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

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

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

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

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

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

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

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.

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

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?

Informed Consent Informed Voluntary Competent

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

Compensation for injury Right to refuse or withdraw without penalty

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?

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.

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.