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Ann Arbor VA Healthcare System Research Services

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IRB Committee

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 that 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

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
  • 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. (application submission deadlines)

Forms

 

Guidance

 

Policy

VA Consent Form   Scanning VA Consent Forms into CPRS   AAVAHS Human Subjects Research Training Policy (2015)
HIPAA Authorization Form   Does my project require IRB review?   AAVAHS IRB Standard Operating Procedures (9/10/2015)
Serious Adverse Events Reporting (9/8/2016)   Human Studies Basics - October 2015   AAVAHS IRB Policy for Department of Defense-Sponsored Research
Annual Tabular Adverse Event Reporting Form (9/8/2016)       AAVAHS Standard Operating Procedures - Provide Notice of Privacy Practice to Non-Veterans
HIPAA Authorization Revocation Form       VHA Handbook 1200.05 - The Protection of Human Subjects in Research
Form IND - Investigational Drugs in Research       VHA Handbook 1605.1 - Privacy and Release of Information
Form IDE - Investigational Devices in Research        
VHA Notice of Privacy Practices        
Acknowledgment of the Notice of Privacy Practices        
Device Management Form