Topic: Ethical Issues in Nursing ResearchAudience: Nursing StudentsDate: SeptemberTime: 11: 30 amDuration: 1 hourVenue: Lecture Room (The Annex)Methodology: Lecture DiscussionNumber of participants: 104Learning Theories: Ausubel: Emphasized the use of advance organizers which he said was different from overviews and summaries. His use of an advance organizer acted to bridge the chasm between learning material and existing related ideas. The advanced organizer used; sought to bridge new knowledge with what was known (sometimes what is known is uncertain and not concrete). Though he specified that his theory applied only to reception learning in schools, it was utilized because it introduced the topic and aided the sequence of the information to be imparted. (Ormrod & Rice, 2003). Rogers: Dealt with the adult learner, he posited that learning is student centered and personalized and the educators role is that of a facilitator. Affective and cognitive needs are central and the goal is to develop self-actualized persons in a cooperative, supportive environment. This theory was used because all the participants were adult learners, thus they were responsible for their learning experience and the teacher sought to guide them through this experience. (Quinn & Hughes, 2007). Bruner: Believed that learners were not blank slates but brought past experiences to a new situation, he also stated that new information was linked to prior knowledge, thus mental representations are subjective. Bruners Discovery learning is an inquiry-based, constructivist learning theory that takes place in problem solving situations where the learner draws on his or her own past experience and existing knowledge to discover facts and relationships and new truths to be learned. (Quinn & Hughes, 2007). Students interact with the world by exploring and manipulating objects, wrestling with questions and controversies, or performing experiments. As a result, students may be more likely to remember concepts and knowledge discovered on their own (in contrast to a transmissionist model). (Quinn & Hughes, 2007). Models that are based upon discovery learning model include: guided discovery, problem-based learning, simulation-based learning, case-based learning, incidental learning, among others. The advantages of this theory are: it encourages active engagement, promotes motivation, a tailored learning experience, and promotes autonomy, responsibility, independence, the development of creativity and problem solving skills. (Quinn & Hughes, 2007) Bruners theory was used because it encouraged active engagement, promotes motivation, a tailored learning experience, and promotes autonomy, responsibility, independence and the development of creativity and problem solving skills for this presentation.Vygotsky: Posited that individuals learn from each other through social interaction and the teacher and the learner collaborate in a reciprocal relationship where each learns from each other through the same process of social interaction (Quinn & Hughes, 2007). This theory was chosen since it lays the overall foundation for human behaviours that of interaction, where students learn from the more knowledgeable other (MKO) it coincides with the topic and the overall mode of delivery of the topic. Aim of the activity: To educate nursing students on the ethical issues found in nursing research Scientific Principle: Resources: Nurse Instructor, lap top computer, multimedia, white board, markers hand outs

Objectives: At the end of 1 hour interactive session students should be able to:1. Discuss the historical background that led to the creation of various codes of ethics according to Nieswiadomy (2012); Silva (1998); Polit & Beck, 2014; Rebar et al, (2011)2. Recognize the potential for ethical dilemmas stemming from conflicts between ethics and research demands according to Polit and Beck (2014)3. Describe the three primary ethical principles articulated in the Belmont report and the important dimensions encompassed by each as outlined by Polit and Beck (2014)4. Explicate procedures for adhering to ethical principles and protecting study participants as proffered by Polit and Beck, (2014); Burns and Grove, (2010); Rebar et al, (2011)5. Evaluate the ethical dimensions of a research report as suggested by Polit and Beck (2014)Evaluation: Formative and Summative. Questions will be asked before and after each objective by an evaluation at the end.

