ORO Created by Public Law
The Office of Research Oversight within VA was mandated under legislation signed by the President on December 6, 2003, as Public Law 108-170 Section 401 of this statute stipulates ORO's functions. ORO published directives and handbooks to provide information to VA's research community on how to comply and monitor its research programs.
Our Mission
ORO serves as the primary VHA office in advising the Under Secretary for Health and exercising oversight concerning all matters of research compliance and assurance, including human subject protections, laboratory animal welfare, research safety, research laboratory security, research information security, research misconduct, debarment for research impropriety, and other matters that the Under Secretary for Health may assign.ORO is also responsible for developing and conducting research compliance officer education programs as directed by the Under Secretary for Health.
Carrying Out Our Mission
The ORO Central Office accomplishes its mission by developing, implementing, and evaluating operational policies and procedures related to assessing facilities' compliance with laws, regulations, and policies related to research, identifying issues arising from research compliance and assurance activities related to the responsible conduct of research, and by providing direction, guidance, and oversight to its Regional Offices that support the office’s mission. ORO is comprised of four regional offices who implement ORO's mission, roles, and functions within VA facilities throughout the country. Regional Office staff serve as subject matter experts in assigned areas of program emphasis who can assist in the identification of problem areas and emergent research compliance issues, propose initiatives, and refer appropriate issues to Central Office. Staff members also conduct frequent routine and for cause reviews of VHA research programs to assess compliance with policies and procedures; provide oversight to ensure VA facilities initiate written appropriate "action plans" to correct any problems and deficiencies identified by VA and other Federal oversight bodies.
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ORO Links
J. Thomas Puglisi, PhD, CIP
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Our Chief Officer — J. Thomas Puglisi, PhD, CIP
As Chief Officer and Director of the Office of Research Oversight (ORO), Dr. Puglisi serves as a principal advisor to the Under Secretary for Health and implements procedures to ensure regulatory compliance related to the protection of human subjects, laboratory animal welfare, research safety and security, and research misconduct in VA research. Tom joined the VA with more than 20 years’ experience in research compliance, 10 years as a funded research investigator, and 5 years as a consultant in the private sector. Tom previously served as the Director of Human Subject Protections in the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP, formerly the Office for Protection from Research Risks, (OPRR), where he was responsible for implementing requirements for the protection of human subjects in research supported by the Department of Health and Human Services (HHS). While in OHRP/OPRR, Tom was responsible for hundreds of compliance oversight investigations and contributed to much of OHRP’s current guidance. Tom has worked extensively with a variety of Federal Agencies and private organizations on human subject protection issues. Prior to his service in HHS, Tom was an Associate Professor of Psychology at the University of North Carolina at Charlotte (UNCC), where he conducted research in Experimental and Developmental Psychology and Human Aging, coordinated the Interdisciplinary Program in Gerontology, and chaired the Human Subjects Institutional Review Board (IRB). He received research grants from the National Institute on Aging (NIA), the Administration on Aging (AoA), and the HHS Office of Human Development Services (OHDS). From 1986 to 1987, Tom was a Congressional Science Fellow with the Select Committee on Aging in the US House of Representatives. Tom has testified before various Committees of the US House of Representatives, a number of Institute of Medicine (IOM) panels, and the National Bioethics Advisory Commission (NBAC). He served as a member of the Subpart A Subcommittee of the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) and as a member of the Accreditation Council of the Association for Accreditation of Human Research Protection Programs (AAHRPP). Tom is frequently invited to participate in national and regional conferences, and has regularly presented at meetings sponsored by Public Responsibility in Medicine and Research (PRIM&R) and the Applied Research Ethics National Association (ARENA). Tom received his PhD in the Psychology of Aging and Life Span Development from the Ohio State University in 1978. He is a fellow of the American Psychological Association and a Certified IRB Professional.
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