TABLE 2.

Proposed Ethical Standards for Consensus Deliberation

1. Patients should be assured that care is not conditional on their participation in research.

2. Consent capacity for research is distinct from consent capacity for clinical interventions.

3. Patients always retain the right to refuse participation in research interventions, including in extraoperative research that may take place over several days in a hospitalization.

4. Repeated postponements or refusals of research protocols may indicate that a broader conversation regarding willingness to participate in research is appropriate, with reminders that patients can always withdraw from research without forgoing continued clinical care.

5. Human intracranial research should only be performed in patients with a clinical indication for invasive electrophysiology.

6. Involvement of clinicians with responsibility for the patient, who are not investigators, may provide further assurance that decisions about clinical applications of invasive electrophysiology are not influenced by scientific considerations.

7. Clinician-investigators have dual roles that must be acknowledged and communicated openly with patients.

8. It may be impractical to exclude treating physicians from obtaining patient consent for research participation; in either case, other safeguards against undue influence are needed, including meaningful assurance that patient care will not be compromised by patient refusals to participate in research.

9. Nonclinician members of the research team who obtain consent require instruction on bedside interactions with patients and on surgical methods and risks, and even when not involved in the consent process may benefit from such training.

10. Standard informed consent procedures may be insufficient to ensure that consent is valid, and innovative methods may be needed.

11. We have proposed a dimensional framework for evaluating potential research applications of intracranial electrophysiology (Figure 4).