By Robin Throne, PhD 

Just when many IRB/HRPP professionals were encouraged to see Diversity, Equity, and Inclusion (DEI) initiatives gaining significant traction in their organizations and institutions, the backlash momentum in higher education across many states began to curb that energy.  

Numerous institutions, such as my own, organizations and professional associations staked ground with public statements regarding efforts to restrict or squelch DEI efforts. Still, other experts suggested organizations should pivot toward ensuring they worked to change systems rather than individuals. Yet, this was not necessarily an option for IRB/HRPP professionals charged to safeguard the rights and welfare of each individual in human subjects research. Instead, we consider autonomous agents who possess the ability to choose to knowingly participate in research, not as a system, but as an individual empowered with informed choice, including both risk and benefit. For to “respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others” (Belmont Respect for Persons).  

While we may be well informed of the historical research exploitations and lack of scientific integrity that brought individual harms in the name of research and to the 1970s establishment of OHRP and institutional review boards (National Research Act, 1974), we may be less aware of the historical and contemporary exclusions from research participation.  

We see the research reports today that illustrate the evidence of how and why underrepresented groups continue to be excluded from research participation, resulting in a lack of representation in research results. While some investigators may be inspired to actively and with intentionality prevent this unique form of research-based social reproduction through deliberate fairness, equity, and inclusive research recruitment efforts, without rigorous intentionality, it may be far from sufficient.   

‘A Fresh Wave of Opportunities’ 
As the Belmont authors stated in the fundamental ethical principle of Justice, “Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects.” Some have pointed to the historical background they describe as emergent today. Amid the ongoing slog of the DEI backlash, or as Forbes magazine recently referred to it, the “DEI-hate train” while also quoting others who declared “DEI is dead,” a fresh wave of opportunities have arisen for IRB/ HRPP professionals and research investigators to reflect on the Belmont Principle of Justice in this new era.  

Under the Belmont Principle of Justice, human protections professionals must examine race. We must consider disability, age, and gender. We must assess the susceptibility and sensitivity of the individual participant. We must consider bias and fairness. Equity as justice. Justice as inclusion. We must consider the vulnerable, the marginalized, the underrepresented. We must examine inclusion as well as exclusion.  

Justice as inclusion is, of course, not a novel concept. While we are all keenly aware of the egregious damages incurred when a member of society is overly burdened by past actions in the name of research and the social reproduction of biased data through the exclusion of underrepresented groups, in recent months, greater transparency and thought leadership on Justice as inclusion, namely the benefits of research inclusion, over individuals “unfairly excluded from the potential benefits of research participation,” have gained substantive attention.  

For example, last fall, OHRP offered its Luminary Lecture, Understanding the Role of IRBs in Promoting Diversity, Equity, Inclusion, and Justice in Human Subjects Research, and this past spring, The Community Coalition for Equity in Research released its Recruitment Guidelines for Equity in Research. This summer, PRIM&R held its Diversity, Equity, Inclusion, and Justice (DEIJ) Tools for IRBs webinar, among many other opportunities to reengage this focus amid a shifting climate.  

DEI+J 
Yes, not solely DEI but a resounding DEI+J. Under Belmont Justice, “another way of conceiving the principle of justice is that equals ought to be treated equally.” We must assess whether certain groups are systematically excluded from or systematically included in research.  

As a recent member of SACHRP reminded us, shall means must, not should. Belmont requires us to closely inspect informed consent so each individual can choose what shall or shall not happen to them. To each person, balanced and equitable risk and benefit. Choice as an individual decision empowers everyone, as everyone has the right to participate in research as they so choose rather than to be systematically excluded or included. Let us leave those injustices where they belong: in the pre-1974 history of human research protections.  

As IRB/HRPP professionals participate in this ongoing dialogue with our peers surrounding Belmont Justice and fairness, equity, and inclusion for research recruitment and participation, we can elevate these insights within our organizations and institutions. Even the work of one or more of us will continue to effect change toward a more fair, equitable, and inclusive future for research participation. As Belmont Justice queries as if from a timeless realm reflecting the present: “Who ought to receive the benefits of research and bear its burdens?” It is an enduring question worthy of our continued grappling, intentionality, and action.  

Robin Throne, PhD, serves as IRB Chair and FWA Human Research Protections Administrator for Western Governors University. Her research agenda continues to address doctoral researcher agency, researcher positionality, and voice/ land dispossession from various social justice approaches. See also WGU Position Statement on Measures to Restrict or Limit DE&I Efforts and The Chronicle of Higher Education’s detailed DEI Legislation Tracker.