What Ethical Issues Need to Be Considered When Doing Research with Patients Undergoing Invasive Electrode Implantation?

Directly recording and modulating human brain activity through invasive techniques takes advantage of unique neurosurgical opportunities provided by patients who have a clinical need for invasive electrode placement. These patients, including those who undergo deep brain stimulator (DBS) implantation or have wires implanted in the epilepsy monitoring unit (EMU), may consent to research to be conducted during these interventions. This research may involve extra recordings, additional behavioral tasks, temporary electrode placement, and modification of implantable wires for the purposes of gaining generalizable knowledge about the brain. The unique context of this research, including the overlap of clinical care and research and the populations of patients eligible to participate, generates a multitude of ethical issues. This chapter provides an overview of these issues and the special contextual features of iEEG research that engender them. Areas of focus will include risk/benefit assessments, informed consent, the dual-role of the physician-researcher, fair access, neurodiversity, and identity. Attention will be centered on non-therapeutic and basic science research conducted in the intraoperative setting with DBS patients and the extra-operative setting with EMU patients. This chapter is meant to inspire deliberation about research design, recruitment, and consent, and foster an appreciation for the unique ethical challenges in invasive iEEG research with neurosurgical patients.