Clinical Trials and Women
Published online by Cambridge University Press: 10 September 2025
Chapter 3, “Experiments in Risk: Women and Clinical Trials,” follows feminist advocates as they set out to use the law to mandate the inclusion of women in clinical trials. With the advent of HIV treatment, people with HIV began to survive longer. A new problem emerged: Women were being excluded from clinical trials due to a 1977 Food and Drug Administration (FDA) guideline concerned about the impact of experimental drugs on women’s reproduction and the fetus. Not only did this mean that women could not access experimental treatments, it also resulted in confusion around how to treat women with HIV. Feminists began to advocate for a change in the FDA guidance which was excluding women from clinical trials. In keeping with the broader demands in the feminist movement at the time, feminists asserted that women should be able to choose to enroll in trials despite potential exposure to risks. Buoyed by ideas of choice and bodily autonomy, feminist AIDS activists were able to undo the FDA’s reticence to enroll women in clinical trials altering scientific research in HIV and beyond.
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