tm-6 ethical principles for biomedical research involving human subjects
TRANSCRIPT
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
1/43
Ethical Principles for
Biomedical ResearchInvolving Human Subjects:
Overview of International Guidelines
http://www.pitt.edu/~super7/21011-22001/21071.ppt
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
2/43
Public Concern forVulnerable Subjects
Nazi Experiments and the Nuremberg Trials Tuskegee Syphilis Study-involvement of black
males
Willowbrook Study-hepatitis study among
children in New York State institution for
mentally defective persons
Jewish Chronic Disease Hospital Study-
injection of live cancer cells into patients tostudy transplant rejection process
San Antonio Contraceptive Study-study of side
effects of contraceptives on Mexican American
women
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
3/43
In research using human subjects, several
categories of persons maybe involved:
Normal healthy adults, including the investigator,and elderly persons
Sick adults, including the acutely and terminally ill
People living in highly controlled situations, suchas, prisoners, soldiers, and students
Children, both healthy and ill Mentally incompetent persons, whether adults or
children
Unborn fetuses or still living aborted fetuses
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
4/43
Use of Vulnerable Persons
Not forbidden by ethical codes or
regulations
Need for justification for their inclusion
Unsuitability of less vulnerable
populations
Use of mitigation to address
vulnerability
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
5/43
NUREMBERG CODE:INFORMED CONSENT
The voluntary consent of the human subjectis absolutely essential.
This means that the person involved shouldhave legal capacity to give consent;
Should be . . . able to exercise free power ofchoice, without the intervention of any
element of force, fraud, deceit, duress, . . . orcoercion;
Should have sufficient knowledge andcomprehension . . . .
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
6/43
NUREMBERG CODE:
INFORMED CONSENT
The duty and responsibility for
ascertaining the quality of consentrests upon . . .each individual who
initiates, directs, or engages in the
experiment. It is a personal duty that may not be
delegated
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
7/43
ELEMENTS OF INFORMEDCONSENT
(1) DISCLOSUREIn general necessary items to disclose include:
a) the patients current medical status includingthe likely course if no treatment is provided.
b) the contemplated procedure or medicationc) alternative available procedures or medication
d) anticipated risks and benefits of both
e) a statement offering an opportunity to askfurther questions
f) in case of research, his right to withdraw anytime
g) a professional opinion about the alternatives
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
8/43
ELEMENTS OF INFORMED
CONSENT(2) COMPREHENSION
7thgrade level (US Standard)
Language understood by the subject Oral or written quizzes to assess
comprehension
Use of educational intervention prior to gettingconsent
Allowed into research environment toexperience routine and procedures
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
9/43
ELEMENTS OF INFORMED
CONSENT
(3) VOLUNTARINESS - The patient must of his
own free will make a choice without beingunduly pressured by anyone else.
Being free in making a decision means
that the patient ownsthe decision, that
the decision is the patients alone, thatthe patient has chosen the option based
on the information disclosed to him/her.
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
10/43
ELEMENTS OF INFORMED
CONSENT(4) COMPETENCE - patients capacity for
decision making. One is considered competent
when(a) one has made a decision (i .e. one can
choose between alternatives)
(b) one has the capacity to justify ones choice
(i.e, give reasons for ones choice)
(c) one justifies ones choice in a reasonable
manner
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
11/43
HUMAN SUBJECTS
OVER SCIENCE AND SOCIETY
. . . considerations related to
the well-being of the humansubject should take
precedence over the interests
of science and society.(Helsinki Declaration, par. 5)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
12/43
Protection of Special
Populations Embryos And Human Fetuses
Since the human individual, in the
prenatal stage, must be given the dignity
of a human person, research and
experimentation on human embryos and
fetuses is subject to the ethical normsvalid for the child already born and for
every human subject.
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
13/43
Pregnant Women, Embryos And Human
Fetuses
Research in particular, that is the
observation of a given phenomenon
during pregnancy, can be allowed only
when there is moral certainty that there
will be no harm either to the life or theintegrity of the expected child and the
mother, and on the condition that the
parents have given their consent.
Protection of SpecialPopulations
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
14/43
THERAPEUTIC CRITERIAONLY
Experimentation is possible only forclearly therapeutic purposes, when noother possible remedy is available.
No finality, even if itself noble, such asthe foreseeing of a usefulness forscience, for other human beings or forsociety, can in any way justifyexperimentation on live human embryosand fetuses, whether viable or not, in the
maternal womb or outside of it.
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
15/43
Experimentation of embryos orfetuses has the risk, indeed in most
cases the certain foreknowledge, ofdamaging their physical integrity oreven causing their death.
