul 4 se referă la Direcțiile ulterioare susținerii acestei teze sunt organizate în:

Perspective ale actului educațional, care vor include procesul de formare continuă (proces

care necesită standarde etice specifice), propunerea unor cursuri obligatorii de etică și

legislație referitoare la actul medical precum și integrarea normativelor și conceptelor etice

în fluxul cercetării clinice și fundamentale.

Perspective în cercetarea clinică vor exploata progresele individuale în aspecte etice

derivate din impactul multicultural în practica medicală, proiecte în parteneriat cu

universități naționale/internaționale sau asociații profesionale, precum și proiecte destinate

responsabilizării tinerilor medici pentru a realiza integrarea conceptelor etice asupra

actului medical la nivelul studenților în științe medicale.

Perspective în cercetarea fundamentală:

Prima direcție se va referi la modularea aspectelor etice generate de evoluția conceptelor de

Inteligență Artificială și „Deep learning” în practica medicală. Voi aborda aspecte etice și

de legislație privind evoluția conceptului de medicină personalizată unde procesele

menționate joacă un rol esențial în selecția pacienților destinați metodelor de terapie

punctuală.

A doua direcție privește aspectele etice și legislative ale procedurilor de editare a

genomului uman. Fiind permanent la curent cu evoluțiile actuale ale procedurilor aplicate în


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editarea genomului uman, voi putea contribui la dezvoltarea și modularea conceptelor etice

care vor deriva din aplicarea clinică a acestor protocoale..

A treia direcție se concentrează asupra conceptualizării unei flexibilități (în limitele unui

rezonabil, documentat științific) a principiilor etice aplicabile în actul medical hibridizat cu

aplicații biotehnologice aflate într-un permanent progres. Mă voi implica activ în procedurile

de redefinire a reperelor etice referitoare la medicina personalizată. Flexibilitatea în adaptarea

unor concepte etice este direct dependentă de modelul evolutiv al biotehnologiilor, iar acest

model necesită o abordare complexă, dinamică și permanent atent documentată, în beneficiul

furnizorilor și beneficiarilor actului medical.


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INTRODUCTION Bioethics has represented the main core in healthcare, disregarding the socio-cultural

context. Medical ethics is essential for professional health carers, mainly to define patient-

medical practitioner relationships, but also to integrate the latter relationships with the fellow-

workers and other people [Casini et al., 2014].

Bioethics is bringing up standards for professional moral behaviour and the

appropriate framework to engage decision-making context and the procedures developed

during the medical act. All the decisions regarding the patient are going to be taken in

agreement with the patient needs and requirements, being also correlated with the co-workers,

medical community and the society.

Integrating bioethics within the contemporary medical act relates to the progress and

promises of the modern medicines. The increasingly complex issues of the modern diagnosis

and treatment methods require the mandatory association of the medical procedures specific

to healthcare with ethical and legal aspects. Healthcare professionals and medical

practitioners in particular, must acknowledge for this mandatory association. They are also

expected to use this association output to fulfil patient expectations and individual needs,

together with family and society expectations too. Multiple recent studies are looking forward

to explore the ethical aspects of the medical act, emphasizing particular terms as therapeutic

privilege, request for the informed consent, cultural interactions, and consciousness objection

[Walker et al., 2013].

According to most authors involved in the analysis of the applied clinical ethics

[Siegler et al., 1990] the assessments regarding bioethics integration in the medical act are

approached as an overload for the National Healthcare System. Fast and consistent progress

of medical science and medical biotechnologies are continuously increasing the complexity of

medical act application on the individual patient and on the general population. This medical

act increasing complexity raises new issues and dilemmas regarding the implementation at

individual/patient level. Modern bioethics is assuming the mediator role for an accurate

integration of the medical act complexity and the patient needs/rights.

Gene therapy, which started to be used to remove defective/mutated genes in order to

replace them by a fully working gene, bionic prostheses for lost/dysfunctional limbs,

bioartificial matrices destined to tissue engineering or skin replacement, all these are

biomedical technologies that are transforming the ethic perception of human life or the human

species evolution itself.

Contemporary medical act is dealing with complex ethical approaches that require not

only a thorough and methodical practitioner analysis but also the participation of other social

resources – law, religion, economics, political sciences, and psychology. The most

representative examples come from the terminal patient care, budget projection in healthcare

systems, off-label therapies for orphan diseases etc. Practitioners admit the need for bioethics

implementation in the medical universities curricula and also required institutionalized

bioethics, focused on the medical act or on the research activities involving patients or

healthcare actions [Meagher et al., 2016]. Ethical Committees are now a constant worldwide

presence, while in Romania it was stated since 2015.

Bioethics integration in the medical act focuses on multidisciplinarity, emphasizing

the ethical standards analysis. Oviedo Convention [Sykora et al., 2017] and other reports

emphasize the need for a modern approach regarding abortion, human reproduction, end-of-

life care and also regarding clinical research. It is now the right time to reconsider ethical

resources and classic approaches regarding the challenging progress performed in medical

practice and research. Some aspects, as conscientious objection in refusing abortion due to

religious beliefs, euthanasia enactment in EU, enactment of reparative surgery versus plastic

surgery, medical practice globalization, or genome editing, must be approached in a different


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way from the classic one. A new, adapted, flexible and broader approach will ease these

concepts integration in the public consciousness and in the current legislation. This new

approach opens the broad expectation horizon for diversity and variability in the way ethics is

perceived and integrated in the medical act. The same time, religion, philosophy, political

ideologies are being considered in classic or modern approach to bioethics in medical practice

and research.

Ethical principles and values are being applied in different ways in various countries.

Thus, informal consent, consciousness objection is different in US and some EU countries

from other countries as India, where the social values, and family hierarchy in cultural context

are dominant [Nijhawan et al., 2013].

Patients in aforementioned countries are supposed to be informed about their medical

status and treatment options in order to decide their fate while in the latter countries it is

considered the patients should not be informed about a terminal disease and its poor

prognosis. Even if there are certain differences among ethical principles interpretation

according to particular cultural fingerprint, the main ethic principles remain the same,

disregarding cultural options. These basic principles are accepted and confirmed worldwide,

according to WMA (World Medical Association), ethical codes, and Oviedo Convention.

The habilitation dissertation, headed “Socio-cultural and technological challenges in

current models of integrated bioethics” includes 4 chapters, is introducing my professional

profile, personal concerns and landmarks regarding academic and research achievements. At

the same time, the present dissertation deals with the milestones that are defining the

perspectives for my professional profile.

My personal career focused on four main topics – bioethical aspects of the medical

procedures, ethical issues in the context of technical progress, interfacing bioethics and

socio-cultural context (addressed to medical procedures) and managing ethical difficulties

and issues in healthcare.

I. I was focusing on the standards in medical practice since I started teaching Bioethics

at the “Grigore T. Popa” University of Medicine and Pharmacy Iasi, Romania. The

current topic integrates good clinical practice as a guiding line in modern medical

act, and extends the personal knowledge accumulated in the Institute of

Gastroenterology and Hepatology, prior and following defending my PhD thesis. I

am currently interested and involved in:

- Interconnections, relationships, corroboration and complementarity of empirical and

normative ethics regarding health care;

- Understanding the way the ethic fundamentals and legal regulation specific to health care

impacts the practitioners, caregivers and patients;

- The diversity and variability regarding clinical ethics projection and integration in

medical practice.

Personal contributions to scientific research were gathered as valuable papers, published in

international journals, and proceeding of professional conferences regarding medical ethics.

II. I have expressed high interest in ethical issues in high tech progress since the onset

of my academic (Faculty of Medical Bioengineering) and clinical (Institute of

Gastroenterology and Hepatology) career. My pursuit focused on the evaluation of

ethical and moral impact of new biomedical technologies. I was constantly looking

for the practical deployment of new biomedical technologies and their potential to

improve health care status. Implementing new biomedical technologies always


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require a careful observation of the patient needs, with respect to ethical and legal

aspects of the whole integrative process.

I also explored clinical simulation procedures by teaching, clinical and research

approaches in the Clinical Medicine Simulation Lab, developed by a project financed

by the Ministry of Education (2008). As project manager, I have founded the first

national platform for Medical Clinical Simulations, meant to be used for lectures and

postdoc training. I have also organized workshops for international congresses (EHB

– 4 editions) and participated as expert scientist in “Integrated e-health solution to

monitor vital parameters in patients with chronic diseases" - SIMPA, 2007 project.

This project had a major influence on my professional career and allowed me to

proceed further for this research within the COST Action: CA16205 - European

Network on Understanding Gastrointestinal Absorption-related Processes, (as

national member of the Management Committee (2017-2021).

III. I was continuously showing interest for the socio-cultural context regarding bioethics

integration in the medical act. I was closely involved in the project „Postdoctoral

studies regarding health ethics policies” (2010-2013) with the research topic

“Ethical, social and economic inferences of medical doctors’ migration from

Romania”. This project has set up multiple interdisciplinary national and

international collaborations, on which I was able to take advantage of. I have

participated at 2 training sessions in Brussels (EU) and Bordeaux (Montesquieu

University - Centre européen d’études et de recherches en droit de la famille et des

personnes – CERFAP). Project results summarized in authoring 9 papers (5 ISI

papers in journals with IF>1; 1 paper published in a book (Cambridge Scholars

Publishing); 1 paper in a joint Elsevier book; 2 papers in joint volumes published by

CNCSIS related Publishing House. I have participated as author on two chapters of

the monograph entitled “On the road with Hippocrates – medical doctors migration

from Romania” (Polirom ed.). The request of a holistic approach regarding medical

migration in the context of health care globalization determined me to include this

topic in the medium and long-term personal research interest.

At present time, I am involved in the EMPOWER project - Protect, Empower and

support refugees, returnees and internally displaced women in response to gander based

violence- a multi-setting intervention advocacy for health and social care, Rights, Equality

and Citizenship Programme, (2017).

Another research topic was “Management of the ethic drawbacks and issues in

healthcare”. As principal investigator I approached the current topic in multiple projects as

CRONNEX, (2013-2015), SIMPA (2009), FARFIS (2009), MMX (2009) and Unit UNESCO

Chair in Bioethics (12th

of April 2017) within “Grigore T. Popa”, University of Medicine &

Pharmacy, Iasi, Romania. I was particularly involved in:

methodologic development for legal and ethical cumulative approach of for health

care; defining a working model to explore the therapeutic resources in patients with

chronic diseases and the characterizing patterns for case studies, focused on the

potential application of ethic concepts in the contemporary medical act;

improvement of the ethical context in medical establishments;

development of a valuable database regarding ethics and law in healthcare.


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Postgraduate studies

The onset of my professional career looks back to 1986 as a fresh graduate of the

Faculty of General Medicine in “Grigore T. Popa”University of Medicine and Pharmacy in Iasi,

Romania and to year 2000 as a graduate of the Faculty of Law, Al.I.Cuza University of Iasi,

Romania.

As an add-on to my university studies, I followed the courses and professional

seminars regarding ethics, clinical and interventional gastroenterology, clinical simulation.

Some landmarks in my postgraduate studies are: Postgraduate Course for Management in

Heathcare, Master degree in the Faculty of Economics and Public Administration, Al.I.Cuza

University of Iasi, Romania, Postgraduate Course for Research Ethics in Romania (2009),

Postgraduate Studies for Ethic Policies in Healthcare (2011, 2012). Mobility Programs in

Bordeaux, Montesquieu Bordeaux IV University (2012) and in some EU official Institutions

(EU Parliament, EU Committee, COM, DG SANCO 2012).

After defending my PhD thesis in 2007, I was granted with the PhD degree in Clinical

Medicine at the “Grigore T. Popa” University of Medicine and Pharmacy in Iasi, Romania.

Clinical profile

- Following graduation, I practiced as internship for 3 years in the County Hospital

Focsani, Vrancea, Romania, then as GP in the same County.

- 1992-2003, I was employed as research assistant and then as medical practitioner in the

Gastroenterology and Hepatology Institute Iasi, Romania

- 2003 – present time, I promoted to consultant in gastroenterology and internal medicine

with competence in general echography and digestive endoscopy in the Gastroenterology

and Hepatology Institute Iasi, Romania

Academic teaching profile

Since 1993 I was employed as associate member in the University teaching staff,

department of Medical Semiology at the “Grigore T. Popa” University of Medicine and

Pharmacy in Iasi, Romania. In 2000, I have been promoted as lecturer in the department of

Legal Medicine, Bioethics and Medical Deontology. Since 2009, I was leading different

teaching modules within the Master Program “General management in healthcare” (Faculty of

Bioengineering) and the Master Program “Paediatric Logopaedics” (Faculty of Dentistry). In

2013 I have been promoted as associate professor in the department of Bioethics and Medical

Deontology.

Other academic activities included:

- Member of the Ethical Committee for Research;

- Member of the Professional Council of the Faculty of Bioengineering;

- Member of the organizing committee of scientific national and international events

- Member in various evaluation groups for university admission, graduation, academic

position contests, clinical management in the Institute of Gastroenterology and

Hepatology, Iasi, Romania.

- Founder and President of the Romanian Association of Medical Law

- Didactic coordinator of Medical Deonthology and Bioethics Discipline, “Grigore T. Popa”

University of Medicine & Pharmacy, Iasi, Romania.

- Head of the Iasi Ethics Unit, of the International Network of the UNESCO Chair in

Bioethics (Haifa) at the “Grigore T. Popa” University of Medicine & Pharmacy, Iasi,

Romania.


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Academic research profile

As ethics represent series of norms for conduct that distinguish between acceptable

and unacceptable behaviour, there must be a permanent process of updating these norms,

according to basic and clinical science progress. Discussing and adapting bioethics principles

to scientific progress requires vast research and reconsideration of the former norms. In order

to proceed for a coherent norm update, one would have to be updated regarding latest

progress on a specific topic, related to the raise of ethical issues. Hence the research in ethics.

I have published 45 ISI papers (22 with IF) and 25 papers included in international

databases (IDB). I have published 9 books on the bioethics, being also author of 12 chapters

in 6 monographs and 23 chapters in other books. I have been participated to more than 100

national and international scientific events, as speaker or chairman. I have presented over 60

works on Bioethics as poster or conference presentation.

The topics I have approached within Bioethics concept refers to: informed consent

particularities in medical practice, people’s fundamental rights, cultural diversity, ethic

aspects of practitioners’ migration, medical education ethics in global context, vulnerabilities,

ethic aspects in digestive pathology, and clinical research ethics.

I have been participated to research projects, clinical studies, and teaching projects.

- Team member in the project 3rd Scientific Workshop ‘IBD and neoplasia’ within

European Crohn´s and Colitis Organisation –ECCO” (2011);

- Postdoctoral team member in the project „Postdoctoral studies regarding Ethic policies

in healthcare” (2010)

- Principal scientist in the multinational multicentric study "Efficacy and safety of oral

budesonide MMX 3mg and 9 mg extended release tablets (CB-01-02) in subjects with

mild and moderate activ ulcerative colitis. A pilot dose-finding multicentre comparative

study versus placebo" (2009);

- Team member in National Partnership Project Framework:

o E-health integrated solution to monitor vital parameters in patients with chronic

diseases (SIMPA, 2008) – as full-time scientist;

o Evaluating the risk-factors in engaging external postoperative digestive fistulas

and the impact on pre and postoperative therapeutic management (no. 42145,

2008) – as gastroenterology consultant. o CHRONEX-RD – the international development project of Eastern European Research

and Development Networks in Chronic Diseases (2013 – 2015), as team member.

I was member of the editors’ team for Romanian Journal of Bioethics (FI=1), and I am

currently member of the editors’ team Journal of Self-Governance and Management

Economics (ISSN 2329-4175), and European Journal of the Economics (ISSN 1959-5832).

Impact of Teaching Projects

I was part of the important academic/teaching projects destined to graduates,

internships and master-students integration in research actions. I have permanently added

value to medical university curricula, being an active part in the continuous teaching-

evaluation process upgrade.

I have contributed to the development of the Clinical Practice Simulation Lab (2008),

through the courses for clinical simulations, clinical applications for medical devices used in

gastroenterology, student workshops, and postgraduate studies. I have introduced new topics

according to the norms related to European integration and globalization process. I was also

involved in teaching projects regarding continuous education (Summer School on

Gastroenterology – Law and Medical Ethics, Malpractice in medical act, Clinical

simulations). I was continuously involved in extracurricular activities as Student Scientific


14

Meetings (as students’ work coordinator on bioethics presentations), Clinical Simulation

Workshops, Simulated Malpractice sessions.

Awards

- Ist

Prize for the paper Epidemiological and clinical features of the young patients with

ulcerative colitis in Iasi county, presented at Falk IBD Symposia, Bucharest, Romania,

Nov. 2000;

- IInd

Prize for the paper Extended inflammatory lesions in ulcero-hemorrhagic

rectocolitis, presented at the XXIXth National Symposia on Gastroenterology,

Hepatology and Digestive Endoscopy, Cluj-Napoca, Romania, June 2009;

- IIIrd

Prize for the paper Remission lasting and long term prognosis in patients with

ulcero-hemorrhagic rectocolitis under maintenance therapy, presented on the National

Symposia on Inflammatory Bowel Diseases, Mamaia, Romania, September 2010. - Diploma „Dimitrie Cantemir” for book Riscul pentru malpraxis în actul medical, Editor

Elena Toader, Editura "Gr.T.Popa" U.M.F. Iaşi, Târgul de Carte Iași, Octomber, 2017, ISBN

978-606-544-493-5.

- Mention for the paper The sensitivity of severity scores in evaluating the causes of death of

cirrhotic patients, autors Chiriac S, Trifan A, Stanciu C, Hordila A, Cuciureanu T, Toader E

3rd UpDate on Hepatology Course, Bucharest 28th-29th April 2016.

- Award for paper Clinical course of ulcerative colitis and disease extension the follow-up

study in patients with distal ulcerative colitis, autors Elena Toader, Rusu Lidia, Croitoru

Liliana, P398 Journal of Crohn's and Colitis, ELSEVIER, Vol. 6 Supplement 1, Page S168

February 2012.ISSN-18739946.


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1. THE MAIN ETHICAL AND LEGAL ISSUES IN

MEDICAL PRACTICE

1.1. ETHICAL AND CONSTITUTIONAL VALUES REFLECTED IN MEDICAL

LAW – RELATED TO NATIONAL HEALTH SYSTEM IN ROMANIA

The fundamental human rights include the Right to Health [Vicol, 2010] as enshrined

in the Romanian Constitution and stipulated by specific laws and European provisions; rights

to health apply also to treatment involving foreign citizens Romania [Vlădescu, 2012]. The

Constitution states that the right to health is endorsed by the State that will consider measures

to ensure hygiene and public health [Constitution, 2003, Vicol, 2010] but it is the medical law

that defines the optimal measures required to achieve this purpose. Whereas, the main

regulation in medical field are comprised in Law no. 95/2006 on healthcare reform

[Constitution, 2003, Vlădescu, 2012], together with other laws, there was a need for

systematization and codification thereof, so as to avoid previous inconsistencies and

omissions.

The purpose was to achieve full compliance and implementation of ethical values in

the normative legal measures necessary for the full and effective protection of the right to

health care.

Presumptions

Presumptions can be defined as logical consequences of a law or whatever an

interpreter concludes about a known fact based on an unknown fact; presumptions can be

legal or judicial, irrefutable or rebuttable. With reference to the legal rules specific to the

medical field, the following presumptions are possible:

- in their complementarity, they reflect a unified and coherent strategy for health care, and

their adoption thereof is performed by considering the best people interests, within the

health protection concept;

- the rules established by laws or ordinances are in full compliance with the rules and

values contained in the Basic Law; otherwise, they could be challenged in front of the

constitutional court;

Toader E, Toader T., Ethical and constitutional values reflected in medical law.

Revista Romana de Bioetica. 2012 Jul 1;10(3).

Toader E, Firtescu BN, Oprea F., Determinants of Health Status and Public Policies

Implications–Lessons for Romania. Transylvanian Review of Administrative Sciences.

2017;13(52):128-47.

Principal investigator and member in multiple projects - CRONNEX, (2013-2015),

SIMPA (2009), FARFIS (2009), MMX (2009)

Founder and the Head of the Iasi Ethics Unit, of the International Network of the

UNESCO Chair in Bioethics (Haifa) at the “Grigore T. Popa”, University of Medicine &

Pharmacy, Iasi, Romania.


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- the rules established by governmental decisions, Minister Order and methodological

standards are in full agreement with the rules and values set in the law, otherwise they

could be challenged in administrative proceedings;

- adoption thereof is made in compliance with the requirements of foreseeability and

predictability, so as to guide the conduct and ensure the use of the right to health;

- National rules are fully consistent with European legislation and meant to ensure the

highest quality standard of health.

Without going to deeper theoretical details, it is important to emphasize that most of these

presumptions are rebuttable.

Ethical and constitutional values reflected by the medical law

Respect for private life. Anybody’s privacy is protected both by Article 26 of the

Basic Law (stating that Public Authorities shall respect and protect personal, family and

private life), and by Article 8 of the Convention for the Protection of Human Rights and

Fundamental Freedoms, (stating that everyone has the right to respect for his private and

family life, home and correspondence). General data regarding population health are being

continuously included in the development process for Legal protection of private life.

Private life protection supposes data confidentiality concerning the individual health

condition. Confidentiality on such data regards any person, excluding however, professionals

involved in the medical act. Law operates this distinction, and it is based on the protected

social value, i.e. the individual health, not the civil relationship to third parties who may

require access to those data. From an ethical perspective, the legislature thus gives priority to

the protection of patient’s private life in relation to any other legitimate interests which the

applicants may have, related for example to heritage, interests that can be achieved through

court proceedings. Thus, the right of inheritance does not allow the heirs to get information on

the health of some specific individual. Medical legislation is very strict regarding this aspect,

and the information on the human beings’ health "falls within the definition of privacy"

[Constitution, 2003]. It is essential to grant the accredited health care providers involved in

specialized treatment access to the specific patient medical data. These data include details

regarding the proposed/approved treatment and they will not be available for other persons,

nod involved in the medical act, seeking access to medical information on the patient

[Constitution, 2003]. At present time, National legislation is correlated with the case-law of

the European Court of Human Rights; the latter stated that "protection of personal data, not

least medical data, is of fundamental importance to a person's enjoyment of his or her right to

respect for private and family life as guaranteed by Article 8 of the Convention (case of Z v.

Finland). Without such protection, those in need of medical assistance may be deterred from

revealing such information of a personal and intimate nature as may be necessary in order to

receive appropriate treatment and, even, from seeking such assistance, thereby endangering

their own health and, in the case of transmissible diseases, that of the community."

Protection of private life is mandatory also after the patient’s death. Extending the

obligation to maintain confidentiality of data on the health of a person, even for deceased

persons, it also seems as a natural reflection of the fundamental rights mentioned above if

consideration is given to the fact that while a person’s ability to use his/her right ceases at

his/her death, by virtue of the respect due to human person, the memory of the deceased and

the choices made during life should be protected after his/her death too. A patient's right of

option with respect to preserving the confidentiality on his/her health condition cannot be

transmitted mortis causa, thus being preserved the option expressed by the time of death of

the right holder.

Social solidarity. Health insurance system is organized and works based on the

principle of social solidarity. Due to the solidarity of those who contribute, the system can

achieve the main objective, which is to provide a basic medical assistance to the general


17

population including those categories of persons who are unable to contribute to the

establishment of health insurance funds. From the same principle it becomes evident that any

voluntary health insurance does not exclude the obligation to pay contributions for health

insurance nor the duty of retired persons performing an activity generating income to

contribute to the health insurance fund. This is also justifying the difference between the

actual amount of contributions among different social categories. The difference is in practice

determined by the income according to which the contribution rate is calculated. At the same

time, higher contribution of people with higher income is based also on the constitutional

principle of fair settlement of the tax burden to bear public spending, but the contribution rate,

expressed as a percentage, is unique, not having a progressive character.

Social protection. Tax burden distribution must take into account the taxpayers' ability

to contribute, respectively, tax burden distribution must take into account the need to protect

the most disadvantaged social strata, taking into account the elements that characterize the

individual situation and social burden of the taxpayers concerned. Without representing a

violation of the above-mentioned principle, social solidarity, and taking into account the

special situation of certain categories of persons, the legislature may take additional measures

of social protection. In this respect, and in accordance with the principle of social protection,

the law may define certain exemptions from contribution without that person losing his/her

quality of being insured. Thus, for disabled people, such an exemption from health insurance

contribution represent a constitutional right. This right is a representation of the mandatory

State protection regarding disabled people, considering Article 50 of the Constitution.

However, the special protection provided by the State to disabled people represents only a

small part, required to ensure that these people can benefit from equal opportunities in

relation to other citizens.

Equal rights. The constitutional principle of equality of rights requires setting an

identical legal treatment for identical situations. This does not mean uniformity, so that

different situations sometimes allow and require different regulation, in full compliance with

the constitutional principle mentioned above. Assessing compliance with the requirements for

equality in determining the amount of contribution to social health insurance fund, the

Constitutional Court found that, on the one hand, Article 257 par. (2). b) of the Law

no.95/2006 provides that it cannot be less than 6.5% calculated at a minimum gross salary per

country per month, and on the other hand, Article 257 par. (2 f) of the Law that establishes

that persons who have an income from the transfer of use of property, income from dividends

and interest, income from intellectual property rights achieved individually and / or a form of

association and other income subject to income tax must contribute to social health insurance

fund in an amount of 6.5% of these revenues, "but not less than a minimum gross salary per

country per month." At the same time, the Court found that the obligation imposed by the

provisions of Article 257 par. (2) f) last sentence of the Law no.96/2006 can lead in practice

to a situation that the insured might pay a higher contribution than income itself. Such a

provision cannot be considered in any respect as ensuring a proportional and reasonable tax

burden within the meaning of the above, and the different legal treatment is not justified by

any objective circumstances. For considerations shown by the decision of interpretation, the

Court held that the provisions of Article 257 par. (2) f) last sentence of the Law nr.95/2006

are unconstitutional insofar as interpreted in the meaning that the minimum contribution

amount to fund health insurance due by those who obtain income from lease of property,

income from dividends and interest, income from intellectual property rights achieved

individually and / or a form of association and other income subject to income tax cannot be

less than the amount of a minimum gross salary per country, per month. Representing the

foundation of legal norms, ethical values give them the social dimension necessary to a

modern and efficient construction of protection and assurance of the right to health.


18

1.2. Decisions in medical act – ethical and legal meaning

1.2.1. Ethical and legal aspects of informed consent in clinical practice and research

Modern professional ethics are always correlated to with the informed consent that, at

its turn, is a guiding principle. All patients have the right to self-determination. Thus, the

informed consent, regarded as basic guideline in various professional fields, became an

ethical prescription articulated within the evolving context of the medical act. Historically,

informed consent may be regarded as an indication for the development of the modern

attempts to code and institutionalize fundamental human rights. Patient autonomy derives as

legal doctrine, from the fundamental hypotheses of human rights [Aronsohn et al., 2012]; this

autonomy also involves the concept of informed consent. Individual choice regarding the

freedom to decide, namely what should and should not happen with one’s own body, is

represented by informed consent and, from the ethical perspective, highlights that the patient

requires complete, accurate and pertinent information, which one must receive before

undergoing a medical procedure or surgical intervention. Thus, it is legally stated that the

freedom to decide cannot be overtaken by any individual and nobody has the right to

constrain the patient to act in a certain way, not even the physician, who must act only as a

facilitator in the decisional process of the patient [Levine, 1988].

As a key concept in providing healthcare, informed consent involves ethical, legal and

practical aspects.

From the ethical point of view, informed consent is an essential element of the patient

right to autonomy based on the principle of freedom of choice.

The process through which the physician informs the patient on the diagnosis

procedures and protocols and treatment options, together with associated risks and benefits

are defining the informal consent. This information supports the patient in making a decision

regarding the care of his/her own health.

Toader E, Damir D, Toader TI., Ethical and Legal Aspects in Biomedical Research

Involving Human Beings. In Advanced Technologies for Enhancing Quality of Life

(AT-EQUAL), 2010 2010 Jul 15 (pp. 79-82). IEEE.

Toader E, Toader T. Patient's rights vs health care professionals’ duties.

Revista Romana de Bioetica. 2003 Jul 1;1(3).

Toader E, Ethical and legal foundation of informed consent in clinical practice and

research

In Medical malpractice - civil and criminal liability of medical staff, Editura „Gr. T.

Popa”, U.M.F. Iaşi, pg. 27-41

Toader E, Correct briefing in the procedure of obtaining informed consent – ethical

and legal aspects

In Medical malpractice - civil and criminal liability of medical staff Editura „Gr. T.

Popa”, U.M.F. Iaşi, pg. 41 – 52


19

From the legal perspective, informed consent represents the manifestation of the intent

to close a civil deed (synalagmatic contract) or agreement of will in bi- or multilateral deeds

with the purpose of achieving a certain goal.

1.2.1.1. Informed consent: historical landmarks

Historically, informed consent represents a milestone in coding and institutionalizing

fundamental human rights stated throughout various stages of the development of

contemporary society. Here are the landmarks for this concept:

1914 – first legal precedent regarding the right of an individual to self-

determination: “a physician removed an abdominal tumour on a patient who

consented only for a diagnosis procedure” (Schloendorff in Report of New York

Hospital Society). The judge ruled that the physician is responsible of violating a

“fundamental individual right to decide what one makes with one’s own body”,

arguing that “each adult human being in his/her right mind has the right to decide

what is done with one’s own body”[Aronsohn et al., 2012].

1950 – the first case that defined the elements of informed consent involved a

potential negligence case, with the inquiry if the patient was provided with sufficient

information in order to make a decision [Levine, 1988]

1957 – it was the first official introduction of the term “informed consent” by legal

ruling in the case Salgo versus Leland Stanford Jr. University Board of Trustees. In

this case, the plaintiff, who became paraplegic after a procedure performed for a

vascular issue, stated that the physician did not present adequately prior to the

procedure the essential information regarding risks that might occur over time.

The “informed consent” is a quite novel concept in medical ethics. It is concurrently

updated with the movement supporting patient rights, and brings together basic principles of

physician-patient relationship. In a contemporary ethical formulation, the informed consent is

regarded as an answer to some of the most severe violations of human rights which were

recorded in XX century [Nelson-Marten et al., 1999].

1.2.1.2. Purpose of informed consent

Patient autonomy dominates the area covered by the informed consent concept

[Beauchamp et al., 2001]. As procedure, informed consent gives the patient the chance to

participate in the decision-making meetings, as long as he/she wants it and has enough

physical/psychological abilities to decide.

Informed consent plays a specific role in the current medical practice, and there are the

milestones that must be considered to proceed further with the medical act: confirmation of

importance of informed consent, respect of autonomy and dignity of the individual, lowering

to minimum any consequences generated by the manner in which the briefing of the patient

was performed. In the clinical context, the practical purpose of informed consent is to ensure

the patient that he will be told the truth, that he will not be constrained or led into error. If the

patient gives just a formal consent, the aforementioned aspects cannot be provided anymore.

1.2.1.3. Structure of informed consent

There are three fundamental structural elements that may define the informed consent [Gupta

et al., 2012]:

1. information, the essential component of a valid informed consent, entails the

presentation of the relevant data, by the physician, communicated in a manner

comprehensible by the patient; briefing designates the provision of information

necessary for the patient to make an informed decision;

2. decision ability entails the capacity of the patient to (a) understand the presented

information and predictable consequences, (b) assess the situation and medical


20

context, (c) use the provided information in a reasonable manner, and (d)

communicate the choice (participation agreement or informed denial)

3. wilfulness signifies the ability of the patient to judge freely, independently and without

constraint, what is good, just, fair and considered to be the best option for one’s own

medical situation, in accordance with one’s specific value system and personal disease

history[Gupta et al., 2012].

