Too Little, Too Late?

Noting the concerning lack of diversity among participants in COVID-19 clinical trials, in September, 2020 the NIH launched the Community Engagement Alliance (CEAL) Against COVID-19 Disparities program, allocating $11 million to fund academic-community partnership consortia in 11 states to “promote and facilitate the inclusion and participation of these [underrepresented] groups in vaccine and therapeutic clinical trials” and conduct COVID-19 outreach and education [19]. Most of these CEAL consortia include members of CTSA community engagement programs. The recognition of the importance of community engagement in COVID-19 clinical research is welcome. But is it too little, too late?

One risk is that corrective efforts may emphasize opportunistic recruitment of more diverse study participants without appreciating the importance of long-term investment in trusting and empowering community partnerships. The fall-out from researchers rushing onto the COVID-19 field without first getting community members on board is evident to many of us working in community engagement programs at research institutions across the US. Investigators struggling in mid-study to recruit the number of participants needed for their studies are seeking assistance from our community engagement programs. Many clinical trialists are discovering that their research teams are ill-equipped to succeed in recruitment when the majority of people in their community infected by SARS CoV2 are BIPOC. Research groups conducting COVID-19 cohort and population studies find their studies being populated with participants from more socially advantaged populations rather than populations at highest risk of COVID-19. Research teams belatedly realize that they lack the cultural and linguistic competency necessary for successfully connecting with individuals from the populations most affected by COVID-19 – expertise held by members of the targeted communities and the local organizations serving those communities. Researchers often fail to include in their grant budgets appropriate levels of funding for community partners [Reference Freeman, Seifer, Stupak and Martinez20].

Approaching community members for help late in the process engenders an understandable backlash [Reference Natafgi, Tafari, Chauhan, Bekelman and Mullins21]. Many community members express frustration about being asked to rescue studies in midstream instead of being invited early on to collaborate in designing the project and have ongoing involvement as respected partners. They take note of multi-million-dollar budgets for clinical trials and the small fraction of expenses allocated to community partners, and see tokenism rather than genuine commitment. Deep wounds of distrust from a history of exploitation in research are reopened and deepened among BIPOC [Reference Cooper and Crews11,Reference Wilkins18].

A prime example of this predicament is occurring with COVID-19 vaccine trials. At trial inception, there was neither an explicitly articulated goal by Pharma or an NIH mandate to recruit participants in proportion to the distribution of COVID-19 cases among different racial-ethnic groups, or even proportionate to their share of the population. Many vaccine trials reached the halfway mark in participant recruitment and had their sponsors and investigators wake up, partly at the prodding of the NIH and community activists, to the need to address the underrepresentation of people of color in the trials [Reference Nania22]. Although the CEAL networks are now focusing on this issue, many of our community partners react with alarm at terms in the informed consent process. For example, informed consent documents for some vaccine trials place extreme limits on financial liability for adverse vaccine events. Community members question why the trials do not assure provision of free health care to participants who become infected with SARS CoV2 during the trial when many of the very people they wish to include lack sufficient access to health care services. When community partners or their trusted ambassadors were not invited to be at the table when study protocols were created, should we be surprised if they lack enthusiasm to promote trial participation among their constituents?

Why Community Engagement Matters

Lack of engagement compromises the scientific validity and relevance of clinical research [Reference Hoffman, Trawalter, Axt and Oliver3,Reference George, Duran and Norris4,Reference De las Nueces, Hacker, DiGirolamo and Hicks9]. Cohort studies that do not recruit populations at high risk of COVID-19 will not give an accurate picture of disease patterns and trends. Therapeutic and vaccine trials may produce misleading findings about efficacy if they fail to include participants from diverse social contexts that influence vulnerability to or resilience against infection. Engaged stakeholders are a powerful force for dissemination of research findings, especially to lay communities, facilitating translation of discovery into practices to improve health. Reduced public confidence in clinical science undermines translational benefit when therapeutics, vaccines, and other interventions become publicly available. For example, Black Americans, compared to whites, report less confidence in medical scientists acting in the public interest, which contributes to Blacks being less likely than whites to say that they would definitely or probably get a COVID-19 vaccine when available to the public [Reference Gramlich and Funk23,Reference Altman24].

