关于早产儿或患病新生儿临床试验同意书的伦理问题：实证研究的系统评价（框架综合）
The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.
作者信息
Wilman E, Megone C, Oliver S, Duley L, Gyte G, Wright J M
机构信息
Inter-Disciplinary Ethics Applied, University of Leeds, Leeds, UK.
Social Science Research Unit and EPPI-Centre, Institute of Education, University of London, London, UK.
出版信息
Trials. 2015 Nov 4;16:502. doi: 10.1186/s13063-015-0957-x.
BACKGROUND
Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials?
METHODS
A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature.
RESULTS
Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent.
CONCLUSIONS
Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.
背景
如果要为这一人群的护理提供可靠的证据支持，对早产儿或患病婴儿进行临床试验至关重要。然而，在这个艰难时期与家长接触，要获得对此类研究的有效知情同意面临诸多挑战。本研究提出：实证文献对围产期临床试验中获得知情同意的符合伦理的合理方法有何启示？
方法
系统检索确定了49项研究。分析首先应用哲学框架，然后根据实证研究中出现的概念进行完善，以呈现广泛文献的连贯图景。
结果
这些研究共同探讨了家长和临床医生对新生儿试验中同意问题的态度；新生儿研究背景下同意过程的有效性；以及不同的可能获得同意的方法。
结论
尽管家长和临床医生之间存在各种意见，但有一种强烈且广泛持有的观点认为，家长对新生儿参与试验给予或拒绝同意很重要。然而，该研究审查的现有同意程序中没有一个是令人满意的。一个重大差距是对广泛存在的紧急“附议”做法的评估，即在紧急情况下家长尽力附议或拒绝其婴儿参与，之后再对持续参与和随访给予完全同意。紧急附议的可接受性、这样一个过程如何处理附议和同意之间新生儿死亡等不良结果，或家长后期拒绝可能对结果产生偏倚的程度均未得到评估。对大量实证论文的这项综述虽然没有带来根本性改变，但完善并发展了用于在此背景下审查知情同意的哲学概念框架。
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