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The Pathway Forward: Insights on Factors that Facilitate Research with Pregnant Women
Author(s) -
Mastroianni Anna C.,
Franceschini Robert,
Wicks Sarah L.,
Henry Leslie Meltzer
Publication year - 2020
Publication title -
ethics and human research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.353
H-Index - 32
eISSN - 2578-2363
pISSN - 2578-2355
DOI - 10.1002/eahr.500058
Subject(s) - clinical trial , clinical research , qualitative research , narrative , medicine , alternative medicine , narrative review , offspring , psychology , family medicine , medical education , pregnancy , sociology , pathology , intensive care medicine , social science , linguistics , philosophy , biology , genetics
The near‐routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway—from protocol development, to IRB review, and ultimately trial execution—that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from “why we cannot” do such research to “how we can.”