Impact of Institutional Review Board Type and Food and Drug Administration Diversity Action Plan Draft Guidance on Demographics of Participants Enrolled Clinical Trials Conducted from 2020 to 2024
Bibliographic Data
| ID | 22426460 |
|---|---|
| Authors | Kersten Wheeler (0009-0005-8789-8793, University of Jamestown, corresponding author), Ann-Margret Ervin (0000-0002-8610-4403, Johns Hopkins University), Marilisa Elrod (Chesapeake Public Schools) |
| Year | 2026 |
| Pages | 15562646261460666-15562646261460666 |
| Publication date | 2026-07-11 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Journal of Empirical Research on Human Research Ethics (JOURNAL) |
| Journal identifiers | ISSN: 1556-2646 • E-ISSN: 1556-2654 |
| Publisher | SAGE Publications (PUBLISHER • US) |
| DOI | 10.1177/15562646261460666 |
| PMID | 42434903 |
| OpenAlex | W7168014387 |
| Language | EN |
We assessed participant representation in phase 3 clinical trials registered on clinicaltrials.gov that were conducted in the U.S. between 2020 and 2024. From the 211 clinical trials analyzed, most relied on commercial IRBs (23.2%). Most of the trials in the “unknown” category were sponsored by pharmaceutical companies which likely relied on commercial IRBs. Trials relying on commercial and other/unknown IRBs had the least Black (10.4 −12.1%) and Asian (3.1–3.8%) participation as compared to Academic IRBs which had the highest Black (13.7%) and Asian (9.4%) enrollment (p
Alternative medicine · Clinical research · Clinical trial · Demographics · Ethnic group · Food and drug administration · Institutional review board · Biomedical Ethics and Regulation · Ethics in Clinical Research · Race, Genetics, and Society
| Highly cited | No |
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