Current Legal and Ethical Controversies in American Health Care

1. Current Legal and Ethical Controversies in American Health Care Legal and Ethical Aspects of the Biomedical Research Enterprise

2. Instructors • Marshall B. Kapp, J.D., M.P.H. • Alice Pomidor, M.D., M.P.H. • Professor of Geriatrics, College of Medicine

3. What is Research? • Interventional/Experimental (Randomized Controlled Trial is the model on which current regulatory system is based) • Observational--Epidemiological research

4. Purpose of Research • Systematically designed collection and analysis of data for the purpose of testing hypotheses and drawing and disseminating generalizable conclusions to benefit people in the future. Process of discovery

5. Types of Research • Animals (Basic science) • Bench/laboratory/physical environment (Basic science) • Human subjects as source of data

6. Distinguish “Research” from: • Consultation • Clinical (diagnostic and therapeutic) practice • Public health practice* *Implementing standard practices, rather than discovering new and better practices • Surveillance • Outbreak investigation/emergency response • Program evaluation

7. Why Regulate Human Subjects Research? (Goals) • Protect people from harm? • Promote confidence in the research process • Promote individual autonomy • Choice (Informed Consent) • Confidentiality • Research is an “ethically optional” activity

8. Sources of Regulation • National Research Act (Pub. L. 93-348) and Common Rule, 45 C.F.R. Part 46 (Revisions pending) • FDA @ 21C.F.R. sec. 50.10-40 & 56.101-121 • HIPAA, 45 C.F.R. Part 164--pp. 334, 340 n. 5. Researchers are not “covered entities”. HIPAA affects what data providers may give to researchers.

9. Sources of Regulation (cont.) • State statutes and regs. • Common law principles of informed consent and confidentiality • Funders’ requirements • Publishers’ requirements

10. Roles of Institutional Review Board • Minimize risks to subjects • Balance risks/benefits. Sometimes it is hard to measure benefits and identify who gets them. • Assure equitable subject selection • Assure informed consent • Scientific review of protocol?

11. Informed Consent • Informed • Voluntary • Competent

12. Informed Consent--Information • Risks • Benefits (“Therapeutic misconception”) • Costs • Confidentiality protections and consequences • Compensation for participating/Voluntariness

13. Compensation for injury • Right to refuse or withdraw without penalty

14. Conflicts of Interest in Research • Researchers’ interests? • Institutional interests? • Sponsors’ interests? • Bias in reporting results? • Whom can the doctor trust? • Whom can the patient trust? • What are the alternatives?

15. Case example • A study was conducted of the prevalence of cocaine use among low-income, mainly African-American patients seen at an inner-city hospital clinic. One goal of the study was to determine the validity of self-reported cocaine use in this population. Researchers asked clinic patients to participate in a study of STDs in return for $10. Informed consent was obtained from participants for the STD study, but not for the undisclosed study of the prevalence of cocaine use and the validity of self-reported information about cocaine use.

16. Participants were told that their urine would be tested for STDs, but were unaware that it also would be tested for cocaine metabolites. Among male participants, 39 percent tested positive for cocaine metabolites in their urine, but 72% of the positive men denied any illicit drug use in the recent past.