Ethics and Human Participants

1. Ethics and Human Participants Foundations of Science

2. Research Ethics • Moral principles applied to research • Ethical responsibility – Who is affected? • Research participants • Scientific community • Society • Initially determined by the researchers themselves

3. The Need for Ethical Principles • Nazi Germany (1930-1940s) • Twin studies • Sterilization experiments • Hypothermia & High-altitude studies • Physicians tried for war crimes • Nuremberg Code of 1947

4. The Need for Ethical Principles • Nuremberg Code • Rules for treating participants • Voluntary agreement • Research must benefit society • Research should be based on previous knowledge • Should not cause mental/physical harm • Don’t conduct if injury/death possible • Risk should be proportional to benefits • Plans & facilities provided to protect participants • Qualified researchers • Participants can stop at anytime w/out penalty • Researchers prepared to discontinue experiment

5. The Need for Ethical Principles • 1932: Tuskegee Syphilis Study • U.S. Public Health Service in Alabama • Short-term study to monitor untreated syphilis

6. The Need for Ethical Principles • Tuskegee Syphilis Study • Vulnerable population • African Americans, rural, low SES, high rates of illiteracy, difficult to obtain medical care • Incentives: burial assistance, medical treatment, hot meals, transportation • What did participation involve? • Periodic health examinations • Not given info (i.e., treated for “bad blood”) • Penicillin withheld (standard cure by 1940s) • Results • Dozens died from syphilis & complications • Many women & children infected • Trust between health community & African Americans broken

7. The Need for Ethical Principles • Milgram obedience studies (1960s) • Study concerning the obedience to authority

8. Guidelines • Belmont Report (1970s) • Respect for persons • Autonomy • Special protection for certain individuals • Informed volunteers • Beneficence • Protect well-being • Do no harm • Max benefits, min harm • Justice • Share in cost/benefit of research • Participant populations

9. Guidelines • APA Ethics Code • General principles (aspirational) • See section 3.2 of Price textbook • Cost-Benefit Ratio • Institutional Review Board (IRB) approval • Protection of participants’ rights • Categories for review process • Exempt • Minimal risk research (can be expedited) • At-risk research

10. Ethics in Research • Vulnerable populations • Pregnant women, prisoners, adolescents, etc. • Those not able to give consent • Assent & consent from legal guardian • Precautions in place? • Amount of risk • No risk– consent may be optional depending on the nature of the study • Any risk – consent is mandatory

11. Informed Consent • Voluntary Participation • Consent form • General purpose of research • Don’t have to tell participants your hypothesis! • Procedures & participants’ responsibilities • Approximate time commitment • Risk & Benefits

12. Informed Consent • Privacy/Confidentiality/Protection • Anonymity vs. confidentiality • Inducements/Incentives/Benefits • Rights of participants • Freedom to withdraw • Contact Information • Researcher, IRB • Signatures • Participants & Researchers

13. Deception Controversy • Why use deception? • No other way to do some research • Confederates • Issues • Limits subject freedom to choose • Implies subject is untrustworthy • Negative public image & suspicious population

14. Ethics in Research • Debriefing • Return participants to same mental/emotional state • Explain purpose of study • Explain any deception • Repeat confidentiality & anonymity • Get feedback about study • Give ASAP

15. Mini-Review What is the difference between confidentially and anonymity? What are some examples of deception? What are the key aspects of the Belmont report? Identify elements that are typically part of a consent form.