1.2.1.4. Informed consent – validity requirements

One informed consent must become valid and gain ethical and legal value. Thus it is

supposed to must fulfil concurrently the following requirements [Toader et al., 2003]:

a) it must be issued by an individual with sane judgement. This requirement is

fulfilled when the patient has the ability to perceive and acknowledge the

consequences of the medical act. Only a person who is aware of both rights and

obligations derived from the medical act must give consent.

b) it must be externalized; on this side, the informed consent protocol may be

expressed (e.g. the written form of informed consent) or silent. The expression of

the will manifestation in an externalized manner represents the stage of will

agreements between parties (patient and physician) and delineates the moment

from which legal effects are becoming effective. Sometimes, depending on

custom, even silence might be considered as a consent. The situation that can be

compared with some forms of implied consent, representing an agreement to be

involved in the medical act while this agreement is just derived from patient’s

behaviour.

c) It must not be vitiated; the expression of will must be a consequence of one’s own

decision, of the autonomy of the patient, without exerting influences or constraints.

It is mandatory to observe that a consent is not valid when it is obtained through:

- error, defined as false representation of reality. In current practice, error

designates a medical reality different from the one in question, which, through the

size of the medical, social and economic impact draws consequences of legal,

moral and professional deontology nature. From the point of view of effect, error

is caused by aspects related to professional competence and can be considered as a

vitiated consent when the element regarding the party in error had a decisive role

for the medical act.

- mistake, defined as violation of rules of professional conduct, may be taken into

consideration for a vitiated consent in situations of insufficient information, lack of

the patient supervision, violation of consent, mistake in diagnosis, prognosis or

medical technique.

- dol is an error caused by bad intentions, and consists from leading someone into

error by deceitful means (e.g. prescription of a therapeutic protocol with multiple

procedures which proves to be unnecessary).

- violence of physical or psychological nature implies a state of anxiety of fear

induced to the patient whose volition involved in the procedure of granting

informed consent is therefore damaged.

1.2.1.5. Ethical standard of informed consent

In the ethical interpretation, standards for medical practice are based on what the

physician is supposed to do from the point of view of that which is of value, good and just

[Codul de Deontologie Medicală, 2005]. In accordance with standards of medical practice, the

standard from informed consent states that the physician must establish what information is

adequate to be disclosed to the patient, the type and amount of information which is to be

communicated. This is modality by which the ethical standard of informed consent ensures


21

the protection of the choice for the patient, which, from the point of view of respecting the

right to self-determination, develops two meanings:

a) warden of the patient’s safety against distortion of medical comprehension and

abuse; in these situations, the use of a complex procedure for consent is required,

written, signed, rigorously respected and monitored;

b) expression of professional loyalty and performance, which suggests that a consent

must be regarded as an aspect in the sincere relationship between physician and

patient, where a correct decision is taken, without requiring formal consent

procedures.

This approach could be viewed as the best ethical standard for informed consent, however the

exclusive usage of this standard is not sufficient in the circumstances where many patients do

not know which information may be useful for their decision. Consequently, physicians have

the responsibility to provide the type and amount of information in accordance with the

professional standard, in order to ensure that the decisions of the patients are not based on

false convictions.

As ethical norm, the standard of informed consent is influenced by several issues encountered

in current medical practice [Cordasco, 2013]:

autonomous choice; the main objection to informed consent according to the

standard is that it undermines the right to autonomous choice, since the standard is

conceived for medical decisions, while the decision to accept or refuse the medical

act belongs to the patient.

Therapeutic privilege; according to the standard for professional practice, protection

of therapeutic privilege offers to the physician the possibility to communicate the

information which he believes to be relevant or useful, as well as refraining from

presenting the information which the physician deems as stressful or confusing for

the patient.

Subjective standard; communication of information with specific details

corresponding to the needs of the patients leads to excessive usage of subjective

standard. As moral justification, the subjective standard is the only one which

recognizes the need of the patient for information.

Correct briefing; communication of detailed information does not always serve the

ethical standard of informed consent, since patients do not expect the physician to

make an evaluation of the personality of every patient, in order to establish which

information would be pertinent.

Externalized consent; in order to fulfil moral requirements, physicians and

institutions should not be limited to a form of signed consent (the externalized

consent) for diagnosis and therapeutic procedures in current medical practice, except

for the cases where consent was especially conceived for a specific investigation.

Communication of truth; in current medical practice there are situations where the

refusal to communicate the truth to a patient is justified:

Case 1. The physician has convincing proof that the truth may cause real and

predictable damage, such as the risk of suicide in the case of a depressed patient,

when this patient finds out the truth. The decision of the physician to not

communicate the truth, known as “therapeutic privilege” is important and may be

evoked only in cases with very probable risks and not only as a hypothetical

damage, where it may represent the object of specific abuse.

Case 2. The patient acknowledges the situation and declares the preference to not

know the truth. Some patients may require from their physician the permission to

consult with family members. In these cases, it is extremely important that the

patient reflects on the implications of waiving the right to decide.


22

religious convictions; patients with specific religious convictions, coming from certain

ethnic or cultural environments may have different opinions regarding the opportunity

of sincerely communicating the truth. For example, the Navajo Indians do not want to

be told about potential risks of the treatment, since, according to their religious beliefs,

hearing such risks means inviting their occurrence. Another example well known in

the Romanian media environment is the case of Jehovah’s witnesses, a religious cult

that refuses blood transfusion.

1.2.1.6. Who can obtain informed consent?

Initially, the consent was perceived as a monovalent act of informing the patient by

the physician reasonably involved in healthcare provision. Later, in order to protect the

autonomous choice, it was established that the ethical, moral and legal requirement to

obtained informed consent pertains to the attending physician. The attending physician may

delegate the responsibility to obtain informed consent to another physician. If the physician

towards which the responsibility was transferred declines, the attending physician is

responsible and liable for the occurring consequences. The resident physician and the

medicine student cannot obtain informed consent, since none of these is responsible for the

care of the patient. We must underline for the resident physician that the limits of competence

corresponding to his/her level of formation must be taken into consideration. According to

guidelines regarding the organization and financing of the Resident Program (article 33),

when the physician graduates the Bioethics module, although he/she may have acquired

limited competences regarding the ethical standard of the informed consent, cannot answer

directly since he/she is not directly involved in the decisive medical act.

1.2.1.7. Barriers and limitations in the procedure of obtaining the informed consent

[Travaline et al., 2005]

The most frequent difficulties in the procedure of obtaining informed consent are due to

situations generated by:

1. lack of time in the case of the physician;

2. controversies between physicians regarding the situations when informed consent is

necessary;

3. too much information which must be presented to the patient;

4. perception by the patient as a “legal release”;

5. patients do not know or understand what medical procedures may be refused or delayed;

6. communication in medical and technical terms, language and cultural aspects;

7. special circumstances (IQ, stress);

8. the quality of the informed consent form and of the correlated educational materials;

9. failure to understand information by the patient;

10. ability of the physician to understand the patient.

1.2.1.8. Limits in the procedure of obtaining informed consent

Considerations referring to validation of informed consent highlight the role of the

classical and normative ethical system in the development of the concept of informed consent,

with the mention that this system cannot provide a general framework which would include

all situations comprising multiple issues of communicating information, especially those

regarding risks, or every diverse circumstance the physician may encounter in current medical

practice. A few common examples from current medical practice point out a series of

limitations in the procedure of obtaining informed consent, generated by aspects such as

[Toader, 2010]:

A. Technical and scientific dimension of the medical act. In medicine there are well-known

simple cases with unpredictable evolutions generated by the occurrence of very serious

complications, as well as serious cases which may present spectacular evolutions. An


23

example of a simple case, which in evolution may present very serious complications: a

patient who undergoes a surgical procedure for appendicitis, under the general anaesthesia

develops a cardio-respiratory stop, goes under life support through mechanical ventilation

under which develops serious sepsis complications leading to death. In this example, the

common situation is the acute appendicitis, curable by surgical intervention with reduced

hospital admittance. The actual situation is acute appendicitis, the surgical intervention

with general anaesthesia, the cardio-respiratory shock, the mechanical ventilation support,

the serious complications, and death. Cause of death, probably due to a secondary effect to

anaesthesia, raises a series of questions regarding the procedure of informed consent: Was

the patient presented with information on risks of anaesthesia, including the risk for

cardio-respiratory shock? Were all measures taken to prevent such complications

(complete anamnesis regarding intolerance or allergy to certain medication, tests

performed, etc.)? Complex situations, such as long coma states (days, weeks) with

spectacular recovery when there was no more hope also raise a series of questions on

informed consent: Who decides continuing life support for the patient? For how long may

he be maintained alive in these conditions? etc.

B. Psychological aspects resulting from the briefing of the patient who must consent, creating

anxiety when the data present is too restrictive (the suspicion to avoid communication of

elements that may influence the status of the patient) or too elaborate, in medical terms,

inaccessible for the comprehension of the patient with respect to the level of medical

education.

C. Deontological aspects. The patient must be informed about all possibilities and must not be

deprived of any chance regarding any type of diagnosis or therapeutic intervention

regarding his/her own health status. By all possibilities we mean both the information

related to existence and availability of diagnosis and therapeutic methods, as well as to the

concrete modality by which the patient may benefit from them. Example: a patient with

neuromotor deficit as a consequence of stroke who requires a rehabilitation program

available only in certain centers with co-payment system. The moral obligation of the staff

is to inform completely the patient of this possibility, including the data on payment

modality and other conditions required by this procedure.

D. Acquisition of legal value by fulfilling and meeting the validity requirements of the

informed consent.

1.2.1.9. Informed consent in specific situations

As fundamental rule, informed consent must be obtained from every patient

individually before performing the medical act in question. However, there are certain

situations, such as emergency or mental incapacity which are considered exceptions from this

general rule, where presentation of information can be adjusted accordingly, partially or

completely. It is worth mentioning that in some special situations the patient has the right to

refuse participation in the medical act.

A. Emergency. It is considered that in emergency the procedure of the informed

consent is unnecessary. The decision is dictated by the medical context governed by the

necessity of an immediate treatment in order to prevent death or grave damage on the health

of a patient with a temporary inability to grant informed consent. In the cases where the

patient is unconscious and unable to grant informed consent, we presume two aspects [Rao,

2008]:

1. It is assumed that the patient would want the intervention but is unable to consent or

consent cannot be obtained from the person authorized to consent for the patient.

2. It is assumed that the patient would not want the procedure; the physician may not initiate

treatment, but it is necessary a very well justified argumentation for this decision.


24

Who decides and how? The responsibility of a decision in an emergency case is transferred on

the family (delegated consent: legal guardian, etc.); if the time does not permit or there are no

relatives or they are unreachable, the physician will act in emergency procedure, applying a

treatment dictated by the necessity to save a life, based on implied consent (presumed or

deduced, considered in the situation where, in the absence or lack of a prior volition

manifestation of the patient, through which refusal towards a procedure was expressed,

consent is implied). For medical practice, the possibility of an existing prior consent granted

by an individual must be taken into consideration for those situations where the individual

may need surgical interventions. Therefore, previously expressed desires regarding a medical

intervention of a patient unable to express them at the time of the intervention will be taken

into account. It is worth mentioning the principle of necessity as defence form adequate for

any lawsuit for therapeutic procedures lacking consent, in the case of an unconscious patient

with no known objection to treatment. In these situations, the physician must not expand

therapeutic approach beyond the procedure required by the situation.

B. Informed consent for underage individuals

The underage individual DOES NOT have the ability to consent to the performance of

a procedure with the purpose to establish diagnosis or treatment, since the underage

individual has a restrained exertion ability (the capacity of an individual to exert his rights and

to assume obligations on his/her own), does not have a proper perception and representation

of his actions and their consequences and requires consent from parents. Consequently,

intervention cannot be performed without authorization from his/her representative, of

another authority or of an individual designated by law. In current medical practice, as

standard of agreement for the wilfulness to take part in the medical act, informed consent of

the underage individual is required.

Regarded from the perspective of the principle of self-determination, consent of

underage individuals is not valid until the age of 14 years old; instead, the consent must be

granted by parents or legal guardians. From the age of 14 to 18 years old, consent is limited,

underage individual being to develop only specific administration acts.

From this rule, there are several exceptions, as follows:

Emergency, where contacting the family is mandatory; in case of failure, the intervention

is performed with the aim to save the life of the patient.

Therapeutic privilege; generally, does not apply to underage patients, and these receive

full information regarding all risks associated with the medical act.

Refusal of the parents to consent; the physician together with another colleague may ask

for the consent of the institution where he/she works, in order to act in the best medical

interest of the underage patient.

Underage patients who can prove their ability to understand their situation and

consequently have the right to consent to treatment, regardless of the position of the

parents. There are certain countries in Europe where underage patients may decide for the

medical act starting from 15 years old in Denmark and 16 years old in England, Hungary,

Scotland and Spain

Underage patients viewed as adults, emancipated or married underage patients, or who

are parents and may decide for their child, if there is no other legal guardian.

C. Informed consent for persons lacking the ability to consent

It is impossible to perform medical interventions on persons who lack the ability to

consent, unless these are for their direct benefit.

Context:

a) the inability to acknowledge and decide; the patient does not possess the ability to

understand risks and benefits of the medical intervention or by comparison with


25

alternate therapy, cannot agree to medical care and is unable to take an informed

decision;

b) serious mental disorder; the patient cannot be subjected without his/her consent to an

intervention aiming to treat this disorder unless the absence of such treatment entails

serious damages to his/her health status, under the restrictions provided by the law,

regarding procedures of supervision and control. Consent will be obtained from

family, and, mandatorily, from the management of the specific institution, which will

establish if the procedure to be performed is legal and to his/her benefit (13).

D. Informed consent for institutionalized patients, voluntarily or involuntarily,

must not be regarded as a similar situation with that of incompetent patients, since the patient

institutionalized involuntarily may be competent, may present discernment and, consequently,

may consent to necessary medical care.

E. Informed refusal, as the negative aspect of informed consent refers to the decision

to not accept or to refuse the therapeutic possibilities presented. As in the case of informed

agreement, informed refusal implies previous briefing of the patient prior to the performance

of any medical or surgical procedure which entails touching the patient’s body. Reasons for

informed refusal comprises frequently religious conviction, anxiety regarding procedural

risks and scepticism towards the success of the procedure.

The exception in the case of refusal is represented by the protection of interests for the

underage child, when there is no other adult who would adequately care for him/her.

1.2.1.10. Informed consent in research

Informed consent is one of the most important aspects in the ethics of research.

Regulations which delineate the necessity for informed consent were formulated in order to

protect human subjects participating in clinical research. The basic ethical principle regarding

the legitimacy of informed consent is the protection of the autonomy of human subjects, in the

sense that the welfare and interests of a subject participating in the clinical research must

always prevail upon interests and welfare of society [Gupta et al., 2012].

Studies on human subjects, coherently formulated and controlled, are essential for the

verification of hypotheses regarding disease mechanisms or treatment efficacy. However, not

all studies on human subjects are justifiable and useful. Towards this end, a series of coded

requirements were formulated, which, by their acquired value, promoted by ethical codes and

guidelines, comprises the rules for any scientific research involving human subjects. Thus, the

first international code, the Nuremberg Code (1949) places the emphasis on the role of

individual responsibility for moral choices in human experiments, responsibility transferred

onto institutional agencies for such choices, as it can be also observed from the Belmond

Report, elaborated in 1978, which makes references to three ethical principles fundamental

for the protection of human subjects included in research: respect for the individual,

benefaction and justice [Resea et al., 1978].

For the protection of human subjects participating in research studies, regulations

include the obligation of correct briefing, with sufficient information which would allow for

the obtainment of a true, wilful and correctly informed consent. Towards this end, the human

subjects participating in the research must receive information regarding: the purpose of the

study, the type of the study, whether experimental or non-experimental; the procedures

involved in the research study alternatives to participation; therapeutic alternatives; all

predictable and possible known risks as well as discomfort which may be perceived by the

subject, including not only possible physical lesions but also possible psychological, social

and economic prejudice; monitoring of the subject; treatments for adverse effects; benefits of

the research for the society and, possibly, individual benefits for the human subject

participating in the research; duration of the study; contact person data for answers to

questions or emergencies correlated with the study; a declaration which would stipulate that


26

participation is volunteer, with the mentioning that refusal to participate shall not lead to

consequences or loss of benefits that the subjects is entitled to; confidentiality of personal data

and of data obtained during the research; the right to retire from the research at any moment,

without any consequence.

As well as in medical practice, informed consent must be provided by every subject,

before he/she participates to the study. However, there are specific situations, emergency

research or therapeutic privilege, classified as exceptions from the general rule, where

briefing of the subject may be accordingly shortened, in part or completely. It is worth

mentioning that even in these conditions, the patients keep their right to refuse participation in

the study.

A. Medical emergency refers to those situations where the life of a patient is in

danger and requires emergency medical treatment. Thus, any delay in therapy, including the

time necessary to present information with the aim of obtaining informed consent may cause

potential harm to the patient, by endangering his/her life. This window of exception for

informed consent is applied only to a limited circle of studies which involve human subjects

requiring emergency care or interventions, who are unable to give consent or there are no

alternate mechanisms available for obtaining informed consent. The guidelines released by

the Food and Drug Administration (FDA) stipulate the exceptional situations regarding

informed consent for research studies classified as emergency research, with the following

mandatory requirements:

a) the emergency state of the human subjects puts their life in danger; human subjects require

an emergency intervention for a situation that puts their life in danger, while available

treatments are unconfirmed or unsatisfactory as therapeutic efficacy;

b) safety and efficacy of the intervention are supported by valid scientific evidence

c) obtaining informed consent is unavailable, since the subjects are not capable to

acknowledge and give consent, as a consequence of their health status;

d) the medical intervention must be performed before obtaining consent from the authorized

legal representative of the subject;

e) lack of a reasonable modality for the prospective identification of the individuals who

might become eligible for participation;

f) participation in the study provides a perspective of direct benefit for the subjects;

B. Therapeutic privilege, although a distinct context from the emergency situations,

where information presentation is based on its impossibility, it remains as an exception from

the general rule of obtaining informed consent. The therapeutic privilege remains restricted to

studies where there is grave damage to the welfare of the patient, a consequence of a suicidal

veridic behaviour, supported by expertise, personal experience of the research or other means.

This exception from informed consent cannot be applied to those situations where disclosure

of information will only lead to denial of medical care or non-acceptance of participation in a

research study that the physician or researcher deems benefice.

In the process of obtaining informed consent, all aspects previously described must be

provided to the participants to the study before their inclusion in the research. Informed

consent must be documented by written agreement, recorded in a special form designed for

the intended clinical research, dated and signed by the participants who fulfil the same

validity requirements mentioned for informed consent in the case of current clinical practice.

It is extremely important that the members of the research team recognize vulnerable patients,

with specific behaviour particularities or health problems and to ensure that when they give

their consent for the participation to the research, their decisions are fully competent and

voluntary.

Both in current medical practice and in clinical research, informed consent has the role

to protect the rights of the patient and of participants to the research. Consequently, it must be


27

clear, explanatory and reflect the confidence in the medical act as well as the conviction of the

best option competently selected after an appropriate briefing.

1.2.2. Correct briefing in the procedure of obtaining informed consent – ethical and legal

aspects

Informed consent, as guiding principle, is strictly correlated with modern professional

ethics. Regarded as basic guideline in various professional fields, informed consent became

an ethical prescription articulated within the evolving context of the medical act, resulting

from the moral interest towards the right of the patient for self-determination. Historically,

informed consent may be regarded as an indication for the development of the modern

attempts to code and institutionalize fundamental human rights. The concept of informed

consent is derived from the ethical principle of the autonomy of the patient, while as legal

doctrine, is based on a series of fundamental hypotheses of human rights [Selinger, 2009].

From the point of view of the freedom to decide, namely what should and should not happen

with one’s own body, informed consent highlights from the ethical perspective the fact that

the patient requires complete, accurate and pertinent information, which one must receive

before undergoing a medical procedure or surgical intervention. In a legal sense, freedom to

decide assumes that no individual has the right to constrain the patient to act in a certain way,

not even the physician, who must act only as a facilitator in the decisional process of the

patient [Tita et al.].

The current topic will approach informed consent focusing on the correct briefing of the

patient, within a presentation framework for the ethical and legal significations of the

expression. Moreover, we will point out the manner in which the importance of correct

briefing is reflected by internal and international legal acts and if requirements for correct

briefing within the procedure of obtaining informed consent correspond to the ethical and

professional standard of the medical act.

1.2.2.1. Correct briefing reflected in legal normative acts

The defining terms for correct briefing within the informed consent procedure are

coming from the wide framework provided by various linguistic, medical and legal sources.

The theme of correct briefing as structural component of the informed content was discussed

institutionally in documents reported at national and international ethical and legal

orientations regarding the implications of the concept in the safety requirements of the

medical act, whose violation represents medical malpractice. Thus, a series of normative legal

acts discuss the role that correct briefing holds within the procedure of obtaining informed

consent for medical procedures. The Constitution of Romania, in article 31 from Chapter II

dedicated to Fundamental freedoms and rights makes a referral to the Right to be informed, as

follows [României, 2003]:

(1) “The right of the individual to have access to any information of public interest

cannot be restricted”.

(2) “Public authorities, according to their competences, are obliged to ensure correct

briefing of the citizens on public matters and on personal interest issues”

(3) Mass information means, public and private, are obliged to ensure the correct

briefing of the public opinion”.

In the European Union, it is the European Chart of the Patients’ Rights that states for

ethical regulations. Chapter 3/14 of the Chart, dedicated to correct briefing, stipulates the

right of the patient to receive all information continuously and detailed, while the briefing of

the patient must be personalized and with direct access to accessible information. Table 1

presents aspects regarding correct briefing in the European Chart of the Patients’ Rights

[Mirgen, 2011].


28

Table 1. Correct briefing – European Chart of Patients’ Rights (selected aspects)

• The right to receive all information regarding his/her own health status, healthcare

services and how to use these, as well as everything scientific research and technologic

innovation may offer.

• The patient has the right to see his/her medical file, to copy, ask questions and correct

possible errors.

• An admitted patient has the right to continuous and detailed briefing, which can be also

guaranteed by a “guardian”.

• Every individual has the right to direct access to information on scientific and

pharmaceutical research and technologic innovation, either from public or private

resources, if they meet the criteria for correctness and transparency.

• Professional staff must perform a personalized briefing of the patient, specifically

adjusted to religious, ethnical and linguistic particularities.

• Accessible information entails removing bureaucratic obstacles, education of healthcare

providers and preparation and dissemination of informational materials.

A special regulation applied for cancer patients included in the European Bill of Cancer

Patients’ Rights stipulates in article 1: Every European patient has the right to receive

accurate information and to be proactively involved in his/her own care. The declaration also

includes the rights and strategies of correct briefing for cancer patients in Europe, displayed

in table 2. [Selejan-Gutan, 2004]

Medical deontology code of the Romanian College of Physicians, which represents a

regulation of professional nature for physicians, dedicates to prior and accurate briefing of

the individual article 14 in Chapter II, assigned to the Informed consent. Table 3 presents the

requirements of the correct briefing for the procedure of the informed consent, extracted from

the updated edition of the Medical Deontology Code of the Romanian College of Physicians

(Official Monitor no. 298, 7.5.2012).

Table 2. Correct briefing – European Bill of Cancer Patients’ Rights

(selected aspects)

The bill includes rights and correct briefing strategies for European citizens

diagnosed with cancer

European citizens should benefit from:

1. Access to all information regarding one’s own health status and to proactively participate

in the decisional process regarding one’s own treatment.

2. Briefing strategies intended for the patients, which would explain clearly, in an accessible

form and language, the fact that they are entitled to an optimal standard of care in all

stages of the disease.

3. Information referring to the extent in which the unit or oncologic center where they are

admitted complies with quality standards regarding the degree of specialized care for

cancer patients.

4. Right to privacy and right of the patient to decide the degree of confidentiality of the

personal data.

5. Access to information available at the local, national and European level regarding

research and innovation activities relevant for their type of cancer.

6. Access to information regarding survival rates and post-treatment support services.


29

Table 3. Correct briefing – Medical Deontology Code of Romanian College of Physicians

(selected aspects)

• (1) The physician will solicit and receive consent only after the person in question or

the individual entitled to give consent regarding medical intervention received adequate

information regarding the purpose and nature of the intervention, as well as regarding

consequences and risks, either predictable or generally accepted by the medical society.

• (2) The physician shall aim that the briefing would be as adequate and personalized as

possible for each individual who will manifest consent.

1.2.2.2. Correct briefing of the patient – ethical and legal significations

A. Signification of the term correct briefing

Since “correct briefing” can be identified in an extremely diverse range of professional

fields, for the medical practice this expression requires term clarification on what briefing and

correct means and, above all, what is the sense, the function and the ethical and legal quality

that this association of terms, “correct briefing” emanates in the procedure of informed

consent. In theoretical language, correct briefing designates an interval of variables

corresponding to the representation of characteristics for terms “briefing” and “correct”

presented in table 4.

For the medical act, correct briefing and the significations attached to this expression

promote an ethical determinism which allows for the identification of the legal potential with

protective value for the informed consent from a double perspective, for the patient and for

the physician as well.

For the ethical sense of the expression „correct briefing” we highlight the terminology

variables adequate to the manner of representation of the medical act referring to:

Aspects that the patient deems important for the decision to accept or deny an

intervention.

Information the physician deems important,

Professional recommendations,

The purpose of informed consent,

Nature and limitations of consent as a form of legal authorization.

Table 4. Linguistic, ethical and legal significations for terms „briefing” and „correct” Term "briefing" Term "correct"

To give

information

on

something,

to make

known, to

notify, to put

up to date on

the basis of

information;

to document,

to gather

information

To take an

interest, to

initiate, to

clarify, to notify

Follows / corresponds

to the rules, norms in a

specific field, adequate,

true, exact, honest,

good, without error in

correlation with

morals, decent,

respects social

conveniences,

characterized by

respect for the

principles of social

morals.

Correct, honest,

equitable, ethical,

with a code of

conduct,

corresponding,

good education,

values, moral,

official, good

reputation,

scrupulous,

impeccable

behaviour, honest,

Correct ≠

erroneous, wrong,

incorrect

In accordance

with good

manners, decent,

good, honorable,

in accordance

with ethics,

respecting

professional

standards,

respecting the

law, respectable,

right, virtuous


30

Transition to legal signification of the expression is delineated by the nature and

limitations of consent as form of legal authorization, which classifies the correct briefing as

autonomous institution with rights and obligations. An example towards this end is ECHR

where solution of a cause in a “reasonable deadline” designates the expression reasonable

deadline as an autonomous institution, as it is stipulated by ECHR jurisprudence and by

European conventions.

Moreover, in the European Bill of Patients’ Rights “correct briefing” means both

related and reciprocal rights and obligations, correlated and specific to the position in which

the two subjects are placed (the physician and the patient) [Selejan-Gutan, 2004]. Towards

this end “correct briefing” develops a series of circumstances related to who has the

obligation to brief, the circumstances in which the briefing must be performed, the

relationship between the two partners (medical staff and patient), consequences of correct

briefing on the basis of the data provided by the patient who can give partial information.

Legally, correct briefing recognizes the necessity to be defined in measurable and operational

terms, such as it can be observed from the documents presented above.

B. How much information should the patient receive?

In practice, medical staff and especially physicians prefer the definition of the concept

of informed consent and of correct briefing to be as specific as possible, in order to be able to

accurately assess how much information should the patient actually receive.

In general, it is believed that the amount of information to be provided must: (a) cover

the professional obligation to offer the best care, (b) to ensure respect towards the patient as

individual, (c) to ensure the right of the patient to participate in healthcare decisions [Rao,

2008]. This approach regarding the correct briefing for current practice is too wide, since

physicians when faced with the preoccupation to provide sufficient information on a possible

intervention prefer more specific, measurable and operational approaches. The most frequent

aspects of informed consent encountered in daily practice refer to:

(1) Discussion of the patient role in the decisional process;

(2) Description of the clinical issue and of the suggested treatment;

(3) Discussion of alternatives to the suggested treatment (including option for no

treatment);

(4) Discussion of risks and benefits for the suggested treatment (and their comparison

with risks and benefits of alternative options);

(5) Discussion of correlated uncertain matters;

(6) Evaluation of comprehension of the patient towards the provided information;

(7) Preferences of the patient.

These aspects, viewed as basic characteristics for the informed consent create the

premises for the insurance and protection of the right to information in the provision of

medical assistance, which entails multiple aspects presented in table 5.


31

Table 5. Informed consent: protection of the right to information in the provision of

medical assistance

The right of the patients to be informed

• They have the right to be briefed on the services and therapeutic methods that they

require and the possibility of the hospital to offer them;

• The patients have the right to freely address medical assistance, according provisions

of the law;

• Patients have the right to know the identity, professional status and qualification of

those who provide healthcare services;

• Patients have the right to be briefed on the facilities available at the hospital for their

personal assistance, safety and comfort;

•Right to access medical information related to themselves through individuals in the

medical staff and through their discharge notice;

• The right to be briefed with respect to their health status, the suggested therapeutic

procedures, and the diagnosis and prognosis of the disease;

• Information is presented to the patient in a manner adequate to his capacity to

understand; in the case of foreign citizens, they have the right to receive information in an

official language, or through a translator, if they do not know any official language;

• Patients have the right to freely express their opinions regarding the care provided in

the hospital;

C. Correct briefing from the point of view of classic ethical and normative theories

From the point of view of ethical theories, correct briefing regards not only the purpose

of the informed consent but also the manner in which correct briefing is performed. Thus,

medical deontology stipulates that the manner in which a purpose is achieved is (often) more

important than what it is gained (the purpose). A reading of these requirements from the point

of view of the principle „primum non nocere” means to translate the weight centre from to

not cause damage (principle of do-no-harm), to prevent (principle of benefaction), which

consequently suggests promotion of the good through the perspective of benevolence as

ethical virtue. Conversely, in current practice, the issue of the available options for various

diagnostic procedures or therapies frequently creates conflict areas and ethical dilemmas with

respect to the manner in which a correct briefing is performed. It is important to point out the

ethical impact on the relationship between patient and physician, especially on the physician

who, when performing a correct briefing, must clarify if his/her actions are directed towards

the ethical principles of autonomy, dignity and respect of the individual.

Regarding the utilitarian ethics, correct briefing is concentrated on maximization of

benefit. “The greatest good for the highest number” makes from the utilitarianism of Jeremy

Bentham an ethical virtue which allows for the maximization of the collective utility of just,

intelligible and desirable institutions (regarding correct briefing as institution emanating rights

and obligations) [Cioară, 2012]. An example towards this end is reflected in the evaluation of

the health status of individuals afflicted by an inherent vulnerability (grave disease, cancer,

etc.) where utilitarian ethics celebrates a series of ethical virtues such as respect for human

dignity, increase of satisfaction level for those placed at a disadvantage, encouraging altruism

and solidarity, protection of personal priority area, and fulfilling a life plan. However, in

current practice, it is necessary to reach the correct balance between deontology and

utilitarianism, which would perform the transition from the impartial acknowledgment of

these ethical virtues to the indication of the manner for their application.


32

1.2.2.3. Correct briefing between standard of medical practice and ethical standard of

informed consent

Definition of key aspects in the information which must be presented to the patients

may contribute to improving the practice regarding the procedure of obtaining informed

consent. However, it is difficult to establish strict rules referring to a specific standard for the

adequate presentation of pertinent information, taking into account the diversity and

complexity of clinical cases. In current practice, correct briefing recognizes that the provided

information should be adjusted to the specific needs of the patient, taking into consideration

their convictions about health and their cultural background. In the ethical interpretation,

medical practice standards are based on everything that the physician must do from the point

of view of what is of value, right and just. Therefore, the professional standard suggests that

the physician should establish what usually and adequately may be disclosed to the patient, as

well as the type and amount of information to be communicated. Such an approach could be

regarded as the best ethical standard of correct briefing. However, exclusive reference to this

standard is insufficient since many patients do not know which information could be relevant

for their decision [Codul de Deontologie Medicală, 2005]. Consequently, the physicians have

the responsibility to provide the information believed to be essential from the professional

perspective and to ensure that the decisions of the patients are not based on false convictions.