References:Burns, N., Grove, K. G. (2010). The practice of nursing research: Appraisal, synthesis and generation of evidence. St. Louis Missouri: Saunders ElsevierNieswiadomy, R. (2012). Foundations of nursing research. Upper Saddle River NJ: PearsonsOrmrod, J. E. & Rice, F. P. (2003). Lifespan development and learning. Boston, MA: Pearson Custom Publishing.Polit, D & Beck, C. (2014). Essentials of nursing research: Appraising evidence for nursing practice. Philadelphia. PA: Wolters Kluwer Health | Lippincott Williams & Wilkins.Quinn, F & Hughes, S. (2007). Quinns principles and practice of nursing education. London: Nelson Thornes Rebar, C., Gersch, C., Macnee, C & McCabe, S. (2011). Understanding nursing research: Using

research in evidenced based practice. Philadelphia PA: Wolters Kluwer Health

Lippincott Williams & Wilkins.

Silva, M.C. (1998). Organizational and administrative ethics in health care: An ethics gap.

Online Journal of Issues in Nursing, Topic 8

TimeObjectivesContentsTeacher ActivityLearners ActivityEvaluation

2 minIce-breakerDavid Ausubel: The advanced organizer used; sought to bridge new knowledge with what was known

Teacher will ask students to identify the role of the person in the picture and consequently ascertain the topic of the presentationStudents will attempt to identify the role of the person in the picture and ascertain the topic for presentation Students will correctly identify the topic of presentation subsequent to looking at the picture

5 minsDiscuss the historical background that led to the creation of various codes of ethics according to Nieswiadomy (2011); Silva (1995); Polit & Beck, 2014; Rebar et al, 2011In any research with human beings or animals, researchers must address ethical issues. Ethical concerns are especially prominent in nursing research because the line between what constitutes the expected practice of nursing and the collection of research data sometimes gets blurred.We might like to think that violations of moral principles among researchers occurred centuries ago rather than recently, but this is not the case.The Nazi medical experiments of the1930s and 1940s are the most famous example of recent disregard for ethical conduct. The Nazi program of research involved using prisoners of war and racial enemies in experiments designed to test human endurance and reactions to untested drugs. The studies were unethical not only because they exposed people to harm and even death, but because subjects could not refuse participation. Similar wartime experiments that raised ethical concerns were conducted in Japan and Australia (Nieswiadomy, 2011).

There are more recent examples. For instance, between 1932 and 1972, the Tuskegee Syphilis Study, sponsored by the U.S. Public Health Service, investigated the effects of syphilis among 400 poor African-American men. Medical treatment was deliberately withheld to study the course of the untreated disease. Similarly, Dr. Herbert Green in Auckland, New Zealand, studied women with cervical cancer in the 1980s; patients with carcinoma in situ were not given treatment so that researchers could study the natural progression of the disease.Other examples of studies with ethical transgressions have emerged to give ethical concerns the high visibility they have today (Nieswiadomy, 2011)

CODE OF ETHICSIn response to human rights violations, various codes of ethics have been developed. One of the first international set of ethical standards was the Nuremberg Code, developed in 1949 in response to the Nazi atrocities. Several other international standards have subsequently been developed, including the Declaration of Helsinki, which was adopted in 1964 by the World Medical Association and most recently revised in 2008.Most disciplines, such as medicine and psychology, have established their own code of ethics.

Nurses also have developed ethical guidelines In the United States, the American Nurses Association (ANA) issued Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research in 1995 (Silva, 1995). ANA (2001) also published a revised Code of Ethics for Nurses with Interpretive Statements, a document that covers ethical issues for practicing nurses primarily but also includes principles that apply to nurse researchers. In Canada, the Canadian Nurses Association published its Ethical Research Guidelines for Registered Nurses in 2002. And, the International Council of Nurses (ICN) has developed the ICN Code of Ethics for Nurses, which was most recently updated in 2006.(Polit & Beck, 2014; Rebar et al, 2011)

Teacher will randomly ask students to discuss any codes of ethics relating to nursing and nursing research with which they are familiar

Teacher will discuss the historical background that lead to the creation of various codes of ethics with the aid of PowerPoint presentation

