Ethics, regulation, and beyond: the landscape of research with pregnant women

被引：8

作者：

Saenz, Carla ^{[1
]}

Cheah, Phaik Yeong ^{[2
,7
]}

van der Graaf, Rieke ^{[3
]}

Henry, Leslie Meltzer ^{[4
,5
]}

Mastroianni, Anna C. ^{[6
]}

机构：

[1] Pan Amer Hlth Org, Knowledge Management Bioeth & Res, Washington, DC 20037 USA

[2] Mahidol Univ, Mahidol Oxford Trop Med Res Unit, Bangkok, Thailand

[3] Univ Utrecht, Univ Med Ctr Utrecht, Utrecht, Netherlands

[4] Univ Maryland, Sch Law, Baltimore, MD USA

[5] Johns Hopkins Berman Inst Bioeth, Baltimore, MD USA

[6] Univ Washington, Sch Law, Seattle, WA 98195 USA

[7] Univ Oxford, Nuffield Dept Med, Oxford, England

来源：

REPRODUCTIVE HEALTH | 2017年 / 14卷

基金：

美国国家卫生研究院; 英国惠康基金;

关键词：

Research ethics; Pregnancy research; Research regulation; Pregnancy; Medication; FALCIPARUM-MALARIA; CLINICAL-RESEARCH; PHARMACOKINETICS; MEDICATIONS; INCLUSION; EXCLUSION; RISK;

D O I：

10.1186/s12978-017-0421-3

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

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.

引用

页数：6

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