Information about Human Volunteers in Research
Institutional Review Boards
All research involving human subjects is reviewed by an Institutional Review Board (IRB). The purpose of an IRB is to protect the rights and welfare of human subjects involved in research activities. No research involving human subjects can begin until the IRB has reviewed and approved the proposed activity.
The IRB has the authority to approve, require modifications in, or disapprove any research in its jurisdiction. Research that has been reviewed by an IRB may be subject to review and disapproval by the institution. However, per the formal agreement between the University and the federal government, and university policy, the institution may not approve research if it has been disapproved by the IRB.
The IRB is comprised of individuals with at least five members of varying backgrounds, experience, and expertise.
The UM IRBs include:
- at least one scientist
- at least one nonscientist
- at least one individual not affiliated with the institution
- additional members are required to approve research involving uniquely vulnerable populations
- use of consultants to ensure appropriate review of research involving vulnerable populations, or when it has inadequate expertise.
The UM IRBs have jurisdiction over all research involving human subjects. In its agreement with the federal government, the University of Michigan has indicated that the IRB shall review and approve all research involving human subjects.
The UM has eight Institutional Review Boards. The primary appointment of the Principal Investigator (PI) usually determines, in general, which IRB reviews and, if approved, monitors the research:
- IRBMED (currently four IRBs) -- PIs from the Medical School or the UM Health System, and all other research involving certain clinical interventions, patients, records or facilities of the UM Health System. Pharmacy, Dentistry and Nursing faculty often submit their applications to this IRB.
- IRB-Health Sciences and Behavioral Science -- PIs from all Ann Arbor units (including LSA) not listed IRBMED apply here.
- Flint -- PIs from UM-Flint apply here
- Dearborn -- PIs from UM-Dearborn apply here.
The Medical School is the administrative home for the IRBMED, which houses five IRBs on the Medical campus. Office of the Vice President for Research (OVPR) provides the administrative home for two other of the UM-Ann Arbor's Institutional Review Boards -- IRB-Health and IRB-BehavSci. The UM-Dearborn and UM-Flint campuses provide the administrative home for their respective IRBs.
UM faculty and staff comprise most of the membership of the IRBs, and each member volunteers a significant amount of time each week to read and evaluate research protocols and attend meetings to discuss and vote on applications.
June 1, 2010