We explored reasons for the failure of patients to recall major portions of the information on consent forms and in oral explanations about consent. Within one day of signing consent forms for chemotherapy, radiation therapy, or surgery, 200 cancer patients completed a test of their recall of the material in the consent explanation and filled out a questionnaire regarding their opinions of its purpose, content, and implications. Only 60 per cent understood the purpose and nature of the procedure, and only 55 per cent correctly listed even one major risk or complication. We found that three factors were related to inadequate recall: education, medical status, and the care with which patients thought they had read their consent forms before signing. Only 40 per cent of the patients had read the form "carefully." Most believed that consent forms were meant to "protect the physician's rights." Although most thought that consent forms were necessary and comprehensible and that they contained worthwhile information, the legalistic connotations of the forms appeared to lead to cursory reading and inadequate recall.
This article has been cited by other articles:
Rao, S. V., Kim, S. Y.H.
(2008). Informing the Consent Process. Circ Cardiovasc Qual Outcomes
1: 7-8
[Full Text]
Hofmeijer, J, Amelink, G J, den Hertog, H M, Algra, A, Kappelle, L J, van der Worp, H B, on behalf of the HAMLET and PAIS investigators,
(2007). Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction. J. Neurol. Neurosurg. Psychiatry
78: 1124-1128
[Abstract][Full Text]
Epstein, M
(2006). Why effective consent presupposes autonomous authorisation: a counterorthodox argument.. J. Med. Ethics
32: 342-345
[Full Text]
Guarino, P., Elbourne, D., Carpenter, J., Peduzzi, P.
(2006). Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding. Clin Trials
3: 19-30
[Abstract]
Lemaire, R.
(2006). Informed consent - a contemporary myth?. J Bone Joint Surg Br
88-B: 2-7
[Full Text]
Burke, T M, Abramovitch, R, Zlotkin, S
(2005). Children's understanding of the risks and benefits associated with research. J. Med. Ethics
31: 715-720
[Abstract][Full Text]
Geppert, C. M.A., Dettmer, E., Jakiche, A.
(2005). Ethical Challenges in the Care of Persons With Hepatitis C Infection: A Pilot Study to Enhance Informed Consent With Veterans. Psychosomatics
46: 392-401
[Abstract][Full Text]
Matsui, K, Kita, Y, Ueshima, H
(2005). Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis. J. Med. Ethics
31: 385-392
[Abstract][Full Text]
Corrigan, O P
(2005). Pharmacogenetics, ethical issues: review of the Nuffield Council on Bioethics Report. J. Med. Ethics
31: 144-148
[Abstract][Full Text]
Wirshing, D. A., Sergi, M. J., Mintz, J.
(2005). A Videotape Intervention to Enhance the Informed Consent Process for Medical and Psychiatric Treatment Research. Am. J. Psychiatry
162: 186-188
[Abstract][Full Text]
Mueller, M.-R.
(2004). Involvement and (Potential) Influence of Care Providers in the Enlistment Phase of the Informed Consent Process: the case of aids clinical trials. Nurs Ethics
11: 42-52
[Abstract]
Ellis, P. M., Butow, P. N., Tattersall, M. H. N.
(2002). Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol
13: 1414-1423
[Abstract][Full Text]
Chassin, M. R., Becher, E. C.
(2002). The Wrong Patient. ANN INTERN MED
136: 826-833
[Abstract][Full Text]
Davis, T. C., Williams, M. V., Marin, E., Parker, R. M., Glass, J.
(2002). Health Literacy and Cancer Communication. CA Cancer J Clin
52: 134-149
[Abstract][Full Text]
Gotay, C. C.
(2001). Perceptions of Informed Consent by Participants in a Prostate Cancer Prevention Study. Cancer Epidemiol. Biomarkers Prev.
10: 1097-1099
[Abstract][Full Text]
McCusker, J., Kruszewski, Z., Lacey, B., Schiff, B.
