Abstract
Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges—as well as the prevailing practices of stakeholders, such as ethics review committees and investigators—may lead to the generalized exclusion of pregnant women from research.
Highlights
The underrepresentation—and often complete exclusion—of pregnant women from participation in clinical research has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring [1, 2]
Because metabolism changes during pregnancy, and some compounds cross the placental barrier, the absence of pregnancy-specific data for most medications means that pregnant women may be taking medications at doses that are ineffective and unsafe for both their own health and the health of their potential offspring [1]
We focus on the 2016 edition of International Ethical Guidelines for Healthrelated Research Involving Humans by the Council for International Organizations of Medical Sciences (CIOMS)
Summary
The underrepresentation—and often complete exclusion—of pregnant women from participation in clinical research has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring [1, 2]. We provide an analysis based on our work experience in the Americas as investigators, members of ethics review committees, and advisors for national authorities in the development and revision of laws and regulations.
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