Clarification Regarding Reporting Requirements for
Studies Supported by the Seven HSR&D REAPs
February 20, 2007

On February 15, 2007, all seven Health Services Research and Development (HSR&D) Research Enhancement Award Programs (REAPs) were directed to cease all research activities immediately, pending certification from the VA’s Chief Information Officer that it meets published standards for information security.

The Directors of VHA facilities housing these REAPs should report their suspended REAP studies toOHRP(attention: Dr. Kristina Borror, 1101 Wootton Parkway, Suite 200  , Rockville , MD 20852 ), with a copy to their ORO Regional Office, as soon as possible.

The Directors of VHA performance site facilities for studies supported by these REAPs should also report their suspended REAP studies to OHRP, with a copy to their ORO Regional Office.

Clarification Regarding Reporting Requirements for
Studies Supported by the Birmingham Research Enhancement Award Program
February 8, 2007

• On January 25, 2007, the Office of Research Oversight (ORO) suspended all research supported by the Birmingham Health Services Research and Development (HSR&D) Research Enhancement Award Program (REAP).

• The ORO suspension includes all research studies supported by the Birmingham REAP, regardless of location or funding source.

• The Office of Human Research Protections (OHRP) has been notified of the suspension by the Director of the Birmingham Veterans Affairs Medical Center (VAMC) and by ORO.

• Local Principal Investigators (PIs) and Institutional Review Boards (IRBs) at the various performance sites for studies supported by the Birmingham REAP should have been notified of the suspension by the Birmingham REAP PI.  If any local PIs or IRBs have not yet been notified, they should contact the Associate Chief of Staff for Research (ACOS/R) at the Birmingham VAMC immediately.

• The Facility Director at any VA performance site affected by suspension of individual studies supported by the Birmingham REAP should report the suspension to OHRP (attention: Dr. Kristina Borror, 1101 Wootton Parkway, Suite 200 , Rockville , MD 20852 ) in accordance with the terms of the Facility’s Federalwide Assurance (FWA).  ORO requests that the appropriate the ORO Regional Office be copied on these letters to OHRP.

• The Information Security Assessment that the Office of Research and Development (ORD) is requiring at each VA research facility (including facilities with HSR&D REAPS) does not itself constitute a suspension reportable to ORO and OHRP. 

• However, if the Facility, through its Information Security Assessment or any other mechanism, identifies a problem that results in suspension of a study by the local IRB, that suspension should be reported promptly by the Facility Director to both the appropriate ORO Regional Office and OHRP.

• ORO Regional Offices are available to provide additional clarification, if needed.

Additional information about requirements for Protecting VA Research Information” may be found at http://www.research.va.gov/resources/policies/cybersecurity.cfm.

ORCA Information Letters