Two Practices to Improve Informed Consent for Intraoperative Brain Research.

Abstract

As the clinical applications of neurologically implanted devices increase, so do opportunities for intracranial investigations in human patients. In some of these studies, patients participate in research during their awake brain surgery, performing additional tasks without the prospect of personal therapeutic benefit. These intraoperative studies raise persistent ethical challenges because they are conducted during a clinical intervention, in a clinical space, and often by the treating clinician. Whether intraoperative research necessitates innovative informed consent methods has become a pressing conversation. Familiar worries about inadequate participant understanding and undue influence dominate these discussions, as do calls for increasing information retention (e.g., using methods such as "teach-back") and minimizing enrollment pressures (e.g., preventing surgeons from consenting their own patients). However, efforts have yet to inspire widespread consent practices that mirror the scope of ethical concern. Focusing on awake, intraoperative intracranial research, we identify 2 underappreciated problems in approaches to informed consent. The first is epistemic: Many practices do not fully consider when and under which conditions participants are adequately informed. The second is relational: Many practices do not fully consider the effects of trust between patient-participants and surgeon-researchers. In exploring these concerns, we also raise questions about whether additional steps beyond preoperative consent may improve the process because decisions at this time are decoupled from both the experiences and vulnerability of awake brain surgery. Motivated by these considerations, we propose 2 practices: first, requiring a third-party patient advocate in initial consent and second, requiring verbal intraoperative reconsent before initiating research.