What People Should Know When Enrolling In Clinical Trials

Main Category: Clinical Trials / Drug Trials
Article Date: 18 Apr 2008 - 3:00 PST

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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.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson's disease, the first indication of bone marrow's critical role in tumor growth, and, most recently, the world's first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar.

NewYork-Presbyterian Hospital
Weill Cornell Medical Center