Abstract
Background: Research participant remuneration has been variable and inconsistent world-wide for many years owing to uncertainty regarding best practice and a lack of written guidelines for investigators and research ethics committees. Recent recommendations are that researchers and regulators should develop regionally appropriate written guidelines to define reasonable remuneration based on expense reimbursement, compensation for time and burden associated with participation. Incentives to motivate participation are acceptable in specific circumstances. Methods: We wished to develop regionally informed, precise and applicable guidelines in Malawi that might also be generally useful for African researchers and review committees. We therefore reviewed the current literature and developed widely applicable and specific remuneration tables using acceptable and evidence-based payment rationales. Results: There were good international guidelines and limited published regional guidelines. There were published examples of best practice and sufficient material to suggest a structured remuneration table. The rationale and method for the table were discussed at an inter-disciplinary workshop resulting in a reimbursement and compensation model with fixed rates. Payment is recommended pro rata and equally across a study. Conclusions: Transparent, fair remuneration of research participants is recommended by researchers and regulators in Malawi. The means to achieve this are now presented in the Malawi research participant remuneration table.
Highlights
Remuneration of participants in research by researchers is accepted practice[1]
Clear statements from the Council for International Organisations of Medical Sciences (CIOMS)[3] as well as country-specific regulators such as the Office for Human Research Protection (OHRP) and the Federal Drug Administration (FDA) of the USA describe a code of practice where remuneration should not be sufficiently large to cause “coercion” or “undue influence” of participants[1,4]
In 1998, research participant remuneration in the USA was shown to be inconsistent between different sites in multi-site studies, between studies at the same site and between procedures in the same study[4]
Summary
Remuneration of participants in research by researchers is accepted practice[1]. There are currently no specific regional guidelines for Malawi. Research participant remuneration has been variable and inconsistent world-wide for many years owing to uncertainty regarding best practice and a lack of written guidelines for investigators and research ethics committees. Recent recommendations are that researchers and regulators should develop regionally appropriate written guidelines to define reasonable remuneration based on expense reimbursement, compensation for time and burden associated with participation. Methods: We wished to develop regionally informed, precise and applicable guidelines in Malawi that might be generally useful for African researchers and review committees. We reviewed the current literature and developed widely applicable and specific remuneration tables using acceptable and evidence-based payment rationales. The means to achieve this are presented in the Malawi research participant remuneration table
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