It is worth emphasizing the fact that even when patients believe that they were briefed

satisfactorily this does not represent a guarantee that they know which are the fundamental

aspects regarding the option of investigation for the precise establishment of the diagnosis,

which is the most efficient treatment or which are the benefits and risks of a study. According

to the ethical standard, the main objection to correct briefing for a standard procedure is that

it undermines the right to autonomous choice. The explanation is that a standard for

professional practice is designed for medical decisions, while the decision of accepting or

denying the medical care act belong to the patients. The alternative through which the

standard allows for the protection of therapeutic privilege, providing the physician with the

possibility to select and present the information they believe to be relevant or useful and

refrain from the aspects they assess as stressful or confusing is not spared from criticism.

Nevertheless, it is considered that refraining from providing information may undermine the

autonomy of the patients, in the case where physicians know or have reason to believe they

desire such information. As ethical and legal norm, the standard of correct briefing influences

the procedure of informed consent by excessive use of the subjective standard, namely

communication with specific details corresponding to the needs of the patients. But detailed

information according to the standard does not serve neither law or ethics, since patients do

not know which information could be adequate for their health issues (due to their level of

medical education) and they do not expect the physician to evaluate the personality of each

individual in order to select the adequate information. However, from the moral point of view,

the subjective standard is justified as the only standard which recognizes the individuals’ need

for information. Consequently, in order to fulfill the moral requirements of the medical act,

the professionals and the institutions should not limit themselves to a signed consent form

with the exception of the case where it was specifically designed for a certain investigation.

Conversely, patients need open communication, time, compassion and understanding.

Hence, based on the standard, correct briefing and quality of information will be assessed

from the point of view of a patient where dignity and self-respect prevail. For a patient, the

standard of care is valued as general or specific medical or psychological treatment

guidelines. A few common examples include:

Standards of health care and treatment applied in public hospitals through which

it is ensured that all patients benefit from adequate care, regardless of financial

means (insurance, co-insurance, emergency etc.)


33

The diagnosis and treatment procedures which a physician should perform for a

specific category of patients, disease or clinical circumstance signifies (in terms

of professional ethics and of the law) the level to which a regular, prudent

professional, with the same training and experience may practice with the same

good results in similar circumstances.

A physician has the duty to brief the patient on significant risks or fiduciary

interests if a prejudice is determined by confidential risk. The patient may prove

that the procedure is performed without benefitting from information

(fundamental rule of the informed consent). Full disclosure of all significant

treatment risks must be achieved if this aspect influences treatment.

A beneficiary of free medical services has the right to the same standard of care

as an individual who pays for the same medical services (as a modality to

prevent providing sub-standard medical care to an individual with limited

financial capacity).

In case of medical malpractice, the plaintiff (patient) must prove that the

adequate standard of care was violated.

Conclusions

It is thus essential to perform a correct briefing regarding basic bioethical principles

(autonomy, benefaction, do-no-harm, and justice), professional and international declarations

(European Bill of Patients’ Rights, European Bill of Cancer Patients’ Rights, Hippocrates’

Oath, Declaration of Helsinki) and juridical aspects specific for each country. Informed

consent must broaden up its definition, so as correct briefing, representing the communication

through dialogue process, would favour the individual optimal circumstances required to

decide if a medical act with impact on the patient’s body, intimacy or other vital situations

should be performed or not.


34

1.3. ETHICAL, LEGAL AND SOCIAL ASPECTS REGARDING MEDICAL

LIABILITY

1.3.1. Social impact of digestive diseases from the ethical perspective

Social, economic and political context is influencing the ethical perspective on the

digestive diseases. Most digestive disorders are being present at high rate in the general

population and will involve high costs due to complex treatment or extended/repeated

admission times. Digestive diseases represent one of the main public health issues, involving

top medical and social responsibility. The implications and social projection of the digestive

diseases might include [Ivan, 2002]:

Descriptive epidemiology, synchronized with developments regarding geographic

distribution, clinical monitoring and chronological evolution of digestive disease, with

morbidity and mortality indicators for chronic liver disease (B and C virus chronic

hepatitis, liver cirrhosis, and liver cancer), disorders of the digestive tract (gastro-duodenal

ulcer, intestinal inflammatory disease, colon polyps and cancer), pancreatic pathology

(acute and chronic pancreatitis and pancreatic cancer);

The financial component involves directly and indirectly the social component in the

equation of digestive diseases, both with respect to disease causality, evolution and

prognosis, as well as to the impact noticeable at the social level [Kabene et al., 2006];

Public health issues of digestive diseases according to the WHO definition (science and

art of disease prevention, prolongation of life and health promotion through organized

efforts of the society) [Robine et al., 2004].

Digestive diseases have evolved fast and developed all over the world, due to a more

intense people migration. Epidemiology data recorder in the last decades pointed that

digestive diseases still represent a major health issue, disregarding the population type,

educational/social status or geographical area. It is important to know that digestive disease

inducing factors can also involve food, chronic alcohol consumption, hygiene, and stress – all

of them with a broad spectrum of social involvement. Analytical studies and descriptive

epidemiology recordings emphasized the important role played by the social-related inducing

factors in developing digestive diseases in general population

Digestive pathology is complex no matter which population it is addressing. Thus, the

specific digestive pathology requires deep approaches and investigation, sometimes extended

beyond medical theory and practice. The social aspect of the digestive diseases is essential to

define a unique, integrated perspective about these diseases impact on the entire society.

Ethical aspects in this area create the cement for binding scientific and social data.

Social echoes of the digestive diseases add value on the delicate process of defining the

main meaning of the digestive disease. On top of this, ethics add value to the individual

Toader E, Balan GG, Iliescu DB, Perju-Dumbrava D. Ethical and legal medicine

aspects related to hepatic encephalopathy. Romanian Journal of Legal Medicine. 2017

Apr 1;25(1):125-7.

Balan GG, Olteanu A., Toader E, To treat or not to treat minimal hepatic

encephalopathy? Ethical dilemmas and liability issues. Filodiritto Editore - Proceedings

Toader E, Social impact of digestive diseases from the ethical perspective

In New concepts in gastroenterology and hepatology intensive course pg. 395-400.

Editura "Gr.T.Popa", U.M.F. Iaşi, 2016


35

health-disease concept, expanding it and inducing the uttermost request for quality and safety

during medical act. The final output of this ethical-aspects improved medical act regarding

digestive diseases is emphasizing the general right to health, at highest standards.

Regarding the aforementioned principles, ethical aspects present in the digestive

diseases panel, and surpassing the standards for clinical practice, claim for a unified approach

of the ethical values and principles together with social moral normative.

How can we define the ethical aspects generated by the social impact of the digestive

diseases?

Considering the perspective of the professional experience, I am introducing here ten

aspects, which are definitely important for the aforementioned relationship between social

impact and digestive diseases. I emphasize the ethical aspects of various digestive diseases

and present them as a common support to the involved actors (patient, medical staff,

healthcare system etc.).

1) Patients’ choice represent the first and significant issue through which digestive

disease generates social impact. In practice, regulations and in academical debates, patients’

preferences impose themselves as a requirement of the contemporary medical act, performed

in safety conditions and to the highest quality standard. These aspects correspond in the

ethical agenda with the involvement of an autonomous patient in the decisional acct. in

current practice, patients’ preferences are nuanced and classified on patient categories. We

can therefore discuss about patients who prefer, solicit and even identify themselves with the

physicians’ recommendations, an option known in the ethical language as paternalism [Dong,

2011]. In the comparisons between solicited and justified paternalism we can identify a joint

component represented by the offset between the level of education of the patient and medical

progress. On the basis of considerations related to the juridical signification of the medical

and social impact, the distinction worth underlining is to what extent can a physician justify

solicited paternalism as the best choice for the patient. Continuing with the ethical highlights,

conceptual developments on paternalism do not assimilate the term of solicited paternalism

and consequently cannot retain the responsibility of the patient. Frequently encountered

expressions in current medical practice such as “do what is best for me” – the ethical nuance

of benefaction, “doctor, you know what is best for me” – the medical professional

responsibility nuance, in ethical as well as juridical reading represent a form of abdication

from the role and involvement of the patient in the process of making decisions or, as an

alternative, delegation of an individual to decide for oneself.

At another level of analysis, the ethical perspective of patients’ preferences invokes

social impact aspects related to the subjective standard, to the adjustment and development of

the physician-patient relationship, to the involvement of the patient in the decisional act

together with the physician, choosing together what is best for the individual in sufferance.

2) Continuation of healthcare provision is related to the necessity of integrated

systems, orientated towards the needs of the individual as well as of the community [Afrite et

al., 2009]. Requirements imposed on these systems are insurance of continuing healthcare

provision at home, doubled as insurance of quality of medical services at standard level. In

Romanian society, the integrated medical care systems are very low represented, while those

represented are poor, developed in a linear manner, on the axis of the medical units such as

hospital, ambulatory, home care [României, 2006]. It is noteworthy that the integrated

systems relate themselves to two weight centres, represented by the institutional and social

slope. From the institutional point of view, medical services through which continuation of

care is ensured have simplistic and insufficient institutional representation which, instead of

bringing the two components together for the insurance of continuity of healthcare

(institutions and society), they bring them further apart, creating hiatus between hospital and

home. According to the ECOG performance status, homecare reimbursed by the Healthcare


36

insurance fund are listed and limited as number and duration (90 days), while involvement of

112 system (emergency, ambulance), Health Insurance Fund and medical non-governmental

organizations are insufficient for continuation of providing health care beyond the hospital

institution, in accordance with standard requirements of safety and quality for the medical act.

3) Vulnerability, this ethical concept attributed almost exclusively to the patient is best

exemplified through the perspective of the elderly patient, the social case or the patient alone,

diagnosed with a digestive disorder [Toader et al., 2013]. These patients, besides their

medical issues bring with them their own social issues, while in the circumstances where

medical assistance in Romania is preponderantly hospital based, in such situations the

hospital becomes a new home. The best choice for the patient in these cases includes aspects

of social assistance, which bring us back to the previous theme, referring to insurance of

continuation of healthcare provision at home, in quality and safety conditions. The home of

the patient who lives alone, of the social case or the elderly patient can clearly display the

hardships, needs and, above all, the helplessness of these patients in front of the disease, a

condition which amplifies the vulnerability generated by disease.

4) The patient in terminal stages (diagnosed with chronic digestive diseases, such as

liver cirrhosis) raises complex and extremely important issues referring to the manner in

which we define the terminally ill patient and, above all, what is the procedure in medical

practice for the approach with such a terminal case. Therefore, the most frequent issues in

current practice are represented by the interrogations on the definition framework of this type

of patient, the role and signification of personal experience and the solicitations and

preferences of the patient and associated family [Takemura, 2009].

Equally problematic are situations where we do not know how and if we should let the

patient know that he/she is in terminal stage (a right of the patient, but also an obligation of

the physician to help the patient acknowledge his/her health status, or invocation of

therapeutic privilege in refraining from communication of information with negative impact),

if we are to recommend continuation of hospitalization with maximal therapeutic protocol or

for homecare, if we initiate resuscitation or if we approach this subject with the patient or

his/her family. All these aspects maximize the responsibility of the medical staff who, besides

the complexity and gravity of the case, are confronted with ethical and medical dilemmas

doubled by anxiety towards possible malpractice accusations.

5) Religious orientation of the patients imposed itself in the public space through wide

media coverage regarding denial of blood transfusions within the religious community called

Jehovah’s witnesses. Legal considerations, regulated by Law of religious cults 489/2006,

which stipulates denial of blood transfusion for the members of the community with this

religious orientation are less known in the public space [Dură, 2010]. The values assumed by

the community generate at the juxtaposition with a medical case conflicts and ethical

dilemmas regarding the competition between sacredness of life versus dignity and respect for

the individual. As physician, one does not know the best way to act, or how security of the

medical act can be insured, or how the fundamental right to life could be protected. At the

social level, such a case generates violent reactions of disapproval and denial, polarizing

opinions and points of view which are not always unitary. For the same ethical and, above all,

legal considerations (Law 489/2006) we must mention the high number of scientific

arguments and proof brought by this specific religious community as solutions for the

situations where blood transfusions are required (e.g. existence of therapeutic methods which

may substitute blood transfusions, as well as special devices, aspect which entail the

obligation of the medical units to insure them). In the case of digestive diseases, the

gastroenterologist, confronted daily with digestive bleeding, if faced with a patient who is a

member of this community, requiring a blood transfusion and in a serious state, knowing that

the religion prohibits the procedure – is confronted with a double dilemma, since besides the


37

medical gravity of the situation, the physician has to choose between respecting the decision

of the patient or to intervene therapeutically on grounds of emergency. Ethical dilemmas

(what is best? Competition between saving a life and respecting human dignity), professional

responsibility and fear for malpractice accusation are a series of considerations which, on the

basis of Law 489/2006, entail a transfer of institutional responsibility, assumed at the

managerial level with the aim of insuring the security of the medical act, as well as protection

of medical staff. If the medical unit has the technical equipment for such cases and if

conditions for the care of such patient are insured are but a few considerations envisioned in

legal procedures concentrated on the evaluation of the manner in which all measures for the

salvation of a life were undertaken. As a reflection of medical practice, ethics opens the

subject with the interrogations on whether the physician constantly asks what is the patients’

religion, if the religion is recorded in the observation chart of the patient and is not left just as

a line to fill in the death certificate.

6) Refusal of the patient to be consulted by an opposite sex physician represents a

preference or conviction of the patient ethically justified on the basis of personal values or

generated by one’s own religious convictions [Friedrichs et al., 2016]. In the contemporary

context of globalization and cultural intersections, the refusal of the patient to be consulted by

an opposite sex physician could become for the Romanian society a new medical challenge

with social impact. The question whether we are prepared concentrates on ethical and social

aspects of dignity and respect for the individual, maintained for the category of digestive

diseases, where there exists a potential of exposure to a possible refusal of the patient to be

consulted by an opposite sex physician. It is the case of digestive exploration such as rectal

examination, care for a comatose patient, bladder catheterization, etc. deemed as equivalent

with recognized and respected situations in the traditions of the Muslim culture, where a

pregnant woman will accept only to be viewed by a female doctor.

7) Liver transplant, raises a series of issues for the Romanian society, which defines

this issue by many expectations, questions and answers. It is worth mentioning that medical

and technical accumulations on liver transplant allowed for the development of a dictionary

that includes paradoxically a restrictive social vocabulary, limited to chance, hope or miracle,

but with social signification and ethical values specific for this subject [Donckier et al., 2014].

For most physicians, this subject remains one of mostly theoretical nature, frequently included

in the agenda of scientific communications and less of the practical debate and public space

nature, in a context where the background of the medical practice of the liver transplant is

ruled by questions which escalade towards the social space such as long waiting lists and

donor issues. Moreover, there are several questions to be acknowledged and waiting for an

answer, such as: How many of the physicians and how many of the patients ask the physician

about a transplant? How frequently is a transplant considered at the physician’s

recommendation or solicited by the patient (whether justified or not)? How many patients are

there on the transplant list? How many patients benefited from the transplant? How do you

brief the patient on risks of the procedure, including death or recurrence of disease?

8) Chronic hepatitis (the case of hepatitis C) is a major public health issue and immense

social expectations [Manos et al., 2013]. At the social level we speak about n% patients

diagnosed with C hepatitis and probably as many undiagnosed. Many of these may be found

in the therapeutic retrospective specific for the Romanian environment, with distinctions for

the optimism in the ‘80s and immunosuppressant therapy (prednisone and imunan), the hope

of the ‘90s and antiviral interferon therapy, and the chance for healing beginning with 2015,

together with the introduction of the oral antiviral therapy, excluding interferon. Until

hepatitis C will pass the test of time for the validation and consolidation of the therapeutic

efficacy, this disease remains a great social issue, with financial and human lives costs,


38

statistically superposed with the ones recorded for liver cancer and cirrhosis, digestive

bleeding, diagnostic investigations at immune-genetic level, monitorization etc.

9) The Romani community concentrates our attention on the fact that Romani people

are human and they can become ill and be patients. However, at the juxtaposition with a

medical event it can be noted that Romani people are different. Circumscribed to the limits of

the values specific for this ethnic minority, the Romani community frequently generates in the

medical context conflicts and ethical dilemmas [Marin et al., 2012]. Developments occur

around the vulnerability aspect, where the paternity attributed to the patient is transferred

towards the medical staff, blamed and attacked from fear of avoiding discrimination and to

insure respect for the individual as patient, regardless of the ethnical minority, religious

convictions, etc.

10) Financial resources for digestive disease care. Approach of financial costs for

digestive disease care as a theme of numbers must be extended to an exhaustive reading

towards ethical and social significations that these numbers represent. For most societies,

digestive diseases represent a financial burden. In an example taken from American statistics,

most costs are recorded for the diagnostic procedures performed in ambulatory for

gastroesophageal reflux, chronic constipation, abdominal wall hernia, haemorrhoids,

diverticulitis and irritable colon syndrome. In the series of examples, we can also mention

hospitalizations for gastroesophageal reflux, diverticular diseases, liver diseases, constipation,

gallbladder stones and ulcer disease, as well as surgical interventions for liver disease, ulcer

and gallbladder stones [Peery et al., 2012]. It is worth mentioning that mortality by digestive

diseases represent 9.8% from the total of deaths, namely 236,000 deaths in 2004, according to

American statistics.

Selection of these aspects and the succinct presentation of the thematic characteristics

which bear the ethical imprint of the social impact of digestive diseases is the result of

participative observation facilitated by our professional experience as physician with over two

decades of direct contact with this pathology. Expansion of the approach of the digestive

issues from the theoretical and practical framework towards other components, such as the

social one raises the question as to which is the correct direction of exploration for this

relationship between digestive diseases and society. In our opinion, it is an ethical reflection

matter whether we choose to remain anchored to the involvement o the social factors as

causes for certain digestive diseases or if we will direct our attention on the manner in which

digestive diseases create an impact in society, and, obviously, what is its dimension. The

importance of exploring the relationship between digestive diseases and society from the

point of view of impact could also be enriched by strategies of optimization or neutralization

of the social impact, in accordance with quantitative and, above all, qualitative significations

(whether positive or negative).

1.3.2. Medical responsibility as moral and ethical foundation for the professional

conduit

From the point of view of professional responsibility, the key aspects of medical

professional responsibility (represented by competence, conscientiousness, prudence and

devotion competence) is a mandatory request for all members of medical community.

Consequently, efforts are necessary to ensure the availability of adequate mechanisms for the

achievement of this objective, taking into consideration that competence in medicine becomes

a type of honesty (doctors must be responsible for the update of their medical knowledge and

clinical abilities necessary in order to be able to provide quality healthcare). At its turn,

Toader E, Damir D., Medical responsibility as moral and ethical foundation for the

professional conduit. Procedia-Social and Behavioral Sciences. 2014 Sep 5;149:955-61.


39

honesty is the commitment towards professional competence, through which trust is bestowed

in the relationship with the patient and value is returned to the professional role, by the

correlations between information and knowledge. The role and significance of competence

result both from the positive meaning, focused on professional accomplishment, but also from

the negative meaning, that of incompetence. By its major effects mostly in emergency

situations, incompetence becomes evident every time the doctor is not adequately informed,

oversteps his competence or refuses to do what is necessary for the wellbeing of the patient.

1.3.2.1. Competence and professional responsibility

The ethical values engaged in correlation with competence and professional

responsibility make reference to a series of aspects:

The standards for medical practice, in the ethical interpretation, are founded on the

basis of everything the doctor should do with regard to what is valuable, good and just [din

România, 2008]. In clinical practice, these standards engage various and controversial points

of view in relation with the safety and quality of the medical act. From the point of view of

the right to practice certain medical procedures, the medical standard generates conflict zones

and ethical dilemmas, while the freedom of choice over the type of medical procedure

preferred makes a reference to the manner of understanding, acceptance and application of the

new as a foundation of Evidence-Based Medicine (EBM) [Upshur, 2013]. EBM comes with a

series of remarks from which we notice the modality of perception of the concept (the new in

medical practice) and moreover, the manner in which the two partners (doctors and patients)

commit for the achievement of EBM in creating opportunities and opening a path for the

global progress [Kruger, 2010]. At the same time, medicine is based also on ethical values,

and a balanced combination between evidence and values remains an objective difficult to

reach, if we take into consideration the mandatory ethical requirements regarding moral and

physical integrity and the do-no-harm principle [Wohlgemut et al., 2013]. This way, bioethics

tries to establish the correctness or incorrectness of certain actions involved in healthcare

focused on the antithesis between risks and benefits, do-no-harm vs deontology, utilitarianism

vs respect and dignity of the individual. The ethical analysis concerning the standards for

medical practice is performed concomitantly with the differentiation between the point of

view of the patient, who relates himself to the professional competences of the medical staff,

and that of the doctor, who relates himself to the point of view of the standards for medical

practice. The translation of these opinions in medical practice allowed for the focus and

exploration of the areas for ethical intervention, aiming to ensure and guarantee the right to

health, with the commitment to turn to advantage the ethical dimensions associated with the

development of medical competences, but also with guarantees for safe and quality healthcare

[UE et al., 2003].

Performance The synthesis care-integrity-compassion-confidentiality, as attributes

associated to competence, redefine performance in terms that emphasize the competence to

become informed and qualified in the evaluation and assuming of risks. As ethical principles,

the risk vs benefits articulate, by a sum of moral and deontologic attitudes, professional

competence to the ability of the doctor to do what is best for the patient. In order to perform

and recommend high performance interventions, doctors need opportunities that allow them

to be active and assume risks in safer circumstances [României]. However, in medical

practice, the requirements for the personal development of the doctor become limited when

the professional environment does not provide learning conditions. This is the reason why the

confidence of the doctor that he can manage successfully certain risks encourages in a

positive way the approach of a superior professional level, which, once “conquered”, helps

him to increase his self-esteem and self-conscience. Thus, the synthesis risk-control-

confidence-competence redefines performance, which, through ethical validation from the

point of view of sense and significance, becomes definitory for the professional responsibility.


40

Informed consent, according to the ethical model, must be clear, enlightening and

comprehensible for the patient [Thompson, 2006]. In practical application, one of the most

important debates on informed consent is related to the influence of the recommendation of

the doctor regarding the options of patients for treatment, as well the discouragement of

therapeutic options without medical recommendation. It is desirable to be cautious and to

increase the responsibility of the doctor to recognize the strong influences in the decisions of

the patient, with the obligation not to manifest personal interests and to respect the objectivity

of clinical recommendations. The ethical analysis of this context brings an emphasis on the

differentiation in interpretation for the utilitarianist attitude, which aims for the maximum

good, as opposed to the deontological approach, which focuses on the means for reaching the

maximum good [Moye et al., 2007].

Communication This bioethical concept comes into conflict with the belief that health is

maintained and re-established only through positive language, for it has the power to form

and control future events. In clinical application, communication, including the presentation

of therapy risks, is deemed as a negative approach for certain patients and their family

members, a breach of traditional values and, by default, of medical practice. Moreover,

communication could change a situation, improving or worsening it, could influence quality

of life or create situation full of dilemmas when the patient is confronted with the diagnosis of

a serious disease with unfavourable prognosis. Bad news, how bad could they be? So bad that

it could influence the comprehension of information, the level of optimism, the satisfaction

regarding received healthcare and invariable psychologic damage that requires qualified help.

The word has power, such as it is proven by the communication in the field of oncologic

disease through SPIKES protocol, which expresses the invaluable dimension of word

regarding the psychological and social aspects of the patient, with the usage of a series of

measures based on survival (time, as essential element), perception (what the patient already

knows), information (what the patient wants to know), knowledge (information transmission),

care for emotions (empathic response) and cooperation (working together in times of

necessity) [Grinberg, 2010].

Deontology vs utilitarianism. In medical practice, the manner in which we investigate a

patient, how long we investigate and especially who do we investigate, as well the choice for

a specific therapy orientation often generates ethical dilemmas, which centre on the conflict

between justice and equity vs utilitarianism. The impact is significant both for patients as well

as for doctors, who have to be clear about the manner in which their decisions and actions

converge towards the essence of ethical principles of autonomy, dignity and respect for the

individual [Gray, 2013]. It is obvious that such an approach, subjected to an ethical analysis,

turns to deontology, which states that the modality to achieve a goal is often more important

than what it is gained. The obligation is to respect the ethical demand to prevent or to get rid

of the bad (do-no-harm principle) and to promote the good (principle of benefaction). This

does not mean that we can dissociate the goal from the means, even if the result is one that

maximizes the well-being of the patient, without taking into account the risks or

counterindications, which, in some cases, overstep the benefits. The conceptualization, on the

basis of win-win principle, of the therapeutic objectives in chronic diseases represents, from

the perspective of the winner, deontological equilibrium between the best decision of the

doctor (for a specific therapeutic protocol) which offers the best chance (for the complete

cure) to the patient [Gardiner, 2003].

Medical error and mistake from the perspective of their effect are based on aspects

related to professional behaviour. Error represents a false representation of reality, which can

be taken into consideration when the element regarding the portion in error had a determining

role for the medical act. In reality, errors, by the dimension of their medical, social and

economic impact, go beyond the field of ethical and moral significations, as it results from the


41

analysis of the information provided by medical institutions. A few examples from the

computerized models in hospitals reveal the consequences of medical errors, i.e. adverse

effects of medication (28%), temporary work incapacity (18%), impressive costs associated

with negative results of medication, estimated to 76.6 billion $, which is the equivalent of the

costs for the care of patients with diabetes mellitus [Donaldson, 2008].

Malpractice synthesizes medical responsibility towards the prejudice inflicted to the

patient by his actions. We must highlight the ethical significations attached to the term of

prejudice: risks, injury, vulnerability, discrimination, dignity of the individual, equality and

equity, identified when an incorrect medical act, a real and definite prejudice, and a causality

relationship between the action or inaction of the doctor and the prejudice of the patient are

produced. Frequent situations which can be regarded as malpractice cases involve

professional negligence in the performance of a medical act with diagnosis or therapeutic

purpose, error, lack of prudency, insufficient medical knowledge, dissatisfaction of the

patient, who feels ignored when doctors are exceedingly preoccupied with strictly medical

aspects [Benner et al., 2008].

1.3.2.2. Conscientiousness

Conscientiousness is another requirement for a behaviour responsible towards

professional obligations.

Doctor-patient relationship. The ethical values that arise from conscientiousness are

centred on the doctor-patient relationship, built on the basis of respect for human dignity,

understanding and compassion for suffering. Thus, from the paternalist attitudes, accepted in

the interest and for the well-being of the patient, until deliberate empathic and altruist actions,

the relationship doctor-patient must be one with a powerful ethical content and deep moral

background. The aim is to preserve the balance that enables the avoidance of dominance or

power excesses. In medical practice, the most competent doctors make as many mistakes,

with effects equally as important and severe as the incompetent doctors, if they are not

conscious about their obligations (e.g. they do not fully examine the patient, do not have the

patience for a complete history etc.). This is the reason for which the doctor has the

responsibility to classify the different realities in accordance with theories, practices,

prejudices, values and convictions, while the patient, under the influence of the healthcare

system and in agreement with the ethical norms, takes part in the medical decisions [Chaytor

et al., 2012].

Consent highlights, with respect to conscientiousness, the significance of the

information element and of the communication manner practiced by the doctor, in order for

the patient to be able to express his will freely and unconditionally. In the interpretation of the

law, the terms free and unconditioned are deemed as causes for invalidation of consent. An

example in this sense is psychic violence, as a state of fear induced to individual by the

exertion of an act of power, or acts of threat or intimidation (WHO) [Goodin, 1986]. By the

inclusion of the term of power, the conventional nature of the definition is broadened by the

underlining of the acts resulted from the negligence and the omission acts encountered in the

study of the phenomenon of violence against the elderly.

Vulnerability For the medical act, vulnerability and the significations attached to it

promote an ethical determinism and recognize the necessity to be defined in measurable and

operational terms. The ethical essence of the concept is given by autonomy, do-no-harm,

benefaction and justice, principles that give signification to this term for different social

categories and healthcare systems, to which the medical act relates. Vulnerability expresses a

commitment to morality, which in the medical act leads to the logical action of care, solidarity

and responsibility. In the European approach, the ethical contents of vulnerability leans

towards biolaw, justified by the interpretation of the concept together with the principles of

autonomy, dignity and integrity [Rheeder, 2016]. Vulnerability, by stigmatization and


42

marginalization, has an impact on the health status, its precarity, in many cases, being the

consequence of public policies and practices without just cause. This is the reason why the

active intervention of bioethics is necessary in order to guarantee the respect of human dignity

for vulnerable individuals, both in healthcare but also in research and mostly health policies.

In this large context of the medical act, the effort to protect vulnerable patients, who do not

have the ability to make informed choices, could be deemed as paternalist, and the autonomy

risks to become a principle with totalitarian attitude [Schramm, 2011].

Equity in healthcare, as ethical concept, is based on the principle of distributive justice

(the distribution of resources in order to equalize health results), which ensures equal chances

to be healthy for all population groups, including less-favored ones [Carse, 1991]. This

conceptualization comes with a sum of equalities that summarize, through “health for all”, the

identical access to healthcare services, resources spent equally for each individual or for each

case with a certain condition, the right to benefit from care according to needs and with the

same quality of healthcare. From the perspective of utilitarianist ethics, equity in health

represent a modality to celebrate the respect for human dignity, which, at the level of health

policies becomes a nuance of sufficientarism, a support for professional human, financial,

logistic resources, etc. for a decent minimum of medical care deemed as sufficient, i.e. a

minimum pack of medical services and cautious health insurance [Pantilat, 2008] .

1.3.2.3. Caution

Caution is another requirement of the professional behaviour, with a prophylactic role

which updates, in the age of medical technology, the principle “primum non nocere deinde

salutare”. Ethical values, as principles, are correlated with risks and benefits.

Do no harm principle means to “not hurt”, because evil is a simple thing and has

infinite shapes (Blaise Pascal). In medicine, the aim is to promote the well-being of patients

by those that have competence and knowledge, with the obligation to prevent and eliminate

evil, to evaluate and balance possible benefits against possible risks, to protect and defend the

rights of other individuals, to save the persons in danger and to help those with disabilities. In

medical practice, the pertinent ethical issue is whether the benefits surpass negative effects,

for many procedures, interventions and medication are (sometimes) more harmful than

benefice. It is a context where do no harm postulates that risks must be understood in the light

of potential benefits (e.g. stopping a medicine which is proven to be harmful or the refusal to

give a treatment whose efficiency is not fully proven).

Confidentiality derives from the special relationship created when a patient requests

care, treatment and/or medical advice. Confidentiality is based on the general principle

according to which individuals that require medical assistance should not be afraid that their

medical issues or conditions will be revealed to others. According to the obligation for

confidentiality, doctors cannot disclose any medical information on their patients without

their consent, and this obligation continues even after the patients are not treated by these

doctors. Although the respect for confidentiality and autonomy represents the basis for

doctor-patient relationship, confidentiality is neither absolute nor universal [Toader et al.,

2014]. However, in medicine, confidentiality is not fully outlined, and consequently, is a

concept which must be particularized for each case.

1.3.2.4. Devotion

Devotion of the doctor towards his professional obligations is another requirement of

professional responsibility. Devotion is best appreciated by the patient and is the attitude that

obligates to always put the interests of the patient before the reputation of the doctor. We

must take into consideration that the individual (patient) “goes into the disease” with a certain

kind of temperament, a specific character and intelligence, with a certain inheritance, with

complexes and misconceptions and a particular cultural horizon. The patient takes various


43

attitudes in front of the disease, but at the same time also in front of the medical team: trust,

respect, sympathy but also, possibly, doubt, fear, sometimes disdain. The integrative synthesis

of doctor-patient relationship helps the patient to better understand the disease and therapeutic

strategy, to cooperate with all factors involved in medical assistance, to live healthy and to

improve quality of life [Sandu, 2012].

