BACKGROUND: The therapeutic misconception occurs when a research subject fails to appreciate the distinction between the imperatives of clinical research and of ordinary treatment, and therefore inaccurately attributes therapeutic intent to research procedures. The therapeutic misconception is a serious problem for informed consent in clinical research.

OBJECTIVES: This paper analyzes the nature and origins of the therapeutic misconception and suggests some ways in which researchers can overcome this problem when obtaining a subject's consent to participation in research.

RESEARCH DESIGN: A conceptual analysis of informed consent to research and a review of the empirical literature are undertaken.

RESULTS: Research and clinical care involve different standards for how the patient/subject is to be treated. The confusion of the two often leads to profound misunderstandings on the part of the patient/subject.

DISCUSSION: A method for describing to patients/subjects the differences between research and treatment is proposed as a potential solution to the therapeutic misconception. Research is needed to determine whether this or any other change in the nature of the disclosure is effective in reducing the therapeutic misconception.