Thomsen Jakob Hartvig, Hassager Christian, Bro-Jeppesen John, Køber Lars, Boesgaard Søren, Møller Jacob Eifer, Nielsen Niklas, Wanscher Michael, Kjærgaard Jesper
Hjertemedicinsk Klinik B, 2142, Hjertecentret, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.
Dan Med J. 2015 Mar;62(3).
Informed consent in incapacitated adults is permitted in the form of proxy consent by both the patients' closest relative (next of kin, NOK) and general practitioner (GP). In research in acute situations not involving pharmaceuticals, Danish legislation allows for randomisation and subsequent proxy consent, as soon as possible. The aim of this study was to describe the delay associated with obtaining consent and to assess whether consent from NOK or GP/Danish Health and Medicines Authority is obtained with delays beyond the intervention.
In a prospective study, 171 comatose out-of-hospital cardiac arrest (OHCA) patients were randomised to targeted temperature management. Patients were randomised before NOK could be informed, and proxy consent was obtained as soon as possible. Written consent from NOK and GP were our study data.
We obtained all legally required consent: 169 cases of consent were obtained from NOK, two patients gave consent before NOK, in no cases was consent denied by the proxy. Consent from NOK was obtained with a median delay of zero days (interquartile range (IQR): 0-1, max. 128 days). Delay from NOK consent to GP consent was a median of nine days (IQR: 6-23, max. 527 days).
NOK fully accepted participation in a clinical trial after OHCA with short delays in consent. Consent from GPs was associated with long delays beyond the intervention, which make GPs less appropriate for proxy consent of incapacitated adults in acute situations. The Ethics Committees' approval of the trial justified by their competence and authority, combined with the NOK´s insight into the patient's wishes may be a relevant and feasible alternative to the current consent procedure.
This work was supported by the European Regional Development Fund through the Interreg IV A OKS programme (NYPS ID: 167157) with regards to authors JHT, CH, NN and JK.
not relevant.
对于无行为能力的成年人，可通过患者最亲近的亲属（近亲，NOK）和全科医生（GP）以代理同意的形式给予知情同意。在不涉及药品的急性情况下的研究中，丹麦法律允许在随机分组后尽快获得代理同意。本研究的目的是描述获得同意相关的延迟情况，并评估在干预之后是否获得了NOK或GP/丹麦卫生与药品管理局的同意以及是否存在延迟。
在一项前瞻性研究中，171名院外心脏骤停（OHCA）昏迷患者被随机分配至目标温度管理组。在通知NOK之前患者就已被随机分组，并尽快获得代理同意。来自NOK和GP的书面同意是我们的研究数据。
我们获得了所有法律要求的同意：从NOK处获得了169例同意，两名患者在通知NOK之前就已给予同意，代理方无一例拒绝同意。从NOK获得同意的中位延迟为零天（四分位间距（IQR）：0 - 1天，最长128天）。从NOK同意到GP同意的延迟中位值为九天（IQR：6 - 23天，最长527天）。
NOK完全接受参与OHCA后的临床试验，同意延迟时间较短。GP的同意与干预之后的长时间延迟相关，这使得GP在急性情况下不太适合作为无行为能力成年人的代理同意方。伦理委员会凭借其能力和权威对试验的批准，再加上NOK对患者意愿的了解，可能是当前同意程序的一种相关且可行的替代方案。
这项工作得到了欧洲区域发展基金通过Interreg IV A OKS计划（NYPS ID：167157）对作者JHT、CH、NN和JK的支持。
不相关。