1.3.2.5. Cultural diversity and religious convictions

Medical responsibility can be discussed also in the context of the medical act that

involves cultural diversity and religious convictions. Thus, respect for cultural differences in

the performance of the medical act and the reduction to minimum of any negative

consequences of cultural differences are prophylactic elements of the professional

responsibility for facts done out of mistake or error. The respect for cultural differences must

be ensured for the comfort and in accordance with patient autonomy, because there are many

situations when doctors are confronted with cultural practices that come in conflict with

medical ones. The respect for different cultural values requires an approach from a pluralist

perspective, which should allow a series of different points of view. In a multicultural context,

a proactive approach is necessary, with flexibility and openness to adjustment, so that the

members of various cultures, patients of different ethnicity, religion or nationality feel

welcomed in a medical institution where competent and high quality care can be provided.

The ignorance of social and cultural factors could lead to stereotypes or discriminatory

treatments, on the basis of culture, language, religion or social reasons. In an UNDP report

from 2004 it is specified that in the world, a person out of seven supports the negative

consequences of the attachment to a cultural community non predominant in the state where

he lives [Sen, 2004].

In conclusion, ethics comes with the central message to give true meaning to the

disease and pain of all those in suffering and to expand the concept of health from a personal

issue, limited to the satisfaction or dissatisfaction of patient, to the promotion and protection

of the right to health to the highest standard. Consequently, in the medical act, Responsibility

and Ethics must be brought together in order for all that is just to be strong and all that is

strong to be just. These requirements of the professional behaviour become guarantees for the

respect of dignity and autonomy of the individual in its quality of patient, who must benefit

equally from the best healthcare

1.3.3. Vulnerabilities in Medical Practice

Vulnerability is a human attribute with a universal character of sensibility of the

individual who, although intact, is at the same time weak, fragile or biologically ill with an

increased predisposition towards supplementary damage [Lang, 2007]. Vulnerability appeared

as a new idea in the philosophical debate area of the question “is that which is moral in

society also just?” and was adopted by the bioethical field, where it developed up to a

potential through which contested order, became principle and imposed itself as an ethical

method applied in the medical domain. The term “vulnerability” comes from the Latin

“vulnerare” (i.e. “to hurt”), which further underlines the suspicion of damage (Oxford English

Dictionary, 1995). Throughout history, the scientific contribution to the definition of the

concept of vulnerability progressed from the empirical observations supported by the internal

and external causality of vulnerability to enlargements and refined expressions focused on

differences of context. The expansion towards the social environment influences the

Toader E, Damir D, Toader T., Vulnerabilities in the Medical Care. Procedia-Social

and Behavioral Sciences. 2013 Oct 10;92:936-40.


44

conceptualization of vulnerability and implies regulations correlated with the adjustment

capacity and the potential to react to environmental exposure [Cutter et al., 2003]. In the

ethical approach, vulnerability is oriented on arguments related to the consolidation of the

concept, the rigorous definition of its status and a better rendition of its meaning. Essentially,

the principle of vulnerability is ontological and it states better than all the other ethical

principles the finality of the human condition [Kemp et al., 2008]. In 1974, this concept

themed on issues for biomedical research is implemented institutionally in documents

correlated with the international ethical directions for the biomedical research on human

subjects (National Committee for the Human Protection, Belmont, 1993, CIOMS/WHO

(1982, 1993, 2002, 196, WMA, Helsinki Declaration: Ethical principles for medical research

involving human subjects (1964, 1975, 1983, 1989, 1996, 2000, 2004) 1997, UNESCO,

Universal Declaration of the Human Genome and Human Rights) (The Belmond Report

April; 1979) [Solbakk, 2011].

1.3.3.1. Vulnerability – knowledge background

From the point of view of knowledge, the terms that define vulnerability are extracted

from the wide framework offered by the opportunities of medical care. Vulnerability is a

comprehensive concept used at a large scale to identify persons, groups or populations whose

autonomy is damaged, in order to understand the intrinsic or extrinsic nature of the concept

and also to explain the manner in which certain macrosocial phenomena generate the

vulnerability state. For the medical care, vulnerability and the significations attached to the

term promote an ethical determinism, recognizing the need to be defined in measurable and

operational terms. The ethical essence of the concept is given by autonomy, non-maleficence,

well-doing, justice, principles that confer an idea on the meaning of the term for different

social categories and healthcare systems to which medical care relates. In the European

approach the ethical content of vulnerability steps towards biological law, justified by the

interpretation of the concept together which principles such as autonomy, dignity and

integrity [Mautner, 1988]. Another meaning of the concept refers to a general recalibration of

the consent to use vulnerability in medical care. The attempts to elaborate an exhaustive

definition of vulnerability in a domain where the autonomy and consent ability of the patient

cross paths with the system of healthcare policies required supplementary elaborations,

specific for the context and also for the approach strategies distinctive for medical research

and practice. It is worth underlining the fact that the wide range of usage of vulnerability

issued a series of term derivatives, which, through their individualization partitioned the

concept, given that this term refers equally to persons, groups and populations vulnerable

involved in the medical care from the medical practice, research and healthcare policies,

which are complementary domains [Flaskerud et al., 1998]. The definition of vulnerability in

the limited context of the access to fundamental research and clinical studies develops an

interpretation with a tendency to understand the concept in a restricted manner. This

restrictive approach, characteristic for some authors in Western countries is used as selection

criterion of the participants involved in research on human subjects. From the perspective of

the authors who prefer the more detailed definitions focused on the underlining of the

condition of “recognition and respect”, the concept of vulnerability appears to be understood

with a broader meaning that may be applied to every domain of human activity. From the

perspective of this approach, representative for the developing countries, a balance is

achieved, with a consideration typical for the medical field that vulnerability must not signify

the basis of differentiation between those who have access to the medical act within research

and those who do not [Solbakk, 2011].


45

1.3.3.2. Vulnerable populations – ethical and medical considerations

From the differences between the proposed definitions we can notice that together with

the multiple connotations the term also reflects the way in which the word vulnerability itself

is used, in the sense of its usefulness as an instrument for the determination of those who are

vulnerable. The term “vulnerable populations” included in the terminological thesaurus of

bioethics in 1997 will undergo developments up to the clarifications on the vulnerability

involved in the healthcare system [Morawa, 2003]. Moreover, bioethics implements the

concept in major projects with the commitment to identify the vulnerable populations in order

to ensure and guarantee their autonomy and dignity according to the principles of well-doing

and justice. One distinction upon which bioethics insists is the usage of the term in the sense

of anthropologically facilitated vulnerability or as an ethical principle. Thus, vulnerability as

“human fragility” applied for everyone is deemed an approach that generates a meaning

believed to be too large, because if everyone is vulnerable than the concept becomes too

vague to become significant [Levine et al., 2004]. Vulnerability as a sensibility to be harmed

and predisposed is narrower connotation centred on the group characteristics of vulnerable

populations with an emphasis on the ability to consent i.e. those who are exposed to certain

conditions of injustice, distress or, from various reasons, are culpable of their situations

[Brock, 2002]. Furthermore, the most important concern for vulnerability is embodied by the

recruitment for clinical research of the individuals who cannot consent or are exposed to

constraint or coercion. Although the term of vulnerable populations has its detractors,

bioethics, in its efforts of identification, definition and classification, reveals significant

aspects of the marginalized groups including children, prisoners, pregnant women,

handicapped persons, mentally handicapped persons, individuals economically or

educationally underprivileged, high risk persons, mothers, chronic or HIV/AIDS patients,

alcohol or drug abuse, persons predisposed to suicide or murder, domestic violence, homeless

persons, immigrants, refugees etc. It is to be noticed the open character of the common norm

list for vulnerable populations, emphasized by the fact that almost everyone, at a certain point

in their lifetime will be confronted with an illness, which represents also a vulnerability state

[Blacksher et al., 2002].

1.3.3.3. Vulnerability in healthcare and medical research

Vulnerability through stigmatization and marginalization has an impact on the health

status, its instability being frequently the consequence of public policies and practices without

just cause. Therefore, for guarantees regarding the respect for the human dignity of the

vulnerable persons the intervention of bioethics is necessary, at the three levels of medical

care: human experiment, medical care, biomedical research policies.

In the human experiment, the vulnerability of each human being may be exploited

intrinsic or inherent in a subtle and even accidental manner. Circumstances such as the

neutrality of the information in the clinical studies, volunteering versus benefits, submit to

ethical debate the recruitment method of the volunteers and also the fact that a series of the

healthcare benefits for the volunteers are in fact mandatory prerequisites for participation.

Moreover, the public release of the success is confronted with the illusion and hope that all

biomedical accomplishments lead definitely to success. In medical care, the application of the

human experiment must not regard consent as less important or place autonomy on a

secondary position. Consequently, the aims intended and followed in medical care are to

protect vulnerable individuals, but also to make the more powerful persons in this relationship

more responsible [UyBico et al., 2007].

Vulnerability in medical care starts from the boundary created by the lack of a unique

approach in the definition of vulnerability, which makes the usage of the concept incomplete

and inappropriate and the criteria for the designation of vulnerable populations are vague,

situational, influenced by personal perception and stratified according to risk degree. An


46

integrative approach of the concept oriented on the cultural formation of relationships that

humans have in the social environment tries to take into consideration the manner in which

financial status, social support, education, income, life changes according to age, sex, race and

ethnicity play a role in the social construction of the vulnerability of the health status [Turner

et al., 2003]. If at the social level vulnerabilities are mostly ignored, mainly because

quantification difficulties in medical care a reconfiguration of vulnerability is necessary, with

the translation of the meaning from “weakness” to “possibility to become fully responsible in

autonomous choices and to compel those that have the power, influence and authority

(society, state institutions) to protect individuals from potential abuse”. Similar to the human

experiment, the exploitation in medical practice in a subtle and even accidental manner of the

vulnerability of each human being through deviation from signification and distancing from

meaning has as ethical consequences the narrowing of the “normality” concept [Sandu et al.,

2013]. Among relevant examples there are those referring to the neglect of the psychological

structure and life experience, which can sometimes determine persons to feel obligated to

volunteer as organ donors for their family members. Also, the medicalization of the society

contributes to the illusion that medicine has solutions for everything and has an impact on the

concept of “disease”. Another example is given by publicity for medication and medical

procedures that create unrealistic expectations in the patient and places a tension between the

vulnerability and the autonomy of those who lost their ability to make informed choices. In

this context, the efforts to protect vulnerable patients who do not dispose of their ability to

make informed choices may be regarded as paternalist and autonomy risks to become a

principle with totalitarian attitude [Ruof, 2004]. From the point of view of the moral values in

medical practice it is required a deontological attitude of support for the balance between

autonomy and the protection of vulnerable patients.

Vulnerability in patient-doctor relationship, as indication of professional integrity,

illustrates by the appreciation of the trust in the medical act and medical personnel the need of

the patient to investigate his health status and to be taken care of. In this relationship, the

doctor, through professional and social legitimacy, through knowledge power, abilities and

resources must act moral in the final choice and not profit from the vulnerability of patients.

In this context, ethics intervenes moderately in order to balance the asymmetry of this

relationship [Benner et al., 2008]. In the field of application of the healthcare and biomedical

research policies a series of “patient lobbies” take place, with benefits obtained through the

power of demand or by the progress recorded in the genetics domain, which by the

identification of new aberrations widens the disease range. The biopolitical concept must be

concentrated on the creation of circumstances for the bioethics to act correctly as an analytical

and normative morality instrument regarding of the aims submitted for medical research

[Schramm, 2011]. One objective must be the warning of institutions and states about the fact

that biomedical progress does not always yield the decrease and/or suppression of

vulnerability but, on the contrary, successes recorded by biotechnologies may be factors of

injustice and discrimination which can create and/or aggravate vulnerabilities.

In conclusion, efforts regarding ethical investigation at all levels enforce the respect for

individual’s vulnerabilities and personal integrity/dignity. No matter the aspect of medical

practice or basic research, despite healthcare policies level, practitioners must always be

aware of the human vulnerability. It is mandatory to consider human vulnerabilities in order

to avoid taking advantage on other’s frailty (negative action). At the same time, positive

actions and institutional guarantees will provide protection for those who, for various reasons,

are more vulnerable. Vulnerability requires morality commitment that is reflected by a logical

action regarding the medical act and involves care, solicitude, solidarity and responsibility.

Vulnerability, through orientation and adjustment, looks at the same time for complementary


47

alternatives of freedom and attempts through change and self-determination to make strong

and just of what is moral in society.


48

2. ETHICAL ISSUES IN THE WAKE OF

TECHNOLOGICAL PROGRESS

The past decades, biomedical technological progress have widely changed the quality of

life for the diseased and disabled, by pinning solutions meant to lead to a new understanding

of the patient status, to control or to remove most of the health-threatening issues. The

impressive potential and access to new technologies are extremely useful in preventing,

diagnose and treat various diseases and in developing preventative programs for proactive

health promotion. Applying these technologies to the statistically evaluated impairments,

based on interactions between technology and medical act norms, have led to intense debates

and controversies, polarize opinions and even scientific ambiguities. The only ethical element

that practitioners may control concerns the users’ skills and competences regarding a specific

piece of technology, procedure or therapy and on the information delivered to the patient after

getting their informed consent.

When should physicians be permitted to use new technologies without supervision

and who is responsible for setting and monitoring standards for new technologies?

This question involves not only the practitioners’ individual responsibility for the

ethical use of a new technology but also willingness to assume its proven efficacy and safety.

As an example, telemedicine promotes high standards for healthcare at reasonable costs, with

fast and ease of access to medical services. However, according to recipients’ opinion, there

are some ethical bottlenecks regarding the controversies involved in the interpersonal

relationships and patient satisfaction. Another example concerns the usage of various

preconfigured or personalized applications connected to mobile data communication devices

regarding healthcare and survey. Besides the obvious advantages provided by the transfer of

the medical care to patient’s place, one would also care about the ethical and legal inferences

that these practices may influence mHealth programs. Public expressed concerns regarding

personal data confidentiality due to mobile data transmission or cloud storage must be

considered each time one elaborates applications or set of rules regarding the way patients are

dealing with such devices.

Is it the right time get rid of the practice of pinpointed measures to fight

complications and exacerbations by considering systematic delivery for chronic disease

care?

A potential technical answer involves orientation toward a particular medical care by

using computer applications to manage medical information with the declared purpose of

improving and speeding up processes. There is, however, a mandatory ethical approach is

required, as just an accurate usage of new technologies in the management of the chronic

diseases is not satisfactory regarding patient data confidentiality. Ethical norms must be

followed regarding patient data usage and sharing, confidentiality (all or nothing principle,

Toader E. - Founder of the first national platform for Medical Clinical Simulations,

destined to lectures and postdoc training

- Workshop organizer for EHB Congresses – 4 editions

- Expert scientist in “Integrated e-health solution to monitor vital parameters in

patients with chronic diseases" - SIMPA, 2007, project

- National member of the Management Committee, in COST Action:

CA16205 - European Network on Understanding Gastrointestinal Absorption-

related Processes (2017-2021).


49

with no discrimination), informed consent, risk-benefit assessment, surveillance, risk for lack

of autonomy and intimacy, increased potential for aloneness.

Biotechnology-side, debates regarding usage of stem cells and embryo research

escalated to the political area, become a hot-button issue, and involves scientists, decision

factors, politicians and religious groups. Similarly, disputes regarding organ transplant,

genome editing, robotics and nanotechnologies have mobilized civil society, scientists and

decision factors in a complex debate regarding ethics and safety.

Eloquently, genome-editing technologies are strongly affecting social perception and

acceptance. As a result, public debates regarding genome editing ethics and legal aspects

cannot be ignored or avoided. More demands for transparency within these debates are

coming up, as mentioned in the Oviedo Convention and Access to Knowledge movement

documents.

What are the ethical implications of emerging tech?

Changes ahead are already included on the Forum’s list of top 10 emerging technologies

for 2017 which alerts us to important changes on the horizon for all sectors, including health

like genomic vaccines, noninvasive biopsies for identifying Cancer or liquid biopsy or human

cell atlas. As always, we must welcome innovation and the benefits it brings us. However, we

must also remain committed to sustainable development, taking into account issues of

inequality, human dignity and inclusiveness. These top emerging technologies also remind us

of the importance of ethical commitment.

Will ethic principles dominate new technologies application in medical units?

This is a key message issued from the academic debates regarding this topic and

launched in Iseron (2002) - The Ethics of Applying New Medical Technologies – and was

reiterated and further developed in valuable international journals. This message became a

milestone for the practitioners education and healthcare administrators. Modern medical

teaching system reveal different levels in acquired medical knowledge, with significant

differences among theoretical and practical skills, and between recommended and applied

standards. These differences are slowing down the process of building up the highest ethical

and educational standards in medical teaching and professional formation To emphasize the

ethics role in decisions regarding healthcare, it is important to point out the area covered by

medical education, the ethical objectives involved in the medical education curricula and the

professional development. In 1998, Stern stated that responsibility and compassion are the

main ethical values for the medical act. He also encouraged teaching these concepts in

medical and academic institutions. These concepts are relevant to medical education, mainly

in order to define doctor-patient relationship and are based on communication, empathy and

altruism toward patient.

In respect to other cultural values, a pluralistic approach is required to handle different

opinions. Cultural competences within medical education can be considered as a “moral

good“ [Wiwanitkit, 2017] through which arise an ethical commitment to respect for the

patient autonomy and legal concepts.

Worldwide, we can notice a trend that challenges the teaching methods toward an

experimental approach that include the best healthcare standards, error management, patient

safety and autonomy and resource allocation. Using computer software in clinical simulations

plays an important role for the teaching and induction actions for students and professional

healthcare. Thus, the stakeholders can improve their abilities and skills. Hands-on workshops

for clinical simulation represent a way for a social integration of the medical teaching

concepts, according to the broader European integration purpose.

As stated by Kolb, transforming experience to knowledge [Kolb, 2014] the most

efficient teaching method is the simulation; its role in medical education is emphasizing the

puzzle Jigsaw method or the “interdependent group method”. This method is integrating the


50

rationale behind clinical diagnosis and therapeutic options with students’ activities, refining

their decision-making abilities at the right time.

2.1. APPLICATION OF BIOMEDICAL TECHNOLOGIES – ISSUES IN MODERN

BIOETHICS

Human health represents a major aim worldwide while modern technologies are filling

the gaps generated by ubiquitous local discrepancies. All efforts engaged to fix public and

global health requirements concatenates efficient actions from classic clinical practice with

modern technologies. The latter is providing sophisticated but fast and complex devices for an

accurate diagnosis, prevention method or treatment that may include new therapeutic

approaches, recombinant vaccines etc. General health improvement supposes a better

characterization of a specific disease, improving treatment efficacy and reducing its duration

and side effects, better hope fighting terminal diseases, and improvement of the quality of life.

Implementing new medicines and modern methods and technologies in medical practice is the

key to success for medium and long term in healthcare improvement. Human health progress

is more and more dependent on the technological leap so the restrictions addressed to basic

research should be not only cleverly limited but also reconsidered. Thus, scientific creativity

will be stimulated to generate profit to healthcare and will accelerate progress on patient

output. At the same time there is an urge for ethic norms regarding the applications of the

biotechnological progress. Patients and other stakeholders in the healthcare system must

benefit from this biotechnological progress according to ethical and legal concepts [Lehoux et

al., 2014, McCormick et al., 2009]. Individual autonomy is and will be heavily impacted in

the years to come by application that involve gene therapy, genome editing, tissue

engineering and tissue regeneration, human cloning, AI and nanotechnologies.

The substantial increase of the medical needs in society triggered the development of

various medical domains that generated a wide field for the applicability of biomedical

technologies, and thus facilitated new perspectives in the worldwide management of

important health issues. Biomedical technologies refer to the application of technologic and

engineering advances in medical sciences, therefore providing an immense opportunity to

enhance all life forms. By providing customized biomedical products, biomedical

technologies have the potential to increase quality of health care and take it to an advanced

level, based on individual needs specific for each patient. Advances in biomedical research

materialized in pharmacological products such as biologic agents, or biotechnical methods for

genetic testing and therapy are used for the treatment of certain diseases (e.g. intestinal

inflammatory diseases, leukaemia), for gathering information on the genetic inheritance of the

individual (e.g. pre-natal screening, genetic disorders) or replacement of defective genes

[Satava, 2003]. However, several ethical and moral issues challenge scientific progress

maintained by application of biomedical technologies in research, treatment and prevention.

Genetic therapy, tissue and regenerative engineering, human cloning, artificial intelligence

and nanotechnology are examples of biomedical technologies that may revolutionize, in the

ethical sense, the perception of what it means to be human, or what could be the final destiny

of human race. Ethical debates regarding therapeutic or reproductive human cloning, genetic

engineering or in vitro fertilization refer to the manner in which biotechnologies redefine

concepts such as beginning or ending of life, statute and rights of human embryo, physical

integrity of the individual. Moreover, the involvement of ethics in the examination of these

Toader E, Eva O, Olteanu A, Anton S. Application of biomedical technologies-issues

in modern bioethics.

In E-Health and Bioengineering Conference (EHB), 2017 2017 Jun 22 (pp. 478-481).

IEEE.


51

aspects renders difficult the clear delineation between the medical profession, the (critical)

relationship between concrete alternatives of the medical advances facilitated by

biotechnologies and the science-fiction area, with interferences from the spiritual sphere, and

important divinity aspects [Hewett et al., 2016]. The novelty itself of the biomedical

technology, increase of complexity for the feasible structures, potential of automation and

personalization of intervention are but a few from the distinctive facets of biomedical

technologies which require careful exploration of moral and ethical implication.

2.1.1. Biomedical technologies – scientific progress and social perception

Biomedical technologies are a useful segment of contemporary medicine and an

omnipresent component of modern society, while they also provide enough reasons in support

of the assertion that their implementation in current health care should not be an exception.

Furthermore, numerous pieces of evidence offered by current medical practice confirms the

potential of biomedical technologies to supply successfully significant contributions to health

care delivery, through accessibility, operational effectiveness and security in patient

management [Costin et al., 2016]. Assessment of perception of scientific progress, of research

results, practical application and public opinions regarding biotechnologies as „human

accessories” require positive media coverage, successful management, justification as

necessary within the health care system, as well as attracting actors and funds, doubled by

ethical evaluations. In the public space, the advances accomplished with the help of

biomedical technologies are generally associated with a wave of social excitement amplified

by a sometimes too large level of expectation. Awareness on necessities and practical benefits

recorded in the field of tissue engineering, regenerative medicine, genetic engineering,

nanotechnologies and robotics begin to gain reputation and to accumulate increasingly more

carefulness for the recommendation of use in medical practice [Soril et al., 2016].

Nevertheless, efficiency of accumulation of medical technical and scientific progress in

current medical practice, as well as the increasing social impact (namely, the illusion that

medical advances offer solutions to any health issue), generate a series of ethical issues.

Tissue engineering and regenerative medicine both in research and in current practice

are stimulated by substantial increase of need for complex health care. In correlation with

aspects regarding „organ donation and transplant”, which in all approaches indicate that

worldwide there is a high level of need for organs and tissues for transplant, the development

of the biomedical domain of tissue engineering and regenerative medicine created numerous

opportunities for treatment and new perspectives in the management of the cases involving

severe damage or loss of tissue and organs. By reconstruction of tissues for grafts or

biological exchange pieces known as organs for the human body, tissue engineering and

regenerative medicine open a new path towards an alternative modality of treatment. Various

structures such as bone, cartilage, skin, bladder, blood vessels (small arteries), trachea or

artificial and bio-artificial matrices destined for repair of damaged tissue (such as bone or

skin) in tumors or others diseases, as well as successful implant of skin substitutes produced

by tissue engineering support the assertion that these technologies play an important role in

the current setting of health care [Otto et al., 2016].

Genetic engineering Finalization of human genome project in 2003 marked the

beginning of a new era in research on human genetic diseases, materialized by inestimable

contributions in the establishment of a precise diagnosis and of concrete healing possibilities.

Unravelling of complex processes involved in various diseases with gene expression and

application of curative genetic therapies would not have been possible without the implication

of a series of techniques merging genetic engineering, recombined DNA technology and

biotechnologies. If in the last century testing for inherited genetic deficiencies for diseases

that afflict entire generations was viewed as a rare occurrence, today, the procedure is

available at a large scale. Genetic screening, by karyotyping chromosomes, allows prenatal


52

checking for genetic abnormalities, for identification of recessive autosomal disorders with a

deep impact for family planning, for genetic susceptibility to diseases that become manifest

later in life (such as Alzheimer’s disease), and for vulnerability to specific diseases [Ross,

2016]. Moreover, genetic engineering expanded its exploration area in the therapy field,

where it exploited the potential to treat and possibly cure a series of chronic diseases and a

variety of cancers. Also, the possibility to remove defective genes and replace them with

functional ones may be enrolled in the range of current genetic therapy advances.

Cloning. The technique of human cloning is a procedure included in the series of

revolutionary discoveries in the area of the nature of life and it reveals the precious role

played by genetics in the development of human species. Human cloning generates in the area

of knowledge a new landmark which could lead to a new understanding of disease and

disability, and could be able to control or eliminate many of the issues that afflict currently

human health. The SCNT technology (somatic cell nuclear transfer) – a technology of nuclear

transplant involved in achievement of human cloning has solid arguments and evidence for

what it can be done in the field of medical industry and biotechnology. The SCNT technology

provides invaluable perspectives for the fundamental biologic processes of human tissue

repair/regeneration and promises high practical benefit with respect to improvement of

production means for pharmaceutical products [Bouma, 1999]. A succinct examination of

benefits generated by SNCT indicates that the most often quoted application are within

programs of infertility, stem cell research, regenerative medicine, genetic cancer therapy,

plastic surgery, etc. Dr. Richard Seed, one of the most important advocates for SCNT

technology stated that “that which will learn from cloning may make one day possible the

deciphering of the aging process” [Rhind et al., 2003]. However, recognized benefits were not

all favourable for application of SCNT in human cloning. The arguments for it are related to

the area of therapeutic cloning for medical usage with involvement of cell donated by the

adult. This perspective maintains therapeutic cloning in the active research area, which could

offer unique modalities for curing diseases deemed so far incurable, such as diabetes mellitus

or Parkinson’s disease [Kfoury, 2007]. On the other hand, the arguments against are centred

on reproductive cloning which involved the creation of human clones. The concern regarding

reproductive cloning, classified as extremely dangerous and with high technologic risk is also

expressed by scientists, who state that until enough medical, ethical, legal and economic

reasons will demonstrate that the human cloning technique is reasonably benign, the

procedure must be subjected to a moratorium regarding its practical application.

Nanotechnologies. Derived from the advances of traditional disciplines such as physics

and chemistry, nanotechnologies may have revolutionary implications with respect to

interventions and the devices that can facilitate them. Nanotechnologies represent applications

of engineering at a very small scale in numerous medical domains, environment, energy,

information, and communication technology. Usage of nanotechnologies in medicine offers

interesting and promising possibilities through the manner in which they can detect

deterioration of human organism, early identification of diseases, their prevention and follow-

up, improvement of diagnosis and application of an adequate treatment. Moreover, progresses

in nanotechnologies based on interaction with biologic molecules, possibility of visualization

and manipulation of matter at nano-scale opened the path for the systematic investigation of

nano-materials and identification of solutions for optimization of healthcare management

through interventions such as [Nikalje, 2015]:

Delivery of chemotherapy medication directly to cancer cells;

Nanosponges that absorb toxins eliminated in blood flow;

Antibodies attached into chips to carbon nanotubes for the detection of cancer cells

into the blood stream


53

Carbon nanotubes incorporated into a gel that can be injected under the skin in order

to monitor the level of nitric oxide in the blood stream

Sensors that can detect cancer cells in one blood sample (one millilitre);

Nanoparticles for early diagnosis of infectious diseases or nanoparticles attached to

molecules in the blood stream that indicate the beginning of infection;

Golden nanoparticles with the role of attachment to the type of proteins generated by

damaged kidneys or of “killing” bacteria;

Nanorobots programmed to repair specific diseased cells that function in a similar

manner with antibodies in natural healing processes. It is to be expected that nanotechnologies

would be as much as promising for other medical domains which would wish to exploit these

very attractive application, without neglecting the fact that admission of nano-materials for

human usage cannot exclude association with unknown risks for health and for the

environment. Given that we do not have predictive methods for the evaluation of potential

toxicity risks signalled for nanomaterials, the regulatory agencies and legislative factors are

bound to be extremely careful in advising clinical usage of nano-products which may have as

consequences such phenomena as bio-accumulation, aging and dissolution of transporters.

The robotics of healthcare, a field of multidisciplinary research and application deserve

increased attention due to the contribution of robots in interventions, instrumentation and

mostly regarding various options for the diseased [PĂSĂRICĂ et al., 2016]. In the United

States of America each day over 500 people lose one member, while 2 million Americans live

with amputations (source CDC). Identification of medical and social solutions articulated to

the reality of these statistically described invalidities, correlated with points of view

developed in the area of interaction between robotics, medicine and informatics, have become

main objectives of Business Review Robotics Report “Healthcare Robotics 2015-2020:

Trends, Opportunities and challenges”, which outlines three main domains for healthcare

robotics: direct patient care by performing surgical procedures, exo-skeletons for bionic

extensions and prosthetics for replacement of lost members [Harwin et al., 2006]. We would

like to point out that values intrinsic of medical robotics are bestowed by the ability of

effector robots to explore the human body in areas which are difficult to reach and where they

may execute interventions at a high level of accuracy and with minimal invasive approaches.

2.1.2. Biomedical technologies application in healthcare: bioethics implications and

concerns

Within the context of modern medicine where biomedical technologies may change the

manner and sense in which we experience health and disease, the way we live and die, ethics

asks questions referring to the complex interaction between science, technology and human

life. Taking this context into considerations, to questions such as how do we establish if a

biotechnological intervention is moral and how do individuals that use biomedical

technologies acquire moral knowledge, we expect answers that would promote in the public

space the moral understanding of scientific progress in healthcare. Therefore, within the

framework of ethical discussions regarding the impact of biomedical technologies, the

emphasis placed on the moral qualities of technological interventions is equivalent with the

interest to evaluate quantifiable medical consequences. Ethical aspects associated with terms

used in tissue engineering, regenerative medicine, human cloning, robotics, genetic

engineering and nanotechnologies, centered on the sources of differentiated/undifferentiated

cells, bio-matrices, nano-technologies etc. raise ethical and moral issues on multiple levels in

Toader E., Technological interventions in medicine - Ethic considerations and

guidelines for the medical practice.

In E-Health and Bioengineering Conference (EHB), 2013 2013 Nov 21 (pp. 1-4). IEEE.


54

a manner resembling that regarding human organ transplantation. Moreover, practical

evidence accumulated at a demonstrable level allow for the statement that products obtained

by tissue engineering, nanotechnologies or robotic techniques have the ability to modify

perception of property over human biological products, dimensions and even of responsibility

towards human body [Rokosz, 1999]. This ethical determinism promoted by usage of

technologies signals that, under the influence of science and technology, there are constantly

triggered moral changes in the life of those involved (medical staff or patients). In a different

formulation, the manner of usage and management of biomedical technologies acknowledges

the necessity of their evaluation in an ethical framework, based on principles of autonomy,

do-no-harm, benefaction, and distributive justice (Beauchamp and Childress).

