Quality of informed consent: A new measure of understanding among researchsubjects

Background: The informed consent of participants is ethically and legally r equired for most research involving human subjects. However, standardized m ethods for assessing the adequacy of informed consent to research are lacki ng. Methods and Results: We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual (objective) and percei ved (subjective) understanding of cancer clinical trials, The QuIC incorpor ates the basic elements of informed consent specified in federal regulation s, 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 fo r 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 p atients enrolled on phase I, II, or III clinical trials, Two hundred seven subjects (72%) completed the QuIC, To assess test-retest reliability, a ran dom sample of 32 respondents was selected, of whom 17 (53%) completed the q uestionnaire a second time. The test-retest reliability was good with intra class correlation coefficients of .66 for tests of objective understanding and .77 for tests of subjective understanding. The current version of the Q uIC, which consists of 20 questions for objective understanding and 14 ques tions for subjective understanding, was tested for time and ease of adminis tration in a sample of nine adult cancer patients. The QuIC required an ave rage of 7.2 minutes to complete. Conclusions: The QuIC is a brief, reliable , and valid questionnaire that holds promise as a standardized way to asses s the outcome of the informed consent process in cancer clinical trials.