知情同意书信息要素完整性研究

目的:研究临床试验知情同意书中要素的完整性,评价撰写质量。方法:对第二军医大学长海医院伦理委员会受理的80项研究的知情同意书要素与标准要点进行对照,统计其吻合度,评价完整性;对要素逐项进行统计,包括缺失情况;调查审查记录,分析伦理审查关注点。结果:知情同意书撰写完整性基本合格,且逐年向好,但如下要素缺失较多:入选/排除标准、研究人员资质、替代治疗方案、指定联系人和联系方式、受试者有充分时间考虑、重新获得知情同意。伦理审查最关注的要素有补偿和赔偿、不良事件的处理、联系人和联系方式等、风险受益告知等。结论:知情同意书既要涵盖必要的要素,又要使每条要素的信息完整,使受试者真正全面理解告知的信息。

Study on the integrity of elements of informed consent

Objective：To assess the integrity and quality of informed consents from clinical trials and researches.Methods： Items of 80 informed consents from clinical trial conducted in Changhai Hospital,Second Military Medical University during 2006 to 2008 were collected,scores were given and the integrity and quality were evaluated according to the basic elements laid down by Changhai Hospital Ethics Committee（CHEC）.The main concerns of CHEC were also collected and reviewed.Results： Generally,the integrity of the informed consents met the requirement of the Institutional Review Board（IRB）,and the quality improved year by year.The elements frequently missed were shown as follows： criteria of inclusion/exclusion,qualification of investigators,alternative treatment,contact person and method,enough time for participants to consider,re-informed during the research.The elements attracting,close attention of IRB were pay and compensation,treatment of adverse events,contact person and method,risk and benefit information.Conclusion：It is important for investigators to provide clinical research participants with an informed consent with necessary elements and integrity of information.