Teacher will ask 4 students in the front to discuss one historical event each that led to the development a code of ethics according to the contentstudents will attempt to discuss any codes of ethics relating to nursing and nursing research with which they are familiar

Students will sit, listen, watch PowerPoint, follow and ask questions if needed as teacher discusses the various historical codes

Four students will discuss one historical event each that led to the development of a code of ethics according to the contentStudents will correctly discuss the historical background that led to the creation of various codes of ethics as evidenced by use of terms such as, the Nazi experiments of the 1930s and 40s..the Tuskegee Syphilis Study..the Nuremberg Code, The Declaration of Helsinki and the ICN Code of Ethics

10 minsRecognize the potential for ethical dilemmas stemming from conflicts between ethics and research demands as cited by Polit and Beck (2014)ETHICAL DILEMMAS IN CONDUCTING RESEARCH

Research that violates ethical principles typically occurs out of a researchers conviction that knowledge is potentially life-saving or beneficial in the long run. There are research problems in which participants rights and study demands are put in direct conflict, posing ethical dilemmas for researchers. Here is an example of research problems in which the desire for rigor conflicts with ethical considerations:

Research question: Are nurses equally empathic in their treatment of ICU patients from different ethnic backgrounds?Ethical dilemma: Ethics require that participants be informed of their role in a study. Yet if the researcher tells participating nurses that their degree of empathy in treating different patients will be scrutinized, will their behavior be normal? If the nurses usual behavior is altered because of the presence of research observers, then the findings will not be valid (Polit & Beck, 2014).

As this example suggest, researchers are sometimes in a bind.Their goal is develop high-quality evidence for practice, but they must also adhere to rules for protecting human rights. Another type of dilemma may arise if nurse researchers face conflict of- interest situations, in which their expected behavior as nurses conflicts with standard research behavior (e.g., deviating from a research protocol to assist a patient). It is precisely because of such dilemmas that codes of ethics have been developed to guide researchers efforts (Polit & Beck, 2014).

Teacher will randomly ask one student to briefly say what the term ethical dilemma means to her

Teacher will discuss the potential for ethical dilemmas stemming from conflicts between ethics and research demands with the aid of PowerPoint presentation according to the content

Teacher will ask three students at the back of the class to outline the similarities and differences in the roles of the nurse as manager and as leader according to the contentOne student will attempt to briefly say what the term ethical dilemma means to her

Students will ask questions and listen to the feedback given by teacher as the potential for ethical dilemmas stemming from conflicts between ethics and research demand

Three students at the back of the class will outline the differences and similarities in the roles of the nurse as manager and as a leader according to the contentStudents will be able to recognize the potential for ethical dilemmas stemming from conflicts between ethics and research demands as evidenced by the use of words such as Research that violates ethical principles typically occurs out of a researchers conviction that knowledge is potentially life-saving or beneficial in the long run. There are research problems in which participants rights and study demands are put in direct conflict, posing ethical dilemmas for researchers

7 minsDescribe the three primary ethical principles articulated in the Belmont report and the important dimensions encompassed by each as cited by Polit and Beck (2014).ETHICAL PRINCIPLES FOR PROTECTING PARTICIPANTS

The Belmont Report articulated three primary ethical principles on which standards of ethical research conduct are based: beneficence, respect for human dignity, and justice.

It is a code of ethics issued in 1978 In the United States, and adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It provided a model for many guidelines adopted by disciplinary organizations worldwide (Polit & Beck, 2014).

1. BeneficenceA fundamental ethical principle in research is that of beneficence, the duty to minimize harm and maximize benefits. Human research should produce benefits for participants themselves ora situation that is more commonfor other individuals or society as a whole.

The Right to Freedom From Harm and Discomfort - Researchers have an obligation to prevent or minimize harm in studies with humans.Participants must not be subjected to unnecessary risks of harm or discomfort, and their participation in research must be essential to achieving societally important aims. In research with humans, harm and discomfort can be physical (e.g., injury), emotional (e.g., stress), social (e.g., loss of social support), or financial (e.g., loss of wages). Ethical researchers must use strategies to minimize all types of harms and discomforts, even ones that are temporary.(Polit & Beck, 2014).

