Clinical Translation, Trials & Regulation

Therapeutic Misconception

The well-documented tendency of research participants to believe that a study's primary purpose is their personal medical benefit, and that the device or procedure has been individually optimized for their care, when in fact the study's aim is to generate generalizable knowledge under an investigational protocol. In BCI trials this risk is acute: participants with severe disability and few options may enroll hoping for restored function, and dramatic demonstrations can reinforce the belief that they are receiving a proven treatment rather than joining an experiment.

Managing therapeutic misconception is central to valid informed consent for BCI research. Disclosures must make the investigational status explicit and convey the realistic — often modest, possibly nil — prospect of personal benefit, the burdens involved, and the uncertainty about how long any benefit or the device itself will last. It is tightly linked to post-trial questions, because a participant who overestimated the benefit is especially harmed when the study ends and support is withdrawn.

Distinct from the impaired-capacity consent issues addressed in neuroethics: even a fully competent participant can systematically misunderstand a study's research aims.

Also called
治療性誤解research-benefit misconception