Towards a fair and transparent research participant compensation and reimbursement framework in Vietnam

Author:

Sansom Lucy J1,Minh Trang Pham Nguyen1,Hill Iona E12,Ha Quyen Nguyen Than1,Trong Thuan Dang1,Vidaillac Celine13,Quynh Nhu Dong1,Turner Hugo C134,Van Nuil Jennifer Ilo13,Phuong Dung Nguyen Thi1,Kestelyn Evelyne13ORCID

Affiliation:

1. Oxford University Clinical Research Unit, University of Oxford, Centre for Tropical Medicine, 764, Vo Van Kiet, Ho Chi Minh City, Vietnam

2. Department of Pure and Applied Chemistry, Technology and Innovation Centre, University of Strathclyde, 99 George St, Glasgow G1 1RD, UK

3. Centre for Tropical Medicine and Global Health, New Richards Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LG, UK

4. MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, School of Public Health, Faculty of Medicine, Imperial College London, Level 2, Faculty Building South Kensington Campus, London SW7 2AZ, UK

Abstract

Abstract Background Providing compensation for participants in clinical research is well established and while international guidelines exist, defining a context-specific and fair compensation for participants in low-resource settings is challenging due to ethical concerns and the lack of practical, national compensation and reimbursement frameworks. Methods We reviewed Oxford University Clinical Research Unit (OUCRU) internal reimbursement documentation over a 10-y period and conducted a scoping literature review to expand our knowledge of compensation and reimbursement practices including ethical concerns. We developed a preliminary reimbursement framework that was presented to community advisory boards (CAB) and clinical investigators to assess its applicability, fairness and transparency. Results The main topics discussed at the workshops centered on fairness and whether the reimbursements could be perceived as financial incentives. Other decisive factors in the decision-making process were altruism and the loss of caregivers’ earnings. Investigators raised the issue of additional burdens, whereas the CAB members were focused on non-monetary elements such as the healthcare quality the patients would receive. All elements discussed were reviewed and, where possible, incorporated into the final framework. Conclusion Our new reimbursement framework provides a consistent, fair and transparent decision-making process and will be implemented across all future OUCRU clinical research in Vietnam.

Funder

Wellcome Trust

Publisher

Oxford University Press (OUP)

Subject

Public Health, Environmental and Occupational Health,General Medicine,Health (social science)

Reference33 articles.

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4. A Malawi guideline for research study participant remuneration;Gordon;Wellcome Open Res,2018

5. A framework for ethical payment to research participants;Gelinas;N Engl J Med,2018

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