Implications of the U.S. Supreme Court’s Affirmative Action Ruling for Clinical Research
If a future Supreme Court ruling on diversity were to be applicable to clinical research, the FDA’s positions on diversity will take on even more importance.
In a landmark ruling, the Supreme Court recently banned affirmative action in higher education, sending shockwaves across the nation, even as far as clinical research. The Court may expand this ruling in its next term with cases that apply directly to the clinical research enterprise.
Students for Fair Admissions, Inc. v. President and Fellows of Harvard College
On June 29, 2023, the U.S. Supreme Court ruled in Students for Fair Admissions, Inc. v. President and Fellows of Harvard College (“Students v. Harvard”) that the race-based admissions policies of Harvard University and the University of North Carolina (UNC) are unconstitutional under the Equal Protection Clause of the Fourteenth Amendment.1 However, the Court also ruled that college and university admissions departments may consider “an applicant’s discussion of how race affected their life, be it through discrimination, inspiration, or otherwise.”
While this seismic case addressed only racial discrimination, Justice Neil Gorsuch, in his concurring opinion, mentions race, color and national origin as illegal reasons for discrimination. The U.S. Equal Employment Opportunity Commission (EEOC) enforces laws that expand “protected classes” to include “race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age (40 or older), disability, and genetic information (including family medical history).”2 Future Supreme Court rulings may cover all of these protected classes.
In its ruling, the Court stated: “Gaining admission to Harvard is thus no easy feat. It can depend on having excellent grades, glowing recommendation letters, or overcoming significant adversity.” The Court thus allows race as a possible source of “significant adversity” that can be considered in the admissions decision for a specific student. While identifying with a particular racial (or ethnic) group does not automatically create adversity, a specific applicant may discuss how they personally have faced significant adversity in the form of racial discrimination. The student’s record of academic achievement can be considered in light of such adversity. Other sources of individual adversity, e.g., poverty, disability and limited educational opportunities, can also be weighed in the admissions process.
In a footnote, the Court stated: “The United States as amicus curiae contends that race-based admissions programs further compelling interests at our Nation’s military academies. No military academy is a party to these cases, however, and none of the courts below addressed the propriety of race-based admissions systems in that context. This opinion also does not address the issue, in light of the potentially distinct interests that military academies may present.” In other words, a future Court ruling may accept race-based admissions that serve a compelling purpose for the institution, just not the ones presented by Harvard and UNC.
The Court found that Harvard’s and UNC’s affirmative action programs violated the Equal Protection Clause of the Fourteenth Amendment and Title VI of the Civil Rights Act of 1964.3 Title VI calls for non-discrimination in federally assisted programs, so it applies to academic and other organizations that receive U.S. government funds, including, for example, the National Institutes of Health. Title VII calls for equal employment opportunity, so it applies to discrimination in the workplace, academic or otherwise, with 50 or more employees. Similarities in the wording of the two sections suggest that the Students v. Harvard ruling on Title VI will also apply to Title VII.
It is certainly possible that the Court will find that employment diversity, equity and inclusion (DEI) programs that look at race per se, rather than race as a source of individual adversity, are unconstitutional. However, by excluding military academies from the scope of its ruling, the Court suggests that, were it to rule on discrimination in employment or other areas, “distinct interests … may present” to limit such rulings for pragmatic reasons.
Application to the Clinical Research Workforce
Numerous organizations engaged in clinical research have established DEI programs that address two intertwined activities: employment and patient recruitment and retention. A clinical research workforce that does not reflect the diversity of the relevant population may struggle to engage effectively with diverse patient populations, potentially widening existing disparities in healthcare.5 A diverse study team is more likely (a) to write a study protocol suitable for diverse patient populations, (b) to select investigators and design patient-centric programs that attract diverse study participants, and (c) to conduct the study in a manner that accommodates diverse study participants. For example, a study team member with a rural background can help the study recognize and minimize obstacles to patients from rural areas.
Since a future Supreme Court ruling may very well address discrimination in the workplace, clinical research organizations should justify their workforce DEI programs with compelling reasons, e.g., helping to ensure that study populations support legitimate scientific and commercial objectives.
Application to Clinical Study Populations
The Supreme Court would probably accept commercial and therapeutic (i.e., scientific) relevance as distinct interests that justify proportionate diversity in study populations. The distinct interests of proportionate diversity can also justify spending more to recruit and retain certain patients – including measures to enhance equity and inclusion. Students v. Harvard presents an additional rationale: It redirects the focus from identification with a class that has suffered injustice toward the current obstacles that individual members of this class must overcome to access the benefits (and share the burdens) of clinical study participation.This rationale, however, requires attention to individual, not class, adversity.