Autonomy, as personal regulation for the individual that can freely control interferences

with other people, but also define personal limits, is the principle that lies at the foundation of

making decisions (such as prenatal testing of a genetic anomaly and organ transplantation

agreement), in order to participate in health care or in research (usage of nanotechnologies in

cancer therapy, stem cell research), knowingly (e.g. presentation of risks and benefits of

therapeutic cloning as well as infectious complications triggered by the procedure of

harvesting stem cells), voluntarily and without limitations, external interferences or

constraints which could significantly inhibit the autonomous choice. In clinical applications,

ethics concentrates on respect of autonomy according to guidelines dedicated to the

promotion of an autonomous behaviour, after correct information on benefits, risks and

therapeutic alternatives, including possibility and duration of delay of technological

intervention. Furthermore, the patient must be ensured of confidentiality, namely that personal

medical information will not be disclosed to other individuals without their approval. In

summary, respecting patient autonomy for autonomous choices may represent a modality of

exploitation of their preferences for application of biomedical technologies, illustrated in the

following examples: 1) bionic prosthesis of right hand is a case focusing on patient’s

dependence on the help of other people, susceptibility to abuse and exploitation due to this

addiction which in exertion of autonomy must be interpreted together with principles of

vulnerability, dignity and integrity; 2) emotional control of a patient identified after genetic

testing with high susceptibility for a serious disease and creation of necessary conditions for

autonomous choice (presentation of risks, benefits and therapeutic alternatives); 3)

interference between anxiety of the patient for the potential toxicity risk due to accumulation

of nano-materials and his/her ability to make autonomous decisions; 4) organ transplant,

tissue and cell donation develop a particular signification regarding autonomous implications

on long term derived from the necessity to respect sacredness of life, integrity of human body,

protection of human rights and respect of dignity [Hewett et al., 2016].

Principle of benefaction. Benefaction, as foundation of health care based on application

of medical technologies, aims to suppress sufferance of patients and promote their wellbeing.

The meaning of helping, to provide individual or collective benefits generated by the

benefaction of application of medical technologies, bestows on this principle, by moral

distinction of practical utility, an ethical signification that must be interpreted in correlation

with chance equity and equality. In practical applications of medical technologies,

benefaction, as moral obligation for the wellbeing of the individual implies actions in the

benefit of the patient such as successful implantation of skin substitutes produced by tissue

engineering, or prevention/elimination of an evil by prenatal testing for genetic mutation, or

improvement of health status by member prosthetics, or evaluation and balancing of possible

benefits against possible risks etc. [Rhind et al., 2003, Satava, 2003].

Do non harm principle articulates the commitment of professionals to avoid causation

of damage through intentional acts or omission. Protecting patients from harm implies to not

do something that would hurt, such as administration of ineffective treatments without


55

benefit, or assumption of risks (including those opportune) which are not balanced with a

proportional benefit. In clinical applications of medical technologies the do no harm principle

supports, as supplementary ethical dimension, the need for medical competence at a

professional standard making the distinction between means and effects, such as application

of nanotechnologies as means of transport and delivery of medication versus the risk of

accumulation in the organism at a toxic level [Hewett et al., 2016]. “Primum non nocere

deinte salutare” in contemporary ethics hints that the nature of the medical act facilitated by

application of technologies must not be intrinsically wrong. Moreover, towards the sense of

proportion, we note that the intention of application of technologies must be only for the

beneficial effects, while the advantages must surpass the predicted allowed damage.

Distributive justice Equal access to healthcare based on usage of medical technologies

is proof of equity in healthcare system. As ethical concept, equity is based on the principle of

distributive justice, which means equal chances to be healthy for all population groups that

may benefit from biotechnologic applications. In current practice, distributive justice is a

complex ethical principle with inherent challenges and significations that vary from equal

treatment of individuals to equal allocation of financial resources for healthcare. Application

of biotechnologies, in terms of equity focuses the discussion on distributive justice on the

concern of the individual that decides the type of technology, whether the decision is based on

personal necessities and if it can be appreciated according to age or prognosis of disease.

Although it seems a simple ethical principle, within the clinical setting application of justice

is often a challenge that requires constant vigilance in order to ensure support for their

intentions. In this interpretation, distributive justice, as opportunity for equitable equality, in

order to support access to expensive technologies must discern the allocation of resources

(available), which in the opinion of K Arrow will never be enough to satisfy all request for

healthcare, since these will be endless [Bloomfield, 2009]. It is an area of ethical sensitivity

that cannot neglect daily pressure exerted on respect for regulations, for improving processes

and increasing attention for clinical results of biotechnological applications.

2.1.3. Clinical Application of Telemedicine - Ethical and Legal Issues

The rapid development of information and communication technology (ICT) has

brought about new ways of diagnosis and treatment based on the relationship between

medical informatics and public health. The growing impact on health care practices of the

combination between medical sciences and telematic computers materialized in an incredibly

wide range of new health applications called telemedicine. The effects of telemedicine on

health care reveal the huge potential of the cooperation and exchange of information among

health professionals, and they facilitate large scale innovation in this field. This presentation

is wide enough to apply to a dynamic environment, such as the Internet, and at the same time

to recognize that telemedicine includes more than a technical development. Telemedicine is at

the same time a state of mind, an attitude, a commitment to think globally in order to improve

health care at the local, regional and international levels by means of information and

communication technology. Currently, new organization strategies should be identified to

improve health care in terms of effectiveness and appropriateness of telemedicine

interventions [Franken Jr et al., 1995, Frenk, 2005]. Current topic approaches telemedicine in

terms of definition and main characteristics, followed by a presentation of various ethical and

legal aspects, which are either barriers or opportunities in clinical practice.

Toader E, Damir D, Toader IA., Ethical and legal issues related to the clinical

application of telemedicine.



56

Telemedicine is a concept widely used to describe new ways of information

dissemination, to work in teams and to provide services using a various range of information

and communication technologies addressed to health professionals [Stanberry, 2000]. This

definition offers a first glimpse of the term, that of disagreement on the use of new

technologies between different social categories and the health system. Telemedicine, due to

the fast electronic remote transfer of medical data (e.g. high resolution images, sounds,

videos, patient records), has become an integral part of health care services [Beolchi et al.,

2003]. Another meaning refers to the reconsideration of the general telemedicine use

acceptance. The wide range of possibilities provided to medical practice, education and

research required further clarification on the functions, technological support and

medical/technical staff involved, as well as on the geographical distribution of the medical

services known two decades ago. Thus, there have been attempts to develop a comprehensive

context- and approach-specific definition of telemedicine as the “field where medical

informatics, public health and business cross their paths, referring to health services and

information disseminated or consolidated through the Internet and related technologies”

[Stoica, 2002]. Defining telemedicine only in terms of access to the Internet is specific to

some authors, yet it is considered limited by others, who prefer more specific definitions,

focusing exclusively on the Internet as a determinant factor of this form of provision of

medical services [Cuneo, 2002, DiMaggio et al., 2001, TANGALOS et al., 1996]. According

to Tangalos, the definition of telemedicine also includes the use of telecommunication

technology for medical information exchange that provides access to health care in time and

at distance, without social and cultural barriers [TANGALOS et al., 1996]. In light of this

definition, it creates an equilibrium, considering that telemedicine should not be the basis of a

distinction between those who "have Internet access" and those who "do not have Internet

access" [Stoica, 2002]. Fast remote access to medical expertise by telecommunication and

information technology means, regardless of the whereabouts of the patient, is the definition

given to telemedicine by the European Commission, which was narrowed down to mean the

"use of telecommunications to set medical diagnosis and patient care" [CEC, 1993]. Coiera

believed that telemedicine was the remote customized process of information exchange (e.g.

opportunity to hear voices, see images, view medical records, send orders for a surgical robot,

etc.) [Coiera, 1997]. These definitions underline the main features of telemedicine, which are

currently well accepted by both health professionals and the public. Telemedicine supports

remote health systems effectively, being a remarkable solution to improving access to medical

care in remote and isolated areas. We note that, in addition to their multiple connotations, the

variations between the proposed definitions also reflect how the very word "telemedicine" is

used, more precisely as a tool that allows a process, a function, a complex service specific to

e-health. Let us also remember the meanings of the term according to which telemedicine

promotes a sort of technological determinism that facilitates communication between two

remote groups, suggesting that this distance is difficult to overcome, that it is a static void,

which actually undergoes a permanent transformation process [Van Dijk, 2008]. Last but not

least, the broad telemedicine meaning resulted into a series of derived terms that

“individualized telemedicine”, as the term equally refers to complementary fields like

teleconsultation, telecare or e- health [Lievens et al., 2007, Stoica, 2002].

Opportunities and barriers in telemedicine

Telemedicine is not a new field, as it enjoys a historical background in clinical practice,

which has gained, over time, both supporters and opponents. According to its supporters,

telemedicine allows fast, easy and general access to health services, promoting high medical

care standards at low costs. Efficiency is one of the health care promises made by

telemedicine, which is possible by cost cutting. A possible way to cut costs would be by

avoiding repetition of unnecessary diagnostic or therapeutic procedures, by enhancing


57

communication among health units and by involving the patient [Stanberry, 2000]. At the

same time, in addition to cost cutting, efficiency increase involves medical care quality

improvement. Telemedicine may improve medical care quality, by guiding patient flows

towards the highest quality providers. Thus, telemedicine opens up new paths that enable

patients to make evidence-based choices. It also encourages a new relationship between

patient and health professionals towards a true partnership, where decisions are made in

common. Thanks to online sources, telemedicine offers possibilities of continuous medical

education and enhances standardized information exchange and communication between

health professionals and medical facilities. By extending the scope of health care beyond

conventional both geographical and conceptual borders, telemedicine provides consumers

with easy online health services from providers worldwide, which may vary from simple

recommendations to more complex procedures [Costin et al., 2007, Lops, 2008]. In the

opponents’ opinion, telemedicine is unsafe for clinical practice and a threat to the traditional

doctor-patient relationship. Most of the risks concern data transfer safety between various

telemedicine applications, as well as health care provision safety, as the information in one

application may be used by the others. Errors in data transmission, which would have

consequences on diagnosis and treatment, are possible, since there is no organization in

charge of supervising medical services and information provided online. The vulnerability of

medical data transfer over the Internet, and telemedicine organization and culture are other

aspects that telemedicine opponents have objected to [Bashshur, 1995]. As it attracts both

supporters and opponents, telemedicine, as both a concept and quickly developing field, leads

to controversies. One of the biggest controversies related to telemedicine refers to healthcare

quality. Given its virtual nature, one might think that telemedicine is a "generic solution"

without adequate testing and a low level of patient satisfaction. While disagreeing with these

views, Bashshur [Bashshur, 1995] points out that the relationship between telemedicine and

healthcare quality improvement focuses mainly on two aspects: technical quality and

interpersonal relationships reflected by the patient satisfaction level. The patient is satisfied if

he is able to get in touch with a healthcare specialist in the privacy of his own home, at any

time, thus avoiding sometimes-unnecessary trips to the hospital. Bashshut's argument is

interesting, as it identifies and supports the positive meaning of the lack of physical

interaction. The author believes that this lack of physical testing will lead to the elimination of

many unnecessary diagnostic procedures and will improve medical care quality [Zanaboni et

al., 2009]. Telemedicine may improve medical care quality, because it allows doctors to see

and monitor patients beyond geographical borders. Telemedicine may also give remote

providers unique and efficient continuous medical education opportunities, and it may enable

them to interact with specialists from other healthcare units, thus reducing medical errors.

Despite all these opportunities, telemedicine cannot find a substitute for physical contact in

interpersonal relations, and the doctor-patient relationship cannot be duplicated online. Patient

satisfaction remains focused on issues involving communication, physical closeness and the

conviction that he will receive the best medical care. Patients wish to talk to the doctor,

whereas the doctor wants to know his patient and feel what his disease represents to him. The

impact on healthcare is not only technical, as a function of the information potential of

telemedicine systems, but also emotional, influencing the doctor-patient relationship as a

function of the communication potential [Scalvini et al., 2009, Toader, 2009]. Another

impediment is the evaluation telemedicine results. The belief that telemedicine is able to

provide cost effective services cannot yet be thoroughly supported. The lack of concrete

information for cost valuation is an important impediment in the way of fast telemedicine

development [Lops, 2008]. Policymakers want to know the value added by telemedicine to

the medical procedures in order to ground their investment-related decisions, whereas


58

opponents focus their attention on the standards and regulations necessary to ensure that the

practice of telemedicine is ethical and legal.

Ethical issues. Technological breakthroughs have brought about extraordinary

improvements to its members in terms of health. But with the development of this technology

there came a number of ethical issues. Telemedicine involves new forms of interaction

between patient and doctor that generates new ethical challenges, such as online professional

practice, informed consent, confidentiality and health equity [Cereghetti et al., 2009]. In order

for the patient to be cured, there needs to be a well- balanced combination of knowledge,

skills and communication, plus trust and intimacy in the interaction between doctor and

patient. Virtual consultations could encourage depersonalization and diminish the trust that

defines the relationship between patients and healthcare providers, which is the very grounds

of medical care [Cała et al., 2004]. The loss of contact and physical closeness of the

traditional doctor-patient relationship, the depersonalization and exploitation potential, the

inclusion in the technological circuit of patients with severe conditions, as well as the inequity

in the provision of telehealth services are some of the ethical concerns that should be

considered. Telemedicine commits to making healthcare more equitable, despite the constant

threat of an increasingly deeper gap between those who have and those who do not have

resources [Stanberry, 2000, Stoica, 2002]. People who lack financial resources, skills and

computer or Internet access cannot use computers efficiently. Therefore, these patients (who

would actually benefit the most from health- related information) are those least likely to

benefit from information technology breakthroughs, unless political measures ensure

equitable access for all. The information communication access gap currently affects rural and

urban inhabitants, the rich and the poor, the young and the old, neglected/rare and common

diseases [Toader, 2010]. Other ethical and professional issues may be added: remote clinical

examination is not accessible and is not completely accepted, whereas telemedical clinical

evaluation efficiency is not standardized in the absence of any clinical guidelines regulating

telemedicine practice, drawn up by professional medical associations [Toader, 2010].

Confidentiality and informed consent in telemedicine. Confidentiality derives from the

special relationship created when a patient requests medical advice, care and/or treatment.

Confidentiality in telemedicine refers to all medical records and communications between

patient, doctor and non-medical staff [Cereghetti et al., 2009, Stanberry, 2006].

Confidentiality is the essence of the relationship between doctor and patient, because it

protects personal information and respects the dignity of patients. Confidentiality is based on

the general principle according to which people seeking medical care should not be concerned

about their medical information being disclosed to others [Cała et al., 2004]. The connection

between cybermedicine and the Internet significantly increases accessibility to medical

expertise and information, thus overcoming any risks related to personal privacy or

confidentiality violation. The possibility of extending virtual communication and access to

information seems to render useless all efforts to preserve this ancient principle included in

the oath of every physician and in Hippocrates’ code of ethics. Given the complexity and

variety of telemedicine occurrences, especially teleconsultation, the prompt and correct

application of ethical principles is rather a desideratum than a reality, which often gives rise to

much more questions than solutions [Şufaru et al., 2009].

• What are the patients' rights? Are personal data secured and protected?

• How is data security ensured? Can access be restricted to those who they are

intended for?

• How can abuse and unauthorized access to electronic records be prevented?

• Who is responsible in case of patient data abuse?

• What are the credentials and competence of remote doctors?

• What standard of care is the patient provided with?


59

• Who regulates and controls information reliability and integrity?

• How is informed consent from remote patients obtained?

Medicine computerization is useful because the data are available at any time, by fast,

easy and remote access. The data are transferred and copied easily, whereas data loss and

medical errors are rather unlikely. The drawback to this consists of possible confidentiality

breaches, because the medical data are no longer the patient’s. They become the property of a

system called telemedicine. Electronic medical data recording is useful for health organizers,

medical staff and, why not, hackers: wherever there is authorized access there is also

unauthorized access. Therefore, we can say that absolute medical data protection in a

computerized system is impossible and excessive security measures is costly and makes

access more difficult.

Ethical dilemmas. Confidentiality dilemmas arise when the principle of confidentiality

conflicts with other ethical principles [Yeo, 2003]:

privacy vs. efficiency – the need to know and share personal data on a patient’s health,

in order to provide high quality healthcare, creates indiscretion and could compromise

confidentiality;

privacy vs. collective good – privacy could be changed for collective good purposes

(research, management, planning, prevention) that the entire community or population could

benefit from.

quality assurance vs. professional autonomy – some professionals fear quality

assurance standards (protocols, clinical principles, etc.) could restrict or diminish professional

autonomy.

safety, standards and protocols. Considering the rapidly changing technology used in

telemedicine, most technical standards or clinical practice guidelines are either in an early

development stage, or they are absent altogether. The lack of standards may have serious

telemedicine effectiveness and

safety implications. Therefore, governments show particular interest in protecting the

public from insecurity and the use of non-tested or non-homologated medical technologies.

effectiveness vs. benefits – while benefits refer to providing the best medical care to

each patient, they may also involve high and unfeasible costs. Given the existing limited

resources, providing a patient with expensive medical care could deprive another of his basic

treatment.

Telemedical ethical aspects may be summarized in three statements on the quality of

medical care, confidentiality and informed consent [Tremblay, 1997].

1. Doctors that see patients in their offices should provide the same healthcare level and

quality as doctors preferring teleconsultations.

2. Doctors should appropriately inform their patients of any procedure that may influence the

ulterior decisions about treatment. In telemedicine, this includes information on the

former’s qualifications and alternative treatments.

3. Teleconsultation must be protected by appropriate technical means against unauthorized

data access, theft or removal.

Legislative sources. In telemedicine, the lack of standards regulating information

confidentiality and security, or informed consent may generate a series of legal issues with

profound implications on the population's acceptance of telemedicine services. The difference

between standard documents used in conventional medicine and data recording methods

employed by telemedicine, which are part of the consultation documents, eloquently

underlines the need for regulations in telemedicine. Medical data protection is regulated at

international, European and national level. For instance, some international regulations such

as the European Convention on Human Rights and the Convention on Human Rights and

Biomedicine are soft law and therefore not binding. Private life protection provisions are


60

generally included in international laws. The Charter of Fundamental Rights and Freedoms

set out by the EU is more specific for privacy protection.

The most important legal source concerning data collection and protection in the

European Union is Directive 95/46/EC, which, together with e-Commerce Directive, makes

up the legal telemedical data protection grounds. The Directive contains rules on how

personal data can be processed so that the processing itself does not harm the privacy of an

individual. Other sources of law for data protection are laid down in EU law for the EU

Member States [Stanberry, 2006, Tremblay, 1997].

Concluding, telemedicine remains an extremely rapidly evolving field, which requires

flexibility and creativity to overcome its challenges. Telemedicine proposes major changes in

healthcare practice, at the same time raising some ethical and legal issues together with

technical and economical ones, which need to be solved prior to proliferation. The main

challenge is whether we can be sure that telemedicine ensures the best articulate application

of these principles. Solving the problems raised by telemedicine and turning it into a viable

alternative requires joint efforts from professional medical associations either subordinated to

governments or coming from the eHealth private sector.

2.1.4. Mobile phone interventions in the healthcare of chronic diseases

Chronic diseases a major public health issue both from the point of view of the alarming

yearly increase in the number of new cases, and of the negative consequences on prognosis

and patient’s quality of life. Available therapies, although have proven efficiency for most

chronic diseases, do not represent a guarantee for decreasing the incidence of complications,

if those afflicted will still benefit from the best healthcare in an adequate medical setting (e.g.

hospital). In order to cover the wider range of problems these diseases generate, a continuous

management is required, with the application of efficient and profitable interventions for the

promotion of patient’s wellness. The management of a chronic case entails actions optimally

integrated and coordinated into a healthcare system organized around the medical staff and

the medical unit (hospital, outpatient), which must continue at the same quality level beyond

the clinical encounter between the patient and the medical team. The experiment of the

countries that coordinated remote healthcare assistance programs based only on the relay of

the information concerning the health status of the patients through electronic devices did not

rise up to the expectations. It was estimated that in order to have a positive impact on

healthcare processes, clinical results and health-related quality of life it is necessary to

actively involve the patients together with healthcare providers and sharing medical

information with them [Krishna et al., 2009]. Several studies that piloted remote healthcare

programs for chronic diseases such as asthma, obesity, renal failure, and diabetes mellitus

based on medical applications with the active implication of the patients in self-care provided

promising results regarding the positive impact on disease behaviour and quality of life, but

they were too limited as evidence basis regarding the value as a whole of mobile-health

programs of chronic diseases care as to be extended at a global level [Dick et al., 2011]. The

manner in which information on patients’ health may be translated into actions which would

improve health outcomes and provide incentives for disease behaviour remains a priority

objective in chronic healthcare management, but also a challenge for healthcare providers

who must identify efficient modalities to motivate and actively engage patients in programs

focused on their own health.

Toader E, Mitrica DE, Balan GG. Mobile phone interventions in the healthcare of

chronic diseases.



61

Mobile applications for chronic disease management

Advances in the field of information technology reconfigured significantly the manner

in which healthcare based on integration of IT instruments is ensured and provided. The

abilities and accessibility of modern information and communication methods using web

technologies were acknowledged in prevention, diagnosis, monitoring and therapy of various

diseases, as well as in the design and delivery of preventive measures and proactive programs

for health endorsement. These technologies called „electronic health” or „e-health” [Pagliari

et al., 2005] use mobile telecommunications and multimedia technologies in medical

assistance, including, besides internet and e-mail, applications for mobile phones [Black et al.,

2011, Pagliari et al., 2005]. For each individual, the mobile phone facilitates access and usage

of various preconfigured or customized applications for healthcare, in order to change or

adjust the manner in which he/she can manage the disease/health issues. At the global scale,

individuals are connected to internet and other digital networks through mobile phones,

accepting a mild transition with medical staff and institutions that perform activities centered

on healthcare services. Mobile-health showed through various programs and applications that

it can improve communication between patient and healthcare provider, regarding the type of

care necessary for the disease management. This aspect is also highlighted by World Health

Organization (WHO) which states that mobile-health has the potential to transform the

manner of healthcare provision, at a level that allows for a worldwide joint management of

chronic diseases. Several population studies using the main functions of mobile phones,

namely communication through vocal, animated and/or text messages attested that integration

of mobile technology in the healthcare system may be a viable modality to complete and

improve current strategies of efficient management of chronic diseases [Beratarrechea et al.,

2014]. Due to the easiness communication between patients and medical services providers is

performed, mobile phone may become a useful and promising instrument in the approach of

several constraints in the healthcare system, such as deficit of medical staff, limited financial

resources, high burden of the disease, difficulties in accessibility to medical assistance.

Mobile-health milestone in chronic disease management

Key aspects in remote healthcare provision for chronic disease patients relates to data

transfer between (two) partners via messages (medical data with informational character,

reminder messages or questions and answers), which generate and involve the participants in

a series of actions intended to improve results that reflect the health status of patients.

Medical information is traditionally generated in the clinical framework of the medical

visit, of investigation lab or in prevention health programs such as screening for the diagnosis

of a disease etc. Besides these situations that entail direct contact between the patient and

health services provider, the generation of data relevant for the health status of the patients, as

often as needed, is also possible with the intervention of new technologies that facilitate

virtual meetings between patients and providers. The inclusion without obstacles of data via

smartphones, as well as possibility of periodic self-control of medical data regarding the

chronic disease encourages patients to use mobile technologies with the purpose to change

behaviour, life style and improve their health. Currently, the increasing number of

smartphones, mobile applications and devices for remote monitoring represent innovative

methods through which easy connections are established between patients and healthcare

services providers. They facilitate the approach of a health problem starting from a set of

medical information which must reflect the history of the disease, symptoms, biometric data,

therapy, life style, etc. [West, 2013]. This data is generated by the patient and can be

completed with pieces of information collected or deduced, or from the individuals designated

for the collection of medical information, such as care partners, family or other assisting

individuals. It is to be noted that the medical information generated in the mobile-health

system involves supplementary responsibility regarding the gathering, recording, direct


62

exchange or distribution of this data towards medical assistance providers [Deering et al.,

2013]. All involved parties are interested to keep the data confidential, secure and adequately

used. In order to ensure its reception, understanding and integration in the electronic database

the transmission of information will be performed in a standardized manner. With respect to

self-care behaviour reminding messages are activated periodically, and possibly the

customization by request or if necessary of (some) messages. These aspects are standard

requirements that define the optimal and large-scale usage of mobile health which in many

countries became a viable instrument for healthcare according to the political framework and

good practices specific for chronic diseases. It is noteworthy that the mobile-health

environment is a dynamic one, an aspect which due to its technical complexity may become at

a certain point critical for the user (patient). Consequently, the usage of mobile-health system

must comprise an innovation system in order to balance the need of reaching and evolving

beyond the standard in healthcare through self-care, whose initiation point is marked by the

patient himself directly involved in the activity of generating medical data [Bodenheimer et

al., 2002].

Participants in mobile-heath program are represented mainly by the patient and the

medical staff as providers of medical services.

Patients as active participants in the healthcare program interact with the

communication system, perform several educational activities, give feed-back and monitor the

manner in which the objectives of the program are achieved. The involvement of the patient

in the mobile phone assisted home care program entails interactions with the mobile system,

namely sending and receiving text messages which reflect the modality in which self-care

actions are executed [Deering et al., 2013, Nundy et al., 2014]. The contents of the messages

may be either informative, reminding or in the form of questions and answers. For example, a

patient with liver cirrhosis undergoing diuretic therapy receives a message (encoded as action

message) through which he/she is required to commit at a certain date (with the definition of

the day and hour) to check urinary density. For this action urinary bands will be used received

from the medical care provider. The employment instructions for the urinary bands were

presented to the patient during the educational modules. The accuracy of the information on

the usage of the bands was verified by messages with option for explanatory text, voice or

animated application. Another example is the message with questions on the drug supply

available for a certain period of time (e.g. two weeks), with options for the patient to answer

through text message (yes I still have, no, I do not) or message through which one of the

boxes displayed must be checked (yes, no).

Educational program implies that the patient must follow a program regarding medical

care with a flexible and customized curriculum which would allow going through it in a

personalized rhythm 9. The items must be organized on subtopics formulated according to

the primary and secondary objects of the healthcare program. Exemplifying still in the sphere

of liver cirrhosis, the self-care activities implies the involvement of the patient in actions

centred on therapeutic aspects, diet, monitoring diuresis, assessment of bodily weight by daily

weighing, measurement of peripheral pulse, blood pressure, etc. As characteristic for the

educational program is the initiation made (preferably) during the direct encounter between

the patient and the medical care provider (in-hospital), which will be later remotely continued

(at home) through the mobile-health system. In the case where new needs will be identified or

at the request of the patient the care program may be expanded with supplementary modules.

Moreover, sending educational or action messages may be restricted or stopped, especially for

the patients opting for receiving mementos and checking through self-evaluation.

The medical staff, represented by physicians and nurses, is increasingly more interested

in the identification of medical care alternatives for chronic disease patients outside of the

hospital, which may be applied to the same standards. Orientation towards mobile-health is


63

justified from the point of view of the multiple facilities through which mobile technology

provides a different modality of supplying informal care at home. Towards this end mobile -

health becomes a binding between partners, a factor of social, economic and cultural

inclusion, a agent with the potential to improve the motivation of the patients to become

involved in the therapeutic process, which, by the quality of the services develops a positive

impact on the care process and reduces implicitly the number of medical visits. The

involvement of the medical staff in the program for remote care giving is focused on the relay

of automated or requested messages. Beyond the informational and instructive function the

messages selected and sent by the medical staff have the value of motivational support for the

self-management of the care for chronic disease patients. The actions and interventions

derived from these messages are destined to improve self-care through several modalities

including education, self-efficiency, social support and health beliefs [Krishna et al., 2009,

Nundy et al., 2014]. An extremely important role during this period of interventions is held by

communication. The usage of an active vocabulary is recommended, consisting of simple

words currently employed by patients [Hamine et al., 2015]. In order to help patients select

and sent useful information, in the text of the messages common words will be identified from

the point of view of signification, function and attribute. Other activities of the medical staff

entail the use of a web-based program executed in a web browser using various technologies

for:

sign-up of eligible patients in the mobile-health system through the use of a form;

inclusion of patients with mobile phones;

the care plan specific for the chronic disease, which is in accordance with the

curriculum of the education module;

schedules or requested messages;

contact and collaboration with the primary medical assistance system.

The interventions for self-management of the chronic disease through home care

coordinated through mobile phone is preconfigured in the software of the program according

with the established objectives (e.g. monitoring clinical constants, diuresis, blood pressure,

pulse, ore a therapeutic objective such as administration of diuretics every morning before 9

o’clock). Furthermore, mobile phones also have a cautioning system that becomes active

when the parameters of interest are placed outside of normal limits. The response to the alert

message is made according to the alert degree classified according to protocol into low,

medium or high [Hamine et al., 2015, Nundy et al., 2014]. For example, it is considered a low

alert when the patient has issues in coordinating the care actions (he/she is late or forgets to

take the medicine for one or two days) or the medication supply is almost exhausted (there is

medication still left for another 5 days). The solution may be through text message or by

collaborating with primary medical nurse. A high-level alert (e.g. low blood pressure,

digestive haemorrhage, diuresis under 800 ml/day) implies serious problems that require

evaluation by phone-call (vocal contact) and possible assistance, if necessary, in secondary or

tertiary medical centres.

Benefits of mobile-health interventions

Benefits are multiple both for participants (patients, medical staff), healthcare system

and for computer systems [Berndt et al., 2014]. For healthcare staff, mobile-health implies a

modality of complete and periodical introduction of data necessary for the individual

customized therapy plan. Thus, the errors caused by the lack of information regarding the

history of the disease are minimized, the care process is improved, the access to patient data is

granted regardless of time and location and there is an automated alert generated by critical

data of the patient. For the healthcare system, the benefits derived from the usage of the

mobile phone can be found in the quality of remote management of chronic disease. Hence,

there are significant changes in the descriptive epidemiology indicators, namely the delay and


64

decrease of complications for chronic diseases, decrease of hospitalization, morbidity and

mortality. Moreover, the structured gathering of relevant data and storage in one single place

allows for the organization of information regarding the health status and disease respectively,

and leads to cost reduction and accelerates transition of patients from hospitals to their homes.

Conclusion

Mobile-health has the potential to translate the care of chronic disease patients from the

medical visit based on the traditional model which implies the episodic delivery of medical

care, to the remotely coordinated one, accessible, easy and continuous. Self-management of

chronic disease through the mobile phone associated with the active engagement of the

medical staff in the self-management process has the potential to improve clinical results and

quality of life. Mobile-health can help in management of health issues for many patients

afflicted by chronic diseases who, if it were not for these instruments they would be

confronted with several difficulties. If mobile-health strategies will become applicable in

every-day life and in customized form, they will held an important role in the home of the

patient where informal medical care will be performed, thus becoming an important part in

their life.

2.1.5. Software Applications Integrated in the Management of the Patient with Chronic

Liver Disease

In response to the challenge of the chronic diseases, many countries tested new models

of health care which facilitate a better coordination of the nursing services for the patients

with these invalidities. If the extension at home of the medical care initiated in the hospital

has a logical basis, the evidence regarding the practical value of the different approaches

remains scarce and scattered [Nolte et al., 2008]. Moreover, the diversity of the health care

systems in Europe makes it that less possible to find a universal solution to cover the multiple

challenges generated by the chronic diseases. Thus, the focus directed towards a manner of

offering medical assistance through the usage of software applications, dedicated to the

storage and management of medical information, comes as a promise to do faster and better

things that can already be done through other methods. If they are correctly exploited, the

software applications could become a new instrument with universal value that could help in

providing high quality health care. The basic concept in the IT implementation is represented

by the open systems, which enable interoperability and integration. The interoperability is the

availability of the information in one application to other applications; for instance, it allows a

symptom or a therapeutic scheme in one file of the patient to be “served” directly in an expert

system for decision assistance and in a European epidemiologic database. Integration is the

interconnection of different specialized applications in a wider system that permits a synergy

between various levels. One example is the integration of the medical charts from different

specializations, imagistic systems and lab analyses (radiology, biochemistry) in a hospital

informatics system; another example is the interoperation within a network of primary health

care and hospitalization systems in different regions, with supplementary connections to an

insurance agency or medical institutions with various specializations [Şufaru et al., 2009]. For

the users of the health care services it is important to underline the probabilistic nature of the

process of health nursing, whose progression towards a common finality is not performed

through a linear system. Hence, the providers of health services must be able to face an

imprecise demand in each stage of the process of health care exploitation [Goodwin et al.,

Toader E., Software applications integrated in the management of the patient with

chronic liver disease.



