Institutional Review Boards of the University of Michigan Medical School
The five Institutional Review Boards of the University of Michigan Medical School (IRBMED) oversee human subjects research conducted by medical school faculty, students, and staff. The IRBMED protects the rights and welfare of human subjects, applying federal and state laws, university policies, ethical principles, particularly those articulated in the Belmont Report.
Investigators must not commence research involving human subjects until the IRBMED has approved the study or determined it is exempt.
OHRP* regulations define a human subject as:a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information (45 CFR 46.102[f]). FDA* regulations define a subject as a human on whose specimen an investigational device is used or as a participant in research, either as a recipient of the test article or as a control 21 CFR 812.3 (p) and 21 CFR 50.3 (g).
OHRP defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. FDA defines research as any experiment that involves a test article and one or more human subjects [or specimens], the results of which are intended to be submitted to the FDA 45 CFR 46.102[d] and 21 CFR 56.102 (c).
The IRBMED office welcomes comments and suggestions from research team members. Please use our online feedback form to give us your input.
All 'key personnel" must complete basic human subjects education in PEERRS prior to IRB approval of a study. (PDF) The principal investigator must see that all other personnel involved in the research complete PEERRS.
*OHRP is the U.S. Department of Health and Human Services Office of Human Research Protections. FDA is the U.S. Department of Health and Human Services Food and Drug Administration.
