Ethics and Decision-Making in Translational Neurological Device Research

The NIH and other sponsors are investing heavily in translational research on new neural, brain, and pain relief devices. Many translational studies involve first in human subjects and include the implantation of brain devices in study participants. Translational neurodevice research raises many important ethical issues. One area that has received comparatively little empirical investigation and attention involves the ethics of decision-making about participation in early translational first-in human (FIH) neuro device research. This gap is concerning given that patients who decide whether to participate in FIH neuro device research are vulnerable due to refractory medical conditions, last resort options, trust and power dynamics with their team, and documented decisional biases such as optimism bias and “translational misconception”. At the same time, we must avoid unjustified paternalism—the belief that patients cannot provide true informed consent to participate in such research or that they should not be allowed to do so. What is essential is patient-centered perspectives on the vulnerabilities and value of participating in FIH neuro device research, their decisional and informational needs, accompanied by tools and approaches to improve decision making. The objective of this proposal is to identify and to address pressing ethical issues related to decision making about enrollment and participation in first-in-human translational research. In Aim 1, we will examine clinician- researchers’ and patient-subjects’ views on the value, vulnerabilities, and decisional and informational needs associated with participation in translational first-in human neuro device research. We will collaborate with and draw upon NIH-funded early and FIH translational research that represent growing areas of translational research with broad application and significance to patient populations: closed loop deep brain stimulation for a.) refractory and chronic pain and b.) treatment resistant mood disorders. In each case study will interview 1) patients with experience participating in first in human translational neuro-device research and patients who are potential future research subjects, 2) their family members and caregivers, 3) clinician researchers (e.g., neurosurgeons) who design the research studies, care for these patients, and implant translational neuro- devices, 4) other care team members including nurses, and 5) study coordinators with experience enrolling patients. In Aim 2 of the project, we will translate our findings from Aim 1 into a communication-decision tool for clinician researchers to use with patients considering participation in translational neurodevice research. We will alpha test this tool and disseminate it to key stakeholders. Project Number: 1R01MH137102-01A1 | Fiscal Year: 2026 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Jennifer Blumenthal-Barby (+2 co-PIs) | Institution: BAYLOR COLLEGE OF MEDICINE, HOUSTON, TX | Award Amount: $445,816 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZMH1 ERB-E (03)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11211519