Quality of informed consent: A new measure of understanding among research subjects
Quality of informed consent: A new measure of understanding among research subjects
复制标题
DOI：
10.1093/jnci/93.2.139
复制
发表时间：
2001-01-17
期刊：
影响因子：
--
通讯作者：
Weeks, JC
中科院分区：
文献类型：
--
作者：
Joffe, S;Cook, EF;Weeks, JC
背景：大多数涉及人类受试者的研究在伦理和法律上都要求参与者的知情同意。然而，缺乏标准化的方法来评估研究的知情同意是否充分。方法和结果：我们设计了一个简短的问卷，知情同意的质量（QuIC），以衡量受试者的实际（客观）和感知对癌症临床试验的（主观）理解，QuIC纳入了联邦法规中规定的知情同意的基本要素，评估了治疗误解（相信临床试验的所有方面都旨在直接使受试者受益），并采用了新的国家癌症研究所知情同意文件模板的语言和结构，我们在收到癌症研究受试者试点测试的反馈以及两个独立专家小组的验证后修改了QuIC。然后，我们将QuIC发送给参加I期、II期或III期临床试验的287名成人癌症患者，207名受试者（72%）完成了QuIC。为了评估重测信度，随机选择了32名受访者，其中17名（53%）第二次完成了问卷。重测信度良好，组内相关系数为0.66测试的客观理解和0.77测试的主观理解。目前版本的QuIC由20个客观理解问题和14个主观理解问题组成，在9名成年癌症患者的样本中测试了时间和易用性。QuIC平均需要7.2分钟才能完成。结论：QuIC是一种简短、可靠和有效的问卷，有望成为评估癌症临床试验中知情同意过程结果的标准化方法。
Background: The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. Methods and Results: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and perceived (subjective) understanding of cancer clinical trials, The QuIC incorporates the basic elements of informed consent specified in federal regulations, assesses the therapeutic misconception (the belief that all aspects of a clinical trial are designed to directly benefit the subject), and employs the language and structure of the new National Cancer Institute template for informed consent documents, We modified the QuIC after receiving feedback from pilot tests with cancer research subjects, as well as validation from two independent expert panels. We then sent the QuIC to 287 adult cancer patients enrolled on phase I, II, or III clinical trials, Two hundred seven subjects (72%) completed the QuIC, To assess test-retest reliability, a random sample of 32 respondents was selected, of whom 17 (53%) completed the questionnaire a second time. The test-retest reliability was good with intraclass correlation coefficients of .66 for tests of objective understanding and .77 for tests of subjective understanding. The current version of the QuIC, which consists of 20 questions for objective understanding and 14 questions for subjective understanding, was tested for time and ease of administration in a sample of nine adult cancer patients. The QuIC required an average of 7.2 minutes to complete. Conclusions: The QuIC is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.