This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (69)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Henry W. Riecken, PhD; Ruth Ravich

JAMA. 1982;248(3):344-348.

Abstract
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.

(JAMA 1982;248:344-348)

Author Affiliations
From the School of Medicine, University of Pennsylvania, Philadelphia (Dr Riecken); the Patient Representative Department of The Mount Sinai Medical Center, New York (Ms Ravich); and the Department of Graduate Studies of Sarah Lawrence College, Bronxville, NY (Ms Ravich).

Footnotes
Reprint requests to School of Medicine, University of Pennsylvania, Philadelphia, PA 19174 (Dr Riecken).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Institutional Review Board Approval: Why It Matters
Parvizi et al.
JBJS 2007;89:418-426.
ABSTRACT | FULL TEXT  

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.
ABSTRACT | FULL TEXT  

How to improve patients' understanding in biomedical research?
Cracowski and Paris
Arch. Dis. Child. 2005;90:1097-1098.
FULL TEXT  

Can We Ensure That All Research Subjects Give Valid Consent?
Wendler
Arch Intern Med 2004;164:2201-2204.
ABSTRACT | FULL TEXT  

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.
ABSTRACT | FULL TEXT  

The Use of Multimedia in the Informed Consent Process
Jimison et al.
J. Am. Med. Inform. Assoc. 1998;5:245-256.
ABSTRACT | FULL TEXT  

The Use of Multimedia in the Informed Consent Process
Jimison et al.
J Am Med Inform Assoc 1998;5:245-256.
ABSTRACT | FULL TEXT  

Research Ethics and the Medical Profession: Report of the Advisory Committee on Human Radiation Experiments
Experiments
JAMA 1996;276:403-409.
ABSTRACT  

Readability of the Childhood Immunization Information Forms
Melman et al.
Arch Pediatr Adolesc Med 1994;148:642-644.
ABSTRACT  

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.
ABSTRACT  

Readability of Informed Consent Forms for Research in a Veterans Administration Medical Center
Baker and Taub
JAMA 1983;250:2646-2648.
ABSTRACT