© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 2, 139-147,
January 17, 2001
© 2001 Oxford University Press
REPORT |
Quality of Informed Consent: a New Measure of Understanding Among Research Subjects
Affiliations of authors: S. Joffe, Department of Pediatrics, Dana-Farber Cancer Institute, and Division of Hematology/Oncology, Children's Hospital, Boston; E. F. Cook, Division of General Medicine, Brigham and Women's Hospital, Boston; P. D. Cleary, Department of Health Care Policy, Harvard Medical School, Boston; J. W. Clark, Division of Hematology/Oncology, Massachusetts General Hospital, Boston; J. C. Weeks, Department of Adult Oncology, Dana-Farber Cancer Institute, and Department of Medicine, Brigham and Women's Hospital.
Correspondence to: Jane C. Weeks, M.D., M.Sc., Center for Outcomes and Policy Research, 454 BRK Suite 21, Dana-Farber Cancer Institute, 44 Binney St., Boston, MA 02115 (e-mail:jane_weeks{at}dfci.harvard.edu).
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.
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