Therapeutic misconception in early phase gene transfer trials

Henderson, Gail E.; Easter, Michele M.; Zimmer, Catherine; King, Nancy M. P.; Davis, Arlene M.; Rothschild, Barbra Bluestone; Churchill, Larry R.; Wilfond, Benjamin S.; Nelson, Daniel K.

doi:10.1016/j.socscimed.2005.05.022

Cited by 107 publications

(103 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…However, almost uniformly, the subjects were much more likely to be told about something than to understand it (Siminoff and Simon, 2004). Henderson, studying TM in gene transfer trials, also found very high levels of TM but concluded ''TM not attributable to subjects alone: the ways in which PIs, SCs and consent forms describe the likelihood of benefit in a study have a strong influence on TM in subjects'' (Henderson, 2004). Although results are certainly preliminary, it seems reasonable to assume that TM might be partially reduced by better disclosure.…”

Section: Is Tm the Results Of Poor Disclosure?mentioning

confidence: 99%

The therapeutic misconception and our models of competency and informed consent

Lidz

2006

Behavioral Sci & The Law

View full text Add to dashboard Cite

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests.

show abstract

Section: Is Tm the Results Of Poor Disclosure?mentioning

confidence: 99%

The therapeutic misconception and our models of competency and informed consent

Lidz

2006

Behavioral Sci & The Law

View full text Add to dashboard Cite

show abstract

“…This is most often seen when participants' prognoses are terminal or the technology under study is viewed as 'cutting edge' . This motivation has been described as the 'therapeutic misconception' 14,15 and depicts the hope that research participants may experience when clinical treatments have failed to help them. In this study, the participants were healthy volunteers and patients with symptoms of coronary heart disease.…”

Section: Discussionmentioning

confidence: 99%

Motivators for participation in a whole-genome sequencing study: implications for translational genomics research

et al. 2011

View full text Add to dashboard Cite

The promise of personalized medicine depends on the ability to integrate genetic sequencing information into disease risk assessment for individuals. As genomic sequencing technology enters the realm of clinical care, its scale necessitates answers to key social and behavioral research questions about the complexities of understanding, communicating, and ultimately using sequence information to improve health. Our study captured the motivations and expectations of research participants who consented to participate in a research protocol, ClinSeq, which offers to return a subset of the data generated through high-throughput sequencing. We present findings from an exploratory study of 322 participants, most of whom identified themselves as white, non-Hispanic, and coming from higher socio-economic groups. Participants aged 45-65 years answered open-ended questions about the reasons they consented to ClinSeq and about what they anticipated would come of genomic sequencing. Two main reasons for participating were as follows: a conviction to altruism in promoting research, and a desire to learn more about genetic factors that contribute to one's own health risk. Overall, participants expected genomic research to help improve understanding of disease causes and treatments. Our findings offer a first glimpse into the motivations and expectations of individuals seeking their own genomic information, and provide initial insights into the value these early adopters of technology place on information generated by high-throughput sequencing studies. European Journal of Human Genetics (2011Genetics ( ) 19, 1213Genetics ( -1217 doi:10.1038/ejhg.2011; published online 6 July 2011Keywords: whole-genome sequencing; personalized medicine; early adopters INTRODUCTION Genomics has already revolutionized the biological sciences, and the future application of genomics to health care has the potential to improve prevention, diagnosis, and treatment of disease by refining individual risk in the clinical setting. However, this potential can only be realized through translational and clinical research studies to establish the relationship of disease risk to genomic variants derived from sequencing data. These studies will necessitate the enrollment of thousands of clinical research participants, and thus methods and approaches need to be developed to interact and communicate with participants regarding clinical genomics. As well, these clinical genomics studies will serve as the foundation for the development of approaches to health-care providers' interactions with patients undergoing sequencing in the clinic and hospital wards of the future.High-throughput genomic sequencing can elucidate an enormous range of sequence and copy number variations for a given individual. A typical whole-genome sequence determination yields on the order of 4 000 000 sequence variations that differ from the current human reference sequence. While most are benign or of unknown consequence, some are associated with a significant increased risk of disease for ...

show abstract

“…Empirical studies have painted a detailed portrait of TM as pervasive across nearly all types of research studies and clinical populations [6][7][8][9][10]. The definition of TM has been discussed at length, with attempts at an expert consensus definition [11] as well as further refinement of the concept into several subtypes [6,12].…”

Section: The Construct Of Therapeutic Misconceptionmentioning

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

Therapeutic misconception in early phase gene transfer trials

Cited by 107 publications

References 23 publications

The therapeutic misconception and our models of competency and informed consent

The therapeutic misconception and our models of competency and informed consent

Motivators for participation in a whole-genome sequencing study: implications for translational genomics research

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

Contact Info

Product

Resources

About