Intracranial electrical recordings and neuro-stimulation of neurosurgical patients have made fundamental contributions to our understanding of vision, speech, decision making, memory, and sensorimotor processing. The use of these methods has burgeoned over the last decade due to technological advances and an increase in the number of patients undergoing neurosurgery for different neurological disorders. Intracranial electrophysiological research is performed only in patients who are scheduled to undergo neurosurgery, but the combination of treatment with research raises neuroethical issues around informed consent and risk assessment.
The Neuroethics Division of the NIH BRAIN Initiative Multi-Council Working Group (MCWG) serves as a resource of expertise to help navigate ethical considerations associated with cutting-edge science supported under the NIH BRAIN Initiative, such as intracranial electrophysiological research. Dr. Winston Chiong, an assistant Professor in the UCSF Department of Neurology Memory and Aging Center and member of the Neuroethics Division, recently published a paper in Neurosurgery with colleagues Drs. Matthew Leonard and Edward Chang. The group identified ethical dilemmas involved in intracranial electrophysiology research and proposed ethical standards for resolving potential issues.
For instance, patients may be unable to distinguish between clinical treatment and research participation, believing that their treatment is conditional on their participation and therefore making it difficult for them to know when they can refuse participation. Furthermore, the ability of these patients to give consent and understand treatment and research may be impaired by the disorder for which they are being treated, or by psychiatric comorbidities. Participants may also struggle to give informed consent in extra-operative procedures (i.e., testing that continues outside the operating room), as they experience changes in their physical or emotional state or in their medications.
Another ethical theme identified in the paper concerns the dual role of the physician as both clinician and investigator. This dual role may confuse patients about not only the distinction between research and treatment, but also the motivation behind a physician’s recommendations. The authors emphasize the value of strong communication between clinical and research teams and critically, among these teams, patients, and patients’ families. Furthermore, the authors point to the importance of determining how the costs of research will be distinguished from the costs of treatment.
The authors propose modifications to informed consent procedures, including that institutional review boards determine who should obtain consent on a case-by-case basis, and that appropriate methods ensure patient understanding that care is not conditional on participation. They encourage the creation of improved procedures to ensure patients understand the difference between treatment and research and can therefore give informed consent. They state that subject selection should be based on clinical determinations, not research ones. If there is any debate about the proper course of treatment for a subject, they suggest the inclusion of clinicians who are not involved in the research in order to come to a decision. Finally, they encourage the inclusion of bioethics specialists on research teams, to ensure maximized benefits and minimized risks for patients.
As invasive neurosurgical procedures and research become more prevalent, the authors emphasize the importance of adequately addressing these themes, to ensure that we continue making strides in understanding how the brain works while also protecting patients and research participants. Indeed, the NIH BRAIN Initiative emphasizes addressing neuroethical issues associated with neurotechnological advances. On October 26th, the NIH Clinical Center Department of Bioethics in association with the Neuroethics Division of the MCWG of the NIH BRAIN Initiative will host a one-day workshop entitled Ethical Issues in Research with Invasive and Non-Invasive Neural Devices in Humans (details, including a videocast link, will be made available here). These and other efforts can help scientists navigate the novel ethical concerns often raised by breakthrough neuroscience research.