Abstract
BackgroundProviding 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.MethodsWe 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.ResultsThe 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.ConclusionOur new reimbursement framework provides a consistent, fair and transparent decision-making process and will be implemented across all future OUCRU clinical research in Vietnam.
Highlights
Researchers are guided by international guidelines such as the Council for International Organizations of Medical Sciences (CIOMS) statements and existing frameworks, but there is a need for enhanced transparency, greater consistency across research programs and practical models.[3,4,5]
The final compensation framework covers five central questions related to the design of the study and how it may affect participants’ wellbeing (Figure 2A). These questions are: (1) What type of study is conducted? (2) Is the participant a healthy volunteer, who enrolls in a clinical study with no prospect of medical benefit? (3) Is there any additional inpatient hospital stay required per study protocol? (4) Are outpatient visits required by the study protocol? (5) Are the participants subjected to burdens for study purposes only? Typical burdens were categorized as single- or long-term non-invasive and single or repeated invasive procedures
While the working group acknowledges that financial incentives can send participants a strong message that researchers value their time and increases their willingness to participate, the concern of ‘undue inducement’ is present and heightened in the context of structural inequalities existing in low and middle income countries (LMICs).[8,15,16,17]
Summary
Providing compensation for participants in clinical research is a well-established practice, defining a fair and appropriate amount remains a challenge and is still an area of debate.[1,2] Researchers are guided by international guidelines such as the Council for International Organizations of Medical Sciences (CIOMS) statements and existing frameworks, but there is a need for enhanced transparency, greater consistency across research programs and practical models.[3,4,5]For many years, discussions on the ethical issues surrounding participant payments have been ongoing, related to a disproportionate research burden on vulnerable populations, coercion (pressure or intimidation) and undue influence, when an attractive offer affects a person’s ability to make an informed decision.[6,7] In low and middle income countries (LMICs), defining a context-specific and fair compensation for participants is challenging due to structural healthcare inequalities, pertinent ethical concerns and conflicting arguments about vulnerable populations, including aspects of economic disadvantages.[1]Ethics committees have previously recommended that payments be kept low to avoid influencing participation by attracting participants through payment incentives.[8,9] refraining from giving cash payments to poorer populations is unfairly discriminative, but this risks making samples within clinical research unrepresentative and it could be detrimental to recruitment if participants cannot afford to take part because their loss of earnings are not reimbursed.[2,10]. Discussions on the ethical issues surrounding participant payments have been ongoing, related to a disproportionate research burden on vulnerable populations, coercion (pressure or intimidation) and undue influence, when an attractive offer affects a person’s ability to make an informed decision.[6,7] In low and middle income countries (LMICs), defining a context-specific and fair compensation for participants is challenging due to structural healthcare inequalities, pertinent ethical concerns and conflicting arguments about vulnerable populations, including aspects of economic disadvantages.[1]. 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
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