To use a human embryo or the fetusas an object or instrument ofexperimentation is a crime against
their dignity as human beings.
Protection of Special
Populations
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
16/43
The practice of keeping humanembryos alive, actually or in vitro, forexperimental or commercial reasons,is especially and altogether contrary
to human dignity.
The informed consent, normally
required for clinical experimentationon an adult, cannot be given by theparents, who may not dispose of thephysical integrity or the life of the
expected child.
Protection of Special Populations
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
17/43
PROPORTIONALITY OFRISKS TO BENEFITS
Degree of risk to be taken should never
exceed . . . humanitarian importance of
the problem to be solved . . . .(Nuremberg, #6)
Medical research . . . should only be
conducted if the importance of theobjective outweighs the inherent risks
and burdens to the subject. (Helsinki,
#18)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
18/43
Right to refusal or withdrawalof treatment
the patient has the right to refuse or withdraw
from treatment to the extent permitted by law
and to be informed of the medical
consequences of his action.- Patients Bill of
Rights
a patient may refuse or withdraw from medical
treatment because their religious convictionsprohibit them from doing so (e.g., a patient
who is a member of a particular religious sect
may refuse to undergo blood transfusions)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
19/43
PLACEBO MAY BE USED:
When there is no established effectiveintervention;
When withholding an established effectiveintervention would expose subjects to, atmost, temporary discomfort or delay inrelief of symptoms;
When use of an established effectiveintervention as comparator would notyield scientifically reliable results and useof placebo would not add any risk ofserious or irreversible harm to thesubjects (CIOMS #11)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
20/43
Are there ethical issues in socialscience or behavioral research?
Most common methodology used
involves interviewing people and asking
questionsWe would just like to ask some
questions
We would just like to observeWe would just like to share your life
Focus Group discussion (FGDs), Survey
Does not involve invasive procedures
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
21/43
Ethical Issues in Social Science
& Behavioral Research Privacy
Confidentiality Linking behavior
with medical
procedure
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
22/43
DO NO HARM
Experiment should . . . avoid all
unnecessary physical and mental
suffering and injury. (Nuremberg, #4)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
23/43
Forms of Harm to Human
Subjects in Behavioral Research Psychological harmrecalling a
traumatic event
Social stigmaloss of reputation Cultural effectsgoing against existing
cultural norms
Political effectsdisturbing existingpower relationships
Economic repercussionsloss of jobs
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
24/43
HOW TO AVOID HARM
The experiment should beconducted only by scientificallyqualified persons. (Nuremberg #8)
. . . human subject should be atliberty to bring the experiment to anend . . . (#9)
. . . terminate the experiment at anystage, if . . . continuation of theexperiment is likely to result ininjury, disability, or death (#10)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
25/43
HOW TO AVOID HARM
[Ensure that] risks involved have beenadequately assessed and can be
satisfactorily managed. Cease . . . investigation if:
1. the risks are found to outweigh the
potential benefits, or2. there is conclusive proof of positive and
beneficial results (Helsinki #17)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
26/43
Mitigating harm to human
subjects Research design- community inputs
Adequate research preparation-
familiarization with local culture,sociopolitical structures, traditions andcultural norms
Good reason to conduct research in aparticular community
Ethical Consideration Section in theprotocol
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
27/43
NBAC Guideline
Whenever possible, preceding the start
of research, agreements should be
negotiated by the relevant parties tomake effective intervention or other
research benefits available to the host
country after the study is completed.
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
28/43
Mitigating harm to humansubjects
Research methodologies should avoid
harm
Mechanisms for protection of privacy and
confidentiality
Avoidance of social stigmatization
Process of data storage
Adequate infrastructure to protect privacy
Research methodologies should provide
opportunities for empowerment-reflexivity
Mitigating harm to human
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
29/43
Technical review
Risk-benefit analysis
Benefits should be defined in the protocol
Provisions for support mechanismsConsent process should be as strict asrequirements in clinical trials
Recruitment procedures Full disclosure of information
Reconsenting mechanisms
Feedback to community
Mitigating harm to humansubjects-Reviewing the protocol
Mi i i h h
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
30/43
Mitigating harm to humansubjects- Reviewing the protocol
Culturally competent consent form Individual consent
Family consent-secondary subjects
Community consent
Mechanisms for protection of privacy and
confidentiality defined in the consent form of
information sheet
Provision of support/coping mechanism
Need to take precaution to protect identity
of host community
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
31/43
Informed consent:
Community Context - CIOMSWhen it is not possible to requestinformed consent from every
individual to be studied, theagreement of a representative of acommunity or group should besought, but the representative shouldbe chosen according to the nature,traditions and political philosophy ofthe community or group.
