HRPP SOP 208
Policy Title: IRB Member Conflict of Interest
Responsible Office: Office of Research Administration
Responsible Official: Associate Provost for Research Administration
Effective Date: March 26, 2018
Revision Date: Feb. 13, 2019
The purpose of this SOP is to set forth the procedures to identify and manage conflicts of interest when they arise for members of the Brandeis University Institutional Review Board when reviewing IRB protocols.
This SOP applies to Brandeis University Institutional Review Board members and the review of human subjects research projects conducted under the auspices of Brandeis University.
Conflict of Interest: A situation in which any financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. Note that financial conflicts need not rise to the level of a significant financial conflict of interest as defined by the Brandeis Policy on Financial Conflicts of Interest in Research.
It is the standard operating procedure of Brandeis University that in those instances where an Institutional Review Board member has a conflict of interest, s/he must recuse him/herself from the review of that human subjects research.
An Institutional Review Board member will disclose to the IRB chair any conflicts of interest s/he may have with a particular research protocol under review by the IRB.
An IRB member may not review any protocol under expedited review in which s/he has a conflict of interest. If the IRB member finds a protocol in which s/he has a conflict of interest is assigned for his/her review, s/he will inform the IRB chair and IRB office of the conflict and recuse him/herself from its review. The protocol will then be assigned to another IRB member for review.
An IRB member will not be present for full-committee review of any protocol, incident or unanticipated problem report, or report of noncompliance in which s/he has a conflict of interest. If the IRB member finds a protocol or report in which s/he has a conflict of interest comes before the committee for review, s/he will inform the IRB chair and IRB office of the conflict and remove him/herself from the room prior to the committee’s review of the protocol or report.
After review, the principal investigator (and student researcher, if applicable) will be informed by the IRB administrator of the committee's decision according to usual procedures. If revisions to the protocol are required, the principal investigator (and student researcher, if applicable) must resubmit his/her revised protocol for re-review. At the meeting in which the revised protocol is reviewed, the IRB member with the conflict of interest may be invited to provide information regarding the revised protocol prior to leaving the room while the committee deliberates the revisions and comes to a decision regarding the protocol.
If an Institutional Review Board member recuses him/herself from review, s/he will not be counted to reach the necessary quorum. If a quorum is no longer reached, the protocol will be tabled and reviewed at the next convened meeting in which quorum is reached without the inclusion of the IRB member with the conflict of interest.
The IRB member’s recusal will be listed in the meeting minutes.
Situations in which an IRB member will recuse him/herself:
The IRB member is listed in the protocol as a member of the research team, including as principal investigator on a student's research project.
The IRB member has a significant financial interest in the research.
The principal investigator is a member of the IRB member's family.
The IRB member feels s/he has personal biases which may interfere with his/her ability to conduct an impartial review.
In addition, the Institutional Review Board may determine if any of the following reach the level of a conflict of interest:
The IRB member has a fiduciary relationship with the sponsor of the research.
The IRB member is in competition with the principal investigator for funding, sponsorship or research subjects.
The IRB member has a relationship with the principal investigator that could influence the judgment of the IRB member in reviewing the research.
The U.S. Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46) contains the following requirements involving an institutional review board member's conflicts of interest:
No institutional review board 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. [46.107(d)]