The Secretary of Veterans Affairs has directed ORO to coordinate a comprehensive review of all VHA research studies involving individuals with Post-Traumatic Stress Disorder (PTSD). The purpose and scope of this review is detailed in a memo from the ORO Chief Officer dated July 1, 2008, addressed to all VHA Directors of facilities conducting research. Copies of all review panel reports and all relevant IRB meeting minutes must be received in ORO Central Office, with a copy to your ORO Regional Office Director, no later than August 15, 2008.
Points of Clarification:
(1) ORO's request refers to all PTSD studies regardless of whether or not drugs are involved. "PTSD studies" means studies directed toward PTSD patients/subjects or studies in which PTSD patients/subjects are compared with others.
(2) ORO's request covers only currently active, IRB-approved studies.
(3) For record review studies, the special review panel should verify that the type of IRB review was appropriate, that informed consent and HIPAA authorization were properly obtained or waived, and that proper safeguards are in place to assure data security and privacy for the database oriented projects.
(4) For ongoing exempt research, the special review panel should verify that the exemption is appropriate and valid.