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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v18.i1.490
51 pages

Abstract of "Good Rum, Good Captain, Good Ship−How the Consent for Biomedical Devices and Implants can be Transformed from an Event to a Process by the Surgeon Scientist"

Luke P. Brewster
Loyola University Medical Center, Maywood, IL 60153; Edward J. Hines Jr. VA Hospital, Hines, IL 60141
Howard P. Greisler
Loyola University Medical Center, Maywood, IL 60153; Edward J. Hines Jr. VA Hospital, Hines, IL 60141

ABSTRACT

As physicians, surgeons place patient care above many other professional and social obligations; however, as scientists we often utilize novel patient-care therapeutics to answer important clinical questions that may not benefit current patients, but hold promise for future patients. Prior to enrollment in clinical trials, the standard consent is an event where the risks and potential benefits are discussed and the involved persons sign a document signifying this discussion and an agreement to participate. Many physicians now have accepted that this event model works for temporary illnesses (e.g., appendicitis) but that it is not applicable to more chronic or complicated medical problems. In years past, the recruitment of seafarers for the dangers and potential rewards of a transatlantic voyage shares some similarities with that of patients for new biomedical devices or implants (e.g., the Jarvik heart). Since the fiduciary relationship of a treating physician can be threatened during concomitant involvement in research of biomedical devices and implants, the consent is a vital component of promoting self-determination. Remote or sporadic patient encounters may further disrupt the intrinsically disproportionate nature of the physician-patient relationship in an adverse manner. Since the implantation of biomedical devices and/or implants is not a single event but rather a long-term process more similar to a transatlantic adventure than that of an evening cruise, we propose that reorienting the consent for biomedical devices and/or implants from an event to a process model with its superior ability to recognize an ongoing relationship may be an effective way of promoting the fiduciary relationship of surgeon scientists with their patients involved in clinical trials.