Monday, November 14, 2011

DOD Releases Revised Instructions for Protecting Human Research Participants

The U.S. Department of Defense (DOD) released a revised instruction for the protection of human participants in research on the DOD Issuances Web site, Number 3216.02. The instruction became effective on the date it was posted, November 8, 2011.

While the new instruction has been in development for some time, its revision and release were accelerated by weaknesses in the review process used to review and approve medical research in Iraq in 2008 and 2009, specifically clinical trials concerning traumatic brain injury after blast injury.1,2

The instruction applies to all research involving human participants that is conducted or supported by the DOD including sponsored research in non-DOD organizations.

The instruction can be found on the following link:


1. mTBI Research Trial Comes Under Fire from DoD IG, U.S. Medicine, Accessed 11/5/2011.

2. Results in Brief: Assessment of Allegations Concerning Traumatic Brain Injury Research Integrity in Iraq, Report No. SPO-20ll-00S (Project No. D2009-DOOSPO-0242.00) March 31, 2011. Accessed 11/5/2011.

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