Compensation of subjects for participation in biomedical research in resource \u2013 limited settings: a discussion of practices in Malawi

Wongani Nyangulu,Titus Divala,Lufina Tsirizani,Nginanche Nampota,Osward Nyirenda,Randy Mungwira,Edson Mwinjiwa

doi:10.1186/s12910-019-0422-6

Abstract

BackgroundCompensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation.Main textIn Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups.ConclusionCompensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research.

Highlights

In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per study visit
The revised Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans published in 2016 are the latest in a series of guidelines published on how ethical principles should be applied in biomedical research in Low and middle-income countries (LMICs) [17, 18]
We welcome strides the Malawi government has made with respect to research regulation and appreciate the setting of minimum amount of money for human research subject compensation as a means to prevent exploitation

Summary

Main text

International research perspective Low and middle-income countries (LMICs) especially in Sub-Saharan Africa have long been fertile ground for research on infectious diseases which are highly prevalent in these settings [11]. Exceptions for payment of $10 stipend have been made for undergraduate and postgraduate students, a cohort of local graduate researchers not undertaking academic study are still required to adhere to guidelines For the exempted, their recruitment efforts may be subject to unfair competition from well-funded studies that are compensating participants at a higher rate. We welcome the consultative meeting the regulators had with researchers in 2018 and hope that more sections of the research community will be reached out to and that outcomes of such meetings will be part of an amended regulation and guideline Alternative compensation It has been proposed previously and we echo this sentiment that compensation or payment should be monetary but can be in the form of goods (e.g. food, soap, educational materials etc.) and services such as “ancillary” care provided to participants and their families [2, 24]. We propose adapting mode of compensation to community preferences determined through consultative meetings or qualitative studies

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