Developed by the National Cancer Institute (NCI) for the National Institutes of Health (NIH), the web-based course offers continuing medical education (CME) credit for physicians and contact hours for nurses and other members of research teams. The new program also responds to the mandate requiring education on human subjects protection for all investigators who apply for or receive NIH funds for research involving people.

Titled Human Participant Protections Education for Research Teams, the course incorporates interactive modules, case studies, and exercises. Topics covered include:

• Roles and responsibilities of researchers and their key personnel

• Guiding ethical principles for research

• Federal regulations

• Informed consent

• Institutional review boards

• Ongoing protections throughout the course of the study

• Data and safety monitoring

• Reporting of adverse events

• Privacy and confidentiality

• Historical events that have impacted policy and legislation

NCI led the development of the program in collaboration with other NIH offices, including the National Institute of Allergy and Infectious Diseases, the National Heart, Lung and Blood Institute, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, and the NIH Clinical Center Bioethics Program.

The program offers up to two hours of category 1 credit of the Physicians Recognition Award of the American Medical Association. Cine-Med., a continuing medical education provider, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor the credits. Application for nursing contact hours is in progress.