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  • IRB: ETHICS & HUMAN RESEARCH

Could the High Prevalence of Therapeutic Misconception Partly Be a Measurement Problem?

It is often said that research participants fail to understand that the purpose of research is not primarily to benefit them, which is a sign of therapeutic misconception (TM). We tested whether this is due to the linguistic context of the TM assessment (and thus measurable even in nonresearch subjects who are competent English speakers): when responding to a question about the purpose of research, people interpret the question as asking about their own motivation for participation rather than about their understanding of the purpose of research. We used a vignette about a phase I study for amyotrophic lateral sclerosis in a layperson online sample to conduct an experimental survey (n = 100), with a confirmatory follow-up study (n = 135). The results show that among people who understand the “purpose-of-research” question as intended, only 2.5% exhibit TM. Further, among those who exhibit TM, 91.4% did not interpret the purpose-of-research question as intended. When subjects appear to exhibit TM, it is essential that the questions used to assess TM are being interpreted as intended.

Key words: Research ethics, informed consent, therapeutic misconception

Kim SYH, Wilson R, De Vries R, et al. Could the high prevalence of therapeutic misconception partly be a measurement problem? IRB: Ethics & Human Research 2015;37(4):11-18.