HIP 516 Protection of Human Subjects

Credits: 1
This course enables clinical researchers to recognize and appropriately address legal, regulatory, and ethical issues in research, with special attention to vulnerable subjects and regulatory issues unique to Oregon. This is accomplished by:

teaching basic concepts in law, federal regulation, study design, and ethics related to clinical research;
reviewing common problems encountered in human subjects protocols and informed consent documents to demonstrate how to identify and remedy deficiencies;
reviewing the roles and responsibilities of institutional review boards, investigators, and sponsors involved in the conduct of human research; and
reviewing the obligations of clinical researchers in relation to initial and continuing reviews, reporting of unanticipated problems, reporting changes in approved research, and consenting human subjects and monitoring safety in research as required by federal regulations.

The course includes discussion of the historical roots for current regulations, Oregon law, federal regulations, OHSU policies, and practical advice for navigating the compliance milieu related to human subjects research.

Graded: Pass/No pass
May be taken only once for credit