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

Ethical considerations and approaches for conducting clinical research studies related to prosthetics, orthotics and wheelchair technology in the low- and middle-income countries
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).
Interational Society for Prosthetics and Orthotics (ISPO)
Andrysek, Jan
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Berthaume, Michael
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Boone, David
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Chang, Sarah
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Chockalingam, Nachiappan
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Dickinson, Alexander
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Gard, Steve
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Harte, Carson
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Healy, Aoife
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Kenney, Laurence
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Metcalf, Cheryl
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Ostler, Chantel Marie
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Andrysek, Jan
77d2ba22-1e3f-448c-ad6b-8e4df2d82e8b
Berthaume, Michael
46923929-e061-4635-a9ab-169f57ea972d
Boone, David
78d57891-04a3-47ae-aeba-4ad1df9c90fd
Chang, Sarah
1c1f7a0f-2646-4d7e-a9d1-148d07a36170
Chockalingam, Nachiappan
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Dickinson, Alexander
10151972-c1b5-4f7d-bc12-6482b5870cad
Gard, Steve
26926e2c-a1e8-4278-a907-fdfc478fcfa8
Harte, Carson
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Healy, Aoife
14455442-1194-403b-ab32-69693e06e43d
Kenney, Laurence
9571afd4-1c57-4f14-8cc4-6eced1ec0aa5
Metcalf, Cheryl
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Ostler, Chantel Marie
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Andrysek, Jan, Berthaume, Michael, Boone, David, Chang, Sarah, Chockalingam, Nachiappan, Dickinson, Alexander, Gard, Steve, Harte, Carson, Healy, Aoife, Kenney, Laurence, Metcalf, Cheryl and Ostler, Chantel Marie (2021) Ethical considerations and approaches for conducting clinical research studies related to prosthetics, orthotics and wheelchair technology in the low- and middle-income countries Interational Society for Prosthetics and Orthotics (ISPO) 3pp.

Record type: Monograph (Project Report)

Abstract

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).

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Published date: 24 March 2021

Identifiers

Local EPrints ID: 449284
URI: http://eprints.soton.ac.uk/id/eprint/449284
PURE UUID: f0de8b0c-b98a-4bbd-9eea-89b30a5a372a
ORCID for Alexander Dickinson: ORCID iD orcid.org/0000-0002-9647-1944
ORCID for Cheryl Metcalf: ORCID iD orcid.org/0000-0002-7404-6066

Catalogue record

Date deposited: 21 May 2021 16:32
Last modified: 22 May 2021 01:41

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Contributors

Author: Jan Andrysek
Author: Michael Berthaume
Author: David Boone
Author: Sarah Chang
Author: Nachiappan Chockalingam
Author: Steve Gard
Author: Carson Harte
Author: Aoife Healy
Author: Laurence Kenney
Author: Cheryl Metcalf ORCID iD
Author: Chantel Marie Ostler

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