Ethical Issues in a Trial of Maternal Gene Transfer to Improve Foetal Growth
Ethical Issues in a Trial of Maternal Gene Transfer to Improve Foetal Growth
复制标题
DOI：
10.1007/978-3-319-26512-4_14
复制
发表时间：
2016-01-01
期刊：
影响因子：
--
通讯作者：
Ashcroft, Richard
中科院分区：
文献类型：
--
作者：
Ashcroft, Richard
本章调查了一项拟议的欧洲基因转移试验的伦理问题，该试验将招募患有严重早发性胎儿生长受限的孕妇(研究计划的详细信息可在方案网站http://everrest-fp7.eu.上找到)。这项临床试验是在正在进行的临床前研究的基础上进行的，很可能在2016年底开始招募。该试验已在美国临床试验网站(NCT02097667)和英国临床研究网络(ID 15717)注册。基因转移的目标是孕妇，而不是她的胎儿，旨在改善血液流动，促进子宫的血管形成。通过胎盘将载体转移到胎儿的血液供应不应在临床上大量发生，也不会计划或预见到对胎儿基因组的修改。在这一章中，我首先考虑这种干预在理论上是否在伦理上是可以接受的。然后，我会考虑这种干预措施的试行是否符合监管准则。这里的核心伦理问题是如何权衡母亲和胎儿的利益。在这一点上，几乎没有监管或法律指导。在这里，我评估了主导伦理学文献的一个和两个患者的胎儿兴趣模型，发现这两个模型都没有充分捕捉到怀孕的独特性。在绝大多数情况下，孕妇和胎儿的利益是相互依存和相互交织的。在这项拟议的试验中(与许多其他影响胎儿生长和发育条件的试验一样)，主要风险是潜在地利用孕妇的脆弱性，这源于她希望承担重大风险以获得胎儿的潜在利益。
This chapter investigates the ethical issues associated with a proposed European gene transfer trial which would recruit pregnant women with severe early onset foetal growth restriction (Details of the research programme may be found on the programme website, http://everrest-fp7.eu. The clinical trial is building on ongoing preclinical studies, and is likely to begin recruitment towards the end of 2016. The trial has been registered with the US ClinicalTrials.gov (NCT02097667) and the UK Clinical Research Network (ID 15717)). The gene transfer is targeted on the pregnant woman, rather than her foetus, and seeks to improve blood flow and promote vascularisation of the uterus. Transfer of the vector across the placenta to the foetal blood supply should not occur in clinically significant quantities, and no modification of the foetal genome is planned or foreseen. In this chapter, I consider first whether such an intervention is in theory ethically acceptable. I then consider whether a trial of such an intervention meets regulatory guidelines. The core ethical issue here is how to weigh maternal and foetal interests. There is scant regulatory or legal guidance on this point. Here I assess the one-and two-patient models of foetal interests that dominate the ethics literature and find that neither model adequately captures the uniqueness of the pregnancy. The interests of the pregnant woman and her foetus are, in the vast majority of cases, co-dependent and intertwined. In this proposed trial (as in many other trials in conditions affecting foetal growth and development), the primary risk is potential exploitation of the pregnant woman's vulnerability, derived from her desire to undertake significant risks in order to gain potential benefits for the foetus.