Human Subject Protection

Definition: The shared responsibility of all investigators to protect human subjects in biomedical and social/behavioral research from unnecessary risk is codified at 45 CFR 46 (the Common Rule) and it's subparts A,B,C, and D. Although all federal agencies have adopted the Common Rule, some federal agencies have yet to adopt all it's subparts.

The Food & Drug Administration (FDA) regulates human subjects research involving drugs, biologicals, and devices. In addition to the "Common Rule", regulations pertaining specifically to research with drugs and devices are found in 21 CFR 50, 54, 56, 312, 600, and 812.

In June 2000, the DHHS published new policies requiring all key personnel in DHHS sponsored human subjects research to complete formal training in the protection of human research subjects. The University of Miami has been a leader in developing educational programs to raise the level of awareness to human subjects protection issues. The web based CITI Program in The Protection of Human Research Subjects is hosted and administered by the Office of Research Education at the University of Miami and provided to over 350 institutions around the world. Completion of the CITI "Core" Course is required to become certified to conduct human subjects research at the University of Miami.

Re-certification is required and is accomplished by completing the CITI Continuing Education course.

The University of Miami Human Subjects Research Instruction Policy has been recently updated (close the new browser window to return here). For more information on this and other requirements  for conducting human subjects research visit the University of Miami IRB Home Page.

Web Based Resources Available

CITI Course in the Protection of Human Research Subjects

Other Instructional Materials and Opportunities