Critical Care Medicine Research Group, Tampere University Hospital, TAYS PL2000, Tampere, Finland.
Resuscitation. 2012 Jan;83(1):81-5. doi: 10.1016/j.resuscitation.2011.07.018. Epub 2011 Jul 27.
According to a directive of the European Parliament, informed consent is required to conduct a clinical trial also in emergencies when the patient is unable to provide consent. In these cases surrogate consent can be obtained from the patient's next of kin. There are no reports describing how patients and their next of kin perceive this policy. The perceptions of patients and their spouses involved in an emergency trial conducted under surrogate consent were surveyed.
A survey was sent to survivors of prehospital cardiac arrest, to consent providers regardless of patient outcome, and to physicians who had recruited the patients.
11 (92%) patients, 17 (68%) consent providers, and all physicians returned the survey. All held a positive attitude towards emergency research and were willing to participate without own consent in a trial approved by an institutional review board (IRB). Opinions among responding groups were similar albeit a significant difference regarding the perceived capability of the consent provider to decide upon patient's enrolment. Spouses felt able to provide consent, but physicians were sceptical of this. Patients and their spouses would have appreciated additional information regarding the index trial after the acute phase.
Emergency research was perceived positively by cardiac arrest victims and their spouses previously involved in a resuscitation trial. Possible own participation in an emergency trial without personal consent was considered acceptable. Patients and their spouses would prefer additional research information after enrolment.
根据欧洲议会的一项指令，在紧急情况下，当患者无法提供同意时，也需要获得知情同意才能进行临床试验。在这些情况下，可以从患者的近亲处获得替代同意。目前尚无描述患者及其近亲如何看待这一政策的报告。本研究旨在调查在替代同意下进行的紧急试验中涉及的患者及其配偶的看法。
向院前心脏骤停的幸存者、无论患者结局如何的同意提供方以及招募患者的医生发送了一份调查。
11 名（92%）患者、17 名（68%）同意提供方和所有医生都返回了调查。所有受访者均对紧急研究持有积极态度，愿意在机构审查委员会（IRB）批准的试验中不经过自己同意就参与研究。尽管对同意提供方决定患者入组的能力存在显著差异，但不同回应群体的意见相似。配偶认为自己能够提供同意，但医生对此持怀疑态度。患者及其配偶在急性阶段后会希望了解更多关于该试验的信息。
先前参与过复苏试验的心脏骤停幸存者及其配偶对紧急研究持积极态度。他们认为，在未经个人同意的情况下，可能会参与紧急试验。患者及其配偶更希望在入组后获得更多的研究信息。