The Right to Protection From Exploitation - Involvement in a study should not place participants at a disadvantage.

Participants need to be assured that their participation, or information they provide, will not be used against them in any way. For example, people describing their economic situation should not risk loss of public health benefits; people reporting drug abuse should not fear exposure to criminal authorities.Study participants enter into a special relationship with researchers, and this relationship should not be exploited. Exploitation may be overt and malicious (e.g., sexual exploitation), but it might also be more subtle (e.g., getting people to complete a 1-year follow-up interview, without having warned them of this possibility at the outset). Because nurse researchers may have a nursepatient (in addition to a researcherparticipant) relationship, special care may be needed to avoid exploiting that bond. Patients consent to participate in a study may result from their understanding of the researchers role as nurse, not as researcher(Polit & Beck, 2014).

2. Respect for Human DignityRespect for human dignity is the second ethical principle articulated in the Belmont Report. This principle includes the right to self-determination and the right to full disclosure.

The Right to Self-Determination - The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking penalty or prejudicial treatment (Polit & Beck, 2014; Burns & Grove, 2010).It also means that people have the right to ask questions, to refuse to give information, and to withdraw from the study.A persons right to self-determination includes freedom from coercion. Coercion involves explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate(Polit & Beck, 2014; Burns & Grove (2010)

The Right to Full Disclosure - Respect for human dignity encompasses peoples right to make informed, voluntary decisions about study participation, which requires full disclosure. Full disclosure means that the researcher has fully described the study, the persons right to refuse participation, and possible risks and benefits. The right to self-determination and the right to full disclosure are the two major elements on which informed consent are based. Full disclosure maybe problematic if the issue being studied is sensitive to explain (Polit & Beck, 2014; Burns & 2010)

3. Justice The third broad principle articulated in the Belmont Report concerns justice, which includes participants right to fair treatment and their right to privacy.

The Right to Fair Treatment - One aspect of justice concerns the equitable distribution of benefits and burdens of research. The selection of participants should be based on research requirements and not on peoples vulnerabilities. (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011), Historically, subject selection has been a key ethical concern, with many researchers selecting groups deemed to have lower social standing (e.g., poor people, prisoners, the mentally disabled) as study participants. The principle of justice imposes particular obligations toward individuals who are unable to protect their own interests (e.g., dying patients) to ensure that they are not exploited for the advancement of knowledge. The right to fair treatment encompasses other obligations. (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)For example, researchers must treat people who decline to participate in a study or who withdraw from it in a non-prejudicial manner; they must honor all agreements made with participants; they must show respect for the beliefs and lifestyles of people from different backgrounds; and they must treat participants courteously and tactfully at all times

The Right to Privacy - Virtually all research with humans involves intruding into personal lives. Researchers should ensure that their research is not more intrusive than it needs to be and that privacy is maintained. Participants have the right to expect that any data they provide will be kept in strict confidence. Further researchers should not invade peoples personal space unless they are otherwise directed to do so (Polit & Beck, 2014).Teacher will ask three students whose surname begins with the letter T to describe to describe three ethical principles (one each) as articulated by the Belmont Report

Teacher will describe the three primary ethical principles as articulated by the Belmont Report with the aid of PowerPoint presentation

Teacher will ask two students who surname begin with the letter B to describe any two of the tree primary ethical principles as articulated by the Belmont report according to the contentThree students whose surname begins with the letter T will attempt to describe three ethical principles (one each) as articulated by the Belmont Report

Students will sit, listen and follow on PowerPoint and ask questions as necessary as topic is presented

Two students whose surname begin with the letter B will describe the any two of the three primary ethical principles as articulated by the Belmont Report according to the contentStudents will be able to correctly describe the three primary ethical principles as articulated by the Belmont Report by using key terms such as, The Belmont Report articulated three primary ethical principles on which standards of ethical research conduct are based: beneficence, respect for human dignity, and justice.

