A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important human neuroscience. They also pose novel ethical concerns, as studies require participation of neurological patients undergoing surgery for conditions such epilepsy and Parkinson’s disease. Research participants this setting may be vulnerable to conflicts interest, therapeutic misconception, other threats valid recruitment consent. We conducted semi-structured interviews with investigators from NIH-funded involving recording stimulation inside skull. elicited perspectives study consent procedures, analyzed transcripts using a modified grounded theory approach. interviewed 26 19 separate intracranial electrophysiology studies, who described two types: opportunity (n = 15) experimental trials 4). Respondents significant heterogeneity even among employing similar techniques. In some clinician-investigators were specifically barred obtaining consent, while required obtain consent; regulatory guidance was inconsistent. various models subject selection, timing continuing temporally extended studies. expressed concerns about participants’ vulnerability communication research-related risks. found lack consensus regarding methods electrophysiology. This likely reflects novelty complexity indicates need further discussion development best practices domain.