On May 24 and 25, 2022, a BRAIN Neuroethics Working Group (NEWG) workshop will seek perspectives around research-related care needs for participants of implanted neural device trials after a trial ends.
An upcoming virtual workshop, scheduled for Tuesday, May 24 and Wednesday, May 25, beginning at 12:00 PM ET on both days, will explore Continuing Trial Responsibilities.
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 BRAIN Neuroethics Working Group (NEWG) is a group of experts in neuroethics and neuroscience that serves to provide the NIH BRAIN Initiative with input relating to neuroethics. The aim of this workshop is to bring relevant stakeholders – including patient and caregiver perspectives, device companies, regulators, insurers, investigators, and ethicists – together to address key remaining questions and seek perspectives on the following:
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What needs may study participants have in relation to their trial participation after a trial ends?
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What do different stakeholders currently provide, and what can/could they provide or facilitate in terms of research-related care needs?
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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?
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What are the gaps between what is currently facilitated and what is sufficient/appropriate? How can we best fill those gaps?
Workshop Details
More information, including the workshop agenda, can be found here. Registering for the event here will enable you to attend the workshop as a Zoom webinar attendee and will ensure that you receive updates about the materials emerging from the workshop.
You can also watch the livestream at the links below:
May 24, 2022 (12:00 p.m. – 5:00 p.m. ET): https://videocast.nih.gov/watch=45079
May 25, 2022 (12:00 p.m. – 5:00 p.m. ET): https://videocast.nih.gov/watch=45081
For workshop content-related questions, please contact Nina Hsu, Ph.D. (nina.hsu@nih.gov).
For technical assistance, please contact Gregory Richards gregory.richards@roseliassociates.com.