Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Ethics and Decision-Making in Translational Neurological Device Research

Award Number: R01MH137102
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/05/2026
PERIOD OF PERFORMANCE END DATE: 12/31/2029

Group Awards By:

View Award Description

Ethics and Decision-Making in Translational Neurological Device Research - PROJECT SUMMARY 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $445,816 )
2026	2026	BAYLOR COLLEGE OF MEDICINE	1 BAYLOR PLZ	HOUSTON	TX	77030	HARRIS	USA	Mental Health Research Grants	000	1	3/5/2026	NEW	$445,816
														Subtotal = $445,816

Grand Total All Awards = $445,816

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Ethics and Decision-Making in Translational Neurological Device Research

Award Number: R01MH137102

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/05/2026

PERIOD OF PERFORMANCE END DATE: 12/31/2029

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer