Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences

Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost

“…In this study, 44 stakeholders were interviewed about their perspectives on post-trial continued access to implantable neural devices. Our results corroborate several important themes from Sankary et al, 2021's previous study of patient-participant perspectives [7]. These include the potential for patientparticipants to be focused on short-term considerations such as symptom relief rather than post-trial access, lack of patientparticipant understanding of (potentially unclear) post-trial options, concern about who will be responsible for post-trial costs and related financial uncertainties, and the implications of all of this for informed consent to neural device trials.…”

“…A critical ethical and practical challenge in neurotechnology development is whether, and if so, how, to ensure that participants who benefit from implantable experimental devices have continued access when clinical trials end [ 1 – 7 ]. The term “continued access” in the implantable neural device context refers to the opportunity to keep the device and maintain the therapy if it is beneficial.…”

“…The term “continued access” in the implantable neural device context refers to the opportunity to keep the device and maintain the therapy if it is beneficial. There have been several known instances of loss of access or difficulty maintaining devices, such as patients implanted with Neurovista’s seizure advisory system [ 8 ], patients who received deep brain stimulation (DBS) as part of the trials of DBS for depression [ 7 , 9 ], and most recently, patients losing access to maintenance and upgrades for Second Sight’s artificial vision devices [ 10 ]. These events highlight an urgent need to address this challenge.…”

Asking questions that matter – Question prompt lists as tools for improving the consent process for neurotechnology clinical trials

“…In addition, making an informed decision to participate in a clinical trial with an implantable neural device can be challenging due to the range of other considerations involved, such as surgical risks (Fenoy and Simpson, 2014), or uncertainties about post-trial care (Hendriks et al, 2019). Recently, there is increased academic awareness about the need for better informed consent to get at issues of exit from a research study (Lázaro-Muñoz et al, 2018;Sankary et al, 2021). While details about those issues might already be in current informed consent documents, they might not be well understood or appreciated by potential participants.…”

“…Schönau et al 10.3389/fnhum.2022.983226 The decision to participate in a clinical trial can be challenging. Among other things, potential participants face a variety of challenges, including surgical risks (Fenoy and Simpson, 2014) and uncertainty about post-trial care (Hendriks et al, 2019;Sankary et al, 2021).…”