SACHRP seeks to fill Belmont’s gaps around the justice principle

In mid-2020, against the backdrop of the Black Lives Matter movement and the visibly disparate impact of COVID-19 on racial and ethnic minorities, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) took up the charge of revisiting and expounding upon the role of justice in the protection of human subjects in research. The key issue being addressed is that the Belmont Report’s analysis, discussion, and applicability of justice is inadequate. SACHRP’s task is to identify where holes exist in the ethical framework and regulations, and comment on what is needed to respond. Underscored by current events, this is overdue work that needs to result in rapid updates to IRB discourse and operations.

Although the Belmont Report is a powerful tool for IRBs, the core of SACHRP’s charge is that Belmont’s discussion of justice is underdeveloped. The Belmont Report equips IRBs with an ethical framework of three principles to underlie ethical conduct of human research: respect for persons, beneficence, and justice. These principles together provide a comprehensive framework, yet are general enough to allow flexibility in their application and require judgment in how the principles are weighed against each other. In its brevity, Belmont’s framework is accessible.

The Belmont Report focuses on equitable selection of subjects as the application of the justice principle. Selection of subjects is, of course, an important consideration for research, informed by a dark historical background of unethical, exploitive, and dangerous research performed on vulnerable populations. However, the relevance and application of justice does not begin and end with selection of subjects. The Belmont Report is missing many contours of justice in both discussion and application. SACHRP plans to examine other aspects of justice such as compensation, community perception and trust, and the impact of research on communities in general rather than emphasis on individuals or isolated studies.

Confounding SACHRP’s task is the need to balance comprehensiveness with conciseness. The list of issues and populations that must be considered in a discussion of justice is long, and volumes would be required to fully describe the scope of issues, their causes, and possible solutions. Racism and structural inequities, among the many considerations emphasized by current national discourse, are woven so tightly into American society that they are invisible to many people. It is impossible to discuss these issues in short timeframes during meetings, or within brief documents. It is also difficult to reflect all voices on these issues to their fullest extent, particularly when concepts sometimes conflict with each other, or if there is a need for more expertise. Where brevity is important to keeping information accessible, the drawback is that important meaning can be unintentionally lost.

As difficult as this task is, it is work that needs to advance now. During their meeting on March 24, 2021, SACHRP demonstrated a genuine commitment to moving this issue forward, and the conversation was robust. Unfortunately, the discussion remains unfinished and their recommendations document is in draft for further development.

If the latest public version of SACHRP’s recommendations resembles the final version, their advice to IRBs regarding the application of justice will likely be complicated and may take ongoing evaluation and effort to put into action. There is some acknowledgement that the role of the IRB can only go so far, but there will inevitably be an appeal to focus greater attention on issues of justice in research. This focus is likely to include a call to develop or expand involvement with local communities.

Practical applications could include incorporating better diversity policies into the structure and inclusivity of IRBs. For example, policies might entail increasing IRB community membership and encouraging their involvement to recognize diverse voices. Too many times, community or non-scientific members are in the room for discussion yet tend to remain silent. Engaging in approaches to counteract this tendency and working closely with community members during the review process may be among ideas for improvement. On a larger scale, community involvement could occur even earlier in the process prior to involvement of the IRB. Calls to action at a local organizational level might find a starting point with the IRB.

Combined with other educational resources, SACHRP’s description of the background, issues, and philosophies linking justice to human research may serve as digestible reading material for IRB offices and members. The recommendations could help IRB offices and members understand the missing facets of justice and how analysis of those concepts will translate during future IRB deliberations and everyday duties.

Alongside SACHRP’s work and the efforts IRBs will take on, the Office for Human Research Protections (OHRP) will also need to respond to SACHRP’s eventual recommendations by issuing authoritative regulatory guidance. OHRP’s rapid response will be important follow-through in reinforcing and harmonizing IRB activities while sustaining progress.

Anthony PeñaAnthony Peña, MPA, is an IRB analyst at Seattle Children’s Research Institute in Seattle, Washington. He has worked in several IRB roles at the University of Arizona and the Southern Arizona VA Health Care System in Tucson.

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