Don't Forget!

• Reporting Unanticipated Problems and Adverse Events to Institutional Review Boards

• What to Report to ORO

ORO Announcements:

• Research Studies Seeking Information from Medical Centers: This memo, co-signed by the Deputy Under Secretary for Health for Operations and Management (10N) and the Chief Research Oversight Officer (10R), was distributed to the field on July 15, 2008.

• 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.

• The Assistant Secretary for Information and Technology has signed a memo approving, with comments, the Under Secretary for Health’s request to use alternative methods of providing clinical trial monitors with access to pertinent medical records of the Department. The comments are suggestions for the manner of implementation of the approved alternative access methods. Click here  to view both the approval memo signed by the Assistant Secretary on June 26^th and the request memo signed by the Under Secretary on April 28.  The documents must be read together to obtain the full meaning.

• 2008 Facility Director's Certification of Research Oversight :  Effective February 21, 2007, VHA policy requires that each Medical Center Director annually certify oversight of the facility's research program.  All six pages of the Certification Checklist and a Remedial Action Plan to address all identified deficiencies must be submitted to the appropriate ORO Regional Office  through the VISN Director no later than July 15, 2008.
  
  Note : The VHA Facility Director’s Annual Certification of Research Oversight may be sent to ORO Regional Offices by delivery service, fax, or encrypted email attachment.  The facility/VISN should arrange to submit the documents in a manner that ensures protection of sensitive information. The Director’s signature and other information provided on the Certification must be clear, and the appropriate Action Plans must accompany the Certification. 

• ORO has adopted procedures for oversight of compliance with VA requirements for the use and storage of electronic and hard-copy research information: ORO Compliance Oversight Procedures for Use and Storage of VA Sensitive Research Information . 
  
  This memo was updated on May 29, 2008.  The changes are in the last section (G) on "Additional Considerations."  There is also a new attachment on "Selected Terms and Definitions." 
  
  NOTE: This memorandum reflects ORO's procedures only.  ORO cannot speak for other VA or VHA offices.

• ORO Lessons Learned - Calendar Year 2007

• VHA POLICY IS MORE RESTRICTIVE THAN NIH GUIDANCE REGARDING RECRUITMENT OF STUDY SUBJECTS UNDER THE HIPAA PRIVACY RULE  (Revised Clarification 9/05/2007).  Please click here for clarification.

Please send your comments, suggestions, or questions regarding this page to Shannon Williams at shannon.williams@va.gov.