PHA 6289 Regulation of Clinical Research


The relatively short history of federal regulation of research is discussed in this class. The “common rule” comprised of sections of federal regulations relating to human subjects research is thoroughly studied, including the distinction between research and innovative therapy, the requirement for informed consent, and the avoidance of conflict of interest. Research regulation by litigation is also studied through a review of legal cases that have applied federal criteria for clinical research. The process for developing risk management strategies for the appropriate supervision of research is reviewed.

Tuition: $2,250
Credits: 3