Regulatory Mandates

The IRB adheres to the following regulations and policies for human subject research activities that fall under its authority:

  1. The Federal Policy regulations for the protection of human research subjects (45 CFR Part 46; “Common Rule”).

  2. When research involves articles subject to regulation by the FDA, the FDA regulations for the protection of human subjects (21 CFR Parts 50) and Institutional Review Boards (21 CFR Parts 56).

  3. Research is defined by the U.S. Department Health and Human Services as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46)