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
32/43
Feedback to the Community
Reporting results to the community
A good means to highlight good practices:
positive reinforcement
Suggestions for improvement should bepresented as constructive recommendations
Public forum: a means to get public
commitment from public officialsOpportunities for researchers to connect
community to larger community
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
33/43
RELEVANCE &RESPONSIVENESS OF RESEARCH
Medical research is only justified
if there is a reasonable likelihoodthat the populations in which the
research is carried out stand to
benefit from the results of theresearch. (Helsinki #19)
CIOMS
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
34/43
RELEVANCE AND
RESPONSIVENESS The sponsor and the investigator must
make every effort to ensure that:
1. the research is responsive to the healthneeds and the priorities of thepopulation . . . ; and
2. any intervention orproduct developed,or knowledge generated, will be madereasonably available for the benefit ofthat population. (CIOMS #10)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
35/43
GENETIC RESEARCH:Privacy, Confidentiality and
Integrity
Respect the privacy of the subject,
the confidentiality of the patient'sinformation and minimize the
impact
of the study on the subject'sphysical and mental integrity
(Helsinki #21)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
36/43
MEDICAL RECORDS &BIOLOGICAL SPECIMENS
Exemp ted from indiv idual consent requirementonly if an ethical review committee hasdetermined that:
Research poses minimal risk
Rights or interests of the patients will notbe violated
privacy and confidentiality or anonymity areensured
Research is designed to answer animportant question
Impracticable if the requirement forinformed consent were to be imposed
(CIOMS)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
37/43
HUMAN GENETIC DATA
Clear, balanced, adequate andappropriate information shall be
provided to the person whose prior, free,informed and express consent is sought.
Information shall . . . specify the purposefor which human genetic data . . . are
being derived, . . . used and stored(International Declaration on Human GeneticDataAdopted by the UNESCO General Assembly on 16 October2003)
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
38/43
WITHDRAWAL OF CONSENT
(a) . . . Consent may be withdrawn by theperson concerned unless such data areirretrievably unlinked to an identifiable person.
(b) When a person withdraws consent, the
persons genetic data, proteomic data andbiological samples should no longer be usedunless they are irretrievably unlinked to theperson concerned.
(c) If the persons wishes cannot be determinedor are not feasible or are unsafe, the data andbiological samples should either beirretrievably unlinked or destroyed.
UNESCO Intl Declaration, Art. 9
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
39/43
RIGHT TO BE, OR NOT TO
BE INFORMED OF RESULTS
The person concerned
has the right to decide
whether or not to be
informed of the results
UNESCO Intl Declaration, Art. 10
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
40/43
GENETIC COUNSELLING
. . . When genetic testing . . . is being
considered, genetic counselling should
be made available . . . .
Genetic counselling should be non-
directive, culturally adapted and
consistent with the best interest of the
person concerned.
UNESCO Intl Declaration, Art. 11
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
41/43
CLINICAL TRIAL REGISTRATIONA Requirement for Publication Trials must register at or before the
onset of patient enrollment.
Selective reporting . . . distorts the
body of evidence available forclinical decision-making.
Trial results that place financialinterests at risk are particularly likely
to remain unpublished and hiddenfrom public view.
Anyone should be able to learn ofany trial's existence and its
important characteristics.
BIBLIOGRAPHY
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
42/43
BIBLIOGRAPHY1. Ethical Review o f Research : Overview o f
Internat ional Guidel ines and Princip lesby Prof.
Leonardo de Castro, Ph.D, Department ofPhilosophy, University of the Philippines, Diliman
2. Ethical Issues in Soc ial Science Research: by Prof.Cristina E. Torres, Ph.D, College of Arts and
Sciences, University of the Philippines, Manila &National Institute of Health
3. Protect ion of Vu lnerable Subjectsby Prof. Cristina E.Torres, Ph.D, College of Arts and Sciences, UP
Manila & National Institute of Health
4. Wor ld Medical Associat ion (WMA): Declarat ion ofHelsinki, Tokyo, 2004
5. The Nuremberg Code 1947
BIBLIOGRAPHY
-
8/10/2019 TM-6 Ethical Principles for Biomedical Research Involving Human Subjects
43/43
BIBLIOGRAPHY6. The CIOMS Gu idelinesNov 2000, International
Ethical Guidelines for Biomedical Research InvolvingHuman Subjects
7. The NBAC Report Aug 2001, Ethical and PolicyIssues in Research Involving Human Participants
8. Internat ional Declarat ion on Human Genetic Data,UNESCO, October 16, 2003
9. The Belmon t Repo rt, 1979, Ethical Principles andGuidelines for the Protection of Human Subjects ofResearch