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.

Keywords:

• Informed consent
• neuroethics
• neurosurgery
• research

This article is referred to by:

The Need for Guidance around Recruitment and Consent Practices in Intracranial Electrophysiology Research

Dynamic Consent in Neuroscience Too?

Avoiding Therapeutic Misconception and Reassessing the Concept of Vulnerability

The Value of Heterogeneity in Practices to Promote Ethical Research

Informed Consent and Voluntariness: Balancing Ethical Demands During Trial Recruitment

Treatment Search Fatigue and Informed Consent

Getting into Their Heads: When the Investigator is also the Treating Physician

The Value of Patient Perspectives in an Ethical Analysis of Recruitment and Consent for Intracranial Electrophysiology Research

ACKNOWLEDGEMENTS

We wish to thank our respondents for generously giving their time to participate in our interviews. Earlier versions of this work were presented at the 2018 Annual Meeting of the International Neuroethics Society and at the 2019 BRAIN Investigators’ Meeting.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by the National Institutes of Health, National Institute on Mental Health [grant number R01MH114860] and National Institute on Neurological Disorders and Stroke [grant number R01NS090913].