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The under-representation of women in clinical studies remains a major issue, recognized by researchers, patients, and legislators alike. In this review, we examine the key legislative documents that have shaped policies governing the exclusion and inclusion of women in clinical research over the past several decades, and their impact on seminal cardiovascular studies. We focus on early federal human-subject regulations codified as the Common Rule, which initially contributed to the near-complete exclusion of women, and trace the gradual recognition of the need for women’s inclusion and the progress achieved to date. Key trials discussed include the Framingham Heart Study, the Multiple Risk Factor Intervention Trial (MRFIT), and the Physicians’ Health Study (PHS), as well as a meta-analysis of over 1, 000 cardiovascular trials conducted between 2017 and 2023. We also discuss the critiques of the legislation including the current reliance on informed consent from a bioethics perspective.
Kovalsky et al. (Fri,) studied this question.