Furyk Jeremy, McBain-Rigg Kris, Renison Bronia, Watt Kerrianne, Franklin Richard, Emeto Theophilus I, Ray Robin A, Babl Franz E, Dalziel Stuart
College of Public Health, Medical and Veterinary Sciences, James Cook University, Townsville, QLD, 4814, Australia.
University Hospital Geelong, Geelong, Victoria, Australia.
BMC Med Ethics. 2018 Nov 20;19(1):89. doi: 10.1186/s12910-018-0327-9.
A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research.
We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis.
Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation.
Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps.
在儿科急诊和急性护理环境中开展研究面临的一项挑战是获得家长有效的前瞻性知情同意。伦理问题复杂，在规划此类研究时，考虑参与者、医护人员和研究人员对无前瞻性知情同意的研究的看法很重要。
我们根据PRISMA指南进行了一项系统综述，涉及儿科急诊或急性护理环境中与前瞻性知情同意替代方案的过程、经验和可接受性相关的实证证据。检索了主要医学数据库和灰色文献来源，由两位作者根据纳入标准筛选和评估结果，并获取相关研究的全文文章。数据提取到数据收集表上，并导入数据管理软件进行分析。
该综述纳入了13项研究，包括9篇全文文章和4篇摘要。鉴于方法的异质性，结果无法进行定量合并以进行荟萃分析，定性结果以叙述形式呈现，根据从数据中确定的主题进行阐述。主要主题包括家长提供知情同意的能力、知情同意的可行性、对知情同意替代方案的支持、过程问题、修改后的同意过程、儿童死亡和社区咨询。
我们的综述表明，儿童及其家庭以及医护人员认识到未经事先同意进行研究的必要性，并且总体上支持在限制风险并尽快通知家长的前提下让儿童参与此类研究。澳大利亚缺乏相关数据以及儿童的观点，这是重要的知识空白。
