What ORO does
ORO monitors, reviews, and investigates matters of research compliance that involve VA research. Specifically, ORO provides oversight of compliance with VA and other Federal requirements for the protection of human research subjects, laboratory animal welfare, research safety, research laboratory security, research information security, and research misconduct. ORO provides such oversight through site reviews, evaluations of VA medical facility remediation plans to resolve noncompliance, and other means. ORO also provides research auditing education to facility Research Compliance Officers (RCOs).
For more information about ORO’s oversight areas, please click the tiles below.
Human Research Protections
The ORO Human Research Protections (HRP) Workgroup’s oversight activities are designed to foster VA medical facility adherence to laws, regulations, and polices governing research involving human subjects and strengthen protections for human research subjects. To accomplish this, the HRP Workgroup conducts proactive evaluations of VA medical facility Human Research Protection Programs; investigates, or provides oversight of investigations into, suspected lapses in the protection of human research subjects; and provides oversight of VA medical facility efforts to remediate serious or continuing noncompliance involving human subjects’ research.
You may email ORO for human subjects research related matters at:
Human Research Protection Program
OROHRP@va.gov
Research and Development Committee
OROCROW@va.gov
Relevant Human Subjects Research Policies
- VHA Directive 1200.05(4) (January 7, 2019, Amended April 1, 2025) – Requirements for the Protection of Human Subjects in Research
- VHA Directive 1058 (November 8, 2024) Office of Research Oversight
- VHA Directive 1200.01(1) (January 24, 2019, Amended April 1, 2025) – Research and Development Committee
Relevant Human Subjects Research Regulations
- Federal Policy for the Protection of Human Subjects (2018 “Common Rule”) (January 19, 2017)
- 38 CFR 16 – VA regulations for human subject research protections, with informed consent and IRB regulations combined in one part.
- 45 CFR 46 – HHS regulations for human subject protections, with subparts for pregnant women/fetuses/neonates, prisoners, and children. Regulations are overseen by the HHS Office for Human Research Protection (OHRP).
- 21 CFR 50 – FDA regulations for human subject protections, including informed consent.
- 21 CFR 56 – FDA regulations for Institutional Review Boards (IRBs), including the review of research.
- 21 CFR 312 – FDA regulations for the use of investigational drugs
- 21 CFR 812 – FDA regulations for the use of investigational devices
Additional pages
Federalwide Assurance (FWA) Registration Instructions
Institutional Review Board (IRB) Registration Instructions
ORO checklists and audit tools
Additional resources
Guidance on information to include in reports to ORO
Guidance on reporting incidents to OHRP
ORD Enterprise Protections, Regulatory, Outreach, and Systems (ePROS)
ORD sponsored clinical trials: registration and submission of summary results on Clinicaltrials.gov
Clinical Trials Registration and Results Information Submission – 42 CFR Part 11
Is my study an applicable clinical trial?
Mandatory IRB reporting: FDA contacts
Requesting a Certificate of Confidentiality for non-NIH funded research
Research Information Security
The ORO Research Information Security (RIS) Workgroup’s oversight activities are designed to foster VA medical facility adherence to laws, regulations, and polices governing information security and privacy in research. To accomplish this, the RIS Workgroup conducts proactive evaluations of VA medical facility Research Information Security and Privacy practices; investigates, or provides oversight of investigations into, suspected lapses in the protection of information security or privacy incidents related to VA research; and provides oversight of VA medical facility efforts to remediate serious or continuing noncompliance in the aforementioned areas.
You may contact the ORO RIS Workgroup via email at:
Additional links
National Institutes of Standards and Technology (NIST)
Special Publication 800-53 Revision 5
Security and Privacy Controls for Information Systems and Organizations
VA Handbook 6500
Risk Management Framework for VA Information Systems (Internal VA download)
VA Office of Information and Technology
Office of Information Security
Knowledge Service (Internal VA website)
VHA Directive 1605.01
Privacy and the Release of Information
VHA Privacy Office
VHA Directive 1605.01 (Internal VA download)
Veterans Health Administration Data Portal
Information about VHA data, policy, resources, and training
VHA Data Portal (Internal VA website)
Research Safety and Animal Welfare
The ORO Research Safety and Animal Welfare (RSAW) Workgroup’s oversight activities are designed to foster VA medical facility adherence to laws, regulations, and policies governing research laboratory safety, research laboratory security, and the use of laboratory animals in research. To accomplish this, the RSAW Workgroup conducts proactive evaluations of VA medical facility Research Safety and Security Programs and Animal Care and Use Programs; investigates, or provides oversight of investigations into, suspected lapses in research laboratory safety, research laboratory security, and the safeguarding of the welfare of laboratory animals; and provides oversight of VA medical facility efforts to remediate serious or continuing noncompliance in the aforementioned areas.
