About IRBMED
2800 Plymouth Road
Building 200, Room 2086
Ann Arbor , MI 48109-2800
Email: irbmed@umich.edu
Phone: (734) 763-4768
FAX (734) 763-1234
- Emergencies/On-call
- FAQs
- Fees for IRBMED Review
- IRBMED Roster (PDF listing members of all five boards and their OHRP#)
- Map to IRBMED Office
- Staff List
- University of Michigan Federal Wide Assurance
- University of Michigan Registration with FDA and OHRP
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 at the Medical School and UMHHC, including research conducted off-site by University faculty and staff as University employees or in connection with their University appointments. The IRBMED protects the rights and welfare of participants in clinical trials and other human subjects research studies by careful review and monitoring of research by applying federal and state laws, university policies, ethical principles, particularly those articulated in the Belmont Report. The IRBMED is composed of five distinct boards (A1, A2, B1, B2, C1) of approximately 90 members.
Investigators must not commence research involving human subjects until the IRBMED has approved the study or determined it is exempt. Faculty and students outside of the Medical School, may need to apply to one of the University's other IRBs. For details on selecting the UM IRB an investigator should apply to visit http://www.irb.research.umich.edu/selection.html.
If you are interested in becoming a member of the IRBMED, please email Jan Hewett, Director, IRBMED, c/o (Board Secretaries) Colleen Bouton at cbouton@med.umich.edu or Maria Camilleri at mgcamill@med.umich.edu. Please attach a letter of interest outlining your reasons for volunteering and attach your CV or resume.
| OHRP | FDA |
|---|---|
| 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. |
| 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). |
Frequently Asked Questions about IRBMED
- How long will it take for an application to be processed and reviewed once received by IRBMED?
- Investigators should allow about 30 days for review of standard applications and 14 days for review of exemption requests. Allow additional time for other review committees that may be required to review and approve your study before the IRBMED receives it [e.g., the Investigational Drug Service (IDS)].
- How often does the IRBMED meet?
- There are three IRBMED board meetings every week. Two boards meet each Thursday between noon and 3 PM, excluding major holidays--A1 and A2 meet one week, B1 and B2 the next week, and the pattern is repeated throughout the year. Board C1 meets every Friday morning 9-10:30 AM. Requests to attend a meeting should be sent to IRBMED@umich.edu.
- How many studies are under IRBMED oversight?
- About 3400.
- How many submissions does IRBMED receive each year?
If you have an emergency related to human subject research and you need to reach the IRBMED, please call our office during business hours or, after hours, the UM operator at (734) 936-4000 and ask them to page the designated Chair on-call.
Examples of emergency situations include (but are not limited to):
- Serious, research-related unanticipated problem that requires immediate IRB attention
- “Emergency use” (i.e., treatment) of a patient with an agent unapproved by the FDA when that treatment must commence within 24 hours
- Enrollment of a ward of the state on a study approved under 45 CFR 46.406 or 407.
Enrollment of a patient who is also a prisoner onto a research trial (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.
- Health and well being reasons to continue a research intervention on a subject who becomes incarcerated (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.
Updated 12/5/11
