Responses of potential users to the intracortical visual prosthesis: final themes from the analysis of focus group data

Abstract

Although visual implant prosthesis projects are advancing, little exists in the literature on the factors that would lead an individual to volunteer for such an experimental procedure. Many ethical issues are raised in recruiting and involving individuals in experimental implant procedures, most involving autonomy and informed consent. This report provides perspectives of 30 totally or legally blind older individuals on their expectations about a potential visual implant, their motivations for volunteering, and the processes they would use for decision making. Data were collected in eight focus groups, using semistructured focus group processes. Among the primary reasons a person with seriously impaired vision would volunteer for a new implant procedure are helping others, exploring the unknown, and restoring perception. The decision to participate in an experimental brain implant procedure is complex. Potential recipients have many questions about the device and the procedure, the perceived risks, and the commitment of a research team to the participants once a device has been implanted. Some would involve their family in a decision; others are more comfortable making the decision independent, after consulting others. The themes identified provide a guide for recruiting and ensuring an ethical experience for participants in experimental protocols.

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users

“…[8][9][10][11][12] An assessment that can capture the functional visual abilities of subjects in clinical trials with these novel treatments needs to be developed. 13 This is the ultimate goal of the work reported here.…”

“…The assessments of functional vision that are available (for example, the National Eye Institute Visual Function Questionnaire (NEI‐VFQ‐25) or the Massof Activity Inventory) have only a few items that can be completed by those with ultra‐low vision (locate a source of light), with the majority of test items requiring higher levels of spatial vision (read, recognise faces, identify colours) . An assessment that can capture the functional visual abilities of subjects in clinical trials with these novel treatments needs to be developed . This is the ultimate goal of the work reported here.…”

Neurobionics and the brain–computer interface: current applications and future horizons

“…Clinical application of a commercial BCI will require regulatory approval for an active implantable medical device, rather than approval as a therapy. It is also important for researchers to ask the potential recipients of this new technology how they feel about it and how it is likely to affect their lives if they volunteer to receive it 61 . This can modify the plans of the researchers and the design of the technology.…”

Psychosocial assessment of potential retinal prosthesis trial participants

“…Research conducted by Lane et al identified a number of key personality traits that relate to motivation to participate in a visual prosthesis clinical trial, including altruism, adventurism, and advanced decision‐making skills . While these are undoubtedly useful considerations when screening for potential implant recipients, this current understanding is limited to findings from focus groups and interviews.…”