IRB Member Conflict of Interest Procedures
No Institutional Review Board (IRB) may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. [45 CFR 46.107(d)]
Conflict of Interest Definition
IRB members should be free of any conflicting interests that may alter their evaluation of and action on research undergoing IRB review.
An IRB member is deemed to have a conflict of interest if one or more of the following
An IRB member:
- Is included on the research as an investigator or member of the research team.
- Has a financial conflict of interest in the research.
- Is an immediate family member of the investigator.
The following situations may be deemed a conflict of interest if expected to preclude
an objective assessment of the research. The IRB Chair and/or Administrator in consultation
with two randomly selected members of the IRB Committee will review each situation
to determine whether it constitutes a conflict of interest.
An IRB member has/had:
- Significant involvement in preparation of materials submitted to the IRB for review or approval.
- A supervisory relationship (either past or present) with the investigator.
- A close personal relationship with the investigator.
- A competitive relationship with the investigator [e.g., direct competition for funding, scholarship, research subjects] or the IRB member is considered a personal or professional adversary of the investigator for reasons not related to the IRB.
- Other interests that would conflict with the member's ability to objectively review the research.
Procedures for Disclosing a Conflict of Interest
- IRB Member Voluntary Disclosure. It is the responsibility of the IRB member to disclose all certain or potential conflicts of interest prior to engaging in any IRB review or determination activities.
- Query at Convened IRB Meetings. At the beginning of each IRB meeting, the IRB Chair asks members to disclose any conflict of interest concerning any items on the agenda.
- Principal Investigator Disclosure. The investigator submitting a protocol may submit a written explanation of an IRB member's certain or potential conflict of interest prior to the IRB engaging in any review or determination activities.
Determination and Resolution of a Conflict of Interest
- Conflict of interest disclosures will be reviewed by the IRB Chair and/or Administrator in consultation with two randomly selected members of the IRB Committee.
- If a conflict of interest is identified, the IRB Member will be notified in writing that a disclosure statement has been submitted to the IRB and by whom. The applicable category description(s) listed in the IRB Members-COI Procedures will also be included in the letter. The conflicted IRB member will not participate in the pre-review, exempt determination, or expedited review of the project. For full board reviews, the IRB member will be recused. This means that the IRB member will not vote and will be asked to leave the IRB meeting before discussion on the item with which they have a conflict unless the IRB requests that they provide information. When recused, the member does not count towards the quorum for the vote.