The therapeutic misconception, beneficence, and respect

Abstract

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of "informational manipulation" that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers' and their sponsors' financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.

Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period

“…17 Therapeutic misconception is an obstacle faced by almost all clinical research and requires that the investigators and institutional review boards account for this common misconception. 18 Modifications to the consent process must ensure that patients understand risk and fully comprehend the nature of the research. In the situation where parents are faced with the potential death of a child, they are more likely to grasp at extraordinary measures and/or research to try to save their infant.…”

Why do parents enrol their children in research: a narrative synthesis

“…The apparent lack of choice and reduced concern for the risks of research by parents with seriously ill children could also be interpreted as therapeutic misconception; parents may have misconstrued research participation as offering therapeutic benefit 39. However as therapeutic research may only be conducted where there is equipoise,40 and controlled trials of therapy must offer standard treatment as the control against which new therapies are tested,41 research participation did offer access to treatment, although this was also available outside the research context.…”

Beyond informed consent: the therapeutic misconception and trust

“…Although some disagreement exists about what exactly the therapeutic misconception is,4 5 it has been often understood as the conflation by research subjects between the goals of research and those of medical care 6 – 9. Clinical medicine’s aim is to provide the best medical care for individual patients.…”

“…The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those of receiving ordinary treatment may seriously undermine the informed consent of research subjects 8 9. If subjects incorrectly attribute a primarily therapeutic intent to research procedures, they are likely to underestimate risks or overestimate benefits 12.…”