This course provides an opportunity to explore issues related to the use of humans as research subjects. The course will begin by examining the history of human subject research, including the abuses that led to the creation of our modern legal protections. Following a discussion of the ethical principles of research involving humans, we will carefully explore the legal treatment of human subjects, focusing on US regulations and international instruments. Core sources will include: the Common Rule (45 CFR 46), Belmont Report, Declaration of Helsinki, Nuremberg Code, and CIOMS. After exploring a series of foundational themes and issues through the first half of the semester, the remainder of the class will focus on in-depth case studies. Topics may include: international research, research involving vulnerable populations (children, prisoners, and pregnant women), informed consent, research on subjects with impaired decision-making abilities, genetic/genomic research, risk-benefit analysis, coercion/undue inducement, use of placebos, and IRB governance.
This seminar provides opportunities for participants to engage in a research and writing project related to humans as research subjects. Participants will conduct independent research and scholarly writing on important problems at the intersection of law, policy and ethics.