Post-trial obligations in neurotechnology

NIH RePORTER · NIH · RF1 · $155,458 · view on reporter.nih.gov ↗

Abstract

Project Summary The proposed supplement will study how stakeholders of implanted neural devices approach the issue of post-trial obligations towards participants and use this data to inform an expert consensus document to guide the field. At present, there is no clear ethical, legal, or policy guidance regarding what researchers should provide participants after a study ends. Participants face uncertainty about continued maintenance of their device or how to pay for removal if the system is not effective. Using discourse analysis, we will examine the issue of post-trial obligations in policy documents, academic literature, and interview data from diverse stakeholders of neural interface research – end-users, researchers, industry representatives, funders, and regulators. These interviews will attempt to understand what stakeholders feel is owed to research participants after a trial concludes, the challenges in providing such care, and the impact on the research enterprise for making such commitments. The empirical data will then be presented at a consensus building meeting that brings together stakeholders to collectively deliberate about post-trial topics. The aim of the workshop is to create consistent guidance for developers and funders of implanted neural devices.

Key facts

NIH application ID
10129798
Project number
3RF1MH117800-01S3
Recipient
UNIVERSITY OF WASHINGTON
Principal Investigator
Sara Goering
Activity code
RF1
Funding institute
NIH
Fiscal year
2020
Award amount
$155,458
Award type
3
Project period
2018-09-22 → 2022-09-20