Therapeutic misconception

Therapeutic misconception is a common ethical problem encountered in human subjects research. It occurs where a subject or potential subject in a clinical trial assumes the intent of the study is to improve the personal health of the subjects: that the primary intent of the trial is therapeutic. Therapeutic misconception was originally described in a 1982 psychiatric journal article and has received increasing attention from the bioethical community since the turn of the 21st century.

Context

Guidelines for human subject research invariably prescribe full, voluntary informed consent from each subject as a general ideal (with specific guidelines for cases in which informed consent is not feasible).

The purpose of research is to increase understanding and/or generate new knowledge (see also Medical Research).

The purpose of medical care is to maintain and/or improve the patient's health and physical well-being (see also Hippocratic Oath.

When a physician introduces the idea of participating in a clinical trial to a patient, the two individuals each take on a second role: the physician is also a researcher, and the patient is also a potential subject. The dual role can create confusion or tension (particularly but not exclusively in the patient-subject) about the aim or aims the physician-researcher pursues: science and/or clinical care.

Definitions

Therapeutic Misconception

• "This therapeutic misconception manifests itself in two ways. In the absence of information concerning the means by which the project will be carried out ... subjects tend to assume that the methodology will advance their therapeutic interests.... [Or e]ven in the face of comprehensive disclosure ... of such methods as randomization, double blind, and placebo, subjects often appeared not to hear, to distort, or to deny what was revealed to them."
• "To maintain a therapeutic misconception is to deny that there may be major disadvantages to participating in clinical research that stem from the nature of the research process itself."
• "The original formulation ... centered on the failure of subjects to appreciate that research imposes practices on investigators that conflict with conventional ways of practicing medicine. Many who later adopted the term have strayed to a definition along the following lines: 'the mistaken belief held by many research subjects that research projects will directly benefit them.'"
• "...[S]ubjects' failure in one of two ways to recognize how their personal care may be compromised by research procedures: an incorrect belief that a subject's individualized needs will determine the treatment that she will receive; or an unreasonable appraisal of the nature or likelihood of benefit due to misperceptions of the nature of the research enterprise."

Other related terms

Unrealistic optimism

• "[O]ptimism may also be the product of a bias in which a person believes that she is more likely to experience positive outcomes (or less likely to experience negative outcomes) than others similarly situated. When optimism is the product of a bias of this kind, it is typically referred to as the 'optimistic bias' or 'unrealistic optimism.'"

See also

• Clinical trial
• Informed consent
• Belmont Report
• Guidelines for human subject research

"For over three decades, bioethics scholarship and research ethics guidelines have identified concerns about the boundaries between research and standard clinical care. Ethicists have argued that informed consent to participate in research should include clarification of the differences between these two activities. In 1982, Appelbaum and colleagues reported on findings from interviews with patients with psychiatric disorders that documented failure to appreciate the difference between research and treatment, labeling the phenomenon “therapeutic misconception” . Henderson et al., Clinical Trials and Medical Care: Defining the Therapeutic Misconception, (2007) Clinical Trials and Medical Care: Defining the Therapeutic Misconception. PLoS Med 4(11): e324 doi:10.1371/journal.pmed.0040324