Notably, Students v. Harvard does not support the notion of recruiting a disproportionately large number of patients from an underserved population to address past wrongs, e.g., racial discrimination. In addition, the distinct interests of commercial and therapeutic relevance do not support disproportion of any type.
If a future Supreme Court ruling on diversity were to be applicable to clinical research, the FDA’s positions on diversity will take on even more importance. The FDA’s Diversity Plans underscore the importance of diverse study participants for a comprehensive understanding of a drug’s efficacy and safety across different populations, i.e., therapeutic relevance.6 The FDA's guidance on Diversity Plans provides a solid foundation, but much more can be done.7
The FDA takes a broad view of diversity, covering race and ethnicity, sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity.8From the FDA’s perspective, the study population goals of a clinical study DEI program should set forth which of these dimensions (and possibly others, e.g., urban vs. rural) are to be addressed, why they should be addressed, and how they will be addressed. For example, researchers from minority backgrounds have been shown to be more successful at recruiting participants from their own communities.9 Regardless of any Supreme Court ruling, every clinical study DEI program should incorporate this information.
Application of the Court’s reasoning in Students v. Harvard to the related goals of “sharing burdens and benefits fairly” and “supporting underserved populations” is more complicated. The most pertinent clinical research document, the Belmont Report, was published in preparation for drafting the Common Rule.10,11 The Belmont Report’s principle of justice requires sharing the burdens and benefits of clinical study participation fairly, i.e., across the relevant populations. When the FDA reviews the marketing application for a pharmaceutical product, it looks at the relevance of the study populations to the manufacturer’s proposed drug label, basically commercial relevance. The FDA’s diversity programs are intended to ensure that underserved populations – which may not be commercially significant – are still included in study populations. Therapeutic relevance also applies to off-label use, e.g., in children or the elderly, a gap in the FDA’s authority.
Conclusion
The tide may already be turning against DEI programs. Even before the Students v. Harvard decision, “thousands of diversity-focused workers have been laid off since last year and some companies are scaling back racial justice commitments.”12 Future Supreme Court rulings on diversity may directly affect clinical research. Clinical researchers are well-advised to understand the implications of Students v. Harvard for shaping workforce and clinical study diversity policies and programs that will stand the test of time, leveraging the direct connection of a diverse workforce to diverse study populations for the advancement of scientific and commercial imperatives.
References
1. “Opinions of the Court – 2022,” Supreme Court of the United States, https://www.supremecourt.gov/opinions/22pdf/20-1199_hgdj.pdf
2. “Who is protected from employment discrimination?” U.S. Equal Employment Opportunity Commission, https://www.eeoc.gov/employers/small-business/3-who-protected-employment-discrimination
3. “Constitution of the United States,” U.S. Constitutional Convention, 1789, https://constitutioncenter.org/the-constitution
4. “Civil Rights Act,” U.S. Congress, 1964, https://www.archives.gov/milestone-documents/civil-rights-act
5. “Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care,” Brian D. Smedley, Adrienne Y. Stith, Alan R. Nelson editors, Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care, 2003, https://pubmed.ncbi.nlm.nih.gov/25032386/
6. “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry,” U.S. Food and Drug Administration, 2020, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
7. Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?” Wendler, D., Kington, R., Madans, J., Van Wye, G., Christ-Schmidt, H., Pratt, L. A., Brawley, O. W., Gross, C. P., and Emanuel, E., 2006, PLOS Medicine, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1298944/
8. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry,” U.S. Food and Drug Administration, https://www.fda.gov/media/157635/download
9. “A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders.” George, S., Duran, N., and Norris, K., 2014, American Journal of Public Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3935672/
10. “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979, https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
11. “The Common Rule (45 CFR 46),” U.S. Department of Health and Human Services, 1982, https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
12. “The Rise and Fall of the Chief Diversity Officer,” Te-Ping Chen and Lauren Weber, July 21, 2023, Wall St. Journal, https://www.wsj.com/articles/chief-diversity-officer-cdo-business-corporations-e110a82f
About the Authors
Nader Daoud is senior manager, clinical trial diversity & inclusion at Moderna.
Norman M. Goldfarb is managing director of Elimar Systems, executive director of the Clinical Study Diversity Score Project (CSDS), executive director of the Site Council, and executive director of the Clinical Research Interoperability Standards Initiative (CRISI).
Enhancing Diversity Through Trial Design
April 3rd 2024In part 2 of this video interview with ACT editor Andy Studna, Tirisham Gyang, MD, assistant professor of neurology at The Ohio State University discusses how industry can effectively enroll patients from underrepresented populations into their trials.
