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ARTICLE |

Informed Consent to Biomedical Research in Veterans Administration Hospitals FREE

Henry W. Riecken, PhD; Ruth Ravich
[+] Author Affiliations

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


JAMA. 1982;248(3):344-348. doi:10.1001/jama.1982.03330030050025
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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)

REFERENCES

Mosteller F:  Innovation and evaluation . Science 1981;;211:881-886.
Barber B: Informed Consent in Medical Therapy and Research . New Brunswick, NJ, Rutgers University Press, 1980;.
Alfidi RJ:  Informed consent: A study of patient reaction . JAMA 1971;;216:1325-1329.
Cassileth BR, Zupkis RV, Sutton-Smith K, et al:  Informed consent: Why are its goals imperfectly realized? N Engl J Med 1980;;302:896-900.
Schultz AL, Pardee GP, Ensinck JW:  Are research subjects really informed? West J Med 1975;;123:76-80.
Levine RJ, Lebacqz K:  Ethical considerations in clinical trials . Clin Pharmacol Ther 1979;;25:728-741.
Lebacqz K:  The National Commission and research in pharmacology: An overview . Fed Proc 1977;;36:2344-2348.
Biomedical Research in the Veterans Administration , National Research Council. National Academy of Sciences, 1978;.
Flesch R:  A new readability yardstick . J Appl Psychol 1948;;32:221-223.
Gray BH, Cooke RA, Tannenbaum AS:  Research involving human subjects . Science 1978;;201:1094-1101.
Grundner TM:  On the readability of surgical consent forms . N Engl J Med 1980;;302:901-902.
Miller R, Willner HS:  The two-part consent form: A suggestion for promoting free and informed consent . N Engl J Med 1974;;290:964-966.

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Mosteller F:  Innovation and evaluation . Science 1981;;211:881-886.
Barber B: Informed Consent in Medical Therapy and Research . New Brunswick, NJ, Rutgers University Press, 1980;.
Alfidi RJ:  Informed consent: A study of patient reaction . JAMA 1971;;216:1325-1329.
Cassileth BR, Zupkis RV, Sutton-Smith K, et al:  Informed consent: Why are its goals imperfectly realized? N Engl J Med 1980;;302:896-900.
Schultz AL, Pardee GP, Ensinck JW:  Are research subjects really informed? West J Med 1975;;123:76-80.
Levine RJ, Lebacqz K:  Ethical considerations in clinical trials . Clin Pharmacol Ther 1979;;25:728-741.
Lebacqz K:  The National Commission and research in pharmacology: An overview . Fed Proc 1977;;36:2344-2348.
Biomedical Research in the Veterans Administration , National Research Council. National Academy of Sciences, 1978;.
Flesch R:  A new readability yardstick . J Appl Psychol 1948;;32:221-223.
Gray BH, Cooke RA, Tannenbaum AS:  Research involving human subjects . Science 1978;;201:1094-1101.
Grundner TM:  On the readability of surgical consent forms . N Engl J Med 1980;;302:901-902.
Miller R, Willner HS:  The two-part consent form: A suggestion for promoting free and informed consent . N Engl J Med 1974;;290:964-966.
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