Throughout the past century, professional voices have predominated in articulating, interpreting and applying ethical principles in the review of research involving human beings (1–4). Eleven individuals with expertise in the medical and behavioral sciences, ethics, law and public policy produced the Belmont Report, articulating basic ethical principles for the prospective review of research participant protection in terms of safety and rights (5). The Report furthered reliance on the review of research by independent boards (6), which have proliferated with increases in funding and in the number of research studies (7–10). Private or for-profit Institutional Review Boards arose to meet the demand for review (11), serving researchers without institutional affiliation and institutions seeking to comply with conflict of interest policies. Associations of professionals have also shaped the management of boards and review processes (12–14).

The growth in the number of research studies and reviews has been accompanied by the emergence of new research methods and study designs. PubMed citations show “pragmatic clinical trial/trials” publications increasing from an average of three per year (1984–2012) to over 200 average citations annually for the last decade. Similarly, “comparative effectiveness trial/trials” citations begin to markedly increase around 2010. Increases in the number of community-based participatory research and community-engaged research studies and publications started to occur even earlier. These types of studies comprise subsets of research conducted within community settings and with community partners (15). The proliferation and diversification in research studies and settings present numerous and sometimes unrecognized challenges for ethical board review.

Few studies have closely examined the structure and function of the institutional review board (IRB): We know even less about private or for-profit IRBs (16). Structure has typically been interpreted as board composition, which forms a foundation for examining board function and board member interaction.

Researchers examining board composition often focus on the requirement of boards to include a non-scientist and an individual unaffiliated with an IRB’s institutional sponsor. While the same individual can fulfill both roles and sometimes does, research into board composition often combines these two roles. The 28 “non-scientists” serving on the fourteen IRBs at the National Institute of Health reported actively contributing to board decisions and feeling they were listened to by others on the board. A large majority felt a primary responsibility for reviewing the informed consent documents (17). Studies of nonaffiliated and non-scientist IRB members within academic health centers reported members in these roles feeling ill prepared to actively contribute to board discussions and not respected (18, 19). All board members reported uncertainty about the roles of non-affiliated and non-scientist board members (20).

A 2011 systematic review found 43 studies of US academic IRBs reporting empirical evidence about board “structure, process, outcomes, effectiveness, or review variation (21).” Collectively IRB interpretation and application of federal guidance to protocols varied. Additionally, the review noted an absence of evidence about the quality of reviews and about IRB effectiveness in protecting human research participants. An absence of data regarding IRB quality and effectiveness of their research reviews persists.

A subsequent study explained variation in board review by summarizing research findings about risk assessment and decision-making at both the individual and group levels. Variation could result from how an individual responds to the wording used to describe risk, from the degree of familiarity with a procedure or sources of stigma as well as from trust in the people involved. Culture and political orientation can also be sources of variation in assessments of risk and its severity. Patterns in the perception and responses to risk were outlined to raise awareness about sources of bias and potentially improve review consistency. However, variation could legitimately result from a knowledge of local context (22).

A qualitative study of a single IRB characterized board members deferring to the professionals with expertise in the room (23). A second study of board structure and function, which was focused on review of social, behavioral, and economic research protocols, found IRBs largely populated by individuals possessing medical expertise and experience reviewing clinical trials. Observation, again of one IRB, suggested heightened scrutiny of social, behavioral, and economic research, including minimal risk projects. Field notes reported more board members actively participated in social behavioral reviews in comparison to biomedical protocols (24). The authors posited that board members reviewing social and behavioral protocols felt empowered to assume a sense of their own expertise. They recommended increasing the proportion of board members with social science expertise and adding members to represent research participants (25). They also recommended board education related to social and behavioral research.

Decades of growth in clinical research has fueled concern about IRB workload and mission creep. Workloads may be lessened somewhat by using reliance agreements to minimize the number of boards that review a protocol. Mission creep is more complicated. It may arise in traditional hospital-based clinical trials due to the current emphasis on increasing heterogeneity among research participants, which may lead boards to consider social/community, economic, environmental and cultural contexts to address issues of autonomy, risk and benefit and social justice (4): As suggested above, reviews might vary due to local contexts and perhaps when factoring in participants from populations that do and do not experience health disparities. Should boards scrutinize proposed samples for their representativeness and recruitment plans in considerations of social justice and equity? Mission creep is certainly a concern for academic health center IRBs where the majority of community-engaged and participatory research reviews likely occur.

The formation of IRBs focused on social and behavioral research seems one response to issues of board composition and mission creep. However, distinguishing biomedical from social and behavioral research is unlikely to ever prove adequate for the exploration of ethical issues that arise from conducting research among diverse populations in community settings, using methods and designs common among community-placed, community-engaged, comparative effectiveness, community-based participatory, participatory action, translational, implementation and dissemination, research studies.

