TY - JOUR
T1 - Research Ethics in Pregnancy
T2 - The Maternal-Fetal Dyad
AU - Haward, Marlyse F.
AU - Lucena, Michelle H.
AU - Fuloria, Mamta
N1 - Publisher Copyright:
© 2023 American Academy of Pediatrics. All rights reserved.
PY - 2023/10/1
Y1 - 2023/10/1
N2 - Pregnant persons and their physicians often make decisions for health care without clinical evidence to guide their choices. Years of exclusionary practices in research, dominated by fears of fetal harm, have resulted in limited evidence on therapies for pregnancy-specific conditions. It has also eroded pregnant persons' rights as autonomous individuals capable of weighing risks and benefits to make choices for themselves and their infants based on sound evidence. A paradigm shift from "routine exclusion" to "fair inclusion" of pregnant persons in clinical trials is needed to ensure that ethical principles are upheld when undertaking research in this population. This article will provide a brief review of the historical aspects of clinical research ethics for pregnant persons, focus on some key concepts within the context of the maternal-fetal dyad, and include a recent example from the coronavirus disease 2019 (COVID-19) pandemic to understand how society has interpreted tensions among the ethical principles of justice, beneficence, nonmaleficence, and autonomy.
AB - Pregnant persons and their physicians often make decisions for health care without clinical evidence to guide their choices. Years of exclusionary practices in research, dominated by fears of fetal harm, have resulted in limited evidence on therapies for pregnancy-specific conditions. It has also eroded pregnant persons' rights as autonomous individuals capable of weighing risks and benefits to make choices for themselves and their infants based on sound evidence. A paradigm shift from "routine exclusion" to "fair inclusion" of pregnant persons in clinical trials is needed to ensure that ethical principles are upheld when undertaking research in this population. This article will provide a brief review of the historical aspects of clinical research ethics for pregnant persons, focus on some key concepts within the context of the maternal-fetal dyad, and include a recent example from the coronavirus disease 2019 (COVID-19) pandemic to understand how society has interpreted tensions among the ethical principles of justice, beneficence, nonmaleficence, and autonomy.
UR - http://www.scopus.com/inward/record.url?scp=85175307459&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85175307459&partnerID=8YFLogxK
U2 - 10.1542/NEO.24-10-E607
DO - 10.1542/NEO.24-10-E607
M3 - Article
AN - SCOPUS:85175307459
SN - 0191-9601
VL - 24
SP - E607-E615
JO - NeoReviews
JF - NeoReviews
IS - 10
ER -