Pediatrics
January 2016, VOLUME 137 / ISSUE 1
http://pediatrics.aappublications.org/content/137/1?current-issue=y

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Ethics Rounds
Ethical Considerations for Including Women as Research Participants
Pediatrics Jan 2016, 137 (1) 1; DOI: 10.1542/peds.2015-3990
In November 2015, the American Academy of Pediatrics endorsed the following publication: American College of Obstetricians and Gynecologists. Committee Opinion No. 646. Ethical considerations for including women as research participants. Washington, DC: American College of Obstetricians and Gynecologists; November 2015. Available at: http://www.acog.org/-/media/Committee-Opinions/Committee-on-Ethics/co646.pdf?dmc=1&ts=20151028T1411564748
Abstract
Inclusion of women in research studies is necessary for valid inference 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 biological differences between men and women. Although significant changes in research design and practice have led to an increase in the proportion of women in research trials, knowledge gaps remain because of a continued lack of inclusion of women, especially those who are pregnant, in 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.