Leveraging firsthand experience, BRAIN-funded investigators conducting intracranial human neuroscience research propose two fundamental ethical commitments: (1) maintaining the integrity of clinical care and (2) ensuring voluntariness. Principles, practices, and uncertainties related to these commitments are offered for future investigation.
This excellent open access paper published in January 2022 reflects on how to design and conduct neurosurgical research respectfully and well. Ethical matters such as consent and the separation between research and clinical care can be especially acute in such research. This paper provides a great starting point for researchers and research ethics reviewers.
Several neurosurgical interventions require intracranial electrodes for either diagnostic or therapeutic purposes, providing unique opportunities to conduct basic intracranial human neuroscience research (henceforth referred to as intracranial research). This research has significantly advanced our understanding of human brain function across multiple domains, including language, sensorimotor function, memory, and emotional and affective processing (Collinger et al., 2014; Kirkby et al., 2018; Mosher et al., 2021). Notably, intracranial research is not intended to provide near-term therapeutic benefit to participants or other patients. While invasive human research is not unique to neurosurgery, the lack of therapeutic benefit, the vulnerability of patient populations with neurological or psychiatric diagnoses, the rarity of access to intracranial data, and the common occurrence of clinician-investigators necessitate ethical scrutiny. However, to date, non-therapeutic intracranial research has garnered little ethical discussion (Chiong et al., 2018; Hendriks et al., 2019; Mergenthaler et al., 2021).
Two recent publications are of immediate relevance (Hendriks et al., 2019, Chiong et al., 2018). Hendriks et al. discuss ethical frameworks for neural device research aimed at developing novel clinical/therapeutic applications, which is distinct from the current focus. Chiong et al. address ethical considerations for intracranial electrophysiology research but acknowledge the need for broader input to capture variability across institutions. Using Chiong et al., 2018 as an initial point of discussion, investigators from the Research Opportunities in Humans (ROH) Consortium, a group of more than 30 investigators funded by the NIH BRAIN Initiative to conduct intracranial research, developed explicit ethical commitments and areas of consensus related to intracranial research. We discuss these commitments, the principles they give rise to, and the associated practices used across settings, noting areas of uncertainty for future study. The goal for these contributions is to offer a framework for critically evaluating and refining future practices in intracranial research.
Feinsinger, A., Pouratian, N., Ebadi, H., Adolphs, R., Andersen, R., Beauchamp, M.S., Chang, E.F., Crone, N.E., Collinger, J.L., Fried, I., Mamelak, A., Richardson, M., Rutishauser, U., Sheth, S.A., Suthana, N., Tandon, N. & Yoshor, D. (2022) NIH Research Opportunities in Humans Consortium. Ethical commitments, principles, and practices guiding intracranial neuroscientific research in humans. Neuron. 19;110(2):188-194. doi: 10.1016/j.neuron.2021.11.011. PMID: 35051364.
Publisher (Open Access): https://www.cell.com/neuron/fulltext/S0896-6273(21)00949-1?_returnURL=https://linkinghub.elsevier.com/retrieve/pii/S0896627321009491?showall=true#secsectitle0085