Who should obtain consent for human intracranial electrophysiology studies?
During today’s seminar, Cailin Lechner presented on a collaborative project investigating consent in human intracranial electrophysiology studies. Regulations and policies attempt to provide recommendations on how to consent, yet often lack guidelines on which members of the study team could best obtain consent. This can be further complicated in studies involving human intracranial electrophysiology research as these require patients, undergoing neurosurgery for serious neurological disease, to consent to technically complex interventions for primarily investigative, non-therapeutic purposes. Providing appropriate context for such decisions may require a team member with a high degree of expertise, typically a clinician involved in the study, to obtain consent. Papers by Morain et al. and Da Silva et al. entertain potential pitfalls of such “dual-role” consent, including therapeutic misconception, conflicts of interest, or compromised voluntariness.
Cailin’s project involved interviewing 26 investigators from various human intracranial electrophysiology studies using semi-structured
interviews. Most studies included employed a hybrid approach,
where more than one team member was involved in the consenting of potential participants. For example, a surgeon or principal
investigator might be responsible for detailing the complexity of the surgery, while a second team member, usually a research coordinator,
would obtain the patient’s signature. While studies varied regarding specifically which team member would obtain
consent, rationales reflected several themes, including the need to provide expert
knowledge while also preserving voluntariness, logistical needs such as availability around the time of surgery, regulatory guidance, and ethical
instinct (where particular team members were chosen based on what seemed like the right thing to do).
Our following discussion centered primarily on navigating between the values of expertise and knowledge versus voluntariness in the consent process. We wondered if a non-physician team member could provide enough expertise to ensure that the patient was knowledgeable about his or her involvement and maintain the quality of the discussion while still preserving the voluntariness of consent. We then considered if IRB guidelines could help provide better consent processes if boards were more aware of the details of the experiments and what degree of understanding would be required in order to have informed consent. Finally, the group also acknowledged the need for additional inquiries on whether or not patients believed if they were adequately informed or if they liked or would have preferred being consented by certain team members, although we also recognized the influence that research outcomes may have on these types of post-hoc responses.