Date of Award
Spring 6-13-2026
Document Type
Undergraduate Honors Thesis
Degree Name
B.A. in Socio-Legal Studies
Organizational Unit
College of Arts Humanities and Social Sciences, Sociology and Criminology
First Advisor
Lisa Pasko
Second Advisor
Tanika Vigil
Copyright Statement / License for Reuse
All Rights Reserved.
Keywords
Women's health, Federal Drug Administration (FDA), Administrative law, Clinical trials, Kefauver Harris Amendments, Healthcare
Abstract
Historically, women have faced grave healthcare disparities stemming from their exclusion in clinical research. For much of the twentieth century, women were left out of medical research as response to the feared possibility of experimental drugs impacting reproductive health and pregnancy. Many of the policies regulating women’s involvement in clinical trials can be traced back to the 1960s, particularly the period following the thalidomide crisis, a widespread panic over birth defects linked to a medication often used during pregnancy. In response to this crisis, government agencies, like the Food and Drug Administration (FDA), enacted increasingly cautious approaches toward women’s participation in clinical trials. While these policies were framed as protective, they created major gaps in our medical understanding of how diseases and medications uniquely impact women. Understanding how and why women were barred from clinical research is important to explaining many health disparities that persist in today’s healthcare climate. This paper will examine the social and legal developments that shaped the exclusion of women from clinical trials, focusing particularly on the FDA’s role and its power as a federal administration. The following questions will help guide this paper’s analysis: What societal and legal frameworks contributed to the historical exclusion of women from clinical research? Why was this decision reached? How do society and the law work in tandem to create policies regarding women’s participation? This paper will argue that the exclusion of women from clinical research emerged from the interaction between societal fears surrounding reproduction and the broad legal discretion afforded to federal agencies, like the FDA. By examining the cultural response to the thalidomide crisis as well as legal doctrines that have empowered agency decision making, this paper shows how administrative law and societal attitudes have overlapped to shape medical research.
Copyright Date
6-8-2026
Publication Statement
Copyright is held by the author. This work may only be accessed by members of the University of Denver community. The work is provided by permission of the author for individual research purposes only and may not be further copied or distributed. User is responsible for all copyright compliance.
Rights Holder
Tinsley Wilkinson
Provenance
Received from author
File Format
application/pdf
Language
English (eng)
Extent
38 pgs
File Size
387 KB
Recommended Citation
Wilkinson, Tinsley, "Exclusion of Women in Clinical Research: Legal History of Male-Centric Medicine and Cultural Consequences for Women's Health" (2026). Restricted Access ETDs. 134.
https://digitalcommons.du.edu/restrictedetd/134