Murphy S, Nolan C, O'Rourke C, Fenton J E
Graduate Entry Medical School, University of Limerick, Limerick, Ireland.
Clin Otolaryngol. 2015 Feb;40(1):36-40. doi: 10.1111/coa.12320.
Medical research involving human subjects must follow ethical standards as outlined in the Declaration of Helsinki of the World Medical Association. The aim of this study was to assess the frequency of reporting of informed consent and regional ethical committee (REC) approval in all reports of trials published in the major European Otolaryngology journals.
Review of all clinical research articles published online in the calendar year 2012.
Three leading European Otolaryngology journals.
Clinical Otolaryngology, The Journal of Laryngology and Otology and The European Achieves of Oto-Rhino-Laryngology.
Evaluate the incidence of reporting of REC approval and informed consent.
Of the 767 articles reviewed, 401 met the inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research which require ethical approval). 49.9% lacked a statement of REC approval and 42.9% lacked disclosure of informed consent. Articles that did not state REC approval were associated with not stating informed consent (P < 0.05).
Articles that lack explicit statements of REC approval and informed consent are frequent and continue to be published in major otolaryngology journals.
涉及人类受试者的医学研究必须遵循世界医学协会《赫尔辛基宣言》中概述的伦理标准。本研究的目的是评估在欧洲主要耳鼻咽喉科期刊发表的所有试验报告中，知情同意和地区伦理委员会（REC）批准的报告频率。
回顾2012日历年在线发表的所有临床研究文章。
欧洲三本领先的耳鼻咽喉科期刊。
《临床耳鼻咽喉科》《喉科学与耳科学杂志》和《欧洲耳鼻咽喉科文献》。
评估REC批准和知情同意报告的发生率。
在审查的767篇文章中，401篇符合纳入标准（报告需要伦理批准的人类受试者、人体组织或可识别个人数据研究的手稿）。49.9%的文章缺乏REC批准声明，42.9%的文章缺乏知情同意披露。未声明REC批准的文章与未声明知情同意相关（P<0.05）。
缺乏REC批准和知情同意明确声明的文章很常见，并且继续在主要的耳鼻咽喉科期刊上发表。
