1. Sex, Drugs, Rock and Role, and Other Ethical Dilemmas in Community Based Research Robert T. Trotter, II General Motors Sigma Xi Lecture Dec. 4, 2003

2. Ethical Pressures and Research on Humans Ethical Guidelines Have Always Been Ethical Guidelines Have Always Been Reactive before being Proactive Key International Guidelines Key International Guidelines –Ethics assumed prior to WWII: Religious Conventions and Disciplinary Ethical Standards –1947Nuremberg Code –1964Helsinki Declaration –1993Ethics and Research on Human Subjects, International Guidelines –2001International Ethical Guidelines For Research Involving Human Subjects

3. U.S. Human Experimentation Policy History U.S. Constitution and Bill of Rights U.S. Constitution and Bill of Rights 1964 Civil Rights Act, Privacy and Confidentiality Act 1964 Civil Rights Act, Privacy and Confidentiality Act 1965 U.S. Public Health Service: formal ethical review 1965 U.S. Public Health Service: formal ethical review 1971 Guidelines for Federal Ethical Review 1971 Guidelines for Federal Ethical Review 1974 National Research Act 1974 National Research Act –Established the National Commission for the Protection of Human Subjects –Formally established IRB’s (Institutional Review Boards) 1978 The Belmont Report 1978 The Belmont Report 1981 Final joint regulations issued by federal government 1981 Final joint regulations issued by federal government

4. Foundations I have vowed eternal vigilance against any form of tyranny over the mind of man. I have vowed eternal vigilance against any form of tyranny over the mind of man. Thomas Jefferson Thomas Jefferson Constitution defines and provides us with a number of critical rights to life, liberty, and the pursuit of happiness: basis for current ethical standards and definitions Constitution defines and provides us with a number of critical rights to life, liberty, and the pursuit of happiness: basis for current ethical standards and definitions

5. Critical Historical Incidents 1947 Nuremberg War Crimes Tribunal 1947 Nuremberg War Crimes Tribunal –Our understanding of violations by others. 1972 Tuskegee Syphilis Study Revealed 1972 Tuskegee Syphilis Study Revealed –Our understanding of violations by us. –Implemented in 1932  Study of the Natural Course of Syphilis  399 African ‑ American Men in Alabama  Uniformed and Untreated

6. Summary: Human Experimentation Policies 1947 Nuremberg Code 1947 Nuremberg Code 1961 Draft Code of Ethics on Experimentation 1961 Draft Code of Ethics on Experimentation 1964 Helsinki Declaration 1964 Helsinki Declaration 1964 Civil Rights Act, Privacy and Confidentiality Act 1964 Civil Rights Act, Privacy and Confidentiality Act 1971 DHEW published policy on protection of human subjects 1971 DHEW published policy on protection of human subjects 1974 Formal establishment of IRB’s 1974 Formal establishment of IRB’s 1978 Belmont Report 1978 Belmont Report 1981 Final regulations issued by DHHS 1981 Final regulations issued by DHHS 1993 Ethics and Research on Human Subjects, International Guidelines 1993 Ethics and Research on Human Subjects, International Guidelines 2001 International Ethical Guidelines For Research Involving Human Subjects 2001 International Ethical Guidelines For Research Involving Human Subjects

7. Key Requirements for Ethical Approval of Human Research (IRB Guidelines ) Distinguishing Research from Practice Distinguishing Research from Practice Sound Research Design Sound Research Design Protection of Confidentiality Protection of Confidentiality Informed Consent Informed Consent Participation is Voluntary Participation is Voluntary Consideration of risks/benefits Consideration of risks/benefits Equality in Treatment of Subjects Equality in Treatment of Subjects

8. Philosophical Principles Governing Research with Human Subjects Respect for Persons Respect for Persons –Free will and self determination: applications  Informed consent procedures  Voluntary participation: without coercion or pressure  Guaranteed privacy, confidentiality protection  Competence assumed: otherwise additionally protected Beneficence/Nonmalficence Beneficence/Nonmalficence –Minimize harm, maximize benefit: applications  Harm-benefit judgment and analysis  Consideration for individuals, communities, society, science Justice Justice –Equity and fairness for both risks and benefits: applications  Special vulnerable groups protection  Principle of Inclusion of all populations

9. Ethical Problems Violations of Ethical Principles and Guidelines Violations of Ethical Principles and Guidelines –Bad stuff Ethical Dilemmas Ethical Dilemmas –No win situations

10. Common Ethical Violations Confidentiality – talking, talking too loud, talking in the wrong place, talking to the wrong people Confidentiality – talking, talking too loud, talking in the wrong place, talking to the wrong people Coercion – asking too hard, asking the wrong people at the wrong time, paying for research Coercion – asking too hard, asking the wrong people at the wrong time, paying for research Competing allegiances to research subjects, research sponsor, organization, community – conflicts of interest Competing allegiances to research subjects, research sponsor, organization, community – conflicts of interest Cultural conflict – conflicts of class, social justice, and imposed values – its for their own good Cultural conflict – conflicts of class, social justice, and imposed values – its for their own good

11. Examples of Dilemmas Confidentiality versus Do No Harm: HIV and Drugs Confidentiality versus Do No Harm: HIV and Drugs

12. Examples of Dilemmas Beneficence versus The Law Beneficence versus The Law

13. Examples of Dilemmas Privacy vs. Public Good: Levels of Benefit and Harm: Sex in the City Privacy vs. Public Good: Levels of Benefit and Harm: Sex in the City

14. Ethical Dilemmas: Cross ‑ Cultural Conditions Language barriers: would you sign something you cannot read? Language barriers: would you sign something you cannot read? Differences in cultural norms, beliefs, values: who are the governmental spies? Differences in cultural norms, beliefs, values: who are the governmental spies? Power (status) differences between researcher and subject: its ok to do this because I trust you, or you scare me. Power (status) differences between researcher and subject: its ok to do this because I trust you, or you scare me. Identification of “right” person to give consent Identification of “right” person to give consent –Authority to provide consent may lie with spouse, family elders, religious leaders, community leaders, or others and not just the single individual who participates in the research Reverse Ethical Dilemmas or Violations in the name of political correctness Reverse Ethical Dilemmas or Violations in the name of political correctness

15. Ethics and Intellectual Property Control over uses of data Control over uses of data –Ownership of data  Ethnomedical example –Access to data  Collaborative Research example –Publication of data  Cross-cultural example

16. Solutions Ethics Training for Researchers: know the principles and their applications Ethics Training for Researchers: know the principles and their applications Ethical Review for Projects: spread the blame, protect the innocent Ethical Review for Projects: spread the blame, protect the innocent Ethical Problem Resolution Procedures Ethical Problem Resolution Procedures –The Ethical Workup Guide