36 minsExplicate procedures for adhering to ethical principles and protecting study participants as cited by Polit & Beck, (2014); Burns & Grove, (2010); Rebar et al, (2011)

INFORMED CONSENTAn important procedure for safeguarding participants involves obtaining their informed consent. Informed consent means that participants have adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily. Researchers usually document informed consent by having participants sign a consent form (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011) DIAGRAM OF AN INFORMED CONSENT TO BE SHOWN WITH ITS VARIOUS ELEMENTS

ISSUES RELATING TO CONFIDENTIALITYStudy participants have the right to expect that any data they provide will be kept in strict confidence (disclosed unwittingly). Participants right to privacy is protected through confidentiality procedures.Anonymity - the most secure means of protecting confidentiality, occurs when the researcher cannot link participants to their data. For example, if questionnaires were distributed to a group of nursing home residents and were returned without any identifying information, responses would be anonymous (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)

Treatment of Vulnerable GroupsAdherence to ethical standards is often straightforward. The rights of special vulnerable groups, however, may need extra protections. Vulnerable populations may be incapable of giving fully informed consent (e.g., developmentally delayed people) or may be at high risk of unintended side effects (e.g., pregnant women).Attention should be payed to the ethical dimensions of a study when people who are vulnerable are involved(Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011)

Among the groups that should be considered as being vulnerable are the following:Children - Legally and ethically, children do not have the competence to give informed consent and so the consent of childrens parents or guardians should be obtained.

Mentally or emotionally disabled people - Individuals whose disability makes it impossible for them to make informed decisions (e.g., people affected by cognitive impairment, coma, and so on) also cannot legally provide informed consent. In such cases, researchers should obtain the written consent of a legal guardian (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011).

Severely ill or physically disabled people - For patients who are very ill or undergoing certain treatments (e.g., mechanical ventilation), it might be necessary to assess their ability to make reasoned decisions about study participation. For certain disabilities, special consent procedures may be required. For example, with people who cannot read or who have a physical impairment preventing them from writing, alternative procedures for documenting informed consent (e.g., videotaping) should be used.

Terminally ill - Terminally ill people can seldom expect to benefit personally from research, and thus the risk/benefit ratio needs to be carefully assessed.

Institutionalized people - Nurses often conduct studies with hospitalized or institutionalized people who might feel that their care would be jeopardized by failure to cooperate. Inmates of prisons and correctional facilities may similarly feel constrained in their ability to give free consent. Researchers studying institutionalized groups need to emphasize the voluntary nature of participation (Polit & Beck, 2014; Burns & Grove, 2010; Rebar et al, 2011).Teacher will ask students to get themselves into five groups, each group will discuss the treatment of one vulnerable group drawn from a bag which the teacher will present

Teacher will explain the procedures for protecting study participants with the aid of PowerPoint presentation

Teacher will ask one student sitting closest to the front door to explain the procedures for protecting study participants according to the contentsStudents will get themselves into five groups and each group will attempt to discuss the treatment of one vulnerable group drawn from a bag which the teacher will present

Students will sit, listen, follow on PowerPoint and ask questions as needed

One student sitting closest to the front door will explain the procedures for protecting study participants according to the contentsStudents will be able to correctly explicate procedures for adhering to ethical principles and for protecting participants as evidenced utilizing terms such as..Informed consent, confidentiality, anonymity, treatment of vulnerable groups.

Evaluate the ethical dimensions of a research report as proffered by Polit and Beck (2014)Members of an Internal Review Board (IRB) or human subjects or ethics committees are provided with sufficient information to answer all these questions, but research articles do not always include detailed information about ethics because of space constraints in journals. Thus, it may be difficult to critique researchers adherence to ethical guidelines. Nevertheless, here are some suggestions for considering ethical issues.Many research reports do acknowledge that the study procedures were reviewed by an IRB or human subjects committee.

