Date of Award

January 2026

Document Type

Open Access Thesis

Degree Name

Medical Doctor (MD)

Department

Medicine

First Advisor

Jaime B. Hyman

Abstract

Background: Historically, research on women and minorities has consisted of unethical experimentation, human rights violations, and crimes against humanity. Numerous examples can be found throughout the past two centuries, including the exposure of pregnant women to radioactive iron in the Tennessee-Vanderbilt Nutrition Project (TVNP), failure to treat cervical carcinoma in situ in the Unfortunate Experiment, surgical experimentation on female slaves by Dr. J. Marion Sims, failure to treat syphilis in the Tuskegee Syphilis Study, intentional exposure to and subsequent failure to treat sexually transmitted diseases in Guatemala, collection of biospecimens from Henrietta Lacks, and nontherapeutic experimentation on minority children in the Fenfluramine Study. These unethical research practices have led to a long-standing mistrust of medical research among impacted groups.Purpose: We analyzed the association between demographic variables and patient participation in a single-center clinical trial by determining if there were significant differences between the racial and ethnic distributions of enrolled participants vs eligible patients. Our hypothesis was that the racial and ethnic composition of enrolled participants would not be representative of the eligible patient population. Methods: This thesis was based on a prospective, randomized, double-blind, placebo-controlled, Phase II clinical trial that examined the effects of a preoperative 5 mg dose of olanzapine on postdischarge quality of recovery, nausea, and vomiting.The study population consisted of women aged 18-50 years who underwent ambulatory surgery with general anesthesia at Yale New Haven Hospital’s York Street Campus and Shoreline Surgery Center. Racial and ethnic information was exported from Research Electronic Data Capture (REDCap) for 398 enrolled participants and Epic Electronic Health Record (EHR) System for 7,324 eligible patients for comparison purposes. Differences in Proportions (DIP = Enrolled % - Eligible %) and Participation-to-Prevalence Ratios (PPR = Enrolled % ÷ Eligible %) were calculated for race and ethnicity. Underrepresentation was defined as a negative DIP value and PPR less than 0.8, whereas overrepresentation was defined as a positive DIP value and PPR greater than 1.2. Results: The number of minority individuals enrolled in the trial was lower than expected based on data from the eligible surgical population. Comparison of enrolled participants vs eligible patients showed 3.02% vs 4.38% identified as Asian, 8.54% vs 21.85% identified as Black, 77.64% vs 56.80% identified as White, 0.25% vs 12.85% identified as Other/Multiracial, and 10.55% vs 4.12% were of Unknown race. Similarly, 12.81% vs 28.06% identified as Hispanic, 83.42% vs 69.59% identified as Non-Hispanic, and 3.77% vs 2.35% identified as Other or were of Unknown ethnicity. The DIP and PPR were -1.37% and 0.69 for Asian, -13.30% and 0.39 for Black, +20.84% and 1.37 for White, -12.60% and 0.02 for Other/Multiracial, and +6.43% and 2.56 for Unknown race. In addition, these values were -15.24% and 0.46 for Hispanic, +13.82% and 1.20 for Non-Hispanic, and +1.42% and 1.60 for Other/Unknown ethnicity. Conclusions: Racial and ethnic minorities continue to be underrepresented in research, potentially limiting the generalizability of research findings, increasing health disparities, and hindering equitable health outcomes.

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