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

Abstract

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

Patient, Caregiver, and Decliner Perspectives on Whether to Enroll in Adaptive Deep Brain Stimulation Research

“…It is important to highlight-as some participants articulated-that if participant enrolls in the trial and gets aDBS, there still an option to turn off the adaptive component and treat them with conventional DBS. Mergenthaler et al (2021) have referred to "opportunity studies" vs. "experimental trials." In the former, there is likely to be only "a marginal increase in risk over the risk associated with the clinical intervention itself, " while in the case of experimental trials, investigators test devices as "stand-alone procedures" and subjects are "unlikely to receive neurosurgery if not for enrollment in research."…”

A comparative review on neuroethical issues in neuroscientific and neuroethical journals

“…On the NE side, for instance, Dunn et al (2011) discuss various consent-related ethical issues involved in deep brain stimulation (DBS) research applied to psychiatry, mainly focusing on the validity of consent by persons with mental illness. Mergenthaler et al (2021) illustrate various perspectives of neuroscience researchers on how to recruit participants and obtain their consent. On the NS side, Feinsinger et al (2022) suggest various ways to ensure the voluntariness of participation in neuroscientific research.…”

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

“…What role, if any, can a prospective participant's treating physician play in the consent process when that physician leads or collaborates in said research? [2][3][4][5][6][7][8] Previously, we have used the term dual-role consent to describe the practice of physician-investigators seeking consent for research participation from individuals with whom they have preexisting treatment relationships. 2 Classic statements of research ethics advise against dual-role consent, based on the view that distinct normative commitments govern physician-patient and investigator-participant relationships.…”