Bionic and robotic prostheses: identifying bioethical concerns from key groups to improve development and clinical translation approaches - ABSTRACT Rates of amputation are expected to double by 2050, and prosthesis use is expected to increase accordingly. As prosthetic technology continues to advance, bioethical concerns surrounding the development and clinical translation of bionic and robotic prostheses persist. Specific concerns include a lack of incorporating user needs and feedback, insurance reimbursements, equitable research participation and device access, as well as the increased use of data monitoring. These bioethical concerns are relevant for prostheses with and without robotic technology. However, these concerns may be magnified in bionic and robotic prostheses due to the addition of higher costs associated with advanced technology, as well as additional concerns specific to advances in technology. Substantial funding, particularly from the National Institutes of Health, has been allocated to develop bionic and robotic prostheses and translate devices into clinical practice. However, bioethical considerations and barriers to development and translation remain undiscussed, contributing to a widening gap between research and clinical practice. No studies have reported bioethical issues related to bionic or robotic prostheses from the perspectives of people with limb loss and difference, clinicians, or policy makers. Perspectives from these groups are critical to help establish policy guidelines, reduce wasted research costs, and ensure these devices can actually improve patient quality of life. Therefore, our objective is to disseminate bioethical concerns among people with limb loss and limb difference (both upper-limb and lower-limb), clinicians, and policy makers to improve approaches in the development and translation of bionic and robotic prostheses. We will recruit these key groups across the US to: 1) determine bioethical concerns from their perspectives, and 2) include these concerns in a brief, decisional support document to help researchers, manufacturers, and funders improve their approaches to development and clinical translation. In alignment with several priority areas of this RFA, we will explore perceptions on topics such as equitable distribution of device access and follow-up care, research participation, and device use. We will target people from underserved communities (e.g., systematically marginalized groups, rural communities) and those who have been traditionally underrepresented in prosthetics technology research (e.g., older adults, dysvascular etiologies) for recruitment to ensure perspectives from this population are included. Participants will complete semi-structured interviews, with interview questions based on the Johns Hopkins conceptual framework for ethics in a learning healthcare system. Descriptive statistics and systematic thematic analysis will be used to help identify key groups’ high priority and prevalent bioethical concerns, which will be summarized in our decisional support document to highlight considerations for researchers, manufacturers, and funders. Findings will be crucial to help inform research and policy decisions, which may positively affect the quality of life for people who can benefit from bionic and robotic prostheses.
