Obtaining informed consent from patients for undergoing experimental treatments may be complicated by the “therapeutic misconception.” Patients demonstrate this phenomenon when they fail to recognize the distinction between the competing obligations of clinicians as their primary care givers and clinical investigators [24]. Patients who maintain a therapeutic misconception disregard the disadvantages of participating in clinical research that result from the research process itself [25]. Individuals with epilepsy are particularly susceptible to therapeutic misconception as it has been previously shown that less optimism regarding personal care and hopelessness about future health states increases the probability of manifesting this phenomenon [26].

During the informed consent process, care must be undertaken to avoid therapeutic misconception by clearly outlining the primary purpose of experimental research, which is to produce generalizable knowledge and not to benefit the patients enrolled. The discussion must also clearly outline the differences between the research and clinical care elements of the treatment. In order to mitigate therapeutic misconception, participants should understand the following five dimensions of research: (1) scientific purpose, to benefit future patients; (2) study procedures that are not necessary for patient care; (3) uncertainty, which is greater than standard treatments; (4) adherence to protocol, which is more strict than standard treatments; and (5) clinician as investigators, the dual roles of the treating physician [27].

Surgical innovation in the modern era requires regulation and careful oversight of its clinical applications. The extent to which a surgical innovation requires regulation and careful oversight of its application to patient care is directly related to the extent to which it deviates from established practices [28, 29]. The extent of its deviation should also be explicitly stated in the informed consent discussion. For instance, Illustrative Case 4 describes a scenario in which invasive monitoring is performed, but the resection margins may be modified by innovative mapping strategies (i.e., pathological high-frequency oscillations). The modified resection plan may be identical or more or less aggressive than traditional methods of identifying the epileptogenic zone. Such discrepancies should be explained during informed consent and reasoning behind different resection strategies should be explored.

Elaborating on this example, during the informed consent discussion, the localization modalities used should be compared to standards of care or other consensus guidelines. There is extensive heterogeneity and interinstitutional variability in the extent to which different localization strategies are employed to determine the epileptogenic zone and ultimate resection strategy in patients with epilepsy [30]. While no unanimous agreements exist on standards of care, various guidelines are in place. For example, the Pediatric Epilepsy Surgery Subcommission of the International League Against Epilepsy (ILAE) has proposed guidelines for the evaluation of surgical candidates including interictal and video electroencephalography (VEEG), structural imaging with magnetic resonance imaging (MRI) and/or computed tomography (CT), functional imaging with single-photon emission CT (SPECT) or positron emission tomography (PET), and neuropsychological evaluation [31, 32]. The extent of institutional deviation from accepted guidelines should be explored and justified both during preoperative planning and informed consent.

The conduct of epilepsy surgery is replete with ethical challenges that are unique to the condition. The impact of the disease of patient agency and capacity as well as the uncertain likelihood of seizure freedom has important implications for the informed consent process. Further challenges may be encountered when obtaining informed consent for epilepsy surgery in children and in the setting of surgical innovations. This chapter provided a general approach to informed consent and explored common ethical dilemmas that may be encountered by clinicians. Patients with medically intractable epilepsy represent a unique neurological patient population. Awareness of ethical challenges in informed consent is central to providing patient-centered care.