Joffe S, Cook E F, Cleary P D, Clark J W, Weeks J C
Department of Pediatrics, Dana-Farber Cancer Institute, and Division of Hematology/Oncology, Children's Hospital, Boston, USA.
J Natl Cancer Inst. 2001 Jan 17;93(2):139-47. doi: 10.1093/jnci/93.2.139.
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.
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.
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.
对于大多数涉及人类受试者的研究，伦理和法律都要求获得参与者的知情同意。然而，目前缺乏评估研究知情同意充分性的标准化方法。
我们设计了一份简短问卷，即知情同意质量问卷（QuIC），以衡量受试者对癌症临床试验的实际（客观）理解和感知（主观）理解。QuIC纳入了联邦法规中规定的知情同意基本要素，评估了治疗性误解（即认为临床试验的所有方面都是为了直接使受试者受益的信念），并采用了美国国立癌症研究所新的知情同意文件模板的语言和结构。在收到癌症研究受试者的预试验反馈以及两个独立专家小组的验证后，我们对QuIC进行了修改。然后，我们将QuIC发送给287名参与I期、II期或III期临床试验的成年癌症患者。207名受试者（72%）完成了QuIC。为评估重测信度，我们随机抽取了32名受访者，其中17名（53%）再次完成了问卷。客观理解测试的组内相关系数为0.66，主观理解测试的组内相关系数为0.77，重测信度良好。当前版本的QuIC由20个客观理解问题和14个主观理解问题组成，我们在9名成年癌症患者样本中对其进行了时间和施测便利性测试。QuIC平均需要7.2分钟完成。
QuIC是一份简短、可靠且有效的问卷，有望成为评估癌症临床试验知情同意过程结果的标准化方法。
