Inclusion of women in research studies is necessary for valid inferences about health and disease in women. The generalization of results from trials conducted in men may yield erroneous conclusions that fail to account for the biologic differences between men and women. Although significant changes in research design and practice have led to an increase in the proportion of women included in research trials, knowledge gaps remain because of a continued lack of inclusion of women, especially those who are pregnant, in premarketing research trials. This document provides a historical overview of issues surrounding women as participants in research trials, followed by an ethical framework and discussion of the issues of informed consent, contraception requirements, intimate partner consent, and the appropriate inclusion of pregnant women in research studies.
Committee on EthicsThe American Academy of Pediatrics, American Society for Reproductive Medicine, and Society for Maternal–Fetal Medicine endorse this document. This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians and Gynecologists as a service to its members and other practicing clinicians. While this document reflects the current viewpoint of the College, it is not intended to dictate an exclusive course of action in all cases. This Committee Opinion was approved by the Committee on Ethics and the Executive Board of the American College of Obstetricians and Gynecologists.
Copyright November 2015 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved.
Official Citation Ethical considerations for including women as research participants. Committee Opinion No. 646. American College of Obstetricians and Gynecologists. Obstet Gynecol 2015;126:e100–7.