Community Engagement in Research: An Antidote to the Social Value Misconception

There is a dissimilarity between the therapeutic misconception and the social value misconception. The therapeutic misconception is a psychological tendency that is difficult to eliminate despite best efforts to effectively communicate risks and benefits during the informed consent process. The social value misconception flows directly from the nature of the clinical research study—it is a problem with the study itself, not primarily a problem with the disclosure and understanding of information during the informed consent process. The target of reform, therefore, should be the quality of the research. Earl, Dawson and Rid (2025) largely take the lack of social value in clinical research as a given, making only a few remarks about the potential to enhance the quality of research. We should struggle against this level of complacency. I argue that community engaged research (CER) practices are an effective strategy to enhance the social value of research. Requiring community engagement for Institutional Review Board (IRB) approval of clinical research has the potential to transform the research enterprise.

The primary responsibility of an IRB is often understood to be the protection of the rights and welfare of human subjects. To accomplish this, IRBs review the importance of the research question and whether the research design is adequate to answer the research question. Many studies fail to be approved because their study design is inadequate, rather than because they pose excessive risks to subjects. Similarly, IRBs review recruitment strategies to ensure that an adequate number of research subjects will be enrolled to answer the research question. One ethical justification for these requirements is that there must be an advancement in knowledge to justify putting a research subject at even minimal risk. Framed in this manner, the requirement is an extension of the requirement to protect individual research subjects. Wenner suggests there is a more foundational justification of the social value requirement (Wenner 2018). She argues that the clinical research enterprise is a component of what John Rawls calls the “basic structure of society.” That is, the clinical research enterprise is among those institutions that determine how the rights, duties and benefits that arise from social cooperation are to be distributed. Because social cooperation makes the research enterprise possible, and because the research enterprise has “deep and lasting impacts on life prospects” of individuals, it is governed by Rawlsian principles of justice. Wenner argues that the negative downstream effects of clinical research with low social value justify restricting the research even if no research subjects would be put at risk (Wenner 2018, 31).

This puts us squarely in the debate over a social value requirement for research. Famously, the Nuremberg Code included a social value requirement: “The experiment should be such as to yield fruitful results for the good of society.” Its position in the code, second after the initial statement about informed consent, suggests this requirement is of central importance to the code’s authors. The social value requirement has been challenged by Wertheimer (2015) and Resnik (2018). The criticisms focus on (1) recognizing that a requirement for the ethical stewardship of public funding does not preclude using private funds for low social value research and (2) the social value requirement does not protect research subjects from exploitation arising from the unfair distribution of the benefits and burdens of research. Wendler and Rid offer a detailed defense of the social value requirement from these criticisms (Wendler and Rid 2017). Wenner, however, undercuts the foundation of the criticisms by viewing the social value requirement for clinical research as a prerequisite for a just society. It is worth noting that regardless of the theoretical justification for a social value requirement, de facto IRBs practice as if there is such a requirement—to be approved by an IRB, clinical research must have the potential to yield important knowledge.

The goals of CER complement Wenner’s justification of the social value requirement. CER seeks the coproduction of knowledge through collaboration between researchers and communities (National Academy of Medicine 2022). Communities can be identified by geographic proximity, shared disease state or health issue, or shared personal identify (for example, identities relating to profession, race, ethnicity, religion, sexuality or gender). CER involves collaboration on all aspects of research, including research question development, study design, recruitment strategies and enrollment processes. Community members may be involved in collecting data, analyzing results and preparing manuscripts. Study findings are disseminated to the community in formats that are understandable and relevant to the community. CER produces research of social value because communities are primed to accept recommendations that come from research questions they deemed important, and that were answered in a study that conformed to community standards. Partnerships between community members and researchers must be nurtured over time, in part to develop a trusting relationship, and in part to allow for the mutual education that occurs between the groups. There are several standardized methods for developing research-community partnership that can be deployed in a variety of settings (Joosten et al. 2015; Norman et al. 2013).

CER proved especially effective at increasing the social value of research during the COVID-19 pandemic. The global health crisis created the need to rapidly develop diagnostic tools, prevention strategies and therapies. The National Institutes of Health relied heavily on CER practices to push research and implementation forward. The American Journal of Public Health catalogued these efforts in a November 2022 supplement (Vaughan et al. 2022). A well-known example is the Rapid Acceleration of Diagnostics—Underserved Populations (RADx-UP) studies that partnered with local communities to identify methods that facilitated COVID-19 testing for various underserved communities (D’Agostino, Oto-Kent, and Nuño 2024). While the development of COVID-19 diagnostics represented a major technological advancement, the effective use of the technology resulted, at least in part, from the CER methods used in to study it in real world settings.

What will IRB’s need to do for studies to conform to CER principles? Fundamentally, IRBs should highlight and strengthen the requirement that research yield fruitful results for the good of society. “Fruitful results” should not be interpreted narrowly as research yielding generalizable knowledge. Rather, the interpretation should be expanded to require that clinical research answer to the priorities of the participating communities. As many authors have pointed out, pushing medical knowledge forward with clinical research is a slow process, so most clinical research will not have a direct benefit (though even negative studies can yield valuable insights). The lack of direct benefit is mitigated by the involvement of the community in deciding what it is important to study and designing research processes that are not harmful or exploitive of community members. Through extensive involvement in the research enterprise, community members will know that a clinical intervention being studied may not pay dividends in terms of better outcomes. But, as co-designers of the research, they will have decided that this is a risk work taking.

An additional difficulty is the mismatch between current IRB procedures and CER practices. The Belmont Report and the resulting Federal Policy for the Protection of Human Subjects (Common Rule) arose in response to ethical violations, and thus understandably focus on protecting human subjects rather than including diverse populations (Friesen et al. 2023). Procedures that afford protection do not always facilitate partnership with communities. There are many examples of this mismatch: IRB requirements for advance copies of community-facing recruitment materials make it difficult to work with communities iteratively to develop these materials; minor changes to approved protocols arising from community input require a time consuming amendment and approval process; including communities members as key study personnel may require Collaborative Institutional Training Initiative (CITI) certification, a barrier for community members who may not be compensated for time spent in the training; institutions may have burdensome documentation requirements to provide any compensation at all. Perhaps most vexing is that some community partners sit on the border between research participant and research team member (Windsor et al. 2024). It is unclear how many of these barriers arise from substantive ethical requirements in the Belmont Report and Common Rule, and how many are associated with administrative procedures developed to manage complex compliance processes. Nonetheless, IRB procedures will need to be evolved to accommodate CER practices.

There is a long way to go in the effort to enhance the social value of clinical research. The barriers are extensive, not the least of which is the influence of for-profit pharmaceutical and medical device companies, who, while not opposed to social value, answer first to shareholders seeking monetary return on investment. In the meantime, research participant autonomy can be served by attempts to curb the social value misconception, as Earl, Dawson and Rid urge us to do. CER can help in this effort, too. With CER, people situated similarly to prospective participants help develop recruitment and consent materials. For good or ill, community members often bring to the process skepticism about the value of medicine and the integrity of medical institutions. Their input will present additional opportunities to curtail misconceptions of every kind.