Ethical considerations and approaches for conducting clinical research studies related to prosthetics, orthotics and wheelchair technology in the low- and middle-income countries

Rapid developments in prosthetics, orthotics and wheelchair technology have increased clinical research and development initiatives worldwide. Testing technology involving human subjects / participants creates ethical concerns that are under-explored and become a critical issue for prosthetists, orthotists, researchers and their clients, especially those in the low- and middle-income countries. While some research initiatives have aligned with existing institutions, companies, and service providers; some research emerging from institutions / organisations with non-clinical and non-assistive technology backgrounds have raised considerable foundation for concerns. It is essential to develop, apply and promote appropriate and clear guiding principles for institutions / organisations conducting clinical research studies or trials, particularly in the low- and middle-income countries. Thus, practicing professionals can enable people with disabilities (often among the most excluded and vulnerable group in the society) to provide informed consent, make informed choices, and facilitate their active engagement in clinical research studies or trials without physical, psychological, and socioeconomic harm. The outcome of the consultation between ISPO and Exceed Research Network (ERN) has led to the development of the guiding principles, laid out below, specifically directed towards the clinical research studies or technology trials involving people with disability (not on broader research into disability-related issues).