There are limited examples of directly engaging community perspectives in considerations of research ethics. The University of California-San Francisco (UCSF) assembled individuals from local communities who were already working with UCSF researchers and who possessed research expertise to bring together community voices within the ethical review of the institution’s COVID-19 related protocols (26).

Two decades earlier, the Morehouse School of Medicine Prevention Research Center Community Coalition Board articulated principles and values for the community review of research. Their principles and values included mutual respect and justice for all people, a commitment to the principle of self-determination, and a recognition that structures and systems within which individuals live, work, and play, limit individual autonomy. Contrary to guidance instructing IRBs to avoid interpreting the creation of community jobs or clinical infrastructure as a research derived benefit (27), the Community Coalition Board required projects to demonstrate a contribution to the community capacity to benefit from research processes and outcomes (28).

The Bronx Community Research Review Board, a product of The Bronx Health Link and the Albert Einstein College of Medicine, was formed to provide consultation about “community-based research proposals.” Bronx residents also demonstrated “substantial interest” in understanding how proposals responded to local needs. The Community Research Review Board goals included community education about clinical research conduct, ethics and the research occurring in the community. It expressly recognized it was not an IRB but it still sought to empower community voices through consultation with researchers and by maximizing benefits of conducting research, of implementation and advocacy based on findings. Community member training for Board service was grounded in Paulo Freire’s conceptualization of participation and community empowerment by expecting trainees to reflect on and further develop the training curriculum (29).

Communities and institutions developed other approaches to research consultation (30). The Community Engagement Studio has gained prominence as a reliable way to obtain community member input on research projects, particularly recruitment and retention plans and materials (31, 32). Academic researchers have proposed sharing information about community consultations to expand their understanding of research ethics for projects collaboratively conducted with community partners (33).

A conceptual model recommending the establishment of an independent community ethical review board, positioned between IRBs and community advisory boards, has been put forward (34). A recent Patient Centered Outcomes Research Institute (PCORI) study similarly recommended sustaining engagement and partner relationships and also encouraging team science by supporting community member and stakeholder participation on research teams (35). The shift from managing research projects individually to an infrastructure for the ongoing management of community relationships and partnerships would begin to address the marginalization of community member voices on IRBs and enhance the potential for local community voices to contribute to the exploration and application of research ethics for community-engaged and participatory projects (36–41).

Prior comments pointed to a professional hegemony in the review of research protocols and in the application of ethical guidance within academic medical center research. Examples were also provided of community initiatives seeking to understand the value of research for communities and expressing expectations of direct involvement in the research occurring within their communities. Also mentioned was literature about research review issues with a focus on challenges faced by researchers involved in community engaged and participatory research. What is lacking in the literature is empirical evidence about the quality and outcomes of IRB decisions. The failure to evaluate and critically reflect on review determinations and their outcomes creates a gap in IRB accountability. It fails to address community mistrust generated by a history of research abuses, it also fails to confirm that the ethical norms developed to guide research that involves human beings within academic clinical contexts are appropriate to or appropriately interpreted and applied to research conducted in community contexts (42).

While not absolute, the distinction between research contexts is not trivial as is evident in Woolf’s contrast between two research stages within translational science (43). The two stages present a contrast in research designs and purposes. Stage one study designs are used to obtain data about the efficacy of new clinical therapies, while stage two designs attend to their effectiveness. Closed system designs ideally control for a single variable to demonstrate causality. By contrast, open system designs acknowledge variability across multiple real-world settings, producing data to address the generalizability of therapies (e.g., pragmatic and comparative effectiveness trials). These contrasting study designs and their focus on establishing internal (closed system) and external (open system) validity, complicate ethical considerations regarding informed consent (e.g., SUPPORT Trial) (44), assessments of risks and benefits (45) and social justice. We begin to address concerns about research ethics by advancing recommendations to empower community perspectives and participation within the education of IRB members, institutional infrastructure, and review board accountability.

This overly brief review of research ethics for community-engaged and participatory research has overlooked stand-alone community ethical review practices (e.g., sovereign tribal nations) (77, 78). This limitation is not meant to minimize their importance nor dismiss their practices, but rather to acknowledge differences in legal status, particularly the continuities and discontinuities of individual and group identities. We acknowledge that cultural and linguistic differences add epistemological challenges for overcoming professional perspectives on late-stage clinical research, something which has been looked at extensively by Canadian researchers. Such challenges highlight assumptions about the universality of the autonomous individual while recognizing continuities and discontinuities within sociological or psychosocial conceptualizations of the person (79, 80).

The application of ethical principles and the review of research involving human beings must continue to evolve by conducting dialogues that collaboratively explore ethics and their axiological interpretations within clinical and health research. As suggested by the Association of American Medical Colleges, institutions capable of supporting sustained community-academic partnerships and disseminating information about those partnerships within diverse community contexts are more likely to become trustworthy community partners (81).

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

The author confirms being the sole contributor of this work and has approved it for publication.

Funding was provided by the Department of Family Medicine and Community Health, University of Minnesota Medical School.

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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