Human Participant Research, Ethics, and IRBS

A Review of Robert L. Klitzman’s (2015) Assessment of Institutional Review Boards (IRBs)

Written by John R. Stone, MD, PhD

I’m reviewing Robert L. Klitzman’s (2015) assessment of Institutional Review Boards (IRBs): The ethics police? The struggle to make human research safe. Klitzman considers input from key IRB personnel and researchers, most from the United States.

For our graduate course in Research Ethics, students discuss whether United States federal regulations “ensure that IRBs … are (1) sufficiently independent from investigators and institutions or (2) adequately representative of communities” (in week 5 of 8). Previous course content recounts historical research abuses of populations with disadvantage and how federal regulations establish and guide IRBs to both protect and equitably include human research “subjects,” or now often “participants.”

Regarding (1) and (2), Klitzman (2015) demonstrates complex interactions of IRB administrators, chairs, committee members, researchers, institutions, and communities, among others. Examples are loyalties and relationships of varying strength and quality among these stakeholders. For instance, IRBs aim for close or distanced relations with investigators, depending on background concepts of needs, roles, and values. Power differences and conflicts of interest are other factors.

IRBs have tremendous latitude in how they function, the author reports. Ethically what are best practices and how should they be determined? Note items (1) and (2) that our students address about IRBs institutional independence and community input. A potentially fruitful approach is analysis with provisional ethical principles/values and critical perspectives that populations with historical research abuses or exclusion would plausibly bring. A later and vital step would be a process in which representatives of those groups have key input.

In kinship with the Belmont Report (1979), I suggest optics of equity and respect. But care, cultural humility, and trustworthiness should be added. Then relevant concerns are populations’ fair opportunity to participate in and benefit from biomedical research; respectful empowerment for autonomous choices to participate and withdraw; community input regarding harm minimization, benefit maximization, research aims and conduct (Xia, Stone, Hoffman, & Klappa, 2016); engagement with cultural humility (Tervalon & Murray-Garcia, 1998; Wallerstein & Duran, 2010); humanistic and empathic interactions throughout; and assurances of trustworthiness (Stone & Dula, 2008). 

The bioethics literature is a rich source for addressing these issues. Klitzman’s (2015) account is a solid addition. I will be reflecting where my related scholarship may go and how his account may enrich our Research Ethics course.

John R. Stone, MD, PhD is a Professor in the graduate program of Bioethics.

References

1. Klitzman, R.L. (2015) The ethics police? The struggle to make human research safe. New York, NY: Oxford University Press.
2. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979) The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Department of Health, Education, and Welfare. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html.
3. Stone, J.R., & Dula, A. (2008) Race/ethnicity, trust, and health disparities: Trustworthiness, ethics, and action. In S. Kosoko-Lasaki, C.T. Cook, & R.L. O’Brien (Eds.). Cultural proficiency in addressing health disparities. Sudbury, MA: Jones & Bartlett, pp. 37-56. 
4. Tervalon M, & Murray-Garcia J. (1998) Cultural humility versus cultural competence: A critical distinction in defining physician training outcomes in multicultural education. Journal of Health Care for the Poor and Underserved, 9(2), 117-125.
5. Wallerstein, N., & Duran B. (2010) Community-based participatory research contributions to intervention research: The intersection of science and practice to improve health equity. American Journal of Public Health, 100, Suppl 1, S40-6.
6. Xia, R., Stone, J.R., Hoffman, & J. Klappa, S.G. (2016) Promoting community health and eliminating health disparities through community-based participatory research. Physical Therapy, 96(3), 410-417.