OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Dr. Sanjur “Sandy” Brooks, DPS, MA, is the Director of the VCU Human Research Protection Program. In this article, she reflects on the importance of the IRB operating independently, free from undue influence or inducement.

There is an inherent conflict and dichotomy in facilitating human subject research that is not always recognized by those of us in the research community. This conflict speaks to the desire of the investigator to progress scientific knowledge, in contrast with the investigator’s duty to avoid allowing the ends to justify the means. Individual investigators generally uphold their fiduciary duties to ensure the well-being of their subjects, but may not be able to fully identify and avoid the influence of inherent conflicts of interest. Thus, Institutional Review Boards (IRB) are charged with maintaining the balance of those ethical obligations. 

Consequently, IRBs are comprised of a diverse pool of members, many of whom conduct human subject research in the same research community as the investigators whose research they are reviewing. These individual members must be able to transition into an objective and independent body that is far removed from an investigator’s career aspirations, research funding sources, and in certain cases, independent of the institution where the research is being conducted. 

Due to the ethical complexities in a changing research landscape, the human research subject protection field itself is grappling with the best approach to conduct reviews with high integrity while operating as an independent body free of undue influence and undue inducement. One consideration is the use of central IRBs, which review research from multiple sites, versus a local IRB, which reviews research from investigators at the same institution. However, both central and local IRBs focus on the board’s ability and level of independence and are anchored in mitigating undue influence and undue inducement of the IRB’s actions and regulatory decisions. 

Without controls in place to prevent, mitigate or remove undue influence or inducement of individual members of the collective panel, any IRB, local or centralized, will be susceptible to coercion and bias within their reviews and deliberations. The IRB must ensure its reviews follow all regulatory and ethical requirements when reviewing and approving research. If that review is compromised by influence or inducement, whether professional or financial, the integrity of the IRB will be compromised.      

An IRB that is not acting independently exposes human research participants to potentially significant risks, as well as erodes public trust in not only the IRB review process and an institution, but human subject research as a whole. It is crucial to the conduct of ethical research that the IRB and individual IRB members remain free of undue influence, coercion, or inducement.

Citations

Klitzman R. How IRBs view and make decisions about coercion and undue influence. J Med Ethics. 2013;39(4):224-229. doi:10.1136/medethics-2011-100439

Virtual Mentor. 2009;11(4):311-316. doi: 10.1001/virtualmentor.2009.11.4.pfor1-0904.

Kim W. O. (2012). Institutional review board (IRB) and ethical issues in clinical research. Korean journal of anesthesiology62(1), 3–12. https://doi.org/10.4097/kjae.2012.62.1.3

Categories IRB Education and Training
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