Continuing trial responsibilities for implantable neural devices

In a recent paper published in Neuron, a collaborative team of neuroethics experts highlight key ethical considerations surrounding continuing trial responsibilities for implantable neural devices and provide points to consider for researchers and others working in this space.

The BRAIN Neuroethics Working Group (NEWG)—a group of experts in neuroethics and neuroscience that serves to provide the NIH BRAIN Initiative with input relating to neuroethics—has been considering the questions surrounding continuing trial responsibilities for implantable neural devices for some time.

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 a 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, many key questions remain regarding how this may be specified and operationalized in practice.

Earlier work from NEWG resulted in two high-level principles. First, potential needs should be planned for, and participants informed. Second, professional parties involved in trials have a limited, shared responsibility to take reasonable steps to facilitate continued access to devices that benefit participants.

Building on these initial findings, the NEWG brought together relevant stakeholders including former trial participants and caregivers, researchers, regulators, insurers, and bioethicists to address key questions and seek perspectives at the Workshop on Continuing Trial Responsibilities in May 2022.

In a paper recently published in Neuron, authors build on the workshop findings and describe participants’ met and unmet needs after implanted neural device trials, consider which needs ought to be covered, and suggest potential strategies.

The authors discuss the importance of including a plan for a participant’s posttrial needs from the onset of their research project that incorporates specific strategies to support the participant; for example, outlining the expectations of a participant’s posttrial experience as a part of the informed consent process so participants have an understanding of what future expenses and care may look like after a trial has concluded.

There are challenges in identifying what posttrial needs should cover as well as differing opinions across fields. Despite these challenges, the authors suggest that researchers pay special attention to non-maleficence—the concept that patients experience harm if they don’t receive posttrial care—when making their plans and approach a participant’s needs from a patient-centered perspective, which places the participant’s experience at the core of a posttrial plan.  The authors reinforce the concept of including posttrial plans before a trial begins, and also acknowledge that plans may change with emerging information and advancements in neurotechnologies.

To close out their recommendations, the authors provide several potential strategies that were proposed in the workshop and address the themes and challenges related to posttrial responsibilities. To further explore details about posttrial needs, specific points to consider, and suggested potential strategies to improve posttrial care for patients, read the full article in Neuron.


Latest from The BRAIN Blog

The BRAIN Blog covers updates and announcements on BRAIN Initiative research, events, and news. 

Hear from BRAIN Initiative trainees, learn about new scientific advancements, and find out about recent funding opportunities by visiting The BRAIN Blog.

This site is protected by reCAPTCHA and the Google Privacy Policyand Terms of Serviceapply.
black and white image of people working on laptops at a counter height table on stools at the annual BRAIN meeting