65

2004]. Moreover, the integration in health assistance of the software applications is less likely

to follow a single path, the variations being unavoidably possible. This fact implies the

existence of norms, standards and guidelines of practice that can simplify the decisional

process in health care services.

Software applications integrated in the home supervision system

The development of a software application for the management of the patient with a

chronic disease (e.g. chronic liver disease) focuses on the initiatives that can interoperate with

the medical records systems available for the care of the patient. This type of application must

function as a companion dedicated to the decrease of the incidence for the complications

developed by the patients with chronic disease and improvement of the quality of life.

Software applications may have different configurations, in order to reflect various

environments in the health care system, and a variable degree of complexity, in correlation

with the range of options available for the establishment and maintenance of the connections

between the components of the program of medical care. The degree and dimension of the

integration of the software applications go from sequential (clinic, professional,

organizational or functional) to complete integration, which joins together all the component

elements [Axelsson et al., 2006].

In descriptive terms, the clinic integration involves joint or team practices, while the

professional integration implies contracts or strategic alliances between professionals in

health care, developed in and between institutions and organizations. The organizational

integration establishes the dimensions (networks, merges, contracts or strategic alliances

between medical institutions) and the type of integration, discerning the horizontal integration

(between activities and work units that belong to a single system) from the vertical integration

(joins together organizations from different levels of the hierarchical structure) [Fabbricotti,

2007].

Integration of the software applications concerns the extent to which the medical care

services are coordinated between different individuals (medical staff) and units in the health

care system. The efficiency nucleus is the ability to adjust the functionality of the program, so

that the entire nursing team could access through a computer or mobile device a unique

combination of clinical, paraclinical and behavioural data about the patient. The application is

designed in order to acquire information on the daily life of the patient, to analyse, summarize

and display data, to inform the users regarding the nutrition, physical activity, emotional

status etc. At the same time, the application will enable the interaction with a case manager

(heterogeneous group of professional medical assistance) in order to provide a better health

care, through the usage of a unique set of instruments especially designed in order to meet the

needs for the gathering, interpretation and documentation of the patient care [Axelsson et al.,

2006]. Moreover, an important aspect in the computer-assisted disease management is that it

provides advice for self-care actions, through the configuration of a personalized model of

continuous care, which, unlike the episodic care available in the traditional model, facilitates

productive interactions between the patient and the providers with expertise in specialized

medical care. With the support of these applications the patient becomes proactive and armed

with the necessary information to maintain the control of the chronic disease. The application

improves significantly the results of the patients, decreases the rate of complications and

reduces considerably the costs of the medical assistance.

Management of the patient with chronic liver disease

There is general consensus that an efficient management of the chronic disease is one of

the biggest challenges that the health care systems have to confront. There is also a consensus

that this will require new modalities to provide medical assistance, involving the integration

of service providers or, at least, a much closer coordination of the activities performed.

However, beyond these common issues, there is less consensus regarding the modality in


66

which this process should be achieved. In practice, the patients with chronic diseases face a

range of necessities that determine behaviour changes and the engagement in activities

promoting physical and psychological welfare. The patients with chronic disorders make self-

management decisions every day for their illness, which involves interactions with medical

services providers, the adoption of therapeutic schemes, monitoring of health status, nursing

associated with the medical decisions and the management of the impact of the disease on the

physical, psychological and social condition [Clark, 2003]. This reality in the care of a patient

with a chronic disease introduce a new paradigm – the professional partnership of a patient,

which involves, through the education and formation of self-care abilities, the concern for the

achievement of the best quality of life for his chronic state. While the traditional education

provides the patient with information and technical abilities, through self-care education the

patient gains abilities to solve problems. A focal concept in the self-management of the

disease is self-efficiency, which consists in the confidence to acquire a behaviour needed for

the achievement of a coveted objective. The education for the self-management of the chronic

disease could become an integrated part of the high quality primary medical assistance, with

the mention that this involves an increase in the self-management responsibility, which may

create serious problems for the patients with multiple pathologic conditions (important and

impairing co-morbidities). Even the clinical studies suggest that although the education for

self-management improves results and may reduce costs, only in certain circumstances the

programs of teaching self-management abilities are more effective in the improvement of the

clinical results [Bodenheimer et al., 2002].

Objectives of the management The objective in the care of the chronic disease is not the

cure, but the improvement of the functional state, the minimization of the symptoms, the

prolongation of the life span through prevention of the complications and the increase in the

quality of life [Grumbach, 2003]. It is clear that these objectives are unlikely to be achieved

through the traditional medical approach based on the individual disease and on the

relationship between the doctor and the patient. The manner to provide a more diversified

palette for the medical assistance is established in a wider framework of the health care

system, where the distribution of the health care services is organized in correlation with the

funding resources and the policies in the area. The increasing larger implication of the

potential for the usage of the information technology in the medical problems may offer an

answer to the challenge to develop a work force for the response to the change in the medical

assistance environment.

In this direction, a first objective in the management of the chronic diseases is to turn

the balance between treatment and prevention, through the identification of the opportunities

to increase early intervention, together with a wider recognition of the benefits obtained

through the reduction in the burden of the disease, as a method to relieve the pressure on

health care systems [Nolte et al., 2008].

Another managerial objective focus on the alternatives for medical nursing provided for

the patients with chronic diseases outside of the hospital. From the point of view of the

organization, the hospital offers more easily complex packages of care, but with

disadvantages for the patient, whose freedom is restricted. The alternative (for patients with

certain conditions) could be the care in their own homes, but with improved medical care or

other types of support (software applications). However, this situation introduces another

level of complexity with respect to the method of evaluation of the patient’s needs and the

care alternatives provided [Hensher et al., 2002].

The implication of the patient in the self-management program must be in balance with

the professional level that the condition imposes. This objective requires a patient informed in

a specialized environment and a permanent contact with the providers of medical assistance

for the necessary support. In the clinical practice, the initial enthusiasm for (self)-care outside


67

the hospital is confronted with the individual characteristics of the patient, which limits the

tendency for self-care through the motivational determinism of the patient, who correlates

himself with the traditional values of the health state [McKee et al., 1995].

Ethical issues in the management of the patient with chronic disease

The most frequent ethical issues involved in the management of the patient with chronic

diseases that integrates software applications concern the usage and distribution of

information, the confidentiality (all or nothing – without discrimination), the informed

consent, the balance between risk and benefits, the supervision and possible loss of intimacy

and autonomy and finally the increase of self-isolation. Without debating in detail these

aspects, we would like to mention also the most frequent questions that this type of

management, developed through the integration of software components, involves: How is the

right to confidentiality ensured and protected? How is ensured the security of the data and

their restriction of accessibility only to the persons they are destined for or that have an

authorization for visualization? How is the unwanted interception prevented or the

information disclosure? Who is responsible in the case of an abuse of the data? What are the

certificates and competences of the remote doctor? What standard of care is offered to the

patient? Who regulates and controls the certificates of the physician, as well as the accuracy

and integrity of the information? How is the informed consent obtained for the patient in a

remote centre?

Another aspect implied by the complex management that integrates software

applications relates to the protection of the information in accordance with the eight principles

of good clinical practice [Şufaru et al., 2009]: the data must be (i) processed clean and legal;

(ii) processed for limited purposes; (iii) adequate, relevant and non-excessive; (iv) accurate;

(v) kept as long as necessary; (vi) processed in accordance with the rights of the patient; (vii)

secured; not available for transfer between countries without adequate protection.

Beyond the benefits resulting from the improvement in the quality of life, the close

contact with the family environment in safe medical conditions and the better results for the

chronic condition, the software applications integrated in the management of the chronic

disease do not remove the generation ethical conflicts and dilemmas. Thus, we will give some

frequent situations in practice, which illustrate eloquently a series of issues [Toader, 2010].

Efficiency versus confidentiality relates to the need to know and share personal data

regarding the health of the patient, with the purpose of a quality care but creating an indiscrete

situation that could compromise the confidentiality.

Intimacy versus the collective good implies that the intimacy could be exchanged with

collective goods (research, administration, planning and prevention) from which the

community or the population could benefit.

Quality versus professional autonomy: some professionals are afraid that the standards

for quality (protocols, clinical principles etc.) will restrict or diminish professional autonomy.

Efficiency versus benefits: while the benefits represent the offer of the best care for each

patient, this can be very expensive and impractical. Within the context of limited resources

available, to provide a patient with expensive health care could deprive another patient of the

necessary basic treatment.

The integration of software applications in the management of the chronic disease will

create opportunities for supplementary benefits for the patient, both from the medical point of

view but also from the professional, economical, social approach, and at the same time from

the viewpoint of the value system correlated with the personal representation of the illness

and chronic affliction.


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2.2. CLINICAL SIMULATIONS – A LEARNING TOOL

2.2.1. Ethical values of the medical education

In a globalized world, health needs are a priority and the integration of ethical

requirements in medical education falls within the lines of this priority by professionally

training the future physician in a multicultural context. Starting from a set of joint values,

which have as focal point the right to health, the development of cultural professional

competencies will contribute to provisioning access to healthcare and guaranteeing quality

and safety of the medical act [Eckles et al., 2005]. Towards this end, medical education is

promoted within the context of globalization as a proactive strategy, with the purpose to

increase health benefit in a world in perpetual movement and change and to contribute to the

increase of protection of worldwide health [Bélanger, 1984, Koehn, 2006]. Here I am aiming

to approach the relationship between medical education of healthcare services providers and

globalization from the ethical perspective. Starting from the argument that the approach from

the ethical perspective of medical education within the context of globalization allows for a

better understanding of the requirements of contemporary medical act, the main issues refer to

the ethical needs of medical profession worldwide, the ethical aspects of medical education

and to the extent to which medical education corresponds to the contemporary level of

globalization.

Ethical requirements of the medical profession worldwide

Globalization is one of the key challenges for political decision factors in health issues

and the public health practitioners [Bélanger, 1984, Eckles et al., 2005]. Although there is

increasing literature regarding the significance of globalization for healthcare there is still no

consensus on the pathways and mechanisms through which globalization touches human

health and, consequently, no adequate health policy answers have been formulated [Crandall

et al., 2003, Paasche-Orlow, 2004]. Furthermore, health is an extremely complex aspect, and

given that globalization processes are far from being simple, an explicit framework is

necessary in order to elaborate appropriate health policies. The consequences of globalization

may have a direct impact for populations, physical individuals and healthcare services

provider systems, or indirect, through economical determinants and other factors such as

medical education [Woodward et al., 2001]. In view of the dimensions and complexity of the

problems the two concepts entail, the investigation of global context health highlights the role

and importance of medical staff (especially physicians) and health equity [Bélanger, 1984].

The approach from the perspective of the „open doors” policy of the importance of the

medical staff who benefited from training abroad, as well as the mobility flux and numerous

interactions with professionals in various countries made the medical profession, with its core

values, specialized knowledge and competencies a worldwide concept increasingly clearer.

Such an international profession cannot become a reality without basic training, which defines

what makes a physician, regardless of the country or academic institution where he/she

attended medical education [Akl et al., 2012].

The worldwide medical profession involves the physician as citizen of the modern

world in the promoting and protection of health at the social level. The agreement to fulfill

this mission represents a commitment to respect the rights of the individual and of human

dignity that define the social essence of well-being. Thus, to be a physician in the global

context appeals to unity in diversity, in order to identify and define fundamental values

through the term of physician. The second aspect of health equity is based as ethical value on

the principle of distributive justice and in accordance with human rights. Through their

Toader E, Balan G, Iliescu DB. Ethical values of the medical education.



69

characteristic features, the two concepts of health and globalization compel the medical

education of future healthcare professionals to contributions that will decrease in a noticeable

manner the inequities in healthcare, conforming with the respect of the individual,

professional competence and correct and equitable distribution of goods and services

(principle of justice) [Akl et al., 2012].

Ethical aspects of medical education in global context

In order to highlight the role of ethics in the process of decision making regarding

health needs, we believe it is necessary to determine the ethical objectives of the worldwide

educational curriculum and the ethical aspects involved in professional training programs for

future physicians.

Medical education in global context – field of study and application domains.

In the context of globalization, medical education must be organized in a formative and

cumulative manner, so that it would be equipped for the identification and consideration of

special and personal circumstances, or social impact ones, for each patient individually.

Towards this end, health initiatives and interactions should be based on a medical education

with curriculum requirements focused on abilities and competencies envisaging health

inequities, evaluated on qualification fields depending on cultural level, degree of social

absorption and usage, and on personal preferences of the patient [Epstein, 2007]. Obviously,

these objectives are commendable for the medical education, but for a practical purpose and

based on ethical arguments it is best to attempt the acquirement of a set of competencies

which would allow students, as future physicians, the identification and solution of ethical

dilemmas that they will frequently encounter in medical practice. The fact that the student is

rarely taught individually empathy, humanity or altruism requires from medical education

training programs with ethical focus, founded on principles such as benefaction, justice and

social justice. These abilities will develop in the future physician the abilities to promote

patient autonomy, to offer trust and self-respect, essential features in the relationship with the

patient. The issue to be solved is how these notable and regrettable absences from the

experiences of the students may be covered by the curriculum in order to generate

competences with ethical value for medical education. Concerned by the evaluation methods

of medical education (basic knowledge, abilities, competencies, ethical requirements), Epstein

states that new methods will be necessary for the combination of the qualitative and

quantitative data for the portfolio of clinical ethical abilities of a student, which can be applied

on a large scale but also withhold the test of time [Schwarz, 2001].

Ethical objectives of medical education curriculum

Current medical education reveals different levels of medical knowledge with

significant offsets between the required practice and the skills gained by the students,

variations between the recommended and the applied standards and last, but not least, lack of

institutional vision and cooperation. Apparently, no global system does not provide the

application of international standards, while the competitiveness level in medical institutions

hinder the task of insuring high ethical standards in medical education and professional

training [Pellegrino et al., 1993]. Furthermore, there are many voices that assert that in order

to develop a comprehensive ethical curriculum the recognition of a wider cultural

environment is necessary for its functioning. The ethical objectives of medical education

suggest two points of view: ethics as means to create virtuous physicians and ethics as means

to provide physicians qualified to identify, investigate and solve ethical dilemmas [Eckles et

al., 2005, Pellegrino et al., 1993]. Ethical virtue is a framework that focuses on moral

character and less and correctness of an action. From Beauchamp’s point of view, the medical

profession must take into account five virtues: confidence, integrity, discernment,

compassion, and dutifulness [Beauchamp et al., 2001]. Ethics as educational and formative

instrument for physicians able to identify, investigate and solve ethical dilemmas takes into


70

consideration relationships, vulnerabilities and emotional motivations, providing a complete

ethical analysis and encourages the application of more flexible and creative solutions than

principialism or consequentialism. This approach proposes the externalization of medical

competences specific for the medical field in social, professional and familial environment.

Moreover, in order to minimize any negative consequence regarding cultural differences,

learning about culture entails embracing pluralism, with the aim to advance in the compliance

with the right to health towards the essence of the principles of autonomy, caution and

responsibility taking into consideration that physicians are frequently confronted with cultural

practices which come against medical practices [Bélanger, 1984].

For a worldwide medical educational curriculum, designed in accordance with the

recommendations of individual researchers, professional associations and reform committees,

the chosen ethical values are honesty, responsibility, compassion, and professional

consideration, ethical values which are frequently brought up by academic discourses as well.

In Stern’s opinion (1998), the ethical values of medical education must be focused on

responsibility and compassion, with the recommendation to encourage their teaching in

medical education [Stern, 1998]. These objectives, relevant for the medical education, place

the emphasis in the relationship physician-patient on communication, empathy and altruism

towards the patient. Additionally, the compliance with other cultural values requires a

pluralist approach, which allows for different points of view. Within this framework, the

cultural competences in medical education may be viewed as a “moral good”, which yields a

simultaneous commitment of the patient to comply with the principles of autonomy and

justice. This is the manner in which cultural competences of medical education and medical

ethics support each other [Paasche-Orlow, 2004].

The moral, ethical and deontological values included in medical curriculum should also

be imposed to healthcare systems in order to bring about appropriate modifications where

they are necessary in order for patients of different nationalities to feel welcomed in any

medical institution that can offer them competent and high quality medical care.

Will globalization of medical education be in accordance with medical practice?

According to WHO (1946), „the right to health must be respected at the highest

standards, without differences regarding race, religion, political convictions and social or

economic condition" [Bélanger, 1984]. It is the duty of healthcare professional to promote

worldwide health as a „global public good” [Kaul et al., 1999] and to guarantee that through

healthcare, the benefits will be for everyone.

Another necessary highlight for medical education refers to the formulation „cultural

competence”, which, in daily practice, yields exposure to the main error, given by the fact that

is based on a unilateral evaluation, focused only on patients, ignoring the moral conscience

and representation of ethical values of the physicians who provide healthcare [Betancourt,

2003]. We must admit that the physician may not have the ability of a complex cultural

identification, but he has the capacity to manage o wide range of cultural beliefs of the

patients originating from different societies with various ethical principles and moral

convictions which bear the hallmark of the cultural environment configured by years of

history [Crandall et al., 2003]. If we exemplify for the European Union, within the framework

of the cultural intersections in the medical field numerous aspects are signalled where ethical

principles are conditioned by the differences originating from multicultural societies (patients

share points of view of the diversity in moral systems from fundamental principles until

affirmation of moral value of each individual [Paasche-Orlow, 2004]. This meaning of

relativity of moral and ethical values raises the question to what extent, in a globalized world,

the ethics of medical education will be in harmony with medical practice? For a student it

would be impossible and he/she cannot be compelled to adopt the whole spectrum of relative

culture, because many of the occidental ethical norms are coded for most situations in medical


71

and law practice standards. The development of international standards submitted by

professional organisms, both in the field of quality of healthcare and in medical education

(Alpha Program, IIME – Institute for International Medical Education, World Federation for

Medical Education) pledge an equivalence for quality acknowledgement (both in medical

education and in healthcare), in accordance with the significant increase in the circulation

potential of patients, and of professionals in healthcare beyond national boundaries and to

externalize medical procedure accepted worldwide [Segouin et al., 2005].

But does the adoption of universal standards contribute to the improvement in access to

healthcare in a globalized world?

In an interpretation founded on economic arguments, reduction of healthcare costs

could provide a wider access to healthcare services. But this aspect must be refined, due to the

fact that in the globalization process of healthcare, the development of international standards

in healthcare provision and medical education may contribute to improving access and quality

of healthcare worldwide, but without any guarantee that they are elaborated in the context of

cultural, social and economic differences in very different countries [Schwarz, 2000]. The

important thing is that the future physicians clarify the manner in which they may maintain

their own values and concomitantly comply with the ethical values of medical education.

The presentation in unified conceptual form of medical education in the context of

globalization with the associated ethical aspects yields joint perspectives, from which the

issues of public health can be envisaged, focused on the human resource (physicians) and

health equity. Taking into consideration the diversity of the contemporary medical act, the

shaping and unification into a conceptual framework of the information from several fields

(education, healthcare, social and politic environment) must be regarded as an assistance for

the student as training physician, when he/she will have the opportunity to exert their

profession in various cultural environment. Because in the context of globalization, new

thinking modalities are necessary regarding the role of ethics in medical education and the

manner in which it can contribute to promoting moral progress and improving worldwide

health.

2.2.2. Clinical Simulation – Efficacy and Tendency in Medical Technological Education

The development of technology and using it on a large scale of medical devices

implicates also legal, and social problems. Using as examples four powerful and largely

unregulated technologies-off-label use of drugs, innovative surgery, assisted reproduction,

and neuroimaging illustrate the difficult challenges faced by clinicians, researchers, and

policy makers who seek to advance the frontiers of medicine safely and responsibly [Eaton et

al., 2007]. Supported by medical history and case studies and drawing on reports from dozens

of experts, medical technology address important practical, ethical, and policy issues. They

consider topics such as the responsible introduction of new medical products and services, the

importance of patient consent, the extent of the duty to mitigate harm, and the responsibility

to facilitate access to new medical therapies. This work's insights into the nature and

consequences of medical innovation contribute to the national debate on how best to protect

Toader E. Ethics in medical technology education.

Revista Romana de Bioetica. 2010 Apr 1;8(2).

Toader E. Damir D., Clinical simulation – efficacy and tendency in medical

technological education.

In Advenced technologies for enhanced quality of life AT EQUAL 2009, p:71-73.


72

patients while fostering innovation and securing benefits [Blair, 2001]. Modern medical

practice calls more and more upon medical technologies based on the necessity and

developing the cooperation between medical staff and specialists in engineering, informatics

and exact sciences. The outstanding but also accessible medical assistance represents an

essential component of the quality of life, assuring in a complex manner a state of welfare in a

physical, psychic and social way. In all times, sciences and techniques had no barrier and their

association entered the medical field defining technological medical education. In

concordance with this evolution a new study domain has appeared as technological medical

education where medical and technical sciences cooperates for resolving these specific

medical problems. Medical clinical simulation plays an important part in teaching, in the

professional orientation with the students and the medical staff because it implies new

practical skills and competencies, as well as in research. A formative program of medical

technological education is first of all interdisciplinary must rely on a modern technical

program, focused on applications’ clinical simulation, contributing in a significant manner to

the growth of practical performances and ethical responsibility [Morgan et al., 2000].

Clinical simulation – goals [Li, 2007]:

Simulation as a teaching strategy with impact on competence and with impact on

patient care;

Clinical simulation is not a substitute for, but a complement to clinical experience;

Clinical simulation - supports the inclusion of state-of-the-art teaching strategies that

complement clinical experiences to ease the way towards practice competency;

The orientation of practical activities towards clinical simulation is specific to medical

training, assuring a greater particularization in the training of the medical staff, contributing in

a significant manner to the growth of practical performances and ethical responsibility. This

way, modern means of training, self-training and team work are promoted. Clinical medical

simulation has an important role for didactic activities and professional training with the

students and medical personal which help on knowing new practical competences and in

research projects [Enderle et al., 2012]. This type of approach is like the objectives of

accession to the European academic and professional structures. Medical simulators are

revolutionizing the practice of medicine. The clinical simulation is combined with traditional

methods of learning and represents a comprehensive method of learning. In modern society

all medical domains benefit of the actual technical progress. According to the technical

progress in medical education and the ever-greater requirements of preventive and curative

medical assistance safety, the need for more appropriate conditions and shorter lapses of time

are greater in the present time. The medical study practice makes it obligatory for the students

to be at the patient’s bed, in the dissection room, in the laboratory and also in the library

[Rogers, 2010]. Using the clinical simulation before actually getting into a medical practice is

a way to ensure a better heath “a social responsibility of medical learning” (OMS concept).

Simulation as a teaching strategy with impact on professional competence, a strategy which

anticipates real situations with guided experiences in a fully interactive way. By reproducing a

realistic medium, simulation does not substitute clinical experience but completes it, assures

the patient a safety and a better preparation for the medical staff. Simulation is not a

technology but a teaching strategy which connects theory and practice, following all the steps

of the class study, practice through simulation, clinical practice and finally real world.

Through clinical simulation there is a better communication between medical services which

reunite skill, simulation, reaction, information, disease, results. Simulation as a teaching

technique with a flexible strategy and standardized principles for the simulator, promotes

great experience and the opportunity of learning [Bronzino et al., 2005]. Medical education

through clinical simulation supports new training strategies and promotes a better training for

the students.


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Clinical simulation tendency and efficacy - T & E [Davis, 1981, Hesselfeldt et al.,

2005]:

E-prepares the students for a modern medical environment taking into consideration

that simulation is an active method in student development as he can apply his knowledge in a

true-to-life practice;

E-an ab initio training of the student in the era when the medical act is getting more

technical; the interest of the simulation is that to avoid all potential dangerous situations for

the patient therefore there is a zero risk for the patient and minimal stress for the students;

E-the clinical simulation is based on a system of preconfigured patients with different

ages, pathologic status, background, sex;

T-multidisciplinary simulation for getting professional competencies which are

fundamental for dealing with situations at various levels of gravity;

T-the simulation by reproducing different clinical aspects allows the student to acquire

new practical skills in patient’s examination;

E-the absence of the patient risk enables a stress-free approach of difficult medical

situations;

E-the absence of the risk gives the teacher the possibility to show students the

consequences of mall-praxis;

E-the standardization of the clinical medical education is for different activity

services, differed student groups or different study years. It is possible to have the same

scenario, yet a different simulation for different persons;

T-diagnostic and therapeutic procedures

T-the possibility of assessment of performances;

T-making work teams for complex situations.

With clinical simulations, students obtain the necessary knowledge for [Christensen,

2013]:

T-activities in medical laboratories;

T-an efficient management in the medical domain for differed medical specializations

(medical, surgery);

E-the knowledge necessary for the correlation between technical principles and

clinical applications of medical devices, imaging, diagnostic and interventional endoscopic

methods;

T-use of state-of-the-art techniques in performing medical actions, the young

graduates and the specialists in bioengineering having complementary technique as well as

medical training;

Conclusion The direct beneficiary of the professional training though medical clinical

simulation according to the curricula, are students, interns and medical practices which obtain

the necessary competence for working in medical or medical teaching environments.

2.2.3. Clinical simulations for learning medical skills: a work-based approach to

simulators

The development of practical abilities by the usage of virtual platforms dedicated to

clinical simulation of the reality in medical practice contributes to the learning and

acquirement of certain skills, reduces risks and complications that may occur during an actual

diagnostic or interventional procedure. The inclusion of clinical simulation in the curriculum

and the courses on medical simulators, in the form of mannequins – artificial patients (human

Toader E. Clinical simulations for learning medical skills: a work-based approach to

simulators. Procedia-Social and Behavioral Sciences. 2015 Jul 25;197:2443-8.


74

patient simulator-HPS) and diagnostic and interventional digestive endoscopy simulators GI

Mentor, are approaches of the medical education destined to promote in an straightforward

manner the increase of basic clinical competences and of efficiency in the formulation of the

objective clinical exam in a structured modality (on devices and systems), finalized with the

endoscopic examination of the digestive tract of the patient [McGaghie et al., 2010].

The definition pictures clinical simulation as a learning strategy with impact on the

professional abilities and competences, a strategy that anticipates or amplifies the concrete

situations, giving an interactive orientation towards the real medical experience. It is a

modern training method of self-learning and team work and it contributes through the realistic

scenarios to the significant increase of the hands-on experience, without any risk to the health

and welfare of real patients. Through the reproduction of the environment with enough

realism, the simulation does not replace but completes the clinical experience and contributes

to a better professional training in the medical field. We must outline that the simulation is not

a technique but a learning strategy that makes the transition from theory to practice, by the

undergoing of the learning process in stages, from the theoretical study to the simulation

practice and finally, real medical practice. In the application of clinical simulation, the

emphasis evidently moves from “to know” various work techniques and devices towards “to

use”, in order to form and exercise certain practical abilities. In this manner, clinical

simulation contributes to the increase in the quality of the medical services, which comprise

information, communication, exercise, ability, skill, reaction, disease and results [Lateef,

2010, Swanwick, 2013, Wallace et al., 2002].

The objectives of clinical simulation are centred on a series of activities focused on

[Bradley, 2011]:

Promotion of modern training methods, self-training and team work;

Acquirement of practical abilities and competences;

Individualization of student training;

Increase of practical efficiency;

Increased security for the patient.

What can be simulated?

Technical abilities involved in the clinical examinations, diagnosis and therapeutic

procedures centred on the capacity to prove dexterity, to use a medical device and to perform

a correct medical act.

Non-technical abilities involved in communication, practice in decision making, team

work, control of efficiency. We must stress that we can also simulate the malpractice cases,

which can be later theoretically commented without real consequences for the patient [Akaike

et al., 2012].

Technical equipment – The practice of clinical simulation requires simulation

laboratories, technically equipped with simulators and accessories necessary and adequate for

the approached medical domain. For the clinical examination, there are simulators (e.g.

artificial patient-mannequin and digestive endoscopy simulator GI Mentor) that can duplicate

various standard or custom configured scenarios, in order to recognize certain signs and

reproduce symptoms according to the clinical case. The clinical simulation is based on a

system of previously configured patients, of various ages, pathologic state, background, sex

etc., with the possibility of using either the patients of the simulator or to modify the existent

patients from the point of view of the above-mentioned parameters.

Clinical simulation – role and significance in student training

The aim of simulation is to train students – future doctors, in order to facilitate the

integration in the modern medical environment, taking into account the fact that medical

education by clinical simulation is an active method of formation, through the accumulation

and implementation of knowledge, in the framework of a practice very close to the real one.


75

For an integrated context of presentation of clinical simulation, we have associated the

theoretical considerations with the experience of application and implementation of this

method / learning strategy in an account of the experience with the students of the Faculty of

Medicine in the University of Medicine and Pharmacy “Gr. T. Popa” Iași.

A group of 135 students, who attended the optional course “Medical education by

clinical simulation”, had the opportunity to practice on simulators and perform various

diagnosis and therapeutic procedures on the simulator – mannequin (HPS) and the digestive

endoscopy simulator GI Mentor.

Aim The implementation of clinical simulation with the interactive simulators HPS and

GI Mentor as an applicable system for the analysis and evaluation of the practical individual

abilities, and the supervision of their development during the module of student training, in

order to gain competences and efficiency.

Method: the simulation of clinical cases (diagnostic and therapeutic clinical scenarios)

on the mannequin – patient – standard or custom configured according to the requirements of

the clinical case and on digestive endoscopy simulator GI Mentor (idem 1).

Location: Clinical Simulation Laboratory – equipped with working material for the

teaching activity: A. Simulator mannequin (HPS-human patient simulator) B. Endoscopy

simulator – GI Mentor.

Mannequin – presentation (essential summary) The simulator is made of plastic and

sized to the real scale; it presents the physical characteristics of a male or female adult (the

sex is changeable). The mannequin is piloted by physiologic and pharmacologic mathematic

models that can automatically reproduce various clinical signs (such as heart and lung

auscultation, peripheral pulse, thoracic movements, opening/closing of the eyelids, voice,

clinical signs, symptoms and physiological status of the patient), as well as the response to

numerous interventions. The characteristics of the mannequin for the study scenario, i.e. the

configuration of the simulated patient are adjusted to the teaching objective and clinical

scenario, respectively [Rodgers, 2007].

The GI Mentor simulator offers an exhaustive teaching environment by modules such

as: cyberscopy; endoballoon, upper and inferior digestive endoscopy; emergency module –

digestive haemorrhage; eco-endoscopy module, ERCP module. The digestive endoscopy

module, through the selection of virtual patients with pathologies specific to the upper and

inferior digestive system facilitates the complete examination of the digestive system, the

identification and recognition of the lesions, therapeutic interventions for virtual patients with

major pathologies (e.g. haemostasis). It uses both virtual images of the digestive tube and

“training programs” for the improvement of individual skills [Fisher et al., 2010].

Teaching objectives (for each student and for the entire team):

Clinical examination, establishment of diagnosis, application of therapy and follow-up

of the post- therapy evolution, on the basis of real symptoms that the HPS presents.

Testing of the skills (dexterity, discovery and development of the abilities for the

employment of a medical device) for the digestive endoscopy on the simulator GI Mentor.

Self-evaluation: On the HPS, the students watched for verbal reactions of the

mannequin, the modification of vital functions (heart frequency, blood pressure, oxygen

saturation, breathing etc.) and response to therapy. For the GI Mentor simulator, the students

verified themselves through the self-evaluation chart of the software, following their

efficiency in correlation with the duration and quality of the examination (measurement of the

time of exploration, instrumentation of the proximal, cardia and distal orifice, pylorus,

intensity of the sonorous and visual- iconographic pain threshold, polypectomy, etc.) [Walsh

et al., 2012].

