1. Ethical Concerns in Research Do no harm!!

2. Ethics • Concerned with human behavior from a perspective of right and wrong. Ethical statements are developed to tell us what we ought to do in the situations we encounter.

3. Where is this Coming From? • Nazi Germany Medical Experiments • Freezing experiments • Malaria experiments • High-altitude experiments Led to the development of the Nuremburg Code This could never happen in America right? • Tuskegee Syphilis Study • Milgram Experiment – Authority and Obedience

4. Nuremberg Code • The voluntary consent of the human subject is absolutely essential • The experiment should be conducted for the good of society, unobtainable by other means of study • The experiment should be designed so that the anticipated results justify the performance of the experiment • Avoid all unnecessary physical and mental suffering and injury • No experiment should be conducted where you have reason to believe that death or disabling injury will occur

5. Nuremberg Code • The risk taken should never exceed that determined by the humanitarian importance of the problem • Preparations should be made to protect the subject against even remote possibilities of injury, disability or death • The experiment should be conducted only by qualified persons. • During the experiment, the subject should be at liberty to bring the experiment to an end • The scientist in charge must be prepared to terminate the experiment at any stage if continuation is likely to result in injury, disability or death to the subject

6. Other Landmark Occurrences • The Helsinki Declaration (World Medical Assembly, 1964) • National Research Act (1974) established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Produced the Belmont Report (1979) • Respect for persons • Beneficence • Justice

7. Informed Consent “The voluntary consent of the human subject is absolutely essential” • Subjects are made fully aware of the nature and purpose of the research • Consent is voluntarily given • The person involved has the legal capacity to give consent • The responsibility for obtaining consent rests with the researcher

8. Sample Informed Consent Form • See pp. 111-112 • I chaired the search committee that hired this guy

9. More Terms • Privacy: individuals have the right to control when and under what conditions others will have access to their behaviors, beliefs, and values • Confidentiality: the ability to link information or data to a person’s identity • Institutional Review Boards:IRB’s have been established by federal mandate to assure compliance to governmental regulations pertaining to research involving human subjects as well as animals

10. Institutional Review Boards (IRB’S) • The “Common Rule” (45 C.F.R. 46) requires that all research protocols involving human subjects be reviewed by an IRB to assure compliance with the requirements set forth in this policy Criteria for approval: • Risks to subjects are minimized • Risks to subjects are reasonable in relation to anticipated benefits

11. Institutional Review Boards (IRB’S) Criteria for approval (cont’d): • Selection of subjects is equitable in relation to the purposes of the research and its setting (vulnerable groups: children, prisoners, pregnant women, mentally disabled persons, those economically or educationally disadvantaged) • Informed consent will be sought from each prospective subject

12. Institutional Review Boards (IRB’S) Criteria for approval (cont’d): • Informed consent will be appropriately documented • When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects • When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data