Informed consent to biomedical research in Veterans Administration Hospitals
H. W. Riecken and R. Ravich
To illuminate the process of obtaining informed consent to research in a
medically dependent population, we interviewed 156 patients and 37
physicians involved in research projects at four Veterans Administration
hospitals. Most patients knew they were research subjects, had voluntarily
consented, and knew the details of their medical treatment, but few
understood the research well. Readability analysis indicated that consent
forms required college-level education. Twenty-eight percent of patients
were not aware of their participation in research although they had signed
consent forms. No single act, omission, or personal attribute completely
explains this unawareness, but it is associated with incomplete consent
forms, the identity of the person explaining the research, the manner of
the explanation, and, in some cases, grave illness.
Institutional Review Board Approval: Why It Matters
Parvizi et al.
JBJS 2007;89:418-426.
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Informed Consent for Research and Authorization under the Health Insurance Portability and Accountability Act Privacy Rule: An Integrated Approach
Shalowitz and Wendler
ANN INTERN MED 2006;144:685-688.
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How to improve patients' understanding in biomedical research?
Cracowski and Paris
Arch. Dis. Child. 2005;90:1097-1098.
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Can We Ensure That All Research Subjects Give Valid Consent?
Wendler
Arch Intern Med 2004;164:2201-2204.
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Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group
Coyne et al.
JCO 2003;21:836-842.
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The Use of Multimedia in the Informed Consent Process
Jimison et al.
J. Am. Med. Inform. Assoc. 1998;5:245-256.
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Effects of Writing/Speaking on Comprehension of Information for Informed Consent
Sorrell
West J Nurs Res 1991;13:110-122.
Informed Consent for Treatment of Childhood Cancer: Factors Affecting Parents' Decision Making
Ruccione et al.
Journal of Pediatric Oncology Nursing 1991;8:112-121.
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