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RESEARCH ETHICS. HISTORICAL BACKGROUND Nazi Medical Experiments (1930s and 1940s) Use of prisoners and racial enemies in experiments designed to test.

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Presentation on theme: "RESEARCH ETHICS. HISTORICAL BACKGROUND Nazi Medical Experiments (1930s and 1940s) Use of prisoners and racial enemies in experiments designed to test."— Presentation transcript:


2 HISTORICAL BACKGROUND Nazi Medical Experiments (1930s and 1940s) Use of prisoners and racial enemies in experiments designed to test the limits of human endurance, human reaction to diseases, and untested drugs

3 This is unethical because subjects were exposed to permanent physical harm or even death and they could not refuse participation

4 Tuskegee Syphilis Study (1932-1972) by US public health service Investigated effects of syphilis among 400 men from a poor African-American community Medical treatment was deliberately withheld to study the course of the untreated disease

5 Injection of live cancer cells into elderly patients at the Jewish Chronic Disease Hospital in Brooklyn Revealed in 1993 – US federal agencies had sponsored radiation experiments since the 1940s to prisoner or elderly hospital patients.

6 CODES OF ETHICS Nuremberg Code One of the first internationally recognized efforts to establish ethical standards Developed after the Nazi atrocities were made public in the Nuremberg trials. Declaration of Helsinki Adopted in 1964 by the World Medical Association then later revised in 2000

7 1995 – American Nurses Association put forth a document entitled Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research

8 ETHICAL GUIDELINES Respect autonomous research participant’s capacity to consent to participate in research and to determine the degree and the duration of that participation without negative consequences.

9 ETHICAL GUIDELINES Prevents or minimizes harm and promotes good will to all research participants, including vulnerable groups and others affected by the research.

10 ETHICAL GUIDELINES Respects the personhood of research participants, their families, and significant others, valuing their diversity

11 ETHICAL GUIDELINES Ensures that the benefits or burdens or research are equitably distributed in the selection of research participants

12 ETHICAL GUIDELINES Protects privacy of research participants to the maximum degree possible

13 ETHICAL GUIDELINES Ensures the ethical integrity of the research process by use of appropriate checks and balances throughout the conduct, dissemination, and implementation of the research

14 ETHICAL GUIDELINES Reports suspected, alleged, or known incidents of scientific misconduct in research to appropriate institutional officials for investigation

15 ETHICAL GUIDELINES Maintains competency in the subject matter and methodologies of his or her research, as well as in other professional and societal issues that affect nursing research and the public good.

16 ETHICAL GUIDELINES Involved in animal research maximizes the benefits of the research with the least possible harm or suffering to the animals.

17 PRINCIPLE OF BENEFICENCE MAXIM: “Above all, do no harm.” FREEDOM FROM HARM Study participants may be harmed physically (injury, fatigue) psychologically (stress, fear) socially (loss of friends) and financially (loss of wages) Minimize types of harm and discomfort to participants

18 Minimal risk is defined as risks anticipated to be no greater than those ordinarily encountered in daily life or during routine physical or psychological tests or procedures.

19 EXAMPLE Varda and Behnke (2000) studied the effect of the timing of an initial bath (1 hr versus 2 hrs after birth) on newborn temperature. To minimize risks, the researchers excluded all infants with conditions (infection, fetal distress, etc) that could predispose them to temperature instability.

20 FREEDOM FROM EXPLOITATION Involvement in a research study should not place participants at a disadvantage or expose them to situations for which they have not been prepared.

21 EXAMPLE A participant reporting drug abuse should not fear exposure to criminal authorities A prostitute study participant telling where she works and gets his/her customers should not fear exposure to criminal authorities

22 Study participants enter into a special relationship with researchers. This relationship should not be exploited. Exploitation may be overt and malicious Examples: sexual exploitation, use of subjects’ identifying information to create a mailing list, use of donated blood for development of a commercial product, etc.

23 BENEFITS FROM RESEARCH People agree to participate in research investigations for a number of reasons –Direct personal benefits Access to an intervention that might be otherwise unavailable to them Direct money or material gains –Desire to help others

24 PRINCIPLE OF RESPECT FOR HUMAN DIGNITY Includes right to self-determination and right to full disclosure

25 RIGHT TO SELF DETERMINATION Self-determination Prospective participants have the right to decide voluntarily whether to participate in a study, without risking any penalty or prejudicial treatment. Humans should be treated as autonomous agents, capable of controlling their own activities.

26 A person’s right to self-determination includes freedom from coercion. Coercion Involves explicit or implicit threats of penalty from failing to participate in a study Excessive rewards from agreeing to participate

27 RIGHT TO FULL DISCLOSURE Full disclosure Researcher has fully described the nature of the study, the person’s right to refuse participation, the researcher’s responsibilities, and likely risks and benefits.

28 Participants have the right to make informed, voluntary decisions about study participation Full disclosure is normally provided to participants before they begin the study

29 Prospective participants who are fully informed about the nature of research and its potential risks and benefits are in the position to make rational decisions about participating in the study.

30 INFORMED CONSENT Means that participants have adequate information regarding the research, are capable of comprehending the information, and have the power of free choice enabling them to consent to or decline participation voluntarily.

31 CONTENT OF INFORMED CONSENT Participant status Study goals Type of data Procedures Nature of the commitment Sponsorship (if there’s any) Participant selection Potential risks and benefits Confidentiality pledge Voluntary consent Right to withdraw/withhold information Contact information Voluntary consent

32 Debriefing sessions –Further disclosure towards the end of the study –Example: Two classes rating a professor’s teaching performance based on reputation.

33 THE PRINCIPLE OF JUSTICE Includes right to fair treatment and right to privacy.

34 RIGHT TO FAIR TREATMENT Participants have the right to fair and equitable treatment before, during, or after the research study.

35 FEATURES OF FAIR TREATMENT Respect for cultural and other forms of human diversity Fair and nondiscriminatory selection of participants with shared risks and benefits Honoring of all agreements between researchers and participants

36 FEATURES OF FAIR TREATMENT Courteous and tactful treatment at all times Participants access to research personnel at any point in the study to clarify information

37 RIGHT TO PRIVACY Virtually all research with humans involves intruding into personal lives. Researchers should ensure that participants’ privacy is maintained throughout the study.

38 Participants have the right to expect that any data they provide will be kept confidential. Anonymity Occurs when even the researcher cannot link participants to their data

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