Don't Forget!

• Reporting Unanticipated Problems and Adverse Events to Institutional Review Boards

• What to Report to ORO

ORO Announcements:

•   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.  NOTE:  This memorandum reflects ORO’sproceduresonly.  ORO cannot speak for other VA or VHA offices.

•  Three ORO checklists were modified on 4/14/08 to more accurately reflect regulations and VA policies and to correct typographical errors: the Human Research Protection Program (HRPP) Checklist, the Institutional Review Board (IRB) Checklist, and the Research and Development Committee Checklist.

• ORO Lessons Learned  - Calendar Year 2007

• ORO recently participated in the VISN 8 Safety Meeting in Orlando.  Click here to see the presentations that were given.

• Memorandum of Understanding between the Office of Laboratory Animal Welfare (OLAW) and the VA Office of Research Oversight (ORO) was signed on November 21, 2007.

• The Research Data Security Assessment Checklist has been updated to include new requirements.  Obsolete or rescinded information has been removed as well.  The main change in the checklist is the revision of Section D.  The subtle changes in other places of the checklist are resulted from the revision of Section D.

  It is important to point out that Section D does not include all security requirements in VA Handbook 6500.  It focuses on only the requirements for use, access, transmission, and transportation of VA information outside of VA facilities.  In a VA research environment, this involves primarily remote access, VA information on affiliate systems, and VA-affiliate interconnections.  We would accomplish a lot if we could make this vulnerable area of information security secure.

• Presentations given at the 2007 SRA International Annual Meeting 

• 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.