Communication with ORO: A joint memo, signed by Mr. William Feeley, Deputy Under Secretary for Health for Operations and Management, and Dr. Tom Puglisi, Chief Research Oversight Officer, was distributed to the VISNs on 9/18/07 to encourage the Network Directors to promote and enhance communication with ORO.

Biosafety Level (BSL) 3 Research Laboratory Physical Security Inspections: The memorandum indicates that most BSL-3 Research Laboratories will be visited by ORO staff every other year for a security inspection; facilities will conduct their own inspections each year that no ORO visit is conducted and submit a report to ORO.   ORO Central Office has contacted the appropriate Facility Directors, Associate Chiefs of Staff for Research, and BSL-3 Research Laboratory Directors via e-mail to advise them of the plan.  ORO Regional Office Directors will be contacting facilities with BSL-3 Research Laboratories to advise them of when the ORO visit will be conducted.  If there are any questions, please contact  Dr. Tom Puglisi, ORO Chief Officer, or  Dr. Joan P. Porter, ORO Deputy Chief Officer, for information. 

Certification of Oversight of VHA Research: VHA policy now requires that Medical Center Directors acknowledge and certify their responsibilities related to the oversight of research at their facility.  The Certification and Checklist must be submitted to the appropriate ORO Regional Office no later than July 1 annually.  Please refer to the  signed memo from the Acting Under Secretary for Health dated February 21, 2007.  (Please note that the Checklist has been amended to remove the two check-off boxes pertaining to Non-Profit Corporations (NPCs).  Please click  here to view the amended Certification and Checklist Microsoft Word.)

ORO’s interpretation of regulatory requirements for reporting unanticipated problems and adverse events (AEs) in research to the responsible Institutional Review Board (IRB) is detailed in a memo  to the Chief Research and Development Officer (CRADO) (12).

What to Report to ORO was distributed via e-mail as well as snail-mail on September 29, 2005.  Please click here to view.

Interim Instructions for Filing Federalwide Assurances (FWAs) and Institutional Review Board (IRB) Registration was distributed via e-mail to facilities on February 11, 2005.  Please click here to view.

Quality Assurance Project to Promote Research Compliance memo dated February 1, 2005 was issued to all VHA Facility Directors using affiliate Institutional Review Boards.  Please click here to view the memo.

The Office of Research & Development (ORD) and ORO have jointly developed a checklist for use in the development of a Memorandum of Understanding (MOU).   A hard copy of this memo was mailed out to those to whom it was addressed on 1/11/05.

• Memo
• Attachment 1: Checklist for VAMC MOU with Affiliated Medical or Dental School
• Attachment 2: Checklist Addendum: Additional Points to Consider for Accreditation of HRPP

Announcement of ORO Initiation of Routine Reviews at VA Facilities Conducting Research  memo was mailed out on November 2, 2004.