Community engagement is also essential for social accountability. In addition to being a necessary component of restorative truth and reconciliation to address a shameful history of exploitation of BIPOC in research, engagement shifts the paradigm to a “for us, by us” model that promotes sharing of power to dismantle racial and class inequities. Community engagement demonstrates respect to communities by recognizing community values and interests that matter to community members as people. This model privileges community voice about who benefits from and is impacted by research and the potential positive and negative consequences of a study. Social justice requires that research be at a minimum bi-directionally transactional, and ideally relational [Reference Wallerstein and Duran5,Reference Michener, Cook, Ahmed, Yonas, Coyne-Beasley and Aguilar-Gaxiola6,Reference Cooper and Crews11,Reference Wilkins18].

Mid-Course Corrections and Best Practices

Community engagement requires investment of time as well as money. In a research culture that considers community engagement optional rather than essential, it may be understandable that the pressure for “warp speed” progress on COVID-19 clinical research contributed to investigators neglecting due diligence in engaging stakeholders early on in research projects. As noted above, through efforts such as the CEAL program, the NIH is attempting to make up for some lost ground. The NIH’s COVID-19 Prevention Network (CoVPN) is building on established networks among BIPOC leaders and communities to develop and disseminate tools and resources targeted to these populations. The CoVPN has endorsed guidelines developed by one of its member groups, the HIV Vaccine Trials Network, to “effectively involve communities as key players in research;” the guidelines recommend establishing Community Advisory Boards for all trial sites [25]. The NIH has also earmarked a portion of the funding for its recent Rapid Acceleration of Diagnostics (RADx) COVID-19 testing initiative to community engaged research.

Many COVID-19 community-based participatory research projects across the nation are demonstrating the power of authentic partnerships with BIPOC communities (Table 1). For example, Howard University, a Historically Black University, and the University of California, San Francisco (UCSF) have taken similar approaches to collaborating with local agencies and coalitions. Both partnered with the local health department and community-based groups to open COVID-19 testing sites in underserved communities. In San Francisco, community coalitions are using the findings from testing studies to advocate with local government to target new resources to meet unmet needs for prevention and social services [Reference Kerkhoff, Sachdev and Mizany26]. Howard faculty partnered with a community led coalition to develop community-level responses to COVID-19 disparities. Community engagement programs at both institutions have developed COVID-19-focused community advisory councils. Howard University’s community advisory board provides guidance on local COVID-19 vaccine trial implementation, ensuring funding for community partner participation and multi-lingual research resources. The UCSF COVID-19 Patient and Community Advisory Board proactively reaches out to UCSF investigators to provide consultation on community engagement strategies for a variety of COVID-19 studies, and has consulted on more than 20 studies to date. CTSA-funded institutes at both universities have dedicated pilot grant funding for new community-engaged COVID-19 studies and social justice research projects. In Colorado, the Partnership of Academicians and Communities for Translation council worked with the COVID-19 equity advisory board to draft a document that Governor Polis signed and sent to researchers to increase awareness of the need for community involvement in COVID-19 vaccine trial decision-making. Many other members of the Association for Clinical and Translational Science Partners for the Advancement of Community Engaged Research (PACER) group (https://www.actscience.org/About/Special-Interest-Groups) are helping to lead similar efforts in their communities.

Table 1.

Types of community engaged COVID-19 research activities conducted by PACER members

PACER, Partners for the Advancement of Community Engaged Research group; Association for Clinical and Translational Science; CE, community engagement; SES, socieconomic status.

Making Community Engagement Obligatory, Not Optional

COVID-19 has been a wake-up call on many fronts – it was a pandemic on top of multiple epidemics, including racism. It is requiring new ways of thinking about disaster preparedness and control, working and delivering care remotely, and health and social inequities. It makes evident the need for a transformational shift in culture, policy, and structure across the research enterprise among both funders and research institutions to support and value community leadership in research. This engagement must center members of BIPOC communities that repeatedly bear the brunt of health disparities, whether from COVID-19 or non-communicable diseases, and acknowledge the need for reparation of the injustices that have contributed to these inequities. It should not have required a pandemic to make community engagement in research leadership a priority. Community engagement must be integrated as an integral operating principle for all types of research and throughout the research enterprise. It should be as essential to the research enterprise as Institutional Review Boards (IRBs).

We call on research funders and institutions to take the following actions (Table 2):

Table 2.

Recommendations for action