Results. The information from the recorded and stored self-evaluation charts reveals

two significant aspects:


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Observation 1. For the simulated cases with multiple lesions (e.g. oesophageal

diverticulum and gastric polyp) or with the association of a lesion with active bleeding (e.g.

gastric ulcer, haemorrhagic duodenal ulcer), the time indicators and the quality of the

examination improved for 77% of the students after three sessions of 15 minutes each. The

indicators supervised for the endoscopic evaluation were:

Pain recorded during the endoscopy/colonoscopy, measured on a visual scale;

Accuracy of the technique, through the dexterity of the insertion of the endoscope in

the oesophagus, cardia and pylorus, inversion of the endoscope in the fundus, surpassing the

splenic and hepatic flexure, instrumentation of the rectosigmoid junction);

Number of identifications and omissions of lesions and pathologic modifications on

the digestive segment examined during the endoscopy;

Best duration of the endoscopy.

For this category of the simulation the patients that undergo endoscopy (the mannequin

GI Mentor) with a beginner endoscopist (the student, respectively) must endure a prolonged

“discomfort” and examination. The endoscopic simulation, by its advantages, comes as

recognition of the necessity for training with the virtual electronic medical devices (preferably

highly modern simulators). The endoscopic simulation allowed the students to familiarize

themselves with the device, the procedure, the skill, but also with the patient (although

virtual) and offered them the possibility to gain fundamental medical abilities for the

management of the situations with various severity degrees and no risk for the patient. The

accommodation with the computerized part of the training module required minimal

instruction, and the practice on the simulator, organized into different levels of learning,

reproduced the actual reality in the majority of the scenarios [Baerheim et al., 1995]. In Table

6 we present a (self)-evaluation chart as an example for the clinical cases simulated.

Table 6. (Self)-evaluation chart

Nr. Type of procedure Occurrences Info

1 Upper digestive endoscopy Colonoscopy

2 Trainer comments

3 Examined percentage of the mucosa 88%

4 Biopsy//hemostasis//polypectomy, etc.

5 Examination of the duodenum – DII (observation of

the Vater ampulla)

Observation of the ileocecal valve

6 Pain during the examination Yes/No

7 Lesions omitted during the examination Yes/No

8 Air aspiration upon retraction of the endoscope Yes/No

9 Help granted/asked during the examination Yes/No


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Observation 2. We noticed an improved management of the complex cases simulated,

with focus on the examination time, diagnosis formulation and therapeutic intervention, for

89% of the students, after four sessions of 15 minutes on the HPS, as opposed to the

management of complex cases simulated on the GI Mentor (e.g. digestive haemorrhages with

haemostasis, stenosis with dilation, polyps with polypectomy, biopsies), where the duration

and quality of the exploration improved for 77% of the students after 10 sessions. For this

category, the practice on simulators regards mainly the indications of the method (simulation),

derived from the necessity of its introduction in the medical practice, the application domain

becoming increasingly wider and diverse. The arguments in its favour are the safety of the

patient, the skill of the examiner, risk reduction, management of training time, introduction of

new techniques, gaining experience etc. The contact with the possible anatomic variations and

the complexity and specificity of the cases offered the students during the entire module the

possibility to study, repeatedly and for an unlimited number of times, certain scenarios until

the acquirement of the dexterity necessary for good practice. An important aspect is that the

simulation lowered the stress induced by the contact with the patient, stress that generates a

negative impact on the professional abilities. Moreover, the adjustment to the medical device,

its understanding and handling, with no fear of incidents, had a positive impact on the student.

The clinical simulation, as method that uses software technology of learning and knowledge,

provided the student with the possibility of discovering himself in a new posture, to translate

the theoretical notions into practice with the help of medical devices, to gain self-confidence

and to surpass safely the anxiety threshold, a barrier that can cause the loss of many (future)

investigators [Morgan et al., 2000, Ziv et al., 2006].

In Table 7 we present the clinical examinations, investigations and therapeutic

interventions that can be performed on the HPS.

The students review: “Before this course I had a little misunderstanding about what it

means to work as a doctor in almost real situations” “This course has given me a greater

appreciation for medicine.” “This course made me see things otherwise, gave me courage in

trying to save lives, especially in emergency situations, and how sometimes it is better to live

the joy of others.”

Clinical simulation revolutionized medical practice. Used in association with the

traditional teaching methods, clinical simulation represents an opportunity for comprehensive

learning. The adjustment of medical education to the technical advances and the increasing

necessity for a preventive and curative medical assistance, safer, quicker and in more

adequate conditions are requirements of the present. The applicative characteristic of medical

training makes the presence of the students at the patient’s bedside mandatory, as well as in

the dissection hall, in laboratories and in libraries. Currently, all the medical domains benefit

from the modern technical progress, so the usage of clinical simulation before actual medical

practice is a modality of increasing public safety, a “social responsibility of medical training”

(a concept of World Health Organization).


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Table 7. Study case – Example

2.2.4. Puzzle method - the option to learn within the team

Medicine is faced with an extremely large volume of information, which often

surpasses the normal ability of reception and processing. Time management is exceptionally

important in covering, selecting and memorizing the information that, by its volume and

diversity raises serious challenges for the identification and experimentation of new methods

for teaching-learning-assessing. In this context, the endeavour that the teacher may initiate

towards stimulation of the student’s interest for knowledge, for the search and use of

necessary information in various circumstances, and for problem solving through planning

and organizing activities towards these ends is extremely important [Wood, 2003]. Modern

theories speak more and more of experience learning, where the teacher guides or facilitates

the process of learning, of exploitation and development of professional abilities,

simultaneously with the respect of cognitive rhythm and type of the participant, who wants to

acquire together with the trainer knowledge, abilities and skills. In the opinion of Kolb, the

transformation of experience into knowledge becomes the most efficient learning method,

because it can be controlled by experimentation [Kolb, 2014]. When applied in the field of

medical abilities and competences which should be acquired by the student, teaching and

learning practical activities through interactive teamwork methods (clinical scenarios,

application of diagnostic and therapeutic techniques) generate a challenging learning

environment that put the participants in the situation to apply what they have learned

[Rubinstein et al., 2009].

Puzzle method in clinical simulation

The puzzle method, when applied in association with clinical simulation (clinical case

scenarios on an artificial patient-mannequin, diagnostic and therapeutic techniques performed

Toader E. Puzzle Method–The Option to Learn within the Team.

Procedia-Social and Behavioral Sciences. 2015 Jul 25;197:445-9.


79

on endoscopy simulators), gains a higher position, as part of the educational strategies that

promote the reasoning of the clinical diagnostic and therapeutic behavior, by the active

involvement of students, with the practice of the ability to analyze and make opportune

decision at the right moment. Moreover, among other educational advantages of the method

we highlight the fact that it ensures a better application in practice of the knowledge already

acquired, as well as the practice of the understanding abilities in various circumstances.

Aim. Here we aim to assess the efficiency of the puzzle method for teams of Medicine

students in the context of the module of clinical simulation on mannequin and digestive

endoscopy simulators.

Educational objectives: the acquirement of knowledge and abilities (communication,

project management, professional conduct) in team activities and competences developed in

the simulation of clinical cases that correspond to current medical issues in the real life.

Work method: puzzle in teams of six students – with activities performed within the

team that represents the basic group. The activities for the completion of the designed goal

take place in several stages (six), called steps.

Step 1. Selection made by the instructor (or students, optional) of two clinical

scenarios from the case library of the simulator.

Scenario 1. Hypertensive crisis (blood pressure BP) = 195/115 mmHg, central pulse =

104 beats/minute, peripheral pulse = 97 beats/ minute, EKG = 3-5 isolated atrial

extrasystoles).

Puzzle by teams regarding the fundamental elements in the establishment of the full diagnosis

and of the therapeutic behaviour in the circumstances of hypertensive crisis.

Scenario 2. Upper gastrointestinal bleeding (UGIB) in a patient with virus B liver

cirrhosis.

Puzzle by teams regarding the fundamental elements in the establishment of the

diagnosis of gastrointestinal bleeding and of the adequate therapeutic behaviour.

Step 2. Each scenario was taken apart in subthemes as pieces of the puzzle, which

were distributed to the students in accordance with the professional and transversal

competences corresponding to their year of study.

Step 3. Formation of the working team; the students were divided into basic groups

(working team) of six students each, from different years of study: IIIrd year – two students,

IVth year – two students and Vth year – two students. Five basic groups were formed.

Step 4. The activities of each student were explained within the basic groups, for each

simulated case (the intervention of the instructor was made only at the request of the

students). The groups made sure that each participant understood exactly what he or she has

to do, in order to relay the necessary information. Table 8 presents the data of the clinical

scenarios in pieces of the puzzle distributed to each student, in accordance with the year of

study, learning objective and competence indicator.

Technical equipment. Simulator – artificial patient: measurement of vital parameters

(BP, pulse, heart rate, and respiratory frequency), EKG monitoring, laboratory data:

haematology, biochemistry, the pharmaceutical library comprises hypotensive medication

organized on therapeutic classes, ways of administration, dosages, perfusions, blood

transfusions, vasoactive medication.


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Table 8. Clinical scenarios in pieces of puzzle

The simulator for upper gastrointestinal bleeding (UGIB) comprise cases of varicose

UGIB, with options for the identification/observation of the source of bleeding such as

therapeutic or haemostasis procedures (pharmaceutical, banding).

Step 5 Evaluation. The teams retraced the selected clinical scenarios through the

summation of the data from the independent reports of the students. In the verification of the

indicators specific for the learning objectives we used the self-evaluation charts from the

software of the equipment, which records correctness of the procedures, number of

lesions/diagnostic and therapeutic procedures omitted during examination of the case. Table 9

and 10 present the self-evaluation parameters for the simulated cases.

Step 6. Results. The results provided by the self-evaluations, after the processing of

the information in the evaluation charts recorded and stored in the software of the simulators

showed:

1. 83% of the participants (students) from the IIIrd

year of study performed correctly the

activities corresponding to the established competence indicator, namely the clinical exam

that entails activities for the measurement of BP, heart rate, peripheral pulse, and

interpretation of EKG (table 11).

Table 9. (Self)-evaluation chart Human Patient Simulator (HPS) IStain Parameters


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Table 10 (Self)-evaluation chart GI Mentor – endoscopy simulator

No. Type of procedure Occurrences Info

1 Upper digestive endoscopy Yes

2 Acute gastrointestinal bleeding Yes/NO

3 Identification source of bleeding Yes/NO

4 Location Esophagus

5 Hemostasis Yes/NO

6 Procedure Pharmaceutical/ banding

7 Examination of the duodenum –

(observation of the Vater ampulla)

Yes/NO

Table 11. IIIrd

year: “pieces of the puzzle” activities for the simulated cases

Note According to the descriptors of structural elements in the professional competences we

noted that most IIIrd

year students used and applied correctly the specific knowledge for the

explanation and interpretation of new situations (the simulated cases) in larger contexts

(applications on simulators, teamwork). For the IIIrd

year students, the participation to the two

scenarios reveals that both theoretical and clinical reasoning frameworks, as well as

experience learning by group activities such as puzzle, may be suggested as foundations for

the increased educational integration of the association between the puzzle method and the

simulation in the clinical environment, preceding actual practice with real patients.

With respect to the IVth

year students the competence indicator regarding the

establishment of diagnosis (clinical, paraclinical, stage, complications) and definition of

therapeutic indications for the two simulated cases were performed correctly and completely

by 80% of the participants (students) (table 12).

Table 12. IVth


Note. The results show that students perceived the teamwork activity on simulators as

learning activities, which were assessed as very similar to those performed in the clinical

context with real patients. An element noted for the students from the IVth

year of study was

the association of the structural elements in professional competences with the practical skills

that the students acquired in the clinical context with real patients. Data from the literature


82

considers this association as an important contribution to the achievement of the educational

objective for practical application of the knowledge of diagnostic reasoning and therapeutic

indications [Bradley, 2011].

With respect to Vth year students, the competence indicator with activities regarding

therapeutic behaviour (selection of medication in the pharmaceutical library, administration in

adequate dosage and assessment of therapeutic effect) was performed correctly and

completely by 73% of the participants (table 13).

Table 13. Vth


Note. The results highlight the extent to which documentation and presentation of the results

from the independent activities to the other members of the group, the communication and

cooperation in the accomplishment of tasks, as well as knowledge transfer between members

of the group contributed to cooperative learning [Weimer, 2002]. This is the reason why we

see as important the manner in which we qualify the result obtained by Vth year students as

satisfactory or good. We believe that the evaluation of the results should not be restricted to a

simple mathematical reading of the percentage obtained by summation of the performed

activities (procedures), because the accomplishment of the educational objective, according to

the evaluation chart, entails complex activities for analysis and decision based on the

information provided also by the IIIrd

and IVth

year students. Thus, omissions and errors in the

simulated cases, although higher in percentage for the Vth year, they belong also to the IIIrd

and IVth

year students.

The group activity for the students within the two scenarios experienced clinical

practice reality and generated active solution of certain issues. The results show that the

students regarded the puzzle working method and the clinical simulation as application

context as correlated with the learning activities corresponding to the year of study and very

similar to those performed in clinical context with real patients. The older students, already

experienced with the activities of integration of the biomedical knowledge into the clinical

practice (IVth

and especially Vth

year students) appraised the puzzle method as a teaching-

learning-evaluation method for the clinical environment and for a stress-free „encounter” with

the patients. A special mention for this learning-evaluation method must be made for the fact

that the puzzle experiment, through the simulation of clinical cases does not produce the

emotional interaction, which the complexity of the real case brings in the real life.

Conclusions

Technological progress significantly influenced basic medical care and treatment

principles application. Complementarity between contemporary medical act and medical

biotechnologies have generated a new prototype of the modern practitioner and its actions.

Technological progress generates a considerable amount of concerns regarding ethical

implementation of the new doctor-patient relationship. Part of the patient’s parameters, part of

his personal life and peculiarities will be recorded and stored in digital format, generating a

hybrid concept that must be considered for future actions that might involve medical

decisions. Part of the direct interaction between patient and practitioner will be digitalized and


83

potentially stored in cloud storage systems. Thus, the whole ethical concept regarding this

relationship will be shifting in the digital area, being subject for a conceptual remodelling.

The practical implementation of the biomedical technologies supposes a continuous and

updatable ethical debate regarding potential usage for top/unconventional technologies at the

interface with human values and opinions diversity, reflected by individual judgement and

social perception of science and innovation. New technologies will always generate

challenges to ethicists due to the mandatory exploration of the potential involvement of the

moral and ethical values in order to avoid negative implications in the medical act.


84

3. BIOETHICS INTEGRATION IN THE SOCIO-CULTURAL

CONTEXT OF THE CONTEMPORARY MEDICAL ACT

3.1. SOCIAL AND CULTURAL REPRESENTATION OF THE MIGRATION OF

ROMANIAN DOCTORS

This chapter investigates the migration of the Romanian doctors focusing on the

interconnection between the social and cultural significations of the phenomenon. We

introduce two sections; the first presents the theoretical background for the analysis of the

migration phenomenon and the second centres on the exploration of the perceptions of

patients and medicine students regarding the social and cultural significations relevant for the

migration of the Romanian doctors.

The first aim is to build a theoretic framework for the explicit analysis of the

phenomenon through the presentation of the main international theories for the migration and

introducing the distinctions relevant for the social and cultural context in the Romanian

environment.

The second aim is to select and exploit the social and cultural significations relevant for

the research. We aimed to identify the variables that define the perceptions on the migration

of the Romanian doctors for the patients and medicine students.

The third aim is to identify the similarity or differentiation degree between the

perceptions of the patients and those of the students. Through the synthesis of the approach

from a dual perspective, both social and cultural of the doctor’s migration act, we aimed to

obtain data for the discovery of a “connection bridge” between the two characters (patients

and medicine students).

Toader E., - Project member „Postdoctoral studies regarding health ethics policies” (2010-2013)

with the research topic “Ethical, social and economic inferences of medical doctors’

migration from Romania”.

- Training sessions training sessions in Brussels (EU) and Bordeaux (Montesquieu

University - Centre européen d’études et de recherches en droit de la famille et des

personnes – CERFAP).

- Author of 5 ISI papers 2 chapters in author on two chapters of the monograph

entitled “On the road with Hippocrates – medical doctors migration from Romania”

(Polirom ed.).

- Member in EMPOWER project - Protect, Empower and support refugees, returnees

and internally displaced women in response to gander based violence- a multi-setting

intervention advocacy for health and social care, Rights, Equality and Citizenship

Programme, (2017).

Toader E., Sfetcu L., The Medical Migration: Experiences and Perspectives of Medical

Students for the Professional Career. Review of research and social intervention, 2013,

vol. 40, p:124-136.

Toader E., Current opinions of doctors and decisional factors on the migration of the

Romanian physicians: a study of several mass-media statements. Review of research and

social intervention, 2012 Jun 1;37:144.


85

Starting from the argument that the migration of the doctors in the contemporary

context imposes research directions in a wider social context, the main question to be asked is

how is the migration perceived as social and cultural significance among certain categories

of subjects with experience in the field, patients and medicine students? We also intend to

identify which are the variables that influence the perceptions of the patient and of the student

on the migration of the doctors.

3.1.1. Theoretical Background for the Analysis of the Doctors’ Migration

The significations that the contemporary society attaches to migration are numerous,

some conflicting, some changing, according to the evolution of the economic context, to the

juridical regulations specific for the domain and to the social and cultural aspects.

Regarding historical landmarks, the first scientific contribution to the building of the

concept of migration was that of Ravenstein (1985) [De Haas, 2010], who formulated the

laws of the migration, essentially connected with a set of deterministic rules on the basis of

which theoretical frameworks were built for the international migration. Later developments

evolved through the theories of neo-classic economy, with the refinement of the formulations

on migration, concentrated on the difference of salary between two geographic locations

[Jennissen, 2007]. This theoretical model takes into consideration the social actors in their

quality as migrants with freedom of decision according to the information and the

opportunities available. Using as central argument the factor of price equalization, the

neoclassic theory tried through the nuance an externalization in the social space, with the

placement within the functional paradigm of the social theory, taking responsibility for the

critic on the explanations convenient for the real migration models in a neo-classic context

[Portes, 1998]. The theoretic endeavors focused on the interaction between the analyses of

economic and those of sociologic nature lead to the development of the background for the

investigation of the migration. From this point of view, the purpose was to combine the

economic analyses offered by the system of the factors push/pull, with sociologic analyses

and concepts. For the migration in the field of healthcare these factors were extensively

described by James Buchan [Buchan et al., 2008]. For Romania, we remarked the opinion that

the “migration is a spatial expression of the social mobility” [Marcińczak et al., 2014] which

means a complex change with social effects, but also the approaches that consider the

migration as “a perspective of the durable relationship between assumed purposes and means.

These are rational structures for action, relatively durable for the agent that adopts them

[Sandu, 2010] or as a form of objection “against changes and abandonment of a country

where they do not find the place they would wish for” [Gentile et al., 2012].

The theory of social resources [Lin et al., 2001] proposes a series of development which

announce the contemporary discussions on the concept of social asset, the source of human

asset through the possibility of its conversion in any form of asset (e.g. educational asset)

[Coleman, 1988]. In the opinions specific for the Romanian context, these aspects have the

signification of brain drain which in most cases expresses the fact that the migration of the

educated and qualified work force from the poor countries towards the rich ones aims for a

superior professional recognition and remuneration, which are achievable in the developed

countries [Stănică, 2008].

The theory of the global system of migration tries to explain from a macro-social

perspective the dynamics between the commercial globalization and the interaction among

different societies as an important factor in the modification of the social aspect [Martínez-

Vela, 2001]

This theoretical presentation of the analysis framework for the phenomenon of

migration of the doctors, with special distinctions for the Romanian context, will allow the

classification of the empirical results of the study performed with the intention of selection

and exploitation of the social and cultural significations relevant for the research.


86

Social and Cultural Significations of Romanian Doctors’ Migration

The second dimension of the research focuses on the analysis of certain data referring to

the perceptions of the cultural and social significations of the migration of the doctors

obtained after the application of questionnaires to two groups of respondents (90 patients and

60 students) with 9 questions (February – April 2012), oriented on two main directions:

personal context and migration of the doctors with distinct sections focused on the interest

and the information in the social and cultural context associated with the phenomenon of

migration of the doctors (reasons to migrate, adaptation in the destination country, healthcare

systems in the EU, healthcare system in Romania, benefits and costs of migration) until

details on the phenomenon. Taking into account the role that the migration of the doctors may

play in the personal context of the respondents, we deem important the exploitation of the

information obtained from the patients, due to their experience with the healthcare system and

from the medicine students, as future doctors. From the methodological point of view we

introduced the opinion of the specialist in the medical field, with the adjustment of the

instruments specific for sociology, specifically for the efficient valorisation of the perceptions

of the two characters at the interface between sociology and healthcare system.

The results obtained reveal that from the point of view of 87% of the patients and 86%

of the students the phenomenon of the Romanian doctors represents an issue. It is worth

mentioning that for 67% of the respondents, the information on the migration of the doctors

comes from a personal context (family, friends, acquaintances) and 24% indicate other

sources of information (mainly media). The 87% respondents that consider the migration as a

solution support the affirmation by financial reasons (92% patients) and material and

professional ones (83% students). With respect to the healthcare system, the migration of the

doctors is perceived by the patients (85%) with a strong impact on the access and mainly on

the quality of the medical services, while the medicine students (89%) believe that the

technical base, the bureaucracy and the difficulties in the professional achievement are the

key aspects. The convictions on the modality of professional and cultural adaptation of the

doctors in their destination country in EU space are obvious for the students, who in 76% of

the cases think about a career abroad. In the group of the patients, although the majority does

not have information on this aspect (79%), it is remarkable that none of them signals that they

know of Romanian doctors creating problems in the EU countries. A suboptimal response

(21%) is registered at the evaluation performed for the level of knowledge and trust in the

healthcare systems from the EU, their performance being acknowledged both by patients and

medicine students, but without informational background on their functioning modalities.

3.1.2. Patients and students on the migrating doctors – social and cultural significations

Connected to the migration phenomenon, the patients through their personal context

(the experience with the healthcare system) and the medicine students as future doctors

present an increased interest and confer importance to the information on the migration of the

doctors. The analyzed data confirmed that the perceptions of the patients on the migration of

the doctors originate in the value associated with health, while for the medicine students these

are focused on the professional achievement. For the patients the migration of the doctors is

perceived from the point of view of the difficulty to access medical services and the

modification of the quality of the medical care, while students, through contact with a series

of difficult situations even during their professional development, acquire an anticipative

socialization of a negative relationship with the national healthcare system where they are to

exert their profession as doctors. The migration, as a solution for a bigger income, represents

the perception of the patients on the reasons of the doctors to work abroad, with the

signification of the “supra-solicitation” by economic component of the relationship between

the status that the doctor has in society and in Romanian outer-medical culture and the

satisfaction of its work [Parsons, 1951]. For a student the migration of the doctors is


87

perceived as a modality to utilize the educational asset in a social and cultural environment in

the destination country which will allow a distinct evolution of the professional status which

is acquired with effort in the native country [Sandefur et al., 1998]. In the emphasis placed on

the income and professional achievement in the formulation (individual or cumulative) of the

motivations of the doctors to migrate, both for the patient and for the student, it is omitted the

social and cultural signification of the efforts as “costs” for the educational asset acquired

through studies paid by the state in the native countries, in the context where education is an

important factor in the determination of ascendant mobility chances.

3.1.3. How is perceived the migration of the doctors by patients and future doctors?

In the designation of the variables that define the perceptions of the respondents we

must underline the role of the social and cultural context as mechanism of conditioning and

the way it filtrates information, having a significant contribution to the formation of the

representations on the migration of the doctors. The variables that determine the perception of

the patients referring to the difficult access to medical services and the modification of the

quality of medical care as consequences of the migration of the doctors were statistically

retained only as a percentage formulation. For a relevant statistic we believe necessary an

expansion of the evaluation of the migration effects (multivariate analysis). Thus, for the

aspects with social signification we consider as important the frequency for the occurrence in

conversation of the aspects related to the migration of the doctors, while for the cultural

signification we deem as determining the importance granted to the migration of the doctors

by the number of autobiographic details evoked, as being linked to this phenomenon. In the

case of the students, the variable by which the manifest their interest to exert their profession

abroad is deductible and supported by the modality of aggregation of the answers related to

the phenomenon of the migration, the perception of the benefits and the easy adaptation in the

social and cultural space of the destination country. The question to be asked is to what extent

the perspective of the students to migrate will become a reality? For an answer prospective

studies are necessary which can confirm of not the reality as a migrant of this optioned

asserted by the medicine students. In these two variables of the perceptions of the social

actors, although distinctively formulated from the perspective of solutions, we must notice the

dominant orientation towards the decisional factors.

3.1.4. Migration of the doctors – similarities and differences

On the demographic structure of the study cases (patients) we can observe differences

of perception according to environment (urban – rural) and level of education. Most patients

from rural environment and with primary educational level do not make a distinction between

the social and cultural values associated with the migration of doctors. Although the patients

and the students recognize that the migration of the doctors is an issue, there is a

differentiated perception in the opinion of the two characters on the sources that generate and

maintain the mechanisms of the development of the phenomenon. The patient believes that

the financial motivation is dominant in the decision to migrate, while the students has a

different approach, from the perspective of the professional, material, social and cultural

cumulated causality (cumulated causality) [Arango et al., 1998]. For them, the best society is

that that manages to offer “proper dosages” from all the great cultural and social values

associated with those political and economic [Hanlon et al., 2011]. If in the perception of the

student the accent is placed on the benefits (material, social and cultural values), the patient

perceives the migration in its negative dimensions, if we refer to the transfer from the

theoretical space in the applied sociology of the signification of the costs for health “as social

right”. The “cost value” is perceived by the massive departure of the doctors which can lead

to the dissolution of the communities, especially in the rural environment, while the migrants

may gain access to a superior social and natural environment [Doboş, 2006].


88

3.1.5. Study limits

As limits for the accuracy of the information we can consider the subjectivity, the

medical education level of the patient and the information degree of the student and patient on

the healthcare systems in the EU states. Another limit is the rhythm of the phenomenon of

migration of the doctors, which inside the development perimeter (EU space) has a permanent

informational dynamic, with numerous transfers and transformations.

Conclusions

The social and cultural significations on the migration of the doctors place an emphasis

on the aspects related to the social objectives of the healthcare system with respect to the

beneficiaries (patients) but also to the human resource, regarding the professional

achievement and social status of the doctors, from the perspective of the medicine students.

The variables on which the perceptions of patients and students are founded underline the

cumulative causality centred on economic dominants (patient) and professional career

(students). It is worth mentioning that the perception referring to the social and cultural

significations of the migration of the doctors in the formulations of the two characters raise a

series issues and place questions oriented for solution by the decisional factors. Knowledge of

the social and cultural significations of the migration of the Romanian doctors from the level

of the patients and medicine students can bring clarifications in the understanding of this

complex phenomenon and can fundamentally influence the efficiency degree in the

implementation of various reforms, in this case of healthcare policies.

3.2. CROSS-CULTURAL MEDICAL EDUCATION A CHALLENGE FOR

MIGRATING PHYSICIANS IN THE GLOBALIZATION ERA

In its various temporary or permanent manifestations, migration defines present and

future world order [Faist et al., 2000]. The specific contemporary problem of this process is

how this will of economic, political and social integration into cultural diversity is articulated.

In contemporary discourse on migration and globalization, the triad nation, culture and

identity is a topic always debated on, whatever the order, as one may start from the issue of

identity to reach culture and nation, just as one may consider culture as a background for

national identity investigations. This discourse becomes even more important in the twenty-

first century when the scope of the demographic dynamics phenomenon triggers new

challenges, including for health. Take, for instance, hospitals in Europe where most of the

beds in maternity and pediatric wards are occupied by emigrant patients, whereas in New

York City, starting with 2000, six of ten children had at least one parent born abroad

[Bernstein, 2005].

In the context of globalization and as a result of poor health system funding, many

countries are not prepared to deal with health problems that people on the move can

experience. The increasing number of problems caused by the connection between freely

moving people and pathogens is a growing concern [Grondin et al., 2003]. The fast

transcontinental spreading of the severe acute respiratory syndrome (SARS), the spreading of

the polio virus from northern Nigeria to Indonesia [McNeil Jr, 2005] and the threat of avian

influenza pandemic are only some examples that confirm that migration reduces both

distances and disease spreading time, especially when infections are concerned, as the latter

Toader E. Cross-cultural medical education a challenge for migrating physicians in the

globalization era.



89

impact both lifestyle and health protection. Most studies on human migration and health

underline the different national concerns for population surveillance and security. In a

globalized world health needs are a priority, and the need for cross-cultural and intercultural

health education subscribes to this professional training priority addressed to healthcare

providers, in particular to physicians, in a multicultural and multinational context.

Arguments supporting cross-cultural medical education [Koehn, 2006]:

• role of medical staff in the healthcare system regardless of geographic area in the

world

• cross-cultural medical education – proactive strategy designed to increase the health

level in an ever changing and even moving world.

• equitable health services – a promise according to which cross-cultural medical

education undertakes to help reduce health disparities in an immediate and noticeable manner.

3.2.1. Transnational skills in the van of medical education in a globalized world

Human mobility cannot keep up with the challenges accompanying it and with the

numerous and rapid changes occurring worldwide. In the context of globalization, the rapid

pace and considerable extent of the migration phenomenon are ahead of the medical education

and professional training curricula. Moreover, many nations are faced with their patients’

multiculturalism in this borderless geographical space [Kasinitz, 2004]. Cultural educational

competence, originally intended for the internal management of the specific interactions of

two or more cultures, has limited use in the ever changing medical field. Regardless of

ethnicity or culture, people with limited financial resources generally tend to have more health

problems than their peers with better socioeconomic positions [Kline et al., 1999]. Health, as

a global public asset, is often unequally and unfairly distributed. Health state differences

largely reflect practices that are mediated by the socio-economic position and the ability to

access and use health opportunities [Korbin, 2004]. Migrants are often confronted with

additional health risks, inequalities in accessing health services, while making compromises

related to their working and living conditions. At the same time, migration encourages

cumulative social change processes (isolation, marginalization, discrimination) and risk-

taking behaviours associated with increased susceptibility to various diseases. Limiting access

to high quality health services, in the absence of social and legal protection, increases the

number of vulnerabilities immigrants are exposed to [Grondin et al., 2003]. In an increasingly

globalized world, health education should enable medical staff to identify and consider the

special personal circumstances or professional social impact of each patient. Health initiatives

and interactions must be supported by medical education training cross-cultural skills. The

transfer of the term education from the general theoretical framework to the field of applied

cross-cultural skills gives new meanings to complex medical practice, in which medical

education is given due consideration:

• different levels of cultural, medical, social involvement

• diversification of the classical Hippocrates’ doctor-patient relation.

In order to be included in this medical education curriculum, cross-cultural skills need

to be assessed on qualification fields, focusing on migration vs. health disparities. Cross-

cultural skill inclusion in education programs is dependent on the cultural level, the social

absorption and use level, on the patient's personal preferences. They require time and trigger a

strong reaction from observers who, although they agree on the need for critical assessment,

consider that they are too costly for an already overloaded medical education curriculum. The

pedagogic development of a cross-cultural skills curriculum is based on the triad skill,

competence, knowledge [Koehn et al., 2006].

Skills

The analytical transcultural compentence (TC) field focuses on developing the ability to

collect, select and analyse problems related to a patient’s health state. For more


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comprehensive assessment of the health needs of emigrated patients and in order to avoid

misinterpreting their messages and explanations, a medical analysis is required in relation

with converging ethnic-cultural and social-political issues. Doctors that possess transnational

analytic skills are able to understand and critically assess the inner and outer forces affecting

the migrants’ health, by adjusting their medical discourse to the patients and the latter’s social

(environment + health-promoting behaviour + health-harming behaviour), professional

(recognition of occupational diseases) and family (hereditary component identification)

background [Kickbusch et al., 2001]. Their understanding may go down to specific macro and

micro-structural connections to particular situations incorporated into the "origins of personal

suffering".