You may contact the ORO RSAW Workgroup via email at:
Additional Links
Research Misconduct
Overseeing the process for responding to research misconduct allegations is one of the Office of Research Oversight’s main areas of responsibility.
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Allegations of research misconduct must be referred to the Research Integrity Officer (RIO) at the responsible VA facility where the research referenced in the allegations was approved and the individual alleged to have committed the misconduct was employed. (See RIO Contact List.) Within one (1) business day of receipt of a formal allegation of research misconduct, the RIO must notify ORO of the allegation.
The ORO Research Misconduct Officer can be contacted at:
VHA Directive 1058.02, “Research Misconduct”
The procedures for responding to allegations of research misconduct are set forth in VHA Directive 1058.02, “Research Misconduct.”
VHA Directive 1058.02 adopts the federalwide definition of research misconduct and establishes detailed procedures for responding to research misconduct allegations involving VA employees and/or VA research. The potential consequences and severity of research misconduct necessitate a procedurally detailed mechanism for handling such allegations.
The response to a research misconduct allegation may involve several procedural stages. An initial assessment of the allegation is conducted to determine whether the allegation meets the criteria for opening an inquiry. If the criteria are met, an inquiry is opened to determine whether an allegation has sufficient substance to warrant an investigation. If warranted, an investigation is convened to make recommended findings about whether research misconduct occurred, and if so, the extent to which it occurred, who is responsible, and what corrective actions are appropriate. Based on the findings and conclusions of an investigation, the appropriate VISN Director adjudicates each case of research misconduct. Respondents who are found to have committed research misconduct may appeal the finding and any recommended corrective action(s) to the Under Secretary for Health.
Sequence of Events for VA Research Misconduct Proceedings referenced in VHA Directive 1058.02.
Relevant policies and resources
The documents contained below do not belong to ORO and cannot be modified; however, hyperlinks to the websites where these documents originated are provided.
- 65 Fed. Reg. 76260: “Federal Policy on Research Misconduct.”
(Website where this document originated.) - 38 CFR Part 0: “Standards of Ethical Conduct and Related Responsibilities.”
(The website where this document originated.) - 38 CFR §§ 1.200-1.205: “Referrals of Information Regarding Criminal Violations.”
(The website where this document originated.) - Department of Health and Human Services Office of Research Integrity
- Whistleblower Protection Act of 1989
Research Integrity Officers (RIOs)
Each VA facility with an active research program must appoint an individual to serve as the Research Integrity Officer (RIO) for the facility’s research program. (See RIO Contact List.) RIOs are responsible for: receiving and processing formal allegations of research misconduct; providing local oversight of research misconduct inquiries and investigations; sequestering, maintaining, and ensuring the confidentiality of documents and evidence; forwarding all information to the appropriate offices or persons as required by VHA Directive 1058.02; and serving as a liaison between the VA facility and ORO.
ORO has developed checklists and other resources to facilitate the ability of RIOs to carry out their oversight responsibilities. (See Checklists.) ORO is also available for individual consultation, and provides remote and on-site training as needed.
Research Compliance Officer Auditing Education Program
One area of focus of ORO’s Education and Data Analytics (EDA) Workgroup is the provisioning of research compliance auditing education to VA medical facility Research Compliance Officers (RCOs). The EDA Workgroup performs remote and on-site assessments of RCO auditing programs, provides tailored technical assistance to RCOs, and identifies good practices for performing and reporting required audits. The EDA Workgroup provides national teleconferences for RCOs and self-study guides for new RCOs regarding VA policy. The EDA Workgroup establishes and updates RCO auditing requirements.
You may contact the ORO EDA Workgroup via email at:
Additional resources
Research Compliance Officer (RCO) resources (Internal VA site)