From concepts to tools: improving participant engagement in brain computer interface early feasibility studies

About This Grant

Project Summary/Abstract Despite growing recognition of the value of participant engagement in other areas, the field of implanted brain- computer interface research has only recently, and vaguely, explored its significance. When engagement is discussed, it is often with disparate meanings and little emphasis on practical measures to engage participants who are currently enrolled in clinical trials. This lack of collective practical guidance is especially consequential for brain-computer interface early feasibility studies (BCI EFS), where implanted BCIs are being developed for people with significant motor or communication disabilities, for whom existing assistive technologies are insufficient. These studies are only carried out with small numbers of participants with significant disabilities, requiring brain surgery and years of intensive involvement, with no promise of direct clinical benefit. The experiences, knowledge, and values of individuals participating in these high cost, high burden clinical trials are immensely important, and the ability to work together with them to co-create BCI technology will ultimately determine whether BCIs provide enough people with enough benefits to be sustainable. While ethicists, researchers, and participants have begun to recognize this need, there has been no systematic and interdisciplinary investigation into what participant engagement ought to encompass in BCI EFS and how to do it. Given the rise of industry partners seeking to bring this neurotechnology to market, now is the critical time to advance guidance on engagement to maximize the benefits of this technology for future and current participants. This grant will collaboratively develop both a framework for designing participant engagement practices in BCI EFS as well as an online tool for assisting research teams in implementing this framework in their own BCI EFS. It will achieve this goal through three aims, each guided by the principles of Human Centered Design: (1) analyzing the state of participant engagement practices in BCI research through qualitative interviews with four groups of stakeholders; (2) co-creating a framework that can guide the design of participant engagement practices for BCI EFS; and (3) piloting this framework and online interface for implementing it in real BCI studies. Through the diverse study team of ethicists, BCI researchers, and tool developers, this grant will produce (i) a new framework and online tool for how to engage participants in BCI EFS that is usable and refinable by the BCI community, and (ii) new research on how to differently disseminate ethics frameworks, the impact of which extends far beyond this grant.