When a report mentions a formal review, it is usually safe to assume that a panel of concerned people thoroughly reviewed ethical issues raised by the study.

QUESTIONS TO ASK

Was the study approved and monitored by an Institutional Review Board, Research Ethics Board, or other similar Ethics Review Committee? Were study participants subjected to any physical harm, discomfort, or psychological distress? Did the researchers take appropriate steps to remove or prevent harm? Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants? Was any type of coercion or undue influence used to recruit participants? Did they have the right to refuse to participate or to withdraw without penalty? Were participants deceived in any way? Were they fully aware of participating in a study and did they understand the purpose and nature of the research? Were appropriate informed consent procedures used with all participants? If not, were the reasons valid and justifiable? Were adequate steps taken to safeguard participants privacy? How was confidentiality maintained? Was a Certificate of Confidentiality obtainedand, if not, should one have been obtained? Were vulnerable groups involved in the research? If yes, were special precautions instituted because of their vulnerable status? Were groups omitted from the inquiry without a justifiable rationale, such as women (or men), or minorities? A person could come to some conclusions based on a description of the study methods. There may be sufficient information to judge, for example, whether study participants were subjected to harm or discomfort.

Reports do not always state whether informed consent was secured, but you should be alert to situations in which the data could not have been gathered as described if participation were purely voluntary (e.g., if data were gathered unobtrusively). In thinking about the ethical aspects of a study, you should also consider who the study participants were. For example, if the study involves vulnerable groups, there should be more information about protective procedures. There might also need to attend to who the study participants were not. For example, there has been considerable concern about the omission of certain groups (e.g., minorities) from clinical research

Teacher will randomly ask students to evaluate a research report shown by the teacher

Teacher will evaluate a research report with the aid of PowerPoint presentationStudents will attempt to evaluate a research report shown by the teacher

Students will follow PowerPoint presentation as a research report is evaluatedStudents will be able to correctly evaluate a research report by asking questions such as, , Did any physical harm, discomfort, or psychological distress occur ? Did the researchers take appropriate steps to remove or prevent harm, Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants?

EVALUATION

1.Name four historical situations that led to the establishment of a Code of Ethics2.Give one example of an ethical dilemma in nursing research3.State the three primary ethical principles as articulated by the Belmont Report4.Identify four groups that should be protected when research is being conducted5.State four pertinent questions that should be asked when evaluating a research report ANSWERS

1. The Nazi medical experiments of the1930s and 1940s; wartime experiments that raised ethical concerns were conducted in Japan and Australia; 1932 and 1972, the Tuskegee Syphilis Study, sponsored by the U.S. Public Health Service; Dr. Herbert Green in Auckland, New Zealand, studied women with cervical cancer in the 1980s; patients with carcinoma in situ were not given treatment so that researchers could study the natural progression of the disease.

2. Research question: Are nurses equally empathic in their treatment of ICU patients from different ethnic backgrounds?Ethical dilemma: Ethics require that participants be informed of their role in a study. Yet if the researcher tells participating nurses that their degree of empathy in treating different patients will be scrutinized, will their behaviour be normal?

3. Beneficence, respect for human dignity, and justice.

4. Mentally or emotionally disabled people; Severely ill or physically disabled people; Terminally ill; Institutionalized people; children

5. Was the study approved and monitored by an Institutional Review Board, Research Ethics Board, or other similar Ethics Review Committee?Were study participants subjected to any physical harm, discomfort, or psychological distress? Did the researchers take appropriate steps to remove or prevent harm? Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants? Was any type of coercion or undue influence used to recruit participants? Did they have the right to refuse to participate or to withdraw without penalty? Were participants deceived in any way? Were they fully aware of participating in a study and did they understand the purpose and nature of the research? Were appropriate informed consent procedures used with all participants? If not, were the reasons valid and justifiable?