VA Ann Arbor Healthcare System Research Services
The VA Ann Arbor Healthcare System IRB reviews all research involving human subjects conducted in any area owned or leased by the hospital. Its goal is to assure the rights and welfare of the human subjects are adequately protected, guided by the ethical principles in the Belmont Report, published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979). As part of its mandate, the IRB reviews new protocols and then monitors them by performing annual reviews and considering all requests for modifications, adverse events, protocol violations and safety concerns.
A human subject is a living individual about whom an investigator (whether professional or student) conducts research, and: (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Certain studies may have the characteristics of human subjects research but may not meet the regulatory definition. Studies which meet the definition require IRB review. There are three categories to be considered: (1) studies that are human subjects research, (2) studies that may be considered human subjects research (this is a gray area so ask the IRB coordinators), and (3) studies that do not qualify as human subjects research (Quality Improvement/Assurance, Single Case Study, etc.). Research Protocols involving human subjects require review and approval by an Institutional Review Board (IRB) BEFORE any work is initiated.
There are research activities that are considered exempt from IRB review and the Common Rule provides 8 specific exemption categories (see Information about human subjects research section on this page for more information about exemption categories). The IRB review level is based on the risk and typically it has to fit in the approved categories of either Exempt or Expedited. Otherwise, the study is reviewed by the Full Board. To be Exempt from the Common Rule generally means not subject to the requirements of the Common Rule; however, it is important to note “exempt” does not mean exempt from all of the requirements of the Common Rule for some of the categories of human subject studies determined to be exempt under the 2018 Requirements.
The IRB meets on a monthly basis, generally on the second Thursday of the month. It includes, as voting members, at least one member of VA R&D Committee, one scientist, two mental health professionals, the VA Research Pharmacist, a licensed physician for the review of research involving an FDA-regulated article, one non-scientist and one community representative.
When your protocol is reviewed the IRB can take four possible determinations:
- Approved, Pending - Responses to well-defined and minor revisions requested by the Committee can be reviewed by the IRB Chair or another IRB member designated by the Chair. This can allow approval to occur prior to the next convened IRB meeting.
- Deferred - If there are substantial clarifications and/or modifications necessary for the Committee to reach a determination, approval is deferred until the response is received from the PI and the convened IRB has completed its review.
- Disapproved - If there are problems intrinsic to its current design, a study will be disapproved.
All submissions are made using AAROW. For new research, you must first add a new project, to be reviewed by the RDC. As soon as the RDC Project form has been submitted, you can create a new proticol for review by the IRB. In general, these forms should be completed 12 business days prior to the R&D meeting. The IRB Committee meets the 2nd Thursday of each month.