Another Consequence of Overturning Roe: Imperiling Progress on Clinical Research in Pregnancy.
Another Consequence of Overturning Roe: Imperiling Progress on Clinical Research in Pregnancy.
复制标题
DOI：
10.1080/15265161.2022.2088894
复制
发表时间：
2022-08
影响因子：
13.4
通讯作者：
Lyerly, Anne Drapkin
中科院分区：
文献类型：
--
作者：
Waggoner, Miranda R.;Lyerly, Anne Drapkin
近年来，在认识到需要改善孕妇的医学知识方面取得了巨大进展，这一人群长期以来一直被排除在临床试验之外，并因缺乏证据基础而遭受伤害，以告知护理（Lyerly, Little, and Faden 2008）。从美国国立卫生研究院（NIH）到美国食品和药物管理局（FDA），联邦机构都表示大力支持缩小妊娠方面的知识差距，部分原因是通过促进孕妇参与临床研究（例如，FDA 2018; PRGLAC 2018）。作为进步的证据，一份新的国家科学院关于改善临床试验代表性的报告强调，一个更公平的研究企业将对孕妇的临床需求做出反应（NASEM 2022）。然而，这一来之不易的进步现在正处于危险之中，因为美国正在考虑后罗伊案的前景。事实上，正如帕特洛、哈里斯和马歇尔（2022）强有力地说明的那样，限制堕胎的后果远远超出了堕胎的获取和护理。在这里，我们强调终止Roe案件的另一个潜在后果：中断或逆转妊娠生物医学研究的关键进展。长期以来，关于堕胎的争论塑造了生物医学研究及其监管的方法。20世纪70年代是美国生殖权利和研究伦理发生重大转变的时期。1973年罗伊案判决时，生命伦理学领域刚刚形成。在罗伊看到塔斯基吉研究曝光的前一年，国家保护人类委员会
In recent years, tremendous progress has been made toward recognizing the need for improved medical knowledge for pregnant people, a population group that has long been excluded from clinical trials and suffered the harms that result from a poor evidence base to inform care (Lyerly, Little, and Faden 2008). From the National Institutes of Health (NIH) to the Food and Drug Administration (FDA), federal agencies have signaled strong support for closing knowledge gaps in pregnancy, in part through advancing responsible inclusion of pregnant individuals in clinical research (eg, FDA 2018; PRGLAC 2018). As evidence of progress, a new National Academies report on improving representation in clinical trials emphasizes that a more equitable research enterprise would be responsive to the clinical needs of pregnant people (NASEM 2022).Yet this hard-won progress is now in jeopardy as the US contemplates a post-Roe landscape. Indeed, as Paltrow, Harris, and Marshall (2022) so powerfully illustrate, the consequences of abortion restrictions extend far beyond abortion access and care. Here, we highlight another potential consequence of ending Roe: interrupting—or reversing—critical progress around biomedical research in pregnancy. Debates about abortion have long shaped approaches to biomedical research and its regulation. The 1970s were a time of major transformation in both reproductive rights and research ethics in the United States. When Roe was decided in 1973, the field of bioethics was just taking shape. The year before Roe saw the Tuskegee study exposed, and the National Commission for the Protection of Human
登录
查看更多内容
影响因子：
7.2
作者：
Spach NC;Jaffe EF;Sullivan KA;Goldfarb IT;Anderson JR;Coleman J;Gilbert SZ;Gross MS;Rahangdale L;Faden RR;Lyerly AD
通讯作者：
Lyerly AD
影响因子：
7.4
作者：
MCCARTHY, CR
通讯作者：
MCCARTHY, CR
DOI：
10.2979/fab.2008.1.2.5
发表时间：
2008-01-01
影响因子：
0.7
作者：
Lyerly, Anne Drapkin;Little, Margaret Olivia;Faden, Ruth
通讯作者：
Faden, Ruth
DOI：
10.1007/978-3-319-26512-4_15
发表时间：
2016-01-01
期刊：
CLINICAL RESEARCH INVOLVING PREGNANT WOMEN
影响因子：
--
作者：
Harris, Lisa H.
通讯作者：
Harris, Lisa H.
影响因子：
13.4
作者：
Paltrow, Lynn M.;Harris, Lisa H.;Marshall, Mary Faith
通讯作者：
Marshall, Mary Faith