The Exceed Research Network (ERN) and the International Society for Prosthetics and Orthotics (ISPO) have published an important paper about conducting clinical prosthetics, orthotics and wheelchair research involving human participants.
The number of research projects involving human subjects or participants has grown rapidly and this paper provides clear guidelines about the standards that organisations carrying out this type of research should apply, especially when working with potentially vulnerable groups in lower and middle income countries, like people with disabilities.
Commenting on the paper, Carson Harte, CEO of Exceed Worldwide and an ERN member who played a key role in the initiative said, ‘Researchers must respect the position of clinical research participants - especially vulnerable people - by ensuring that they can provide informed consent, make informed choices and engage in clinical studies or trials without physical, psychological or socio-economic harm.’
The new paper ensures that this will happen by specifying 9 steps that researchers involved in clinical trials should follow. These are based on the 1978 Belmont Report, which outlined 3 principles to protect people participating in research studies:
1. Respect for persons – courtesy, respect and informed consent;
2. Beneficence - “do no harm” while maximising research benefits and minimising risks;
3. Justice - reasonable, non-exploitative, well-considered, fair and equal procedures.
ERN and ISPO believe that the guidelines will be a useful practical tool for researchers and, most importantly, that vulnerable people taking part in clinical research will be involved as partners and equals in a respectful and safe environment. The guidelines will be reviewed regularly to address issues that emerge in an ever-changing research world and the paper can be accessed here:
ERN members who contributed to the position paper came from a range of organisations and disciplines:
Prof Jan Andrysek, Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital; Dr Michael Berthaume, London South Bank University; Dr David Boone, Orthocare Innovations; Dr Sarah Chang, Orthocare Innovations; Prof Nachiappan Chockalingam, Staffordshire University; Dr Alex Dickinson, University of Southampton; Dr Steve Gard, Northwestern University; Mr Carson Harte, Exceed Worldwide; Dr Aoife Healy, Staffordshire University; Prof Laurence Kenny, Salford University; Dr Cheryl Metcalf, University of Southampton, Ms Chantel Ostler, Portsmouth Hospitals University NHS Trust.