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Coined by Appelbaum et al in response to perceived problems in the consent process of psychiatric patients enrolled in clinical research,1 ‘therapeutic misconception’ (TM) appears a simple concept on the surface. Appelbaum identified that “research subjects systematically misinterpret the risk/benefit ratio of participating in research because they fail to understand the underlying scientific methodology” (p. 20).2 Although the ‘informed consent’ of research subjects had been viewed as an essential component of ethical research for a number of years, nonetheless there appeared inadequate disclosure or explanation or understanding of the mechanics of clinical trials; of randomisation, control groups, double blinding and the use of placebos. At the heart of TM lies the mistaken belief that the purpose of a clinical trial is to benefit the individual subject/patient, as opposed to its real function which is the production of scientific knowledge. This generates two particular problems – the validity of consent obtained under conditions of misapprehension, and the false appraisal of the nature or probability of medical benefit or risk from participation in the study by the subject.
Multiple studies have attested to the prevalence of TM. Peculiarly, for …
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