Appendix A

Study Approach and Methods

STUDY APPROACH AND METHODS

The committee was tasked with evaluating the current use of race and ethnicity in biomedical research and providing recommendations for the use of these constructs in future research. To accomplish this charge, the committee examined the current literature, engaged in targeted outreach to relevant parties, and hosted a series of public information-gathering sessions to gain diverse perspectives across multiple avenues.

EXPERTISE

The committee was composed of 16 individuals with expertise spanning biomedicine, human genetics, epidemiology, sociology, biostatistics and biomedical informatics, real-world data, clinical algorithms and tools, health disparities research, bioethics, health policy, medical anthropology, implementation science, and community-engaged research practices. Committee biographies can be found in Appendix D.

LITERATURE REVIEW

To inform its work, the committee examined current literature related to the study charge by using staff-led targeted searches along with reviews of available guidance on the use of race and ethnicity in biomedical research. National Academies staff conducted a literature search in Embase, Medline, and Scopus between August 17 and September 15, 2023. These databases index research in biomedicine, health sciences, and other relevant fields. The search terms were composed of MeSH terms in addition to specific vocabulary related to race, ethnicity, biomedical study design and execution, clinical algorithms, race norming/adjustment, health disparities, and other related topics (see Table A-1). Relevant publications in English from 2010 to present day were considered.

TABLE A-1 Preliminary Search Terms—Keyword Matrix

The initial search results were organized by National Academies staff based on emerging themes that were relevant to the statement of task, some of which included the use of race and ethnicity in clinical algorithms, the development of clinical trials, and specific subfields of biomedicine. Committee members, speakers, and members of the public also submitted articles and comments that informed the committee’s deliberations and drafting of the report.

PUBLIC MEETINGS

The committee convened four public meetings to solicit information from experts and members of the public, which included representatives from community organizations and patient advocacy groups. The committee’s first meeting was held virtually in October 2023, and the public session provided an opportunity for the committee to clarify questions related to the statement of task with the sponsoring organizations. Subsequent public sessions were held on December 14, 2023, January 31, 2024, and March 14–15, 2024. The agendas for these meetings are included in chronological order.

FIRST COMMITTEE MEETING OPEN SESSION

October 24, 2023

Session Objective: To hear from the sponsors of the study regarding their perspectives on the charge to the committee.

OPEN SESSION

December 14, 2023

SESSION I: HISTORICAL CONTEXT AND PERSPECTIVES ON THE USE OF RACE AND ETHNICITY IN BIOMEDICAL RESEARCH

Moderator: M. Roy Wilson, Wayne State University

Session Objectives:

• Explore the historical context of the use of race and ethnicity in biomedical research
• Consider consequences of the past and current use of race and ethnicity in biomedical research

SESSION II: EXAMINATION OF EXISTING GUIDELINES AND LESSONS LEARNED IN RELATED FIELDS

Moderator: Aliya Saperstein, Stanford University

Session Objectives:

• Learn about existing guidelines and their reexamination
• Discuss lessons learned from other fields and sectors grappling with questions of race and ethnicity and related guidance

PUBLIC WORKSHOP

January 31, 2024

SESSION I: HUMAN PHYSICAL VARIATION AND EFFECTS ON HEALTH RESEARCH

Moderator: Neil Powe, University of California San Francisco

Session Objectives:

• Learn how human phenotypic variation in skin pigmentation, for example, can be characterized
• Discuss how variation in traits like skin color and hair contributes to downstream effects in biomedical research
• Consider new approaches to measure and account for phenotypic variation in research

SESSION II: ALTERNATIVES TO USING RACE AND ETHNICITY CATERGORIES IN RESEARCH

Moderator: Roland J. Thorpe, Jr., Johns Hopkins Bloomberg School of Public Health

Session Objectives:

• Discuss alternatives to using race and ethnicity categories (e.g., the OMB categories) in research
• Explore qualitative and quantitative methods for examining race and ethnicity in research
• Consider the advantages and disadvantages of collecting race and ethnicity data

SESSION III: RACE AND ETHNICITY IN CLINICAL DATA COLLECTION, ALGORITHMS, AND TOOLS

Moderator: Shyam Visweswaran, University of Pittsburgh

Session Objective:

• Examine how race and ethnicity are currently used in clinical algorithms and decision-making tools and discuss the effects of this use
• Explore whether and how race and ethnicity could be used in the development of future clinical algorithms

SESSION IV: INTERSECTION OF RACE AND ETHNICITY IN BIOMEDICAL RESEARCH AND CLINICAL APPLICATIONS

Moderator: Carmen Guerra, University of Pennsylvania

Session Objective:

• Discuss how incorporating race and ethnicity (or not) in early-stage research influences applications in the clinic
• Explore best practices for collecting patient or research participant information for use in research

SESSION V: INDUSTRY PERSPECTIVE ON THE USE OF RACE AND ETHNICITY IN RESEARCH

Moderator: Husseini Manji, Oxford University, UK Government Mental Health Mission

Session Objective:

• Discuss how regulatory considerations influence collection of race and ethnicity data
• Explore incentives and disincentives for changing how race and ethnicity data are collected for industry research

OPEN SESSION

March 14, 2024

COMMUNITY PERSPECTIVES ON THE USE OF RACE AND ETHNICITY DATA IN HEALTH RESEARCH

Session Objectives:

• Understand experiences from community groups about the collection and use of race and ethnicity data during different phases of community-based participatory research, including:
  • learning about the research goals, building partnerships, designing the study, participating in research, and learning about the results and benefits to the community.
• Learn from community members and research participants about current research practices involving race and ethnicity that should be continued, stopped, or modified.
• Listen to what changes related to the use of race and ethnicity in research community members may want to see and discuss possible ways to implement those changes in biomedical research practices.

OPEN SESSION

March 15, 2024

RACE AND ETHNICITY IN BIOMEDICAL AI

Session Objectives:

• Hear from experts in artificial intelligence (AI) about the growing impact of this technology on biomedical research and implications for the use of race and ethnicity in research and algorithms
• Learn about potential applications of natural language processing (NLP) and large language models (LLMs) in biomedical research and how race and ethnicity are used in biomedical and clinical AI
• Explore whether and how race and ethnicity could be used in the development of future clinical algorithms

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