Implantable neurotechnology devices such as Brain Computer Interfaces and Deep Brain Stimulators are an increasing part of treating or exploring potential treatments for neurological and psychiatric disorders. While only a few devices are approved, many promising prospects for future devices are under investigation. The decision to participate in a clinical trial can be challenging, given a variety of risks to be taken into consideration. During the consent process, prospective participants might lack the language to consider those risks, feel unprepared, or (...) simply not know what questions to ask. One tool to help empower participants to play a more active role during the consent process is a Question Prompt List. QPLs are communication tools that can prompt participants and patients to articulate potential concerns. They offer a structured list of disease, treatment, or research intervention-specific questions that research participants can use as support for question asking. While QPLs have been studied as tools for improving the consent process during cancer treatment, in this paper, we suggest they would be helpful in neurotechnology research, and offer an example of a QPL as a template for an informed consent tool in neurotechnology device trials. (shrink)

The number of clinical trials for experimental brain implants continues to grow, and with this growth comes an increased reliance upon patients with treatment-refractory conditions to volunteer as...

There is a growing recognition that the ongoing use of investigational neural implants requires continued access to clinical expertise and specialized healthcare (e.g., Hendriks et al., 2019). Howe...

The work of Sankary et al. (2022) provides valuable insights into the experiences of participants exiting brain device research. Empirical bioethics research such as this is critical to understandi...

In their article, Sankary et al. (2022) provided important preliminary findings on how research participants exiting from clinical trials engage in decisions related to the removal or post-trial us...

Family members can provide crucial support to individuals participating in clinical trials. In research on the “newest frontier” of Deep Brain Stimulation (DBS)—the use of DBS for psychiatric conditions—family member support is frequently listed as a criterion for trial enrollment. Despite the significance of family members, qualitative ethics research on DBS for psychiatric conditions has focused almost exclusively on the perspectives and experiences of DBS recipients. This qualitative study is one of the first to include both DBS recipients and their (...) family members as interview participants. Using dyadic thematic analysis—an approach that takes both the individuals and the relationship as units of analyses—this study analyzes the complex ways in which family relationships can affect DBS trial participation, and how DBS trial participation in turn influences family relationships. Based on these findings, we propose ways to improve study designs to better take family relationships into account, and better support family members in taking on the complex, essential roles that they play in DBS trials for psychiatric conditions. (shrink)

In their article, Sankary et al. (2022) interviewed participants who underwent implantation (n = 16) and subsequent explantation (n = 9) of brain stimulation devices associated with their recent (n...