Fall 2022 Course Schedule

Bioethics and Reg of Human Subject Research (LAW-774-001)
Heidi Gertner

Meets: 07:00 PM - 08:50 PM (W)

Enrolled: 19 / Limit: 22

Administrator Access


This course is titled "Bioethics and Regulation of Human Subjects Research." This course satisfies the Health Care Compliance Certificate.


This course examines how the law reconciles conflicting values and interests in medicine, public health, and research involving human and non-human animal subjects. Topics include compliance with regulatory requirements applicable to human subjects and life sciences research —including informed consent, IRBs, including vulnerable populations in research, non-clinical research, and conscientious objection in the clinical context.

Textbooks and Other Materials

The textbook information on this page was provided by the instructor. Students should use this information when considering purchases from the AU Campus Store or other vendors. Students may check to determine if books are currently available for purchase online.

Carl Coleman et al., The Ethics and Regulation of Human Subjects Research (2d ed. 2015). Additional reading assignments will be posted on MyWCL.

First Class Readings

Coleman: 3-61


Carl E. Schneider, “Bioethics in the Language of the Law,” 24 (4) Hastings Center Report 16 (1994).


Use your MyAU username and password to access the syllabus in the following format(s):