Justice, Diversity, and Research Ethics Review David H

require special efforts to include members POLICY FORUM of those populations in research” (9), and by the World Medical Association Declaration ETHICS AND DIVERSITY of Helsinki, which states, “Groups that are underrepresented in medical research should be provided appropriate access to Justice, diversity, and research participation in research” (10). Therefore, consideration of diversity is essential to the question of fairness in subject selection and ethics review to IRB review. Diversity in clinical research is respon- It is time for institutional review boards and research ethics sive to the principle of beneficence, which committees to address the ethics of inclusion places priority on the welfare of research participants and creates the obligation that research presents a favorable balance of By David H. Strauss1,2, Sarah A. White1,3, serve efforts to address mistrust of research benefit to risk, after risks and burdens have Barbara E. Bierer1,3,4 and health care (6, 7). Responsibility to the been minimized. In calling for “maximiza- goals of diversity lies with all stakeholders tion of benefits” in the research, Belmont he disproportionate impact of in the clinical research enterprise (6), and directs attention to both individual benefit COVID-19 on certain populations, a commitment to diversity, individually and to the broader value of research to so- Downloaded from such as Black, Latinx, and Indigenous and collaboratively, by research sponsors, ciety. A clinical research enterprise that is populations in the United States, has funders, academic institutions, contract re- not inclusive does not adequately address focused attention on inequalities in search organizations, study sites, investiga- the health needs of a diverse society. Group health and on the need to increase en- tors, and IRBs is necessary. differences in susceptibility to disease and Trollment of racial and ethnic minorities and in treatment outcome can only be identi- other underrepresented groups in biomedi- RESPECT, BENEFICENCE, JUSTICE fied when those groups are studied. It is cal research (1). Yet too often, in the United Most regulated clinical research undergoes the obligation of an IRB to maximize ben- http://science.sciencemag.org/ States and globally, participant enrollment obligate review and approval by an IRB. efits through the inclusion of understudied in research has not reflected the demo- IRBs are charged with safeguarding the groups in a manner that is consistent with graphic composition of the general popu- rights and well-being of human partici- the study aims and does not introduce un- lation, those affected by the health condi- pants in accordance with the foundational acceptable harm or burden. tions being studied, or those for whom the tenets of respect for persons, beneficence, Belmont describes two ethical convic- investigational product is intended (2), with and justice, as described in the Belmont tions in relation to respect for persons, racial and ethnic minorities and the young Report (8). An IRB’s ethical responsibilities self-determination, and decision-making: and the elderly, among others, being con- with regard to diversity derive from these the obligations to treat individuals as au- sistently underrepresented (3). Underlying and other principles, guidelines, and stan- tonomous agents and to protect those with causes for this underrepresentation have dards (9, 10). diminished autonomy. IRBs provide ad- on March 19, 2021 been described (4, 5), but change has been The discussion of justice in Belmont ditional safeguards for research involving slow. Notwithstanding the roles of other cites “moral requirements that there be participants with compromised voluntari- stakeholders in addressing this issue, we fair procedures and outcomes in the selec- ness (e.g., prisoners) or impaired compre- maintain that the specific value of institu- tion of research subjects.” As Belmont and hension. With regard to the inclusion of tional review boards (IRBs) and research other codes of ethics emerged from a his- diverse populations, respect for persons ethics committees (RECs) in promoting di- torical backdrop of abuse and injustice in demands efforts to foster informed and versity has been underrecognized and their research, “fair procedures” have been ap- autonomous decision-making and, there- authority underutilized. Here, we substanti- plied by IRBs largely (and, we believe, too fore, to address common barriers posed ate the role of and outline practical steps narrowly) to ensure that subjects are not by age, language, culture, and educational for the IRB and REC (hereafter “IRB”) to exploited and enrolled as a matter of con- disadvantage. Respect for persons requires help achieve greater diversity in clinical