Vulnerability of pregnant women in clinical research
Vulnerability of pregnant women in clinical research
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DOI：
10.1136/medethics-2016-103955
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发表时间：
2017-10-01
影响因子：
4.1
通讯作者：
van Delden, Johannes J. M.
中科院分区：
文献类型：
--
作者：
van der Zande, Indira S. E.;van der Graaf, Rieke;van Delden, Johannes J. M.
背景尽管需要对孕妇的药物治疗产生基于证据的知识，但她们在临床研究中的代表性仍然不足。有时她们被排除在外，因为她们被认为是弱势群体，但没有普遍接受的标准将孕妇视为弱势群体。我们的目的是探讨是否，如果是在什么程度上孕妇是脆弱的research subjects.Method我们进行了概念和实证分析适用于孕妇的脆弱性。分析一个概念分析支持赫斯特的定义的脆弱性。因此，我们认为，孕妇是脆弱的，如果他们遇到了一个可识别的增加的可能性，招致额外的或更大的错误。根据文献，这种增加的可能性可能存在四个所谓的孕妇的脆弱性特征：（一）知情同意，（二）对胁迫的敏感性，（三）由于缺乏知识而更高的风险暴露，（四）胎儿的脆弱性。讨论根据赫斯特的定义测试的功能表明，他们都关注同一个问题：孕妇之所以易受伤害，是因为缺乏科学知识导致风险增加，从而增加了错误。研究伦理委员会有责任保护弱势群体，但更高的风险暴露，由于缺乏科学知识是一个更广泛的问题，也需要解决的其他stakeholder.Conclusions的唯一原因为什么孕妇是潜在的脆弱性的程度，他们越来越多地暴露在更高的风险，由于缺乏科学知识。因此，讨论可以推进到实际战略的发展，以促进公平纳入孕妇在临床研究。
Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects.Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women.Analysis A conceptual analysis supports Hurst's definition of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: (i) informed consent, (ii) susceptibility to coercion, (iii) higher exposure to risk due to lack of knowledge, (iv) vulnerability of the fetus.Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders.Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research.