What People Should Know When Enrolling In Clinical Trials

An article published in the March 2008 issue of the Journal of Medical Ethics explores often-neglected aspects of the "therapeutic misconception," an ethical problem present in many clinical research studies. This misunderstanding arises when research subjects believe they will be receiving optimal medical care as opposed to being participants in an experimental trial whose main goal is the benefit of future patients. Such misconception can lead subjects to underestimate risks and overestimate benefits.

Discussions on the therapeutic misconception usually center on whether it invalidates the consent of subjects. But lead author Dr. Inmaculada de Melo-Martín of the Department of Public Health at Weill Cornell Medical College and co-author Dr. Anita Ho of the Department of Philosophy at the University of British Columbia argue that focusing only on how the therapeutic misconception affects informed consent doesn't capture the ethical complexity of the problem.

Equally significant are negative consequences to subjects, researchers and others resulting from misplaced trust, especially if this trust is exploited in order to recruit and retain subjects. The manipulation of subjects' misplaced trust, whether intentional or not, can undermine the trustworthiness of the research enterprise. It is therefore crucial for investigators and institutions to make efforts and employ strategies that are likely to dispel the therapeutic misconception and not to enroll those who still suffer from the misconception.