The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

BackgroundConducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials?MethodsIn a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature.ResultsBetween them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment.ConclusionsIn addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

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临床医师对电子病历相关知识认知的调查研究

目的:了解临床医师对电子病历书写的态度和行为现状以及电子病历管理和对医疗质量的认知等情况,为制定科学的电子病历管理方案提供借鉴。方法:选取两所2所三级甲等和2所三级乙等医院临床医师共计450名进行调查,采用问卷调查医师对电子病例相关知识(如临床医师对电子病例相关法规认知、电子病例监控对电子病历影响及电子病历优点等)的认知和需求。结果:临床医师电子病历总体书写现状调查显示,对于书写电子病历中相似的部分,48.7%(219例)的医师直接复制粘贴再修改;复制粘贴使用比率≥40%占76.7%(345例);电子病历书写出错原因主要为认为责任心不强(38.2%)和病历系统掌握不到位(29.6%);促进临床医师按要求写好病历的主要动力为法律证据(32.9%)和培养临床思维(49.1%);54.9%(247例)医师能对自己的病历进行经常检查;科室负责人对电子病历经常检查的占33.1%(149例);50%左右人员对电子病历系统操作掌握情况一般;79.33%的临床医师认为电子病历的使用有助于提高医疗质量;临床医师认为电子病历对医疗质量的影响主要是提高病历书写速率、病历完成及时性、管理系统性、病历安全性和患者满意度。结论:临床医师在电子病历书写中复制粘贴比例较高,且对相关的法律法规认识一般,对医院电子病历系统掌握不熟悉,应加大相关内容的培训,更有利于医院电子病历的管理。