Biomedical Research Regulation and Ethics

This upper-level seminar explores ethical principles, legal regulations, and emerging issues related to biomedical research involving human participants. After foundational classes introducing the nature and history of such research, the seminar will focus on federal regulations and international guidelines aimed at protecting human participants. Students will become familiar with the purpose and function of institutional review boards (IRBs), in theory and in practice, through their identification of regulatory and ethical issues raised by a mock IRB application and consent form. Specific topics vary each offering and may include, but not be limited to: informed consent; issues of justice and vulnerability in the recruitment of research participants; risk-benefit assessments; the inclusion of pregnant women, children, racial and ethnic minorities, and captive populations in research; international research; research during public health emergencies; compensation for research-related injuries; and research involving emerging technologies.

Grades will be based primarily on two writing assignments of approximately 10 pages each. With the permission of the instructor, a limited number of students may instead write a substantial research paper aimed at satisfying the Advanced Writing Requirement. There are no prerequisites.

This course is not currently scheduled.
Last offered Spring 2020.

Key to Codes in Course Descriptions
P: Prerequisite
C: Prerequisite or Concurrent Requirement
R: Recommended Prior or Concurrent Course