Ethical Considerations for Including Women as Research Participants

Publications & Guidelines, Endorsed Partner Pub,

ABSTRACT: 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.

Original Article


TAGS: research, professional, randomized controlled trials, scope of maternal-fetal medicine, ultrasound 

CATEGORIES: SMFM Endorsed Partner Publication