Participants of implanted neural device trials may have research-related care needs after the trial has ended. For example, these needs could include continued access to the device, device maintenance and support, explantation, and/or medical care resulting from participating in the research study. Discussions in the field suggest that investigators, grantee institutions, device manufacturers, funders and others involved in the trial have shared responsibilities to facilitate some of these needs. However, it is still unclear how this may be specified and operationalized in practice.
The aim of this workshop is to bring relevant stakeholders together to address key remaining questions and seek perspectives on the following:
- What needs may study participants have in relation to their trial participation, after a trial ends?
- What do different stakeholders currently provide, and what can/could they provide or facilitate in terms of research-related care needs?
- What should be the minimum research-related care that should be facilitated in implanted neural device trials? When would stakeholders have responsibilities to provide or facilitate more than the previously defined minimum?
- What are the gaps between what is currently facilitated and what is sufficient/appropriate? How can we best fill those gaps?