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Sex, Drugs, Rock and Role, and Other Ethical Dilemmas in Community Based Research

Sex, Drugs, Rock and Role, and Other Ethical Dilemmas in Community Based Research

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Sex, Drugs, Rock and Role, and Other Ethical Dilemmas in Community Based Research

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

  3. U.S. Human Experimentation Policy History • U.S. Constitution and Bill of Rights • 1964 Civil Rights Act, Privacy and Confidentiality Act • 1965 U.S. Public Health Service: formal ethical review • 1971 Guidelines for Federal Ethical Review • 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 • 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. • 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

  5. Critical Historical Incidents • 1947 Nuremberg War Crimes Tribunal • Our understanding of violations by others. • 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 • 1961 Draft Code of Ethics on Experimentation • 1964 Helsinki Declaration • 1964 Civil Rights Act, Privacy and Confidentiality Act • 1971 DHEW published policy on protection of human subjects • 1974 Formal establishment of IRB’s • 1978 Belmont Report • 1981 Final regulations issued by DHHS • 1993 Ethics and Research on Human Subjects, International Guidelines • 2001 International Ethical Guidelines For Research Involving Human Subjects

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

  8. Philosophical Principles Governing Research with Human Subjects • 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 • Minimize harm, maximize benefit: applications • Harm-benefit judgment and analysis • Consideration for individuals, communities, society, science • 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 • Bad stuff • Ethical Dilemmas • No win situations

  10. Common Ethical Violations • 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 • 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

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

  12. Examples of Dilemmas • Beneficence versus The Law

  13. Examples of Dilemmas • 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? • 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. • 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

  15. Ethics and Intellectual Property • 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 • Ethical Review for Projects: spread the blame, protect the innocent • Ethical Problem Resolution Procedures • The Ethical Workup Guide