Curriculum Guide · Courses
Research with Human Subjects: Law, Policy & Ethics
Professor Benjamin Berkman
LL.M Seminar 837 (cross-listed) | 3 credit hours
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 requires a paper. J.D. students must register for the 3 credit section of the seminar if they wish to write a paper fulfilling the Upperclass Legal Writing Requirement for JD students. The paper requirements of the 2 credit section will not fulfill the Upperclass Legal Writing Requirement for JD students.