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Almost 35 years ago, my colleagues and I first reported a new phenomenon: the decisions of many freshly enrolled research subjects appeared to be based on confusion between the nature of research and of ordinary treatment.1 We called the phenomenon ‘therapeutic misconception’ (TM), and noted that it was characterised by inaccurate beliefs about the degree of individualisation of treatment and likelihood of benefit associated with enrolment in a clinical trial. Since that original paper, dozens of studies from around the world have confirmed the existence of TM and its substantial prevalence, with rates of some degree of TM approaching or exceeding 50% in many studies.2 The concept of TM has become a given in the world of research ethics.
Commonly accepted concepts, of course, are prime targets for academic revisionism, so it is not a surprise to see an article like that by Kim et al in this issue of JME.3 Indeed, Kim et al have embarked on a series of studies aimed at challenging the idea that TM is a major concern in consent to research. This is not the place to comment on the project as a whole, but the study reported here exemplifies its problems. It is based on the notion that “the apparent prevalence of TM indicates [sic] a form of measurement error”, that …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.
↵i In an ongoing study of TM led by my colleague Chuck Lidz, we found that subjects recruited from a list of people who indicated an interest in participating in research in general (n=36), compared with newly recruited subjects from a clinic population (n=55), had significantly higher scores (ie, indicating less TM) on the scale used to measure TM (mean scores 38.1 vs 30.4; analysis of variance F=8.491, df=1, p=0.005).5