Memorandum

Department of
Veterans Affairs

Date:	August 4, 2006
From:	Chief Officer, Office of Research Oversight (ORO) (10R)
Subj:	ORO Review of Ongoing VA International Human Research
To:	Director, VA Research Facility Participating in the ORO Review
	
1.	Your facility recently participated in an ORO review of international human research that was ongoing when VHA issued Directive 2005-050 requiring that all proposed international human research receive the prospective approval of the Office of Research and Development (ORD).  We are extremely grateful for the assistance that your facility provided for this project.  

2.	The project was designed to assist ORO in exercising oversight of international human research and to assist ORD in developing relevant policy and guidance.  The project did not include making determinations regarding regulatory compliance in individual studies, and the findings should not be construed as such. The following findings emerged:

a.	Thirty-three active projects meeting the definition of international human research were reported to ORO.  
b.	All 33 of the reported international human research projects had been reviewed and approved by the VA facility’s IRB of record.
c.	International sites for 23 of the 33 projects held Federalwide Assurances (FWAs) under which the research was reviewed and approved by a local (in-country) IRB or Independent Ethics Committee (IEC).  Research at four international sites without FWAs had been reviewed and approved by an IRB or IEC local to the site of the research.  It was unclear to what extent the remaining studies needed or received local review.
d.	Eleven of the 33 international projects reported to ORO involved children. Two of these 11 projects were in need of the required CRADO waiver for research involving children and subsequently submitted waiver applications before ORO completed the project.
e.	In addition to the 33 studies reported to ORO by VA facilities, two international ORD Cooperative Studies Program (CSP) studies were active as of May 2006.  Both were being conducted through the Tri-National Council (VA, Canada, and the United Kingdom) Research Coordination Initiative.  Each country follows it own national standards for protecting human subjects.  Non-identifiable data from each country are submitted to a CSP coordinating center for analysis.  

Thanks again for the assistance that your facility provided to ORO for this project.

Sincerely,

J. Thomas Puglisi, PhD

cc:	Under Secretary for Health (10)
	Principal Deputy Under Secretary for Health (10A)
	Deputy Under Secretary for Health for Operations and Management (10N)
	Chief Research and Development Officer (ORD)(12)
	Associate Chief of Staff for Research & Development, Participating VA Facility