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Back Issues

May 24, 2001

Consent from VA Patients Enrolled in Research Studies

On Oct. 30, 1992, the Veterans Affairs federal requirement (M-3, Part 1, Chapter 9) dictated that informed consent obtained from Veterans Administration patients being enrolled in research studies should be documented on a VA10-1086 form. With recent public scrutiny of research conducted in VA facilities, the administration is now enforcing the use of the VA Research Consent form VA10-1086 for those studies approved to enroll VA patients in research. If your study has been approved to enroll VA subjects, you will be required, at the time of a modification request or continuation review process, to provide a consent form to be used exclusively for enrollment of VA subjects. This form can be downloaded from the following website: www.va.gov/forms/dotindex.asp.

Currently approved consent documents can continue to be used to enroll VA subjects until the time of modification request or continuation review. Continued approval for enrollment of VA subjects will require that you submit a separate consent form for this population, formatted on the VA10-1086. The consent document for the enrollment of subjects other than VA patients will continue to be based on the UK-approved model consent form.

Please note that this is a VA initiative. Studies that do not involve the enrollment of VA patients will not be affected. If you have questions about the VA research consent form, please contact Reuben Walize at the VA (phone 17-4927).

UK Research • University of Kentucky