Committee Opinion No. 646: Ethical Considerations for Including Women as Research Participants.

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.

journal_name

Obstet Gynecol

authors

doi

10.1097/AOG.0000000000001150

subject

Has Abstract

pub_date

2016-05-01 00:00:00

pages

e100-7

issue

5

eissn

0029-7844

issn

1873-233X

pii

00006250-201511000-00054

journal_volume

127

pub_type

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