Clinical Research Ethics – New Paper Sets Out the Ground Rules

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:

Download paper 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.

Online Teaching and Conference Boost for Exceed, Cambodia

New Conference Facilities PP.jpeg

Online Conference Facilities at Exceed Worldwide’s specialist Prosthetics and Orthotics (P&O) School in Phnom Penh have be upgraded and expanded, with support from the UK’s University of Southampton Engineering and Physical Sciences Research Council.  

Commenting on the development, Sisary Kheng, Exceed’s Cambodian Country Director, said, ‘This development comes at a great time. We are moving a lot of our teaching online, so that our Cambodian and international students can continue to study despite Covid-19 restrictions and the new equipment is making this much easier as the quality of both sound and images is so much better.’ 

The Exceed school, which is the Department of Prosthetics at the National Institute of Social Affairs, is a world leader in Prosthetics and Orthotics education. It has trained P&O professionals from 26 countries and given hundreds of disadvantaged Cambodians the opportunity to study by providing scholarships.

A 'step change' in prosthetics - Improving access to prosthetic limbs in Cambodia

Around 100 million people worldwide need a prosthetic limb to replace an amputated arm or leg, or an orthotic device to support a damaged limb. Yet it’s estimated around 80 per cent of these people don’t have access to these services – and this is a particular issue for low- and middle-income countries.

Southampton researchers are working with clinicians, academics and policymakers in Cambodia to develop digital tools to improve access to prosthetic and orthotic services. The team will also be training clinicians in the use of these digital tools, and undertaking their own research. These results should ensure that funding allocated for prosthetic services is spent more efficiently.

Dr Alex Dickinson, Lecturer in Engineering and Physical Sciences, is leading a multidisciplinary team of engineers and health scientists from Southampton to assess how useful a range of digital technologies could be to prosthetic limb provision in Cambodia.

You can read the rest of this article on University of Southampton’s website here: https://www.southampton.ac.uk/news/2019/01/a-step-change-in-prosthetics.page

University of Southampton is a member of the Exceed Research Network.