1.0 Policy Purpose
This Policy describes when Institutional Review Board (IRB) members or consultants engaged by the IRB have a Conflict of Interest; sets forth the procedures that must be followed for disclosure, recusal, and exclusion; and governs IRB review of research when an IRB member has or may have a Conflict of Interest. Federal regulations do not permit IRB members or consultants of the IRB to participate in the review of research in which they have a conflicting interest, except to provide information requested by the IRB. This requirement helps to ensure that financial or other interests do not compromise the rights and welfare of human research subjects.
2.0 To Whom the Policy Applies
This Policy applies to individuals formally appointed as members of Brown University’s IRB and any individual consultant engaged by the IRB for the review of human subject research.
3.0 Policy Statement
Conflicts of Interest must not compromise the rights and welfare of research participants or the integrity of the research review process. Federal regulations do not permit or provide flexibility in the management of an IRB member’s conflicting interest. Specifically, the regulations prohibit IRB members from participating in the review of research in which they have a conflicting interest, except to provide specific information requested by the IRB.
3.1 Financial Conflict of Interest
IRB members may have financial or monetary interests that could impact or influence their professional judgment as IRB members and their ability to provide unbiased, impartial review of a research protocol. Such interests could include IRB members’ or their Immediate Family Members’ relationships with or financial investments in entities that are involved in the proposed research. IRB members with a Financial Conflict of Interest cannot participate in the review of a research protocol to which the Financial Conflict of Interest relates.
3.2 Non-Financial Conflict of Interest
Conflicts of interest may also be non-financial, such as when an IRB member is asked to review a research protocol in which the IRB member or a Family Member is participating as Principal Investigator (PI) or is a member of the research team. IRB members with a Non-Financial Conflict of Interest cannot participate in the review of research to which the Non-Financial Conflict of Interest relates.
Non-Financial Conflicts of Interest may include, but are not limited to, the following:
- An IRB member or Immediate Family member is a member of the research team or advisory committee involved in the design, conduct, or reporting of the research;
- An IRB member or Immediate Family member is related to a member of the research team or advisory committee involved in the design, conduct, or reporting of the research;
- The PI of the research protocol is the IRB member’s immediate supervisor.
3.3 IRB Member disclosure, recusal and/or exclusion
When an IRB member has a Conflict of Interest, that IRB member must be excluded from any type of IRB review of the specific research protocol with which the IRB member has a conflict. This includes initial or continuing reviews, review of amendments, or other reviews (e.g., adverse event reports, potential noncompliance, etc.). This requirement applies to reviews conducted by the convened IRB and those performed by expedited procedures.
An IRB member with a Conflict of Interest must disclose to the Human Research Protection Program (HRPP) that a conflict exists at the time a review of a research protocol is assigned, to enable the HRPP to reassign the research protocol to another reviewer. During a convened meeting, an IRB member must disclose to the IRB Chair that a conflict exists with any research protocol assigned to the agenda for review, and cannot be present during the relevant discussion of that protocol unless asked to answer questions or provide information to the IRB. That IRB member may not be present for voting.
IRB members may recuse themselves from review of a specific research protocol for any reason, including a conflicting interest not specifically described by this Policy. Center, Departmental, Institute, or School affiliation is not automatically considered to be a conflicting interest.
A PI submitting a research protocol may make a written request that an IRB member be excluded from review if the PI provides a written justification regarding why the IRB member has a Conflict of Interest. Such requests must be submitted to the HRPP at the time of IRB application submission for review by the IRB Chair or the IRB Chair’s designee. The IRB Chair or designee’s determination as to whether a Conflict of Interest exists, as defined by this Policy, will be final.
3.4 Documentation of recusal or exclusion
The Office of Research Integrity (ORI) staff are responsible for documenting that an IRB member did not participate in the convened review of an IRB protocol from which the IRB member was recused or excluded because of a Conflict of Interest. IRB minutes will record when the member left the IRB review, with the reason noted as “due to a Conflict of Interest.” IRB members excluded from the review due to Conflicts of Interest are not counted toward the meeting quorum. ORI staff are responsible for monitoring IRB meeting attendance to ensure that a quorum is maintained. If an alternate is present for the IRB member with the conflict, that person can vote and be counted toward the meeting quorum for that review item only.
For the purpose of this policy, the terms below have the following definitions:
- Conflict of Interest:
A Financial Conflict of Interest, a Non-Financial Conflict of Interest, or an opportunity for personal benefit of an IRB member or Immediate Family member that exerts, could exert, or could be perceived to exert an influence on the individual’s professional judgment in exercising the individual’s role as an IRB member.
- Financial Conflict of Interest:
An interest of an IRB member or Immediate Family member of monetary value (a) that is, could be, or could be perceived to be impacted by the research under review, including an IRB member or Immediate Family member’s interest in or relationship to an entity that the research impacts, may impact, or could be perceived to impact; or (b) that influences, could influence, or could be perceived to influence the IRB member’s professional judgment in exercising his/her role as an IRB member. Financial interests may include, but are not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights)
- Immediate Family Member:
An IRB member’s spouse or domestic partner and children.
- IRB Member:
A member of the Brown University IRB appointed by the Vice President for Research and any consultant engaged by the IRB.
- Non-Financial Conflict of Interest:
An interest, other than monetary, of an IRB member or Immediate Family member in the design, conduct, or reporting of the research under review, or other interest that compromises, could compromise, or could be perceived to compromise the individual’s professional judgment in exercising the individual’s role as an IRB member.
All individuals to whom this Policy applies are responsible for becoming familiar with and following this Policy. University supervisors are responsible for promoting the understanding of this Policy and for taking appropriate steps to help ensure compliance with it.
6.0 Consequences for Violating this Policy
Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures, or for non-employees, may result in the suspension or revocation of the user’s relationship with Brown University.
7.0 Related Information
Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.
7.1 Related Policies
7.2 Related Procedures
7.3 Related Forms:
7.4 Frequently Asked Questions (FAQs):
7.5 Other Related Information:
- 21 CFR 54; 21 CFR 56.107; 42 CFR 50, Subpart F; 45 CFR 46.107
- Department of Health and Human Services “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection”
- FDA “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosures by Clinical Investigators”