The second wave: Toward responsible inclusion of pregnant women in research.
The second wave: Toward responsible inclusion of pregnant women in research.
复制标题
DOI：
10.2979/fab.2008.1.2.5
复制
发表时间：
2008-01-01
影响因子：
0.7
通讯作者：
Faden, Ruth
中科院分区：
文献类型：
--
作者：
Lyerly, Anne Drapkin;Little, Margaret Olivia;Faden, Ruth
虽然在将非孕妇纳入研究方面取得了很大进展，但关于将孕妇纳入研究的深入讨论却落后了。我们概述了由此产生的知识差距及其成本，然后强调了四个原因，为什么在道德上，我们有义务面对的挑战，包括孕妇在临床研究。这些是：对怀孕期间妇女进行有效治疗的必要性、胎儿安全、不愿开出可能有益的药物所造成的伤害，以及更广泛的公正问题和获得参与研究的好处。要想向前迈进，就需要将解释理由的责任从纳入转移到排除，并制定适当的伦理框架，具体说明将孕妇排除在研究之外的适当理由。
Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research.