Guarino Peter, Elbourne Diana, Carpenter James, Peduzzi Peter
Department of Veterans Affairs, Cooperative Studies Program Coordinating Center, West Haven, CT, USA.
Clin Trials. 2006;3(1):19-30. doi: 10.1191/1740774506cn133oa.
Despite widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy of current consent procedures and documentation.
The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators. The study was a cluster randomized, controlled study embedded in a 'parent' randomized controlled trial of 1092 participants with Gulf War veterans' illnesses recruited in 1999-2000 at 20 US medical centers. Centers were randomized to the investigator-developed or participant-developed consent document. The primary outcome measure was an Informed Consent Questionnaire-4 (ICQ-4), a validated four-item scale measuring self-reported participant understanding scored from 0 to 1. Secondary outcomes included the Client Satisfaction Questionnaire-8 and measures of study refusal and adherence to the parent trial protocol.
There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points. Mean (95% CI) treatment differences ranged from +0.020 (-0.015, 0.055) (better understanding) at entry to -0.021 (-0.054, 0.012) (worse understanding) at three-months for the participant versus the investigator document group. There were also no significant differences in satisfaction, adherence to the protocol, or in the proportion of patients who refused to participate in the trial.
The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document. The outcome assessment questionnaire was not validated prior to the trial's initiation.
Consumer modification of the consent document did not lead to either benefit or harm in understanding, satisfaction, or study refusal and adherence rates. This study did demonstrate, however, that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study.
尽管临床研究中对知情同意的重要性已达成广泛共识，但对于当前同意程序和文件记录的充分性仍存在不确定性。
本研究的目的是比较由潜在研究参与者的消费者群体制定的知情同意文件与研究调查人员制定的知情同意文件。该研究是一项整群随机对照研究，嵌套于一项“母”随机对照试验中，该试验于1999年至2000年在美国20个医疗中心招募了1092名患有海湾战争退伍军人疾病的参与者。各中心被随机分配使用由调查人员制定或由参与者制定的同意文件。主要结局指标是知情同意问卷-4（ICQ-4），这是一个经过验证的四项量表，用于测量自我报告的参与者理解程度，得分范围为0至1。次要结局包括客户满意度问卷-8以及研究拒绝率和对母试验方案的依从性测量。
总体上或在任何时间点，同意文件在ICQ-4得分上均无显著差异。与调查人员文件组相比，参与者文件组在入组时的平均（95%CI）治疗差异为+0.020（-0.015，0.055）（理解更好），在三个月时为-0.021（-0.054，0.012）（理解更差）。在满意度、方案依从性或拒绝参与试验的患者比例方面也没有显著差异。
消费者群体可能不具有研究参与者的代表性，并且他们并未对同意文件提出重大修改建议。结局评估问卷在试验开始前未经验证。
消费者对同意文件的修改在理解、满意度、研究拒绝率和依从率方面既未带来益处也未造成损害。然而，本研究确实表明，将同意研究嵌入临床试验是可行的，并且可以在不干扰主要研究的情况下解决有关知情同意的重要问题。
