Evaluating the Therapeutic Misconception

Harvard University, Cambridge, Massachusetts, United States
Kennedy Institute of Ethics journal (Impact Factor: 1.21). 01/2007; 16(4):353-66. DOI: 10.1353/ken.2006.0025
Source: PubMed


The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.

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    • "whether participants recruited into clinical trials have mistaken beliefs about potential personal benefits (Lidz & Appelbaum, 2002; Miller & Joffe, 2006) or that they had been allocated on the basis of their individual therapeutic needs (Snowdon, Garcia, & Elbourne, 1997) as well as incorrect expectations of what the trial can offer them (Lidz et al., 2004). Therapeutic misconception is thought to undermine informed consent, because it leads people to a faulty weighing up of risks and benefits (Henderson et al., 2007). "
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    ABSTRACT: This study explored participants' experiences of randomized controlled trial (RCT) participation to examine their understanding of the trial design and whether their consent was indeed informed. A nested qualitative interview study was conducted with 38 participants from a sample of 282 who participated in a complex RCT evaluating the effectiveness of laser compared with needle acupuncture for chronic knee pain. Overall participants had a good understanding of the RCT, and concepts such as randomization and placebo. Their experiences of being in the trial were largely positive, even if they did not experience any knee pain improvement. Their responses to unblinding at the end of the study were accepting. Participants had a good functional understanding of the RCT, sufficient for valid informed consent.
    Journal of Empirical Research on Human Research Ethics 10/2015; DOI:10.1177/1556264615610209 · 1.25 Impact Factor
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    • "" This means that for some, opinions about biobank participation and policy issues were being formulated for the first time. Although we clarified in our education presentation and focus groups that clinical care was not the same as research participation, a number of participants expressed the expectation that biobank participation would provide interpretable findings helpful for personal clinical treatment, which is consistent with findings of possible therapeutic misconception described in other studies [Ormond et al., 2009; Miller and Joffe, 2006]. Some participants also grappled with the concept of broad consent, which was defined and explained in the education sessions. "
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    ABSTRACT: To be respectful of the public, biobank guiding principles and operations should be responsive to and inclusive of the values and beliefs of their participants. In an effort to increase knowledge and inform institutional policies, we conducted a deliberative engagement of individuals from two healthcare facilities in South Side Chicago that serve different socioeconomic communities to consider biobank policies regarding return of research results. We recruited primary caregivers of children receiving care at either a Federally Qualified Health Center or a university-based practice to attend two full-day deliberative engagement sessions, which included four educational presentations followed by focus group discussions. Surveys were administered to assess attitudes before and after the engagement, and an evaluation was conducted to assess the deliberative engagement process. All 45 participants self-identified as African-American. Focus group themes included: (1) overall interest in biobank participation, broad consent, and recontact; (2) root causes of distrust and potential biobank strategies to facilitate trust; (3) perceived positive and negative aspects of receiving research results; and (4) strong interest in receiving and managing their children's research results. Survey data indicated the same degree of interest in receiving results about themselves as about their children. Pre- and post-session findings showed mainly non-significant attitudinal changes in level of interest in biobank participation and return of research results, although there was a decrease in level of concern regarding identification from research data. Our findings reveal shared community insights important in facilitating relationships and policy discussions between biobank researchers and research participants.
    American Journal of Medical Genetics Part A 05/2012; 158A(5):1029-37. DOI:10.1002/ajmg.a.34414 · 2.16 Impact Factor
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    • "Little is known about how research participants weigh the benefits and burdens of their participation in clinical trials. Joffe and Miller (2006) rightfully argue that a risk/benefit assessment is part of any research review process . In fact, the Belmont Report, an enduring historical medical ethics document, outlines three specific ethical principles for the protection of human subjects enrolled in clinical research: respect for persons, beneficence, and justice . "
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    ABSTRACT: Recruiting and retaining human participants in cancer clinical trials is challenging for many investigators. Although we expect participants to identify and weigh the benefits and burdens of research participation for themselves, it is not clear what burdens adult cancer participants perceive in relation to benefits. We identify key attributes and develop an initial conceptual framework of benefit and burden based on interviews with individuals enrolled in cancer clinical research. Semistructured interviews were conducted with a purposive sample of 32 patients enrolled in cancer clinical trials at a large northeastern cancer center. Krueger's guidelines for qualitative methodology were followed. Respondents reported a range of benefits and burdens associated with research participation. Benefits such as access to needed medications that subjects otherwise might not be able to afford, early detection and monitoring of the disease, potential for remission or cure, and the ability to take control of their lives through actively participating in the trial were identified. Burdens included the potentiality of side effects, worry and fear of the unknown, loss of job support, and financial concerns. Both benefit and burden influence research participation, including recruitment and retention in clinical trials. Dimensions of benefit and burden include physical, psychological, economic, familial, and social. Understanding the benefit-burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research.
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