False Hopes and Best Data: Consent to Research and the Therapeutic Misconception

Appelbaum, Paul S.; Roth, Loren H.; Lidz, Charles W.; Benson, Paul R.; Winslade, William J.

doi:10.2307/3562038

Cited by 789 publications

(385 citation statements)

References 13 publications

Supporting

Mentioning

362

Contrasting

Unclassified

Order By: Relevance

“…Patients' understanding of the difference between therapeutic and nontherapeutic research has been called into question (Appelbaum et al, 1987;Lidz et al, 2004). The published literature on patient motivation to participate in clinical trials suggests that altruism may not be the sole motivating factor; self-interest is also important (Penman et al, 1984;Rodenhuis et al, 1984;Kodish et al, 1992;Daugherty et al, 1995;Itoh et al, 1997;Yoder et al, 1997).…”

mentioning

confidence: 99%

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

et al. 2005

View full text Add to dashboard Cite

Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a ‘very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a ‘very important' motivating factor were ‘trust in the doctor' (66%), ‘being treated by the latest treatment available' (66%), ‘better standard of care and closer follow-up' (61%), and ‘closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any ‘reasonable' alternatives to the trial. In total, 71% strongly agreed that ‘surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

show abstract

mentioning

confidence: 99%

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

et al. 2005

View full text Add to dashboard Cite

show abstract

“…As Appelbaum notes, "insofar as the justification for a departure from the principle of personal care is premised (at least in part) on the subject's knowing relinquishment of an entitlement to a physician's undivided loyalty, a subject's failure to appreciate that this is occurring renders consent invalid" [5]. Appelbaum and colleagues recommended steps to mitigate the therapeutic misconception through better education of participants about differences between research and clinical care in order to help them better assess the risks and benefits of participating in research [2].…”

Section: The Construct Of Therapeutic Misconceptionmentioning

confidence: 99%

“…Participants' incorrect assumption that decisions are made to advance their personal therapeutic benefit is the crux of therapeutic misconception and may compromise informed consent. In a seminal article titled "False Hopes and Best Data: Consent to Research and the Therapeutic Misconception," Appelbaum and colleagues [2] provided further descriptive evidence of TM based on interviews with 88 patients with a range of psychiatric disorders, conducted immediately after the participants provided informed consent to participate in one of several clinical studies. The findings indicated that many participants failed to appreciate key distinctions between the purposes, methods, intended benefits, and potential disadvantages of research compared to those of clinical care.…”

Section: Introductionmentioning

confidence: 99%

When Does Therapeutic Misconception Affect Surrogates' or Subjects' Decision Making about Whether to Participate in Dementia Research?

Dunn

Palmer

2017

AMA Journal of Ethics

View full text Add to dashboard Cite

Abstract"Therapeutic misconception" (TM) refers to inappropriate assumptions and beliefs on the part of research participants regarding key distinctions between the purpose, methods, intended benefits, and potential disadvantages of research compared to those of clinical care. Despite an extensive literature describing TM across varied types of research and populations, minimal work has addressed TM in the context of dementia research. This is a serious gap, for several reasons: people with dementia are at significant risk of diminished capacity; surrogate decision makers are typically asked to provide consent on behalf of the person with dementia; and available treatments for dementia are quite limited. More research is needed on the prevalence, nature, and impact of TM in the context of clinical dementia research.

show abstract

“…According to this model, research participants entrust the relevant aspects of their health to the researchers, not because they think they are entrusting them and not because they trust the researchers to act in any particular way. As we know, what participants expect researchers to do for them is sometimes prone to the therapeutic misconception 19 specifically, to the form thereof that involves an "unreasonable appraisal of the nature or likelihood of medical benefit from participation in the study, due to a misperception of the nature of the research enterprise." 20 Rather, the model holds that what matters is that, during the informed consent process, the participants have waived certain of their rights that the researchers not touch or probe their bodies or collect their medical histories.…”

Section: Engagementmentioning

confidence: 99%

Secondary researchers’ duties to return incidental findings and individual research results: a partial-entrustment account

Richardson

Cho

2012

Genetics in Medicine

View full text Add to dashboard Cite

special articleExisting attempts to explain why secondary researchers might have any obligation to return findings to the contributors of genetic samples falter because of the lack of any direct interaction between the secondary researchers and the contributors. The partial-entrustment account of these obligations defended here circumvents this problem by explaining how a chain of special responsibilities can be forged even in the absence of any direct interaction. 2012:14(4):467-472 Genet Med

show abstract

False Hopes and Best Data: Consent to Research and the Therapeutic Misconception

Cited by 789 publications

References 13 publications

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

When Does Therapeutic Misconception Affect Surrogates' or Subjects' Decision Making about Whether to Participate in Dementia Research?

Secondary researchers’ duties to return incidental findings and individual research results: a partial-entrustment account

Contact Info

Product

Resources

About