IRB Chair Perspectives: The Importance of the Independence of IRBs
Dr. Ron Evans is an Associate Professor in the Department of Kinesiology and Health Sciences and currently serves as Chair of the VCU IRB Social Behavioral/Biomedical panel. Dr. Evans has been a faculty member at VCU since 2003 and an IRB member since 2005. In this article, Dr. Evans reflects on the importance of the IRB operating independently, free from undue influence or inducement.
The Declaration of Helsinki, which outlines a foundational set of ethical principles for human subjects research, stresses the importance of perspective “consideration, comment, guidance, and approval” of research protocols by a “research ethics committee”. The document goes on to emphasize that “this committee must be transparent in its functioning, must be independent of the researcher, the sponsor, and any other undue influence”. As such, at the beginning of every VCU IRB meeting, the members present are asked to 1) confirm they have reviewed all pertinent materials for the meeting, and 2) disclose any potential conflicts they may have related to any study being reviewed. If a panel member has not reviewed the research protocol (RAMS-IRB Smartform), the informed consent document, the principal investigator’s qualifications, and any number of other ancillary documents (e.g., research questionnaires, required brochures for investigational products, and/or advertisement materials) they cannot adequately consider whether the required criteria for approval of research are met as outlined in the Code of Federal Regulations (Title 45 Part 46.111). If a panel member were to acknowledge they had not had adequate time to review a study under consideration, they would be asked to abstain from the voting process.
Additionally, if a panel member were to acknowledge an actual or potential conflict (e.g., financial conflict, relational conflict, or conflict of roles), that panel member would be asked to recuse themselves from the discussion and any voting on the study under consideration. In these circumstances, panel members with an identified conflict will be asked to leave the room (virtual or in-person), thus allowing the remaining panel members to freely discuss identified issues without any involvement of the conflicted panel member unless the panel determines that additional information from the panel member can provide clarification as to some aspect of the study. The panel member with the identified conflict would still not be present during the voting process.
While asking and receiving answers to these two questions at the beginning of every panel meeting may seem like an insignificant exercise, it is these two questions that set the trajectory for the meeting by requiring our IRB panel members to acknowledge a central tenet of IRB review and affirm their commitment to protecting research participants at VCU by ensuring that someone, other than the study investigators or other stakeholders, has carefully evaluated the risks of the proposed study and has determined that the risks are reasonable about the potential benefits. This is not always an easy task, and often requires lengthy discussion, a careful review of regulatory language, and guidance from the HRPP staff. But it is imperative that IRB panel members involved in these discussions, and ultimately charged by this institution with determining whether a study meets the criteria for approval as outlined in the federal regulations, be allowed to make these determinations free of undue influence from other panel members, colleagues, supervisors, study sponsors, or administrators. It is this institution-wide commitment that will help ensure that research participants at VCU can confidently participate in research activities with the assurance that their rights and welfare are being protected without bias.