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.
Do you have questions about VA research oversight? Please send us an email.
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.
FEDERAL REGISTER NOTICE on VA Research Data Access Plan
On October 7, 2015, the Department of Veterans Affairs announced an opportunity for public review and comment on its Policy and Implementation Plan for Public Access to Scientific Publications and Digital Data from Research Funded by the Department of Veterans Affairs. The period for comment closed on November 6, 2015, with minimal responses, and the Plan was adopted without change as originally posted in the link below.
Federal Register Link: https://federalregister.gov/a/2015-25448.
Link to VA Plan: http://www.va.gov/ORO/Docs/Guidance/VA_RSCH_DATA_ACCESS_PLAN_07_23_2015.pdf
Document Citation: 80 FR 60751, Page: 60751-60752 (2 pages)
Document Number: 2015-25448
VA's plan for increased public access to the results of its research was developed in response to White House initiatives on federally funded scientific research. In its February 22, 2013, memorandum, the White House Office of Science and Technology Policy (OSTP) directed each federal agency with over $100 million in annual expenditures for the conduct of research and development to develop a plan to support increased public access to the results of research funded by the federal government, including digital data sets and results published in peer-reviewed scholarly publications arising directly from federally-funded research (OSTP, Increasing Access to the Results of Federally Funded Scientific Research, February 22, 2013).
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
On March 1, 2016 the Office of Research Oversight (ORO) transformed its operations and structure to address facility-specific and system-wide research noncompliance more efficiently and effectively by prioritizing its oversight activities according to identified compliance oversight vulnerabilities.
Onsite Review Program. ORO has redesigned its onsite review program around regularly scheduled Comprehensive Program Reviews (CPRs) that provide a high-level, integrated evaluation of all components of the facility's research compliance program that are subject to ORO oversight (i.e., human research protections, research information security, laboratory animal welfare, research safety, and general research administration). A CPR may be followed by an onsite focused compliance review, remote remediation, and/or onsite/remote technical assistance, targeting the specific areas of high vulnerability or potential noncompliance identified in the CPR.
ORO'S Organizational Structure. ORO will no longer include Regional Offices as part of its organizational structure. Rather, ORO will be organized into subject matter workgroups specializing in each of ORO's areas of responsibility. After March 1, reports of serious adverse events, noncompliance, and other communications should be directed to the appropriate subject matter group (see transformation presentation).
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 to ORO by contacting the Human Research Protection Program at OROHRP@va.gov. Complaints related to research information security, research safety and security, or laboratory animal welfare should be directed to the group responsible for oversight in those areas by emailing the relevant group (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.