A new ethical framework to determine acceptable risks in fetal therapy trials.
A new ethical framework to determine acceptable risks in fetal therapy trials.
复制标题
确定胎儿治疗试验中可接受风险的新伦理框架。
作者：
Fetal therapy trials pose complex ethical challenges because risks and benefits to both fetuses and pregnant persons must be considered. Existing regulatory guidance is limited and many proposed ethical frameworks have unnecessarily restrictive criteria that would block the development and implementation of important new fetal therapies. We aimed to develop a new ethical framework for assessing the risks and benefits of fetal therapy trials. We reviewed existing regulatory and ethical guidance on fetal therapy trials. We used conceptual analysis to design a new ethical framework, which is grounded in general ethical principles for clinical research. We propose a new framework for assessing the risks and benefits of fetal therapy trials. We suggest that the potential benefits of a fetal therapy trial – for the fetus, the pregnant person, and society – should outweigh the risks for the fetus and the pregnant person. Furthermore, the risk-benefit profile for just the fetus and the risk-benefit profile for just the pregnant person should be appropriate. We hope that this new framework will permit important studies while protecting pregnant persons and fetuses from disproportionate harms.
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影响因子：
3
作者：
Adzick, N. Scott
通讯作者：
Adzick, N. Scott
DOI：
10.1007/978-3-319-26512-4_14
发表时间：
2016-01-01
期刊：
CLINICAL RESEARCH INVOLVING PREGNANT WOMEN
影响因子：
--
作者：
Ashcroft, Richard
通讯作者：
Ashcroft, Richard
影响因子：
3
作者：
Chervenak, Frank A.;McCullough, Laurence B.
通讯作者：
McCullough, Laurence B.
影响因子：
3
作者：
Chervenak, Frank A.;McCullough, Laurence B.
通讯作者：
McCullough, Laurence B.
影响因子：
9.8
作者：
Cohen, Alan R.;Couto, James;Wax, Joseph R.
通讯作者：
Wax, Joseph R.