Competence

Transnational emotional competence includes the ability to express interest in different

cultural patterns - language, family life, diet, etc. Emotionally speaking, each clinical

encounter is a multidimensional interaction between cultures both for patients and doctors.

The ability to gain and maintain genuine respect for a variety of values, beliefs, traditions,

experiences, preferred communication style, feelings of satisfaction and emotional stress

results from various social circumstances. When examining patients of different nationalities,

emotional skills as well as competence are a poorly developed area, as the interactions with

the patients are often of an ethnic and cultural nature. Approaching and using transnational

emotional skills requires "a desire to try a different type of dialogue" with the patient designed

to read the latter’s mind and help him what he is going through [Zweifler et al., 1998].

A person “enters into a disease” with a certain hereditary, with a certain type of

temperament, with a specific character and intelligence, with a particular education, with

complexes and preconceptions, with a particular cultural horizon. The patient has different

attitudes towards his disease and the medical team: trust, esteem, sympathy and also possibly

doubt, fear. At the interface between migration and health, it is very important that doctors

and even healthcare providers learn to respect rather than dismiss expertise and practices

affecting acceptance of and compliance with non-biomedical treatment protocols [Oster et al.,

2000]. Emotional competence within a cross-cultural education context emphasizes the

appreciation for the ability of migrants to regain their emotional strength highly affected in

their confrontation with cultural or linguistic constraints, stressful conditions and vulnerability

generated by the new social context. In the interest of medical practice training, cross-cultural

skills focus on flexibility and adaptability. We exemplify by the components of the synergism

between doctor and patient when developing a health plan based on the relations with ethno-

culture, cultural mix and micro- and macro-social issues [Şufaru et al., 2009].

• communication: "listening is the first condition of a dialogue". Verbal and nonverbal

communication skills, the ability to communicate in a simple appropriate manner, to notice

the patient's doubts and fears, the use of translators, the ability to recover miscommunications,

the ability to notice the patient’s concerns to include his ideas into his health plan improve

individual and collective responsibilities and perceptions on the effectiveness of transnational

skills and strengthen confidence, perseverance and power to support the new health-

enhancing demands and psychological and physiological behaviours.

• closeness: closeness to the patient does not mean humiliation. The transnational

functional competence dimension is promoted by a partnership between clinician and patient.

Transnational therapeutic cooperation and therapeutic patient education involves a "process of

negotiation between doctor and patient" materialized in the development of actions that are

consistent with both the patient’s and the doctor’s values and goals.

• trust: a fair behavior towards the patient means “non-disclosing” personal medical

data, which is a guarantee to the patient that he can share his suffering, that he will be given


91

highly qualified medical care, at the same time giving his permission to participate in the

investigations, treatment, medical care.

Knowledge and pedagogical approaches of cross-cultural

Pedagogical approaches of cross-cultural skills are aimed at acquiring social-economic,

cultural, traditional practices, disease epidemiology, food behaviour, occupational status

information. Cross-cultural medical training requires attention paid to faculty selection

criteria, to resources needed for the development of adverse qualification fields, to logistic

arrangements and assessment exercises, to external development support and contributions of

specialists in different fields. Medical schools and teaching hospitals will also have to

strengthen or establish relations with migrant associations. For maximum effect, the essential

elements of a cross-cultural education should be designed on pre-clinical and clinical

modules, with theoretical and practical substantiation, by training approaches including

lectures, small group discussions on the consequences of patient-related stereotypes, case

study analyses, references to clinical applications, interaction with community leaders. Let us

point out the importance of training interviewing skills for the relationship between doctor

and patient, with practical approaches such as role playing, mannequin patient simulation with

pre-set clinical scenarios, simulation on endoscopic, laparoscopic and imaging medical

devices, etc. [Betancourt, 2003]. When working with patients of different nationalities, the

ability to identify their health problems together with their vulnerabilities supports the success

of the interventions proposed in the health plan.

3.2.2. Ethics of cross-cultural medical education

Cultural competence ethics involves a series of activities: learning about culture,

embracing pluralism and adapting to the new socio-cultural context. Although the aim of

these actions is mostly to enhance patient autonomy and legal fair considerations, there will

be inherent limitations caused by the tension between cultural relativism and human rights, in

the context of culture crossing and globalization.

The explicit evaluation of the role that ethics can play in the educational curriculum

relies on a series of points of view that substantiate three directions [Paasche-Orlow, 2004].

• confirmation of the importance of the culture of a people. In the context of the doctor-

patient relationship, when applying the principle of confirmation of the culture of a people,

both partners need to understand, learn and appreciate the role and considerable influence that

cultural factors have in the patients' lives. Doctors have a responsibility to develop a deep

understanding of their patients, in order to ensure high quality health care. Thus, the

knowledge on a patient's preferences should guide them in making decisions.

• respect for cultural differences. In order to respect the cultural differences encountered

in clinical practice, healthcare providers will have to provide medical services at a level of

comfort that is in agreement with the patient’s autonomy. Doctors often come across cultural

practices that are in conflict with medical practices. The observance of other cultural values

requires a basically pluralistic approach, which allows a number of different viewpoints.

• minimizing any negative consequences of cultural differences. Cross-cultural medical

education competence may be considered a moral asset that grounds a simultaneous patient-

orientated ethical commitment: autonomy and justice. In this respect, medical ethics and

cultural skills are mutually supportive. Ignoring the socio-cultural factors may lead to

stereotypes or discriminatory treatments based on racial, cultural, linguistic or social status

grounds. The exceptions allowed are considered "good" for medical practice and health

systems, but this can be a complicated and costly process [Gallant et al., 2008].

• To what extent is cultural competence ethics in agreement with medical practice in a

globalized and constantly moving world?

• To what extent does culture influence health?


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• Is it necessary to have cross-cultural medical training in the third millennium

medicine, which is the technological medicine, nanotechnology, genetic engineering and

bioengineering, transplant and artificial fertilization era?

The answers are probably mostly positive, preserving their nuances depending on the

weight and influence of the multiple and various factors involved in this relational complexity

that defines a worldwide fundamental human right, the RIGHT to HEALTH. People from

different countries are different as they have different values, attitudes and experience.

Everyone has a behaviour that reflects his own forces, including those specific to his original

culture. Patients often fail to follow the style of another culture, where other people find the

strength that the former lack, a style that will highlight rather their natural weaknesses than

their strength, thus creating additional vulnerabilities. Differences among national cultures not

only influence this superficial behaviour, but also substantiate fundamental values.

Let us keep in mind that the main error in this "cultural competence" concept is that it

relies on a unilateral patient-based assessment, which disregards the moral conscience of

doctors who provide health care. Clinicians are unable to reach a deep complex cultural

identification, but they have the ability to unconsciously regulate a wide range of cultural

beliefs [Crandall et al., 2003]. If we look at the examples, we may say that the most common

ethical issues occurring in the European medical culture crossing process originate in four

currents: absolutism, which claims that moral truths are obvious and extend beyond spatial or

temporal limits, fundamentalism, which was developed on fundamental principles,

multiculturalism, which agrees with the principle of moral system diversity, and

postmodernism, which supports the moral value of every person [Paasche-Orlow, 2004].

Relativism encourages exploration of the grounds that substantiate the moral beliefs of other

cultures and thus challenges cross-cultural skills to review the grounds of the doctors’ own

beliefs and the moral values surfacing during the meeting with an ethno-cultural patient. In a

globalized world that enhances and makes inevitable ever-closer contacts between different

societies and cultures, cultural skills do not need ethical relativity. The most radical objection

to relativism is the idea according to which some practices and beliefs, which different

cultural communities consider fully natural and legitimate, are ethically unacceptable and

hence rejected. Stating, in the name of "the fundamental right to difference" or emancipated

tolerance, that any practice is just as legitimate as any other only because a cultural

community believes in its legitimacy is both a theoretical error and an act of moral

responsibility [Betancourt, 2003].

In our age of mobility, cross-cultural-oriented medical education is a promising way to

provide clinicians and public health professionals with complex interpersonal skills, which are

a must for efficient healthcare providers worldwide. Cross-cultural skills may improve health

outcomes in multinational encounters. Their integration in the education curriculum must be

supported by further thorough and comparative investigations. Experiments conducted in

some medical schools will provide data that will validate any curricular development

demands. Student assessment, clinician mentor modelling, patient satisfaction levels, high

quality medical care, mistake avoidance and health disparity reduction must prove cross-

cultural skill training effectiveness. In the context of globalization, through their intrinsic

human and professional motivation, and through their highly developed transnational skills,

doctors should interact more efficiently with ethno-cultural patients, providing the latter with

high quality medical care.


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3.3. CONSCIENTIOUS OBJECTION IN THE MEDICAL MIGRATION CONTEXT:

CULTURAL INTERFERENCE

In medicine, the debate on the morality of the medical act, regarding the exploration and

solution of opinion variations developed around certain ideas, generates a framework for

analysis, which often seems to be neither homogenous nor heterogeneous enough in order to

encourage a different approach of common issues in medical practice. Such an example is

conscientious objection, one of the most frequent conflict situations between the professional

obligations of the doctor and the rights of the patient, based on the contradiction between the

request of the patient for certain health-care services and the principles (moral or religious) of

the medical staff. Although recognized, accepted and regulated by law in many states, the

phenomenon remains extremely challenged in the medical field, due to the ethical disputes

derived from the right to freedom of conscience. The current aim is to focus on the main

ethical aspects involved in conscientious objection in the medical field. In order to expand the

knowledge on the conscientious objection within the current context of globalization we

followed the placing of this concept within the context of the medical migration phenomenon

in the European Union (EU) and non-EU space, taking into account the fact that Romania is

one of the EU countries with a high rate of medical migration.

3.3.1. Ethical issues

The main ethical issues that conscientious objection involves were extracted from the

analysis of medical act and refer to the relationship between the autonomy of the doctor and

the actions of benefaction for the patient. Doctors always granted a special place to their own

values involved in the decisions on healthcare provision. Arguments stimulating the

conviction that they should decide in a paternalist manner which treatments or procedures are

adequate or not for their patients derive from the approach of their professional training

[Savulescu, 2006]. Recently, several of the values of the doctors surged as a right to refuse

certain health-care services, a refuse ethically justified by the principles of autonomy and

equity, conjugated within the context of value diversity. In the opinion of certain authors,

conscientious objection decreases the moral conscience of the doctors by granting too much

protection to the individual conscience. From the ethical perspective, the interpretation of the

autonomy of the doctor with a distinction between individual and professional autonomy

critically underlines the negative impact of the conscientious objection on basic medical

obligations because positive conscience obligations are not adequately taken into

consideration in healthcare provision [Wicclair, 2011]. From the point of view of moral

values there are authors with advanced approaches who suggest that doctors should be

enabled to define the domain of application of their practice according to their own

conscience judgments, when legal and ethical professional obligations for towards the

protection of fundamental rights may come into conflict with the obligations derived from

individual conscience. We must note that in the discussions referring to fundamental values,

the interpretation of the concept together with the principles of autonomy, dignity and

integrity marks the orientation towards the legitimacy of conscientious objection. Some

authors derive the just character of conscientious objection from regulations in the

international instruments for the right to freedom of thought, conscience and religion,

especially to freedom of conscience, which is expressed by conscientious objection.

However, this freedom is not absolute, and its acceptance in the terms of the law tends

to not contradict law systems from the point of view of the respect of the obligations for

Toader E., Conscientious Objection in the Medical Migration Context.

British Journal of Education, Society & Behavioral Science, 2015, 8. 197-204.


94

public safety, protection of public order, health or moral, or protection of other people’s rights

and freedoms. According to the principle of proportion, the ratio between the necessity of

restricting conscientious objection and the significance of limited rights must be in favor of

the rights of the patients to care and treatment in due time in an, adequate manner and

regardless of the medical, cultural or geographical context [Takemura, 2009].

3.3.2. Conscientious objection in the medical migration

In the context of medical migration, we can identify a detailed formulation of the

aspects referring to conscientious objection, surprising the complexity and diversity of the

phenomenon in multicultural societies. Debates on conscientious objection, by the emphasis

placed on the interactions between moral convictions, religious motivations and right to

freedom of conscience, articulated with the medical analyses and concepts, delineate the

passage from the attention on the importance of ethical restrictions towards moral dialogue of

values. From the ethical point of view, it is important to clarify the manner in which the

migrating doctor can preserve his or her own values but also authentic respect for a multitude

of beliefs, values, traditions and experiences resulted from various professional

circumstances. Within the framework of globalization, migration entails adjustment to a new

professional, social and cultural environment, and integrating approaches and the support of

pluralism are actions converging towards the essence of the ethical principles of autonomy,

freedom, equity and legal consideration on human rights [Toader et al., 2013]. Integration of

these ideals in the medical act specific to the context of medical migration will participate in

the prevention of certain issues engaged by conscientious objection when it comes into

contradiction with a clinically justified point of view (protection and promotion of health

interests of the patients according to international professional standards), ethically (valid

informed consent) or legally (medical act permitted or prohibited by law). Towards this end,

the ethical endeavour comes with the main message to maintain a balance between

professional obligations of doctors, the right to not act against their convictions and the rights

of patients to have access to medical services performed during the medical act.

3.3.2.1. Medical Areas of Application of Conscientious Objection

Conscientious objection draws attention to a series of ethical issues identified in

reproductive medicine, terminal stages of diseases, facial reparatory and aesthetic surgery.

From the point of view of the cultural interferences, the exemplification and argumentation of

conscientious objection motivations in these medical domains provide a concrete level of

recognition for the significance of ethical and legal aspects engaged by the phenomenon.

In reproductive medicine, the argument that “human life, in all its stages of

development, deserves the highest degree of protection” indicates the tendencies for

expansion of conscientious objection from the classical example of refusing abortion up to the

refusal of medical prescription and/or release of contraceptive for the prevention of pregnancy

or an abortive drug. For the medical staff experienced in the assistance of pregnancy and

birth, witnesses of the miracle of life, the refusal to terminate pregnancy based on the belief

that abortion is an act of deliberate murder is a beneficent one. For them, conscientious

objection is a symbol of the freedom of conscience and, concomitantly, a symbol of the

prevalence of just judgment over an unjust law. Moral objection has become almost a rule in

many countries in Western Europe, where more than half of the medical staff do not practice

abortion [Grimes et al., 2006]. Terminal stages of critical diseases are situations that develop

many ethical issues regarding pain management or sedation in uncoscientious state. A special

place must be granted to the aspects derived from the medical context of critical diseases,

such as artificial nutrition and hydration in terminal stages. Often, doctors in intensive therapy

departments are confronted with difficult situations regarding the decision of terminating life

support treatment and the assignment of responsibility if death occurs earlier. Advance


95

directive may represent a modality through which the wishes of the individuals may be

respected when they do not have the ability of competent decision, but uncertain legal value

decreases the representation of the document in the decisional process based on earlier desires

of the patients [Kinlaw, 2005]. In the field of facial reparatory surgery, the main ethical

dilemma recognized by the specialists derives from the contradiction between the application

of correct moral principles regarding the purpose of recovery surgical interventions

(morphologic and functional) and the legitimate exertion of freedom of conscience in the

refusal of expanding these interventions for aesthetic reasons [Torjuul et al., 2005].

Integration of these distinctions relevant for the conscientious objection within the framework

of the contemporary medical act could condition from the point of view of medical migration

the modality of providing health-care at the global level. The fact that some doctors and even

students could claim the right to refuse the performance of a medical act on reasons of

conscientious objection justify the question if and in what way medical migration could

become a concern for many individuals, from doctor to decision-maker and patient, taking

into consideration that the regulation and practice of conscientious objection seem to be

fuelled by the lack of joint attitudes to all decision levels, which would contribute in the

management of the phenomenon. In this context, it is important to know in what way the

medical profession at global level will relate to the content of the new social and professional

background concurring with adequate ethical requirements with the purpose of protecting the

right to health of individuals originating from different cultural environments.

3.3.2.2. Conscientious Objection in the Opinion of Doctors and Medical Students

In order to give a realistic image of the local situation regarding conscientious objection

we explored the significance of the phenomenon in the medical community of doctors and in

the academic community of medical students who experienced or intend to experience

migration in countries from the EU and non-EU space. Justification of choosing medical

migration as investigation space is supported by statistic arguments (dimension, size,

tendency and complexity of phenomenon) but also by the sensitivity of the ethical issues

which conscientious objection involves in the context of medical migration. In Romania, the

rate of medical migration is one of the highest in the EU.

3.3.3. Methods

As research instruments, we used semistructured interviews (applied on doctors N=10)

and a questionnaire (applied to doctors and medical students N=75). The approach of the

subject was performed on directions focused on the suggestion of the most important ethical

aspects, allowing for the gathering of detailed information on the conscientious objection

within the context of medical migration. We classified the information obtained from

interviews, statistical data resulted from the processing of the questionnaires, and we provided

explanations referring to ethical implications in the manifestation of the conscientious

objection. In order to broaden the interpretation perspective of the phenomenon we associated

statistical data with the opinions expressed by the interviewed doctors, analysing the

significance of the figures, beyond their strictly statistical dimension. We believe that the

approach of the subject within a framework that reunites the professional experience of the

migrating doctor in the space of multicultural societies and the interest of students for medical

migration is a novelty element which promotes the interest for the conscientious objection in

the debate on the safety of the medical act in global context.

3.3.4. Results

Connected to the phenomenon of migration, doctors, by their personal background

(experience in medical migration in EU and non-EU countries) and medical students, as

future doctors, show interest and convey importance to the information on conscientious

objection. The manner in which the doctor and the student process the experience and the


96

information, shaping an opinion regarding the conscientious objection, determines the

significance of the noted details. The investigated data confirmed that the perceptions of the

doctors on the conscientious objection originate in the value given to the right to freedom of

conscience in relation with the protection of the right for health, whereas for medical students

they are concentrated on the role and importance of moral convictions in the acquirement and

exercise of professional competences specific to certain medical areas (ex. abortion, terminal

stages, intensive therapy, oncology and legal medicine). Table 14 and 16 present the primary

and secondary subject resulted from the structural analysis of the opinions of doctors and

students regarding conscientious objection. The descriptive account (Table 15 and 17) of the

effect of the conscientious objection on professional obligations, the importance of the

phenomenon in the performance of the medical act in global context, institutional

involvement in manifestations of conscientious objection, conscientious objection in

correlation with basic requirements of curriculum and conscientious objection and the moral

diversity of the medical act are presented below.

3.3.5. Discussions

Conscientious objection in the context of medical migration: opinion of doctors. From

the point of view of the doctors, the main ethical constraints regarding the conscientious

objection are related to the basic professional obligations to respect the dignity and autonomy

of the patient during the medical act destined to the promotion of his or her health and

welfare. They believe that the assertion as conscience objector of an individuality separated

from the role in the medical institution and manifestation of a conviction through the refuse to

participate in a medical procedure damages the rights of the patient. Moreover, doctors

believe that the involvement in discussion of the aspects regarding responsibility of decisions

give alternative meanings to conscientious objection and develops secondary issues such as:

• Correlation between the concept of medical profession at global level and integration

of ethical requirements corresponding to the globalization of the contemporary medical act,

with the aim to preserve and protect the right to health for individuals originating from

various cultural environments;

• Promotion of diversity and rejection of unjustified discrimination in medicine in

complex societies with multiple beliefs, environments and cultures;

Clarification of the expression ”professional competence”, because daily practice in the

professional environment specific for medical migration exposes to the main error, given by

the focus on an unilateral evaluation, centred on patients, ignoring moral conscience and

representation of ethical values of health-care providing doctors [Betancourt et al., 2016].

Table 14. Doctors’ opinion structural analysis regarding conscientious objection (NSS = no

statistical significance)

Doctors’ opinion. Professional obligations generating ethically justified constraints

regarding conscientious objection are related to:

Ethical significance NO YES

Discrimination (NSS)* (NSS)*

Patient harms and burdens 8% 92%

Disclosing option 65% 35%

Advance notification (NSS) 75%

Referral and/or facilitating a transfer (NSS) 65%

An important point of view noted in the opinions of doctors are the ethical meanings

derived from the explicit evaluation of the role that conscientious objection may play with

respect to medical migration, which are involved in the design of the main directions of the

performance of medical act in global context. Doctors consider that refusal based on moral


97

convictions risks the undermining of patient autonomy, taking into account the fact that most

patients are not able to exert autonomy in taking health-care decisions without external

intervention. Moreover, many patients do not detain medical knowledge and as to the option

of learning themselves about the disease or treatment they should access various sources on

their own. Consequently, the refusal to give information or treatment expands the power of

the doctor towards the area that contradicts with the professional obligation to grant priority to

patients’ interest. However, in a morally open environment, the doctor who supports the right

to conscientiously object must also expand this consideration for the patients, in order not to

lose the justification of the refusal to facilitate access to adequate clinical services [Cantor,

2009]. The right to conscientious objection expands only on physical individuals and does not

apply to public or state institutions because its endorsement must be doubled by the obligation

to inform and to facilitate the transfer of patient in order to avoid the infringement on the legal

rights of the patient, including the right to health. It is noteworthy from the remarks of the

respondents that at the institutional level it is not a priority to restrain the freedoms of the

doctors to stand against the performance of a medical act through the manifestation of

personal belief, with the exception of those situations where the rights of the patients to

adequate treatment and time are put into question. In the literature it is highlighted the fact

that the regulation and practice of conscientious objection in the states members of EU is

heterogeneous.

Table 15. Descriptive account of impact of conscientious objection in medical practice –

doctors’ opinion

Impact areas of

conscientious objection

Ethical Legal

Basic professional obligations Patient’s dignity and autonomy Promotion of the

patient’s health and

welfare

Decisions regarding

healthcare

Responsibility of medical

profession at world level

Ethical requirements of

medical act

The right to health

Institutional involvement Ethical dimension of diversity,

professional competence

Patients’ rights

Conscientious objection impact

over the medical act within the

global context

Codification of ethical norms,

standards for medical practice

Professional

responsibility

and accountability

Table 16. Descriptive account of the impact of conscientious objection in medical practice –

student opinions

Students Ethical Legal

Basic professional

obligations

Patient’s dignity

and autonomy

Promotion of the patient’s health and welfare

Decisions regarding healthcare

International

medical ethical

standards

Cultural diversity Codification of ethical norms


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Table 17. Doctors’ and students’ opinion structural analysis regarding conscientious objection

(NSS = no statistical significance)

STUDENTS - conscience-based exemptions are important and

also ethically permissible?

Ethical significance NO YES

Established core educational

requirements

13% 87%

Local core curricula (NSS) (NSS)

Non-discrimination (NSS) (NSS)

Impact on patients (NSS) 95%

Impact on students, internships and

supervisors

(NSS) 96%

There are many states that adopted laws, ethical codes and regulations or guides which

guarantee the right to conscientious objection in medical institutions, while the national courts

developed jurisprudence on this subject. Some member states have a constitutional protection

for the freedom of conscience, while others recognize only the right to conscientious

objection within the context of specific medical procedures. Certain countries do not regulate

the practice of conscientious objection in every domain or the implementation of the

regulation framework is inadequate [Cook et al., 2009]. Conscientious objection in the

context of medical migration - opinion of medical students. Students believe that exemptions

based on conscience reasons are important through the impact on patients but also on

themselves. They are accepted from the ethical point of view if they concur with the basic

requirements established by the curriculum, which emphasizes non-discrimination.

At the global level, students believe that the ethical approval of conscientious objection

must be the result of a careful analysis in order to determine which cultural values are relative

and which are based on universal ethical principles and standards and are internationally

irreducible, so that all societies and cultural communities would be respected. Regarding

exemption of students to participate in certain medical procedures, conscientious objection

could be allowed if it is in accordance with international medical ethical standards that impose

the compliance with the following conditions:

• Theoretical and clinical basic knowledge regarding the modality in which these

procedures are performed;

• Diagnosis and management of complications;

• To be able to provide care for the patients.

We must stress the necessity of this knowledge requirements of medical ethical

standards as foundation for the manifestation of conscientious objection. To this end, we

highlight the point of view of Frader and Bosk, who explored conscientious objection from

the perspective of medicine students and stated that while they must be ready to facilitate

access to medical care that contravene their own moral convictions, they are not obligated to

provide care [Frader et al., 2009].

The extrapolation of the explicit appraisal of the role that conscientious objection may

play in the relationship between medical migration and cultural diversity emphasizes a series

of points of view which lay the grounds for the main directions of the performance of the

medical act in global context: confirmation of the significance of conscientious objection,

respect of cultural differences and reduction to minimum of any negative consequences of

conscientious objection. In this sense, the global framework of cultural interferences provides

a good opportunity to investigate if and how the conscientious objection puts “pressure” on

the autonomy, dignity and responsibility in moral, social and professional comparisons as

well as between public health policies in origin and destination country. Regardless of cultural


99

specificity, the standards for the protection of the fundamental rights and freedoms of the

healthcare provider (the doctor) as well as insurance of the right to health for the patient

relates to European and international standards in healthcare. In reality, the students admit

that they rarely discuss with their mentors about a possible personal moral code, which could

come into conflict with health-care standards in certain fields. In Frader’s opinion an accepted

explanation in this sense would be the reticence of students with moral issues towards the

involvement and awareness of the doctors for the solution of these issues [Frader et al., 2009].

Regardless the motivations, students with ethical objections towards specific routine medical

procedures should take them into account when they choose a specialty.

As a conclusion, from the analysis of the opinions of doctors and medical students on

the significance and perception of the conscientious objection, beyond the importance and

ethical implications detected in reference frameworks of specific domains of medical practice,

this phenomenon remains for bioethics a subject insufficiently explored in the literature,

especially in the context of cultural interferences specific to medical migration. In order to

turn visible the ethical dimension, of the debate on conscientious objection, it must be

expanded into the theoretical and current practice field, in order to identify and reveal the

passage from occult to obviousness of the phenomenon in its various aspects and

implications. In this sense, bioethics must intervene focusing on the moral unity of

professional and individual conscience with the purpose of establishing a balance between the

right to conscientious objection of an individual, to not perform a specific medical procedure,

and the responsibility of the medical profession, and the right of every patient to have access

to medical care in due time.


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4. PERSPECTIVES

4.1. PERSPECTIVES IN TEACHING

I will permanently be involved in the continuous formation process that require ethical

standards, norms and value application to go together with efficient resource management,

modern methods and teaching procedures, aiming for personal and professional

development.

I consider that a stronger ethical medical teaching system will improve the output for

graduates, postgraduates and future practitioners.

I intend to propose mandatory courses on ethics and law related medical issues,

practitioners responsibilities or corporate/social responsibility (focused on medical act).

It will be interesting to propose a novel approach regarding integration of ethical

concepts in lectures/clinical stages/courses, without necessarily creating a new class for

this. Teaching ethics can be easily associated to extracurricular activities in order not to

charge students’/professionals’ timeline.

I strongly advocate for ethics concepts and norm integration within clinical and basic

research storylines. From a teaching perspective, this aim can be achieved by

adopting/generating/optimizing the tools required to push students, graduates,

postgraduates, practitioners, healthcare providers toward a personal commitment to ethics

and also to an integrated ethic concept.

Teaching ethics must consider the potentially barriers associated to this process, barriers

that are often inducing knowledge-practice gaps. Paul Hibbert [Hibbert et al., 2015]

promoted this principle in business ethics but it applies in the medical practice as well. His

approach to fill in these gaps can be easily adapted to ethics teaching in medical practice.

The recipients for these implementations will be provided with stronger impact concepts

that will open them different perspectives and will ease the concept integrating in their

future practice. It is also important to provide bedside ethics teaching, as provided since

William Osler’s vision [McCarthy et al., 2017]. However, bedside teaching has been

eroded by the professoriate migration toward laboratories and administrative positions.

Even in 2017, few hospitalists have received a proper ethics induction and integration.

Thus, it is essential that the teaching is integrated in a modular way, either in the

preclinical or clinical medical teaching.

Feedback is essential to guide further approaches in ethic norms integration in medical

teaching and practice. It is essential to provide the bioethics courses and workshops

recipients the way to react and to respond to the challenges launched during the

educational process. I am aiming for an informed feedback that will help me building

further ways to integrate ethic principles in recipients’ knowledge database.

I will be permanently focused in knowledge transfer from bioethics to all related

domains, interested in ethical aspects. Active participation to postgraduate training as

coordinator, lecturer or to master modules will be a priority to me. I intend to perform

topic selection and to integrate knowledge acquired at national and international level,

continuously developing a guiding teaching standard. I will be permanently involved in

the building process for the concept “I will get informed, to inform and in turn to help

forming others”

4.2. PERSPECTIVES IN ACADEMIC AND CLINICAL RESEARCH

I intend to focus on ethic aspects derived from multicultural impact role in medical

practice, in the context of globalization. I will develop case studies focused on overseas

students or on internships/practitioners that have experienced migration. All these projects


101

will be developed in a collaborative manner with Social Sciences professionals, and will

follow standardized methods and protocols.

I will develop partnership projects, together with other local/national Universities,

professional associations, in order to organize workshops, debates and joint-events

regarding medical responsibility. At the same time, I will continue the international

cooperation with Bordeaux and Brussels specific institutions.

I will do my best to develop a project for junior doctors to integrate medical and ethical

knowledge on medical students clinical stages [Gray et al., 2017]. As bedside teaching is

a time-consuming method and while we are continuously running out of time, it is

important to consider well-trained junior doctors as a valuable resource for teaching. Any

MD in postgraduate training can be considered as Junior Doctor and can play an important

role in giving students an appropriate induction not only in curricular data but also in ethic

aspects of the medical context. Proper training of the Junior Doctors suggest this resource

as ideal for bedside teaching.

4.3. PERSPECTIVES IN BASIC RESEARCH

First direction will focus on ethical issues generated by AI and deep learning.

Considering ethic and legal aspects in AI supposes an accurate and honest disease/treatment

personalized models developments, as once the data are being loaded in a neural networks it

is almost impossible to control the resulting biases. The most susceptible systems to generate

internal biases are the hybrid ones, in which the human factor is interlaced with neural

network capabilities and decisions can be overwritten. The main issues with the AI models

and machines is that, despite the real help they are providing to medical decision, the more

complex they get, the most unpredictable results are supposed to come up. Since Alan Turing

developed the ideal computer concept in 1930, the demand to prevent machine-decisions

glitches supposes the raise of a simple yet efficient AI dedicated ethical model. Decision

making software in medical act is more and more involved in defining protocols and clinical

procedures. At all time we should be aware that the implemented deep learning algorithms are

working the right way and stay clean as the input data and onset algorithms are clean. Data

input ethics is an ongoing topic on which I intend to allocate time and efforts, regarding the

technological outbreak in diagnosis and treatment methodology. This will be an important

way to consider ethical and legal aspects of the developing personalized medicine, while deep

learning and AI are playing an active role in patient selection for targeted medicines.

Second direction focuses to approach the topic regarding human embryo genome

editing. An intense debate is getting the floor as the Council of Europe is resolutely on its way

to reaffirming a 20‐year‐old policy banning all inheritable interventions involving the human

genome. This approach, which was well justified two decades ago, is now outdated, overly

restrictive and will hamper promising research for germline gene therapy. A ban no longer

makes sense from an ethical point of view. Modern therapeutic resources offered by genetic

engineering technologies in humans (the flagship CRISPR/Cas9 system) are more precise and

safer than older ones (recombinant DNA technology). Being permanently updated with the

new technologies, their efficacy and safety level will help me to offer new insights regarding

applicable changes to ethical principles to be applied in the next decade medical act.

Third direction is pointing for the ethics involved in the fast progress regarding

personalized and individualized medicine. It is important to redefine not only the landmarks

for the personalized medicine ethics but also to modulate its principles in order to provide

certain flexibility. A flexible but firm ethical norm set will be able to educate practitioners in

the light of the technological progress to rise in the next decades (including practitioners and

patients’ lifetime).


102

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