About IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603
- Emergencies/On-call
- FAQs
- FDA Part 11 Electronic Signature Certification for eResearch
- FDA Part 11 Electronic Signature Certification for CareWeb
- 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 FWA 00004969
- University of Michigan Registration with FDA and OHRP
The purpose of the Institutional Review Boards of the University of Michigan Medical School (IRBMED) is to promote the protection of human participants in 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 is composed of five distinct boards (A1, A2, B1, B2, C1) of approximately 90 members. 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 in accordance with applicable laws, regulations, and University policies.
Faculty and students outside of the Medical School, may need to apply to one of the University's other IRBs. For details on selecting at the University of Michigan a particular 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.
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 addtional 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 University of Michigan operator at 734/936-4000 and ask them to page the designated Chair on-call which will be Dr. Michael Geisser or Dr. John Weg. The person on call should be contacted first. If not available, contact the alternate as listed on this linked schedule.
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 Food and Drug Administration 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 9/2/09
