WCG’s Philosophy of Ethical Review

One of the most important aspects of Institutional Review Boards (IRBs) is their independence. While an institution can choose to be more restrictive than the IRB, human research regulations under both Office for Human Research Protections (OHRP) in section 45 CFR 46.112¹ and U.S. Food and Drug Administration (FDA) in section 21 CFR 56.112² took specific care to note that an institution cannot override an IRB decision and approve research that has not been approved by the IRB. The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), an organization whose mission is to promote rigorous standards for quality and protection of human research protection programs, also identifies the independence of the IRB as an element of its accreditation standards. “ELEMENT I.1.C.: The organization has and follows written policies and procedures that allow the Institutional Review Board or Ethics Committee to function independently of other organizational entities in protecting research participants.”³

When originally conceived, IRBs were assumed to be embedded in institutions.  The image that comes to mind of undue influence in this context is of a university president overruling the IRB and insisting on approval of research to support a star researcher or a wealthy and generous donor. Independent IRBs are private companies acting on behalf of independent clinics, research institutes, or academic institutions. While they are, perhaps, less likely to be unduly influenced by a university president, concerns have been raised about for-profit independent IRBs and whether they can remain truly independent from the company’s financial interests. 

At WCG we have a strong foundation of policies prohibiting undue influence of our IRBs, and that foundation supports a robust series of firewalls around the boards and committees including both our membership decisions and our culture. WCG’s flagship IRB was the first central IRB to receive accreditation by AAHRPP in 2003.

Policies

WCG enacted policies to protect the independence of our board by “walling” them off from the rest of the business. The heart of our undue influence policy is that “No individual in the organization may attempt to unduly influence the decisions of individuals involved in the oversight of research.”

The first wall insulates the IRB from business development activities of the company. Individuals engaged in business development are considered to have a conflict of interest with any related research. They may not discuss business matters with IRB members, and they may not participate in any way in the IRB review of that research. Examples of business development activities include: working in a booth at a trade show to solicit business, calling or meeting with potential clients to persuade them to use company services, and meeting with current clients to increase or expand their use of company services.  

The second wall is the protection from influence by other divisions of the company. Because WCG provides clinical trial services of various types, our undue influence policy requires any questions or comments from another part of the business about an IRB review to be routed to the chief compliance officer.  The chief compliance officer determines how and whether the questions or comments can be posed to the IRB review committees without jeopardizing their independence.

The third wall is comprised of the company staff. Staff may not communicate financial issues regarding specific research to individuals involved in the IRB review. Additionally, they may not answer questions from an individual involved in the IRB review about business issues when the answer might influence or appear to influence review decisions. No information related to the financial implications to WCG regarding its relationship with the sponsor is included in the materials the board receives.    

Finally, the fourth wall is the IRB members themselves. Individuals involved in IRB review are not allowed to ask questions about or engage in business development activities. While our IRB members may attend conferences, they will never be working in a trade booth or soliciting business.    

Membership

IRB regulations (45 CFR 46.107 and 21 CFR 56107) require that at least one member of the IRB is unaffiliated with the institution. WCG IRB unaffiliated members make up almost 2/3 of our IRB membership. In most meetings, unaffiliated members comprise the majority voting on whether to approve research. WCG IRB invests in recruiting, supporting, and training such a large proportion of unaffiliated members to support the independent nature of the IRB review. WCG also seeks to maintain a diverse membership on the IRB in as many dimensions as possible, including educational and professional backgrounds. Our primary board membership is made up of six scientific members and three non-scientific members. While we rely on our scientist members to provide the necessary expertise to understand the research under review, we rely on our board members without formal training in a scientific field to bring alternative viewpoints to the table. Every member undergoes training on conflicts of interest and company policies including undue influence annually.   

Culture

WCG IRB supports a culture of independence among our board members, and we communicate this via our policy governing committee review conduct. Our meeting chairs are expected to encourage IRB members to ask questions, speak their minds at every protocol review, share information that has not been discussed, listen, and learn from the group, respect dissenting opinions, and to think and vote independently.

WCG as a company values the IRB’s independence. Encouraging vigorous discussion in board meetings while operating efficiently requires our IRB Chairs to facilitate board members’ understanding of the material before them, to direct IRB member concerns to the criteria for approval, and to encourage and reward dissent when criteria for approval are not met. IRB Chairs also encourage our IRB members to use their unique perspective to contribute to IRB deliberations and ensure all IRB members know their opinions count. WCG has established policies in place to support the independence of our IRB, and WCG reinforces this perspective through our internal training, norms, and culture.

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References

1. 45 CFR 46. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
2. 21 CFR 56. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56
3. Association for the Accreditation of Human Research Protection Programs, Inc. https://www.aahrpp.org/resources/for-accreditation/instruments/evaluation-instrument-for-accreditation/Domain-I-Organization/standard-i-1/element-i.1.c