venience. The idea of justice within the the identification of opportunities and re- research. Belmont Report also includes the notion sources to engage understudied popula- The appropriate inclusion of diverse pop- of access to the benefits of research (i.e., tions and to enhance awareness, access, and ulations in clinical research is necessary if knowledge gained); this has direct implica- inclusion in research (4, 6). It also demands we are to understand how biological vari- tions for populations that have been under- modification of those aspects of research ability and social determinants of health studied, whether incidentally or systemati- and of consent that inadvertently limit the contribute to disease prevalence, transmis- cally. Subject selection cannot be equitable, participation of understudied populations. sion, course, experience of illness, and treat- and the requirements of justice cannot be For example, although inclusion of non- ment outcome. The inclusion of understud- met, when there is de facto exclusion of un- English speakers in a study may involve ad- ied and underserved groups informs clinical derstudied populations. ditional expenses of translation and/or in- decision-making and health policy and can This notion of justice is supported by the terpreters, it strengthens the commitment World Health Organization’s International to autonomy and justice. 1Multi-Regional Clinical Trials Center of Brigham and Ethical Guidelines for Health-related The ethical positions presented above Women’s Hospital and Harvard University, Cambridge, Research Involving Humans, Guideline 3, compel attention to inclusion of diverse MA, USA. 2Vagelos College of Physicians and Surgeons, which states, “In cases where the underrep- populations in clinical research and define Columbia University, New York, NY, USA. 3Brigham and Women’s Hospital, Boston, MA, USA. 4Harvard Medical resentation of particular groups results in or a specific duty for the IRB. In a 2019 sur- School, Boston, MA, USA. Email: [email protected] perpetuates health disparities, equity may vey (11), a majority of IRB chairs, IRB ad- SCIENCE sciencemag.org 19 MARCH 2021 • VOL 371 ISSUE 6535 1209 Published by AAAS INSIGHTS | POLICY FORUM ministrators, and investigators During review, an IRB should agreed that “IRBs should play consider the feasibility of study a key role in ensuring diversity Institutional review board oversight: methods that seek to identify, among participants in terms of Points to consider by reviewers recruit, and retain underrepre- gender, ethnicity, and language.” sented populations. Research Despite this, there has been INITIAL REVIEW team partnerships with pa- scant regulatory consideration, Study aims and subject selection tients and their families, ad- and little formal discussion • Do the demographics of the proposed sample reflect those vocacy groups, and commu- within the field, as to whether of the population affected by the condition or for whom the nity representatives have been diversity falls within the IRB’s intervention is intended? shown to be effective in inform- remit. There are also little data • When they do not, is the deviation adequately justified? ing recruitment and retention as to whether and when IRBs • Is planned under- or overrepresentation by age, race, strategies (12) as well as in exercise this authority, but the ethnicity, sex, gender, or social determinants of health in the providing input on study ques- observed underrepresentation sample scientifically justified? tions and participant-relevant in completed studies suggests endpoints, study conduct, and • Is there a statistical plan for examining heterogeneity in that IRBs do not consistently culturally and linguistically ap- outcome or across subgroups? attend to this responsibility. propriate communications. The Further questions relate to re- Criteria for inclusion and exclusion IRB should require a statement cent U.S. regulation and policy • Will inclusion and exclusion criteria inadvertently or in the study proposal summa- requiring a single, designated rizing the nature, process, in- unnecessarily result in under- or overrepresentation of Downloaded from IRB to serve as the IRB of record understudied subgroups? put, and impact of such patient for multicenter research and • Have alternative approaches to minimizing risk that do not rely and community engagement whether this will offer benefit in on exclusion been considered? and how this information has consistency and reach with re- shaped the study itself and the gard to diversity and inclusion. Recruitment recruitment plan; simply ask- • Have recruitment procedures considered specific approaches to ing the question will prompt INCLUSION AND PROTECTION engage underserved populations?

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