Therapeutic misconception and the appreciation of risks in clinical trials
Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design...
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| Published in | Social science & medicine (1982) Vol. 58; no. 9; pp. 1689 - 1697 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford
Elsevier Ltd
01.05.2004
Elsevier Pergamon Press Inc |
| Series | Social Science & Medicine |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0277-9536 1873-5347 |
| DOI | 10.1016/S0277-9536(03)00338-1 |
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| Abstract | Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the “therapeutic misconception”. Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA.
Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols.
The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. |
|---|---|
| AbstractList | Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. (Original abstract) Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. [PUBLICATION ABSTRACT] Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the “therapeutic misconception”. Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation.Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception". Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified and coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages and risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs and restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks and disadvantages of participation. Studies repeatedly have shown that clinical research subjects have trouble appreciating the implications for their clinical care of participating in a clinical trial. When this failure is based on a lack of appreciation of the impact on individualized clinical care of elements of the research design, it has been called the "therapeutic misconception." Failure to distinguish the consequences of research participation from receiving ordinary treatment may seriously undermine the informed consent of research subjects. This article reports results concerning appreciation of the risks of trial participation from intensive interviews with 155 subjects from 40 different clinical trials at two different medical centers in the USA. Working from transcripts of the interviews, every statement of a risk or disadvantage of trial participation was identified & coded into one of 5 different categories. Totally, 23.9% of subjects reported no risks or disadvantages in spite of being explicitly asked about them. Another 2.6% reported only incidental disadvantages such as having to drive a long way to get to the experimental site. In all 14.2% reported only disadvantages associated with the standard treatment (usually side effects). Another 45.8% told the interviewer about disadvantages & risks associated with the experimental intervention (usually side effects). Only 13.5% could report any risks or disadvantages resulting from the research design itself, such as randomization, placebos, double-blind designs & restrictive protocols. The results of this research suggest that subjects often sign consents to participate in clinical trials with only the most modest appreciation of the risks & disadvantages of participation. 1 Table, 27 References. [Copyright 2004 Elsevier Ltd.] |
| Author | Renaud, Michelle Lidz, Charles W Grisso, Thomas Appelbaum, Paul S |
| Author_xml | – sequence: 1 givenname: Charles W surname: Lidz fullname: Lidz, Charles W email: chuck.lidz@umassmed.edu organization: Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA 01655, USA – sequence: 2 givenname: Paul S surname: Appelbaum fullname: Appelbaum, Paul S organization: Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA 01655, USA – sequence: 3 givenname: Thomas surname: Grisso fullname: Grisso, Thomas organization: Department of Psychiatry, University of Massachusetts Medical School, 55 Lake Ave North, Worcester, MA 01655, USA – sequence: 4 givenname: Michelle surname: Renaud fullname: Renaud, Michelle organization: Salem State College, Graduate School of Social Work, 352 Lafayette St., Salem, MA 01970-5353, USA |
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S., Lidz, C. W., & Grisso, T. Therapeutic misconception in clinical research: Frequency and risk factors (under review). – reference: Washington, DC: US Government Printing Office. – volume: 307 start-page: 719 year: 1982 end-page: 724 ident: BIB21 article-title: The ethics of the randomized clinical trial publication-title: New England Journal of Medicine – volume: 47 start-page: 687 year: 2000 end-page: 688 ident: BIB8 article-title: The use of placebos in randomized clinical trials of mood disorders publication-title: Biological Psychiatry – reference: National Bioethics Advisory Commission (NBAC). (1998) – volume: 358 start-page: 1772 year: 2001 end-page: 1777 ident: BIB15 article-title: Quality of informed consent in cancer clinical trials publication-title: Lancet – volume: 324 start-page: 1585 year: 1991 end-page: 1589 ident: BIB14 article-title: Of mice but not men publication-title: New England Journal of Medicine – volume: 8 start-page: 191 year: 1990 end-page: 205 ident: BIB23 article-title: Randomized clinical trials and the problem of suboptimal care publication-title: Cancer Investigation – volume: 160 start-page: 356 year: 2003 end-page: 362 ident: BIB7 article-title: The Declaration of Helsinki and Clinical Trials publication-title: American Journal of Psychiatry – volume: 317 start-page: 141 year: 1987 ident: 10.1016/S0277-9536(03)00338-1_BIB11 article-title: Equipoise and the ethics of clinical research publication-title: New England Journal of Medicine doi: 10.1056/NEJM198707163170304 – ident: 10.1016/S0277-9536(03)00338-1_BIB19 – volume: 307 start-page: 719 year: 1982 ident: 10.1016/S0277-9536(03)00338-1_BIB21 article-title: The ethics of the randomized clinical trial publication-title: New England Journal of Medicine doi: 10.1056/NEJM198209163071204 – volume: 5 start-page: 319 year: 1982 ident: 10.1016/S0277-9536(03)00338-1_BIB4 article-title: The therapeutic misconception publication-title: International Journal of Law and Psychiatry doi: 10.1016/0160-2527(82)90026-7 – volume: 2 start-page: 849 year: 1984 ident: 10.1016/S0277-9536(03)00338-1_BIB20 article-title: Informed consent for investigational chemotherapy publication-title: Journal of Clinical Oncology doi: 10.1200/JCO.1984.2.7.849 – volume: 55 start-page: 709 year: 2002 ident: 10.1016/S0277-9536(03)00338-1_BIB10 article-title: “Why don’t they just tell me straight, why allocate it”? 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| SubjectTerms | Academic Medical Centers Adolescent Adult Aged Appreciation Biological and medical sciences Clinical research Clinical trial. Drug monitoring Clinical trials Clinical Trials as Topic - adverse effects Clinical Trials as Topic - psychology Clinical trials Risk Informed consent Therapeutic misconception USA Decision Making Drug therapy Experiments Female General pharmacology Health Health Knowledge, Attitudes, Practice Health risk assessment Human subjects Humans Informed Consent Informed Consent - psychology Interviews Interviews as Topic Male Medical Research Medical sciences Medical treatment Medicine Middle Aged Misconceptions Participation Patient Acceptance of Health Care Pharmacology. Drug treatments Research design Research Subjects Research Subjects - psychology Risk Risk Assessment Risk factors Side effects Social sciences Therapeutic Human Experimentation Therapeutic misconception Therapy Treatment U.S.A United States United States of America USA |
| Title | Therapeutic misconception and the appreciation of risks in clinical trials |
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