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 ) and Common Rule, 45 C.F.R. Part 46 (Revisions pending)
21C.F.R. sec &
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.