(2001). Monitoring clinical research: report of one hospital's experience. CMAJ
164: 1321-1325
[Abstract][Full Text]
Brundage, M. D., Feldman-Stewart, D., Cosby, R., Gregg, R., Dixon, P., Youssef, Y., Davies, D., Mackillop, W. J.
(2001). Phase I Study of a Decision Aid for Patients With Locally Advanced Non-Small-Cell Lung Cancer. JCO
19: 1326-1335
[Abstract][Full Text]
Joffe, S., Cook, E. F., Cleary, P. D., Clark, J. W., Weeks, J. C.
(2001). Quality of Informed Consent: a New Measure of Understanding Among Research Subjects. JNCI J Natl Cancer Inst
93: 139-147
[Abstract][Full Text]
Ferguson, D.J.
(2001). Informed consent - who knows? Results of a hospital audit project. Health Education Journal
60: 371-377
[Abstract]
Westman, J., Hampel, H., Bradley, T.
(2000). Efficacy of a touchscreen computer based family cancer history questionnaire and subsequent cancer risk assessment. J. Med. Genet.
37: 354-360
[Abstract][Full Text]
Lashley, M., Talley, W., Lands, L. C., Keyserlingk, E. W.
(2000). Informed Proxy Consent: Communication Between Pediatric Surgeons and Surrogates About Surgery. Pediatrics
105: 591-597
[Abstract][Full Text]
Bottrell, M. M., Alpert, H., Fischbach, R. L., Emanuel, L. L.
(2000). Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction. Arch Surg
135: 26-33
[Abstract][Full Text]
Ad Hoc Committee on Health Literacy for the Counci,
(1999). Health Literacy: Report of the Council on Scientific Affairs. JAMA
281: 552-557
[Abstract][Full Text]
Cassady, J. F. Jr., Wysocki, T. T., Miller, K. M., Cancel, D. D., Izenberg, N.
(1999). Use of a Preanesthetic Video for Facilitation of Parental Education and Anxiolysis Before Pediatric Ambulatory Surgery. Anesth. Analg.
88: 246-246
[Abstract][Full Text]
Jimison, H. B., Sher, P. P., Appleyard, R., LeVernois, Y.
(1998). The Use of Multimedia in the Informed Consent Process. J. Am. Med. Inform. Assoc.
5: 245-256
[Abstract][Full Text]
Chapman, G. B., Elstein, A. S., Hughes, K. K.
(1995). Effects of Patient Education on Decisions about Breast Cancer Treatments: A Preliminary Report. Med Decis Making
15: 231-239
[Abstract]
Rothman, K. J., Michels, K. B.
(1994). The Continuing Unethical Use of Placebo Controls. NEJM
331: 394-398
[Full Text]
Twomey, P. L.
(1991). Invented Review: Getting Started in Clinical Nutrition Research. Nutr Clin Pract
6: 175-183
[Abstract]
Sorrell, J. M.
(1991). Effects of Writing/Speaking on Comprehension of Information for Informed Consent. West J Nurs Res
13: 110-122
Ruccione, K., Kramer, R. F., Moore, I. K., Perin, G.
(1991). Informed Consent for Treatment of Childhood Cancer: Factors Affecting Parents' Decision Making. Journal of Pediatric Oncology Nursing
8: 112-121
[Abstract]
Sachs, G. A., Cassel, C. K.
(1990). Biomedical Research Involving Older Human Subjects. J Law Med Ethics
18: 234-243
Nusbaum, J. G., Chenitz, W. C.
(1990). A Grounded Theory Study of the Informed Consent Process for Pharmacologic Research. West J Nurs Res
12: 215-228
Deardorff, W. W.
(1986). Computerized Health Education: A Comparison with Traditional Formats. Health Educ Behav
13: 61-72
[Abstract]
Annas, G. J.
(1980). The Goals of Informed Consent. J Law Med Ethics
8: 13-13