Informed consent and therapeutic misconception

Over the years, it's become clear to me that a significant part of the conventional wisdom about research participants ('true informed consent is impossible,' 'research participants misunderstand the purpose and the risks and benefits of research because they are so desperate,' etc) is due to our (the bioethics researcher's) failure to accurately understand the participants' perspective.  For example, in a series of studies, we have shown that when a participant seems to not understand the purpose of research, it is most likely due to their not interpreting as intended the questions we are using to measure their understanding. Kevin Weinfurt has reminded us of this common fallacy among researchers in a recent article. This research draws on considerations of pragmatics.

There is a widespread belief that, since the primary purpose of research is societal or scientific, there is something wrong with participants in clinical trials being motivated by desire for therapeutic benefit.  But this confuses motivation with understanding. (People are motivated by money in buying a lottery ticket but they aren't confused about what it is--a gamble).  In fact, this confusion keeps us from providing the kind of information that would be useful to people who are in fact motivated by desire for benefit.  Several of my studies are designed to probe this issue.  For example, many early phase research informed consent forms use the phrase "it is not guaranteed that you will benefit" as though benefit is so likely that the question really is about whether it is certain or not.  Or when available effective treatments are withheld in order to test a new drug, we seldom tell the subjects all that we should about what they are giving up.

Perhaps the problem with informed consent is not the misconceptions and motivations of research participants; maybe we do not pay enough attention to how the world looks from their point of view?

Kim SYH, De Vries R, Holloway RG, Wilson RM, Parnami S, Kim HM, Frank S, Kieburtz K. Sham Surgery Controls inParkinson Disease Clinical Trials: Views of Participants. Movement Disorders 2012; 27(11): 1461-1465.

 Kim SYH, De Vries R, Wilson RM, Parnami S, Frank S, Kieburtz K, Holloway RG. Research Participants’ ‘Irrational’ Expectations: Common orCommonly Mismeasured? IRB: Ethics & Human Research 2013; 35(1): 1-9.

Kim SYH, Wilson R, DeVries R, Kim HM, Holloway RG, Kieburtz K. Could the High Prevalence of Therapeutic Misconception Partly Be aMeasurement Problem? IRB: Ethics & Human Research 2015;37(4):11-18.

 Kim SYH, DeVries R, Parnami S, Wilson R, Kim HM, Frank S, Holloway RG, Kieburtz K. AreTherapeutic Motivation and Having One’s Own Doctor as Researcher Sources of TherapeuticMisconception?  Journal of Medical Ethics. 2015; 41: 391-397. DOI: 10.1136/medethics-2013-101987.

Kim SYH, Wilson R, De Vries R, Kim HM, Holloway RG, Kieburtz K. “It is not guaranteedthat you will benefit”: True but misleading?  Clinical Trials. doi: 10.1177/1740774515585120.

Chen S, McCullumsmith C, Kim SYHDisclosing the Potential Impact of PlaceboControls in Antidepressant Trials. British Journal of Psychiatry Open.  Jun 2015, 1 (1) 1-5; DOI: 10.1192/bjpo.bp.115.000109

Kim SYH, Wilson R, De Vries R, Ryan KA, Holloway RG, Kieburtz K. Are patients with amyotrophic lateral sclerosis at risk of a therapeutic misconception? Journal of Medical Ethics. March 10, 2016.