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T h e N EW ENGL A N D JOU R NA L o f M EDICI N E

november 26, 2020

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The only way out of today’s misery is for peo-ple to become worthy of each other’s trust.— Albert Schweitzer As the race to develop a vaccine for Covid-19 has reached phase 3 clinical trials, concerns are in- creasing about the low rates of trial participation in important subgroups, including Black com- munities. Recent data show that although Black people make up 13% of the U.S. population, they account for 21% of deaths from Covid-19 but only 3% of enrollees in vaccine trials. This problem threatens both the validity and the generalizability of the trial re- sults and is of particular concern in vaccine trials, in which differ- ences in lifetime environmental exposures can result in differenc- es in immunologic responses that could affect both safety and effi- cacy. Despite long-standing calls from the Food and Drug Admin-

istration (FDA) and the National Institutes of Health (NIH) to im- prove the participation of under- represented subgroups in drug trials, the problem persists.1

What are the barriers to great- er participation of Black people in Covid-19 trials? Although they are multiple, a critical factor is the deep and justified lack of trust that many Black Americans have for the health care system in gen- eral and clinical research in par- ticular. This distrust is often traced to the legacy of the infamous syphi- lis study at Tuskegee, in which investigators withheld treatment from hundreds of Black men in order to study the natural history of the disease. But the distrust is far more deeply rooted, in centuries of well-documented examples of

racist exploitation by American physicians and researchers.2

How can these long-standing barriers to trust be overcome? The presidents of Dillard and Xavier Universities, two of the 104 his- torically Black colleges and uni- versities (HBCUs) in the United States, recently wrote to their com- munities saying that they them- selves were participating in one of the vaccine trials and asking their students, faculty, and staff to consider doing the same. The pushback from parents of some students came quickly. One wrote on Xavier’s Facebook page, “Our children are not lab rats for drug companies. I cannot believe that Xavier is participating in this. This is very disturbing given the history of drug trials in the black and brown communities.”3

Presidents of the four histori- cally Black U.S. medical schools recently called for measures to in- crease the participation of Black

Trustworthiness before Trust — Covid-19 Vaccine Trials and the Black Community Rueben C. Warren, D.D.S., Dr.P.H., M.Div., Lachlan Forrow, M.D., David Augustin Hodge, Sr., D.Min., Ph.D., and Robert D. Truog, M.D.

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patients in clinical trials, correctly arguing that without such involve- ment, “there will be no proof that our patients should trust the vac- cine.” The presidents added that “Black doctors are the best way to build trust in our communities” and called on other HBCUs to join the effort to “foster trust in com- munities throughout the country.”4

Though we applaud these ef- forts, we fear that once again the responsibility for addressing the sequelae of centuries of racism is falling on Black people themselves. Our country has yet to compre- hend adequately that overcoming racism is not primarily the re- sponsibility of Black people; the racist ideas and practices that constitute today’s “structural rac- ism” were created, and have been sustained, primarily by White peo- ple. It would be wrong, as well as ineffective, to ask Black commu- nities to simply be more trusting. Clinicians, investigators, and phar- maceutical companies must pro- vide convincing evidence — suf- ficient to overcome the extensive historical evidence to the contrary — that they are, in fact, trust- worthy.

What can we do to earn and deserve increased trust?

First, trial sponsors and regu- latory agencies can ensure that the informed-consent process is exemplary, including ensuring that all relevant aspects of the design and conduct of the clinical trials are maximally transparent.

Second, all clinical research depends on people who are will- ing to accept the risks posed by trial participation in order to im- prove health for the people who come after them. Black partici- pants who agree to enroll in these trials have a right to expect and trust that Black communities will

have fair access to vaccines once they become available. The recent guidelines from the National Academy of Sciences (NAS) are no- table in this regard, recommend- ing that priority be given to “peo- ple who are considered to be the most disadvantaged or the worst off,” as defined by measures such as the Social Vulnerability Index created by the Centers for Disease Control and Prevention.5 Though this approach would not directly target people in specific racial or ethnic groups, it is functionally antiracist in that it prioritizes peo- ple who have suffered from the social determinants of poor health that are unfortunately prevalent in many Black communities.

Third, politicization of the vac- cine trials has engendered wide- spread mistrust among the gen- eral public. The joint pledge by nine pharmaceutical companies that they will “stand with science” and not submit a vaccine for ap- proval until it has been thorough- ly vetted for safety and efficacy is welcome, but earning trust will require credible evidence that this pledge is being honored. Just as important, however, is that the ev- idence must not only be convinc- ing to the general public, but — in the words of the NAS guidelines — also be perceived as convinc- ing “by audiences who are socio- economically, culturally, and ed- ucationally diverse, and who have distinct historical experiences with the health system.”5

Fourth, to earn and deserve trust from prospective trial partici- pants, we must ensure that they will receive appropriate medical care if they are injured as a result of receiving an experimental vac- cine. In addition to often lacking access to health care, Black peo- ple are also disproportionately

likely to be uninsured, and phar- maceutical sponsors in the Unit- ed States are not required to pro- vide compensation to people who experience research-related inju- ries. Even when participants have insurance, there is no guarantee that they will be covered for such injuries. In many cases, injured participants will be forced to rely on the tort system for compensa- tion — a situation that is morally indefensible, especially for par- ticipants who lack the means to engage in this time-consuming and expensive process. One way to demonstrate trustworthiness would be for the pharmaceutical companies sponsoring these tri- als to establish a fund to guaran- tee health care coverage and death benefits to patients and families as compensation for serious vac- cine injuries or possible deaths.

When Covid-19 vaccines are eventually approved by the FDA, their success in Black and other communities will depend on whether members of these com- munities not only trust that they are safe and effective, but also believe that the organizations of- fering them are trustworthy. Trust could be earned more quickly by a collaboratively designed Opera- tion Build Trustworthiness that matches the seriousness and scope of Operation Warp Speed. To be effective, this effort would need to be firmly grounded in grass- roots involvement of individuals and organizations with solid, well- earned reputations for trustwor- thiness in Black and other mi- nority communities, including respected elected representatives, trusted local and national faith leaders, community advocates, and others. Active, ongoing, and fully bidirectional collaboration, learn- ing, and communication will be

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essential. Time is running short, and trustworthiness, not trust, must be our first and most ur- gent priority.

Disclosure forms provided by the au- thors are available at NEJM.org.

From the National Center for Bioethics in Research and Health Care, Tuskegee Uni- versity, Tuskegee, AL (R.C.W., D.A.H.); and the Center for Bioethics, Harvard Medical School, Boston (L.F., R.D.T.).

This article was published on October 16, 2020, at NEJM.org.

1. Warren RC, Shedlin MG, Alema-Mensah E, Obasaju C, Augustin Hodge D. Clinical trials participation among African Ameri- cans and the ethics of trust: leadership per- spectives. Ethics Med Public Health 2019; 10: 128-38. 2. Washington HA. Medical apartheid: the dark history of medical experimentation on Black Americans from colonial times to the present. New York: Doubleday, 2006. 3. Moss W. Parents concerned about vac- cine study taking place at some HBCUs: remembering the Tuskegee experiment. HBCUConnectcom. September 3, 2020 (https://hbcuconnect . com/ content/ 359255/ parents - concerned - about - vaccine - study

- taking - place - at - some - hbcus - remembering - the - tuskegee - experiment). 4. Frederick WAI, Montgomery Rice V, Car- lisle DM, Hildreth JEK. We need to recruit more Black Americans in vaccine trials. New York Times. September 11, 2020 (https:// www . nytimes . com/ 2020/ 09/ 11/ opinion/ vaccine - testing - black - americans . html). 5. National Academies of Sciences, Engi- neering, and Medicine. Framework for equi- table allocation of COVID-19 vaccine. Wash- ington, DC: National Academies Press, 2020.

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