Olson C M, Jobe K A
University of Washington, Seattle 98195-6123, USA.
Resuscitation. 1996 Jun;31(3):255-63. doi: 10.1016/0300-9572(95)00928-0.
To determine how frequently reports of research in human cardiopulmonary resuscitation mention approval by a research ethics committee and address subjects' consent.
Retrospective review of published reports of interventional research in human cardiopulmonary resuscitation. Reports were retrieved from the MEDLINE database and selected according to pre-established criteria. Data were abstracted independently by the two authors with differences resolved by mutual agreement. Results were analyzed according to whether the research took place in the prehospital setting, the emergency department, or the hospital; whether it was conducted within or outside the United States; whether it received any funding from the US government; its randomization scheme; the year of publication; and whether the journal's instructions required mention of REC approval or subjects' consent.
Reports of 47 studies met our criteria for inclusion. Of these, 24 (51%) mentioned approval by a research ethics committee and 12 (26%) addressed subjects' consent. Significantly more studies reported ethics committee approval or addressed consent during more recent years. Authors were more likely to report consent, REC approval, or both when journal instructions required that REC approval be mentioned.
Reports of resuscitation research have not consistently mentioned approval from a research ethics committee or addressed subjects' consent for interventional studies using human subjects. However, they are doing so more frequently in recent years as journal requirements for reporting change. REC approval is now almost always being reported, but subjects' consent is often not addressed. Journal editors and reviewers should ensure that authors adhere to the journal's instructions about reporting ethical conduct of experiments.
确定关于人类心肺复苏研究的报告提及研究伦理委员会批准及受试者同意的频率。
对已发表的人类心肺复苏介入研究报告进行回顾性审查。报告从MEDLINE数据库中检索,并根据预先设定的标准进行选择。数据由两位作者独立提取,分歧通过双方协商解决。根据研究是在院前环境、急诊科还是医院进行;是在美国境内还是境外开展;是否获得美国政府的任何资助;其随机化方案;发表年份;以及期刊的要求是否需要提及研究伦理委员会的批准或受试者的同意来分析结果。
47项研究的报告符合我们的纳入标准。其中,24项(51%)提及了研究伦理委员会的批准,12项(26%)涉及受试者的同意。近年来,报告伦理委员会批准或涉及同意的研究明显增多。当期刊要求提及研究伦理委员会批准时,作者更有可能报告同意、研究伦理委员会批准或两者皆有。
复苏研究报告并未始终提及研究伦理委员会的批准,也未涉及使用人类受试者的介入研究的受试者同意情况。然而,随着期刊报告要求的变化,近年来他们这样做的频率更高。现在几乎总是报告研究伦理委员会的批准,但受试者的同意情况往往未被提及。期刊编辑和审稿人应确保作者遵守期刊关于报告实验伦理行为的要求。