WPP #: VIII-10
Evaluating and Managing Investigator Conflicts of Interest
01-15-08, 11-30-09; 06-09-2014
The VCU IRB reviews the financial conflicts of interest management plans developed by the Conflict of Interests Committee and determines whether additional actions are needed to assure investigator objectivity and research participant protection. The VCU IRB also addresses identified non-financial conflicts of interest and institutional conflicts of interest that may impact study integrity.
The term Conflict of Interests (COI) refers to situations in which financial or other personal considerations may, or have the appearance to, directly and significantly affect a researcher’s professional judgment in exercising the design, conduct or reporting of research. Unaddressed conflicts of interest may impact the research integrity of the investigator and the University and may affect participant safety.
VCU has developed the Activity and Interest Reporting System (AIRS) which confidentially houses Financial Interest Reports (FIRs) of all ‘COI investigators’ who are designated by the PI as having independence and responsibility for the design, conduct and reporting of research. The COI Program, on behalf of the Conflict of Interests Committee (COIC), reviews FIRs for all VCU IRB expedited and full board protocols concurrent with initial and continuing review, regardless of funding. The COIC utilizes a Competing Financial Interest (CFI) disposition to designate investigators’ financial relationships that are below a COI determination threshold but can be perceived as imposing bias into the research. While the COIC will recommend additional management of COI or CFI for IRB consideration, the IRB retains authority over management actions related to human subjects protection. Definitions, procedures for investigator reporting, COIC review, and management are described in the VCU Conflicts of Interest in Research Policy.
IRB Processes and Responsibilities
- After receipt of an expedited or full board initial or continuing review submission, the IRB administrator submits a review request to the AIRS for designated investigators on the protocol.
- Exempt submissions are not routinely submitted for COI review unless the submission indicates a potential conflict, or the study does not qualify for exemption and is reviewed by expedited or full board review.
- The COI Program reviews the FIRs of ‘COI investigators’ for conflicts of interest in the context of the protocol. The review is conducted by COI Program staff, and may be referred to the COIC Chair, or referred for COIC review. The COI Program review is conducted concurrently with IRB review of the research. Formal approval of the VCU IRB protocol cannot be granted until the ‘COI disposition’ on all relevant ‘COI investigators’ has been forwarded to the IRB administrator.
- Although FIRs are reviewed relative to each submitted protocol, the RAMS-IRB application also asks about known financial, non-financial, and institutional conflicts of interest specific to the study. IRB staff or reviewers should notify the COI Program when there are affirmative responses and/or when language in the research plan conveys the suggestion of conflict of interests.
- A COI or CFI that has been managed by the COIC is forwarded to the IRB, with an explanation of the conflict and management plan, as well as recommendations, if any, for IRB actions. A COIC management plan may include, but is not limited to: (a) public disclosure of the financial interest, (b) naming another individual to serve as the principal investigator, (c) assigning internal or external data oversight, (d) protection of students or trainees, (e) divestiture of the financial interest causing the conflict, (f) severance of relationships that create actual or potential conflicts, or (g) VCU administration declining an award. If the conflict of interests is complex and/or at a level at which research subjects protections can be impacted by the conflict, the IRB Chair and/or reviewer(s) from the panel that is reviewing the research protocol will be asked to consult with the COIC on a COI management plan for the conflicted investigator(s).
- The IRB may augment the COIC’s management of the COI or CFI. Additional actions that the IRB may require to further protect research participants from actual or perceived bias related to conflicts of interest include but are not limited to:
- disclosure about the conflict in the informed consent form,
- consideration about whether the conflicted investigator can reasonably participate in:
- subject recruitment,
- subject selection, including prescreening for inclusion/exclusion criteria,
- the consent process,
- conducting research interventions.
- consideration about whether the protocol should be conducted at VCU in light of the identified conflict and research risk.
- The IRB Chairperson or his/her designee and reviewer(s) should review the COIC’s determination, management plan, and recommendations to the IRB, if any.
- If the protocol in question is a full board study, and the Chair and/or reviewers agree that additional IRB action to protect research participants from risk or harm due to potential bias is warranted, the convened IRB Panel must review any recommended changes within IRB purview prior to the release of the IRB approval letter.
- If the protocol is expedited, the IRB reviewer considers the COIC management plan and makes recommendations for further IRB action, if any. Required changes to the protocol as a result of the COIC determination are reviewed and approved according to expedited review procedures before the release of the IRB approval letter.
- Protocols submitted to external IRBs are subject to review of investigator FIRs by the COI Program at initial submission to RAMS-IRB and concurrent with subsequent funding transactions in the Office of Sponsored Programs. Reliance agreements will not be approved, and external IRB applications will not be cleared for submission to the outside IRB until a COI review is complete. COI investigators at external institutions that are deferring to the VCU IRB are subject to COI assessment and management either by their home institution or VCU COI assessment per VCU COI policy requirements.