Use of deferred consent for severely ill children in a multi-centre phase III trial.
Use of deferred consent for severely ill children in a multi-centre phase III trial.
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DOI：
10.1186/1745-6215-12-90
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发表时间：
2011-03-31
期刊：
影响因子：
2.5
通讯作者：
Lang T
中科院分区：
文献类型：
--
作者：
Maitland K;Molyneux S;Boga M;Kiguli S;Lang T
受试者自愿参与研究尊重了受试者的权利，加强了其道德行为，并通过知情同意程序正式化。医疗紧急情况下的救生干预措施的临床试验往往需要招募事先不可能获得个人书面知情同意的患者。尽管有关于保护紧急研究受试者的法规和指南，但这些法规和指南因其有限和不必要的限制而受到批评。在整个欧洲和美国，严格的法规导致涉及紧急干预的临床试验大幅下降。我们正在三个疟疾流行的非洲国家的六家医院对患有低血容量性休克的儿童进行液体复苏试验。设计是务实的，因为儿童仅根据临床标准登记，并在具有非洲许多地区医院典型设施的医院进行。该试验旨在为管理发热性疾病和休克特征的儿童提供信息。为了为试验制定适当的知情同意程序，我们对目前国际上关于紧急知情同意的建议进行了叙述性审查。实际或具体的指导通常是稀疏或混乱的文献中的几个例子，以指导我们的知情同意过程。对于一个患有重病的儿童小组，或者父母本身因其他原因过于痛苦而无法考虑事先书面同意的儿童，我们选择了一种经过修改的延期同意形式。这包括监护人在入学时的口头同意，以及在稳定儿童后获得的完全书面同意。对于在获得完全书面同意之前死亡的儿童，获得伦理许可以放弃完全同意。鉴于这一领域的指导和法规的争议，我们报告了我们如何以及为什么在儿童紧急干预试验中使用了修改后的延迟同意系统。虽然所有相关的伦理委员会都批准了这一方法，并在非洲3个国家实施，但现在仍有必要进行正式研究，以探讨父母、卫生工作者、研究人员和伦理委员会对经修改的推迟同意方法的看法和经验。
Voluntary participation of a subject in research respects a subject's rights, strengthens its ethical conduct, and is formalized by the informed consent process. Clinical trials of life-saving interventions for medical emergencies often necessitate enrolment of patients where prior written individual informed consent is impossible. Although there are regulations and guidelines on protecting subjects in emergency research, these have been criticised for being limited and unnecessarily restrictive. Across Europe and the United States stringent regulations have resulted in a substantial decline of clinical trials involving emergency interventions. We are conducting a trial of fluid resuscitation in children with hypovolaemic shock in six hospitals across three malaria-endemic African countries. The design is pragmatic as children are enrolled on clinical criteria alone and is being conducted in hospitals with facilities typical of many district hospitals across Africa. The trial aims to inform strategy for managing children with febrile illness and features of shock. In order to develop appropriate consent processes for the trial, we conducted a narrative review of current international recommendations for emergency consent. Practical or specific guidance was generally sparse or confusing with few examples in the literature to direct our informed consent process. For a sub-group of children who were critically sick or where parents themselves were otherwise too distressed to consider prior written consent, we opted for a modified form of deferred consent. This included verbal assent from guardians at the point of enrolment, with full written consent obtained after stabilising the child. For children who died prior to full written consent, ethical permission was received to waiver full consent. In light of the controversy around guidance and regulations in this area we report how and why we have used a modified system of deferred consent in an emergency intervention trial in children. Although approved by all relevant ethics committees and operational in 3 countries in Africa, formal research is now necessary to explore the perceptions and experiences of parents, health workers, researchers and ethics committees of the modified method of deferred consent.
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