Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness
Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness
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DOI：
10.1186/s13063-015-1110-6
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发表时间：
2015-12-29
期刊：
影响因子：
2.5
通讯作者：
Nichol, Alistair
中科院分区：
文献类型：
--
作者：
Gobat, Nina H.;Gal, Micaela;Nichol, Alistair
背景：在疫情/大流行期间，需要一个严格的研究响应来为临床和公共卫生决策提供信息。然而，这种往往涉及危重患者的研究的道德行为可能会因为同意能力的减弱和在短时间内启动试验疗法的必要性而变得复杂。因此，可以使用采取预期知情同意的替代方法。我们的目标是快速审查关键利益相关者(患者、他们的代理决策者、临床医生和监管机构)对与大流行相关的急性疾病研究相关的各种获得同意的方法的可接受性的看法的证据。方法：我们利用互联网、数据库和手工搜索1996年至2014年关于急性疾病研究中使用的利益相关者对同意模式(预期知情、第三方、延期或放弃)的意见的英文实证出版物，进行了快速证据审查。我们排除了关于同意治疗、筛查或其他此类程序的研究、非紧急研究和二级研究。结果：共筛选出689篇引文，审阅104篇全文，收录52篇。只有一篇论文专门与大流行研究有关。在其他紧急研究情况下，潜在的研究参与者、临床医生和研究人员发现，第三方、延期和放弃的同意是可行地进行此类研究的一种手段，是可以接受的。潜在参与者的可接受性受到利他主义、对医学界的信任和对医学研究的感知价值的激励，并随着与参与相关的感知风险的增加而下降。在替代同意模式的概念和应用或经验的可接受性方面观察到差异。患者接受临床医生作为代理决策者，随着干预措施侵入性的增加，他们更倾向于两个决策者。研究监管机构在批准使用替代同意模式进行的研究时更加谨慎；然而，他们的观点通常没有得到充分的代表。结论：第三方、延期和放弃的同意模式对于急诊研究的潜在参与者、临床医生和/或研究人员来说是广泛可接受的。需要与关键利益攸关方，特别是与监管机构进行进一步磋商，并进行专门侧重于疫情/大流行研究的研究。我们强调存在的差距和建议，以便为流行病研究和机构审查委员会进程的建立和方案制定提供信息。
Background: A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research.Methods: We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis.Results: We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented.Conclusions: Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes.