Informed Consent for Neurosurgical Innovation [BOOK CHAPTER]

Informed Consent for Neurosurgical Innovation [BOOK CHAPTER]
Faith C. Robertson, Tiit Mathiesen, Marike L. D. Broekman
Ethics of Innovation in Neurosurgery, 22 February 2019; pp 11-25
While innovation in neurosurgery introduces novel medical devices, lifesaving therapies, and critical advancements in procedural care, it also presents ethical challenges regarding informed consent, particularly as innovative treatment options may provide better patient outcomes, but unprecedented surgical interventions may include unknown risk. The process of informed consent relies on appropriate provision of information to a competent patient in efforts to permit patient autonomy over healthcare decision-making without coercion. Importantly, informed consent is not isolated to a single conversation and document signing but is rather an ongoing process of communication throughout the trajectory of the patient’s care. However, neurosurgical patients are one of the most vulnerable populations, as those eligible for experimental procedures often have illnesses refractory to standard therapies, and alternative treatments may be limited. Furthermore, for disease processes affecting information processing or the ability to participate in high-level cognitive decision-making, an individual’s capacity to partake in informed consent may be hindered. At present, there is limited guidance for how neurosurgeons should approach the informed consent process for novel treatments, and there is controversy over the extent to which a surgeon should discuss the innovative nature of the procedure, the evidence or lack thereof, the associated or unknown risks and benefits, the operating surgeon’s learning curve with respect to experience with the procedure, and the alternative treatment options. This chapter summarizes the importance and difficulties of informed consent within neurosurgery, including patient capacity, content and format of discussion, and coercion—all key factors in the attainment of proper consent and the clinical decision process. We underscore the inherent complexity in balancing scientific evidence, clinical expertise, and patient and family preference when pursuing innovative neurosurgical treatments, in efforts to bring about discussion on improvements we can make within the field. Ultimately, this moral discourse is invaluable in creating a situation where investigators assume a responsibility of ensuring respect for persons, beneficence, and justice as we work to propel the field of neurosurgery forward.

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