TY - JOUR
T1 - Ethics, regulation, and beyond
T2 - the landscape of research with pregnant women
AU - Saenz, Carla
AU - Cheah, Phaik Yeong
AU - van der Graaf, Rieke
AU - Henry, Leslie Meltzer
AU - Mastroianni, Anna C
N1 - Funding Information:
This work was supported in part by the Wellcome Trust [203160/Z/16/Z for ACM and LMH, and 106698/Z/14/Z for PYC] and the US National Institutes of Health [NIAID R01 AI108368 for ACM and LMH]. The publication cost of this article was funded by the Wellcome Trust.
Publisher Copyright:
© 2017 Pan American Health Organization.
PY - 2017/12/14
Y1 - 2017/12/14
N2 - 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.
AB - 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.
KW - Medication
KW - Pregnancy
KW - Pregnancy research
KW - Research ethics
KW - Research regulation
UR - http://www.scopus.com/inward/record.url?scp=85041220710&partnerID=8YFLogxK
U2 - 10.1186/s12978-017-0421-3
DO - 10.1186/s12978-017-0421-3
M3 - Article
C2 - 29297343
SN - 1742-4755
VL - 14
SP - 9
EP - 14
JO - Reproductive health
JF - Reproductive health
IS - Suppl 3
M1 - 173
ER -