Institutional Review Boards of the University of Michigan Medical School
The five Institutional Review Boards of the University of Michigan Medical School (IRBMED) are charged with the oversight of human subjects research conducted by medical school faculty, students, and staff at any University of Michigan Health System (UMHS) facility or site. The purpose of an IRB is to protect the rights and welfare of human subjects in research. Guiding this process is the application of federal and state laws, university policies, ethical principles; particularly those articulated in the Belmont Report.
Investigators should not commence research involving human subjects until the IRBMED has approved the study or has determined it is exempt.
Federal OHRP* regulations define a "Human Subject" as: "[A] living individual about whom an investigator . . . conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information" (45 CFR 46.102[f]). FDA* regulations use the definitions "a human . . . on whose specimen an investigational device is used . . .;"21 CFR 812.3 (p) or "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient." 21 CFR 50.3 (g)
"Research" is defined by OHRP as: "[A] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" 45 CFR 46.102[d] and by FDA as " [A]ny experiment that involves a test article and one or more human subjects [or specimens]. . . the results of which are intended to be submitted to . . FDA." 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.
*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.
