Information for Veterans
Are you interested in volunteering for a research study? Here are some things you should know.
Site Visit Preparation
Is your facility expecting an ORO site visit? Here are some things you should know.
The Office of Research Oversight (ORO) 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.
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.
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 Office that support the office'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, providing oversight to ensure VA facilities initiate written appropriate "action plans" to correct any deficiencies identified by VA and other federal oversight bodies.
Date: December 14, 2014
To: Members of the VHA Research Community
From: Executive Director, Office of Research Oversight (ORO)(10R)
Subj: Proposed Public Access to Reports of ORO Onsite Compliance Reviews
In the interests of openness and transparency, ORO is considering making reports of its onsite compliance reviews available to the public through its website, effective sometime in CY2015.
ORO believes that such access would ultimately strengthen the trust of Veterans, and the public, in VA’s systems for protecting the health and safety of human research participants and the welfare of laboratory animals.
Under this proposal, reports would routinely become available through ORO’s website 120 days after they are finalized and issued to the facility. This timeline would give facilities ample opportunity to effect appropriate actions in response to ORO’s findings.
Individually identifiable private information, proprietary information, and other VA sensitive information would be redacted from reports before posting.
ORO appreciates your continued commitment to the protection of Veterans and others participating in VA research, and invites your comments regarding this proposal. Comments should be forwarded to me via e-mail (email@example.com) no later than January 31, 2015.
Thanks very much,
Tom Puglisi, PhD
Complaints related to VA research can often be resolved by contacting the VA Medical Center conducting the research.
When direct contact with the Medical Center is not desired, complaints related to the protection of human research subjects may be directed ORO by contacting the appropriate Regional Office. Complaints related to research information security, research safety and security, or laboratory animal welfare should be directed to ORO Central Office by telephone (202-632-7620) or by emailing the group responsible for oversight in those areas (click here).
Specific allegations related to fabrication, falsification, or plagiarism (“research misconduct”) should be presented to the Research Integrity Officer (RIO) at the VA Medical Center conducting the research. When direct contact with the Medical Center is not desired, research misconduct complaints may be directed to ORO Central Office at 202-632-7688. Click here for more information on research misconduct.
ORO does its best to honor the confidentiality of persons who file complaints about VA research.
Persons who do not wish to identify themselves and would rather remain ANONYMOUS may call ORO’s toll-free COMPLAINT LINE at 1-877-343-6562.
Please provide as much information as possible when calling the Complaint Line. ORO may not be able to follow-up effectively without sufficient information.