A Malawi guideline for research study participant remuneration

Stephen B Gordon, Lameck Chinula, Ben Chilima, Victor Mwapasa, Sufia Dadabhai, Yohannie Mlombe, Malawi Research Ethics Workshop 2018 Participants, Stephen B Gordon, Lameck Chinula, Ben Chilima, Victor Mwapasa, Sufia Dadabhai, Yohannie Mlombe, Malawi Research Ethics Workshop 2018 Participants

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.

Keywords: Health research; Malawi.; compensation; ethics; remuneration.

Conflict of interest statement

Competing interests: Stephen Gordon: As a member of the research community in Malawi, I have an interest that best practice is followed and that was the motivation to organize the workshop. Having organised the workshop, I wanted the findings to be as widely available and discussed as possible.

References

    1. Gelinas L, Largent EA, Cohen IG, et al. : A Framework for Ethical Payment to Research Participants. N Engl J Med. 2018;378(8):766–71. 10.1056/NEJMsb1710591
    1. Emanuel EJ, Currie XE, Herman A, et al. : Undue inducement in clinical research in developing countries: is it a worry? Lancet. 2005;366(9482):336–40. 10.1016/S0140-6736(05)66992-9
    1. Reimbursement and compensation for research participants: Council for International Organizations of Medical Sciences (CIOMS) with WHO. [Guideline 13; Guideline 13 and commentary].2017.
    1. Dickert N, Emanuel E, Grady C: Paying research subjects: an analysis of current policies. Ann Intern