Navigating the Informed Consent Process When Using Innovative Surgery

Navigating the Informed Consent Process When Using Innovative Surgery
Research Article
Daniel Wehrmann, Glenn E. Green, MD, Kevin J. Weatherwax, Andrew G. Shuman
Otolaryngology–Head and Neck Surgery, 24 December 2019
… Expanded access (EA), also referred to as “compassionate use,” is a Food and Drug Administration (FDA) mechanism by which patients with serious or life-threatening conditions for which there is no approved treatment may access novel investigational drugs, biologics, or medical devices. The benefits of the proposed drug/device must outweigh the risks to that patient or group of patients… Obtaining informed consent in this setting is complicated due to the conflation of clinical care and research, with each directed at different primary goals. Traditionally, clinicians are expected to solely focus on the best possible outcome for the patients they are treating. Researchers, on the other hand, are primarily focused on creating generalizable knowledge to help all patients. Of course, these goals may be more or less divergent, especially when surgeon-scientists are acting in both capacities… Surgical innovation using the EA program represents a thoughtful balance between patient/family choices, our duty to potential future patients, and the regulatory landscape in which we practice. The informed consent process represents an amalgam of standard clinical components, as well as clinical research regulations that necessarily meet a higher standard and level of scrutiny. As such, our obligations as researchers, clinicians, and our dual roles as both, highlight the need for us to uphold the highest levels of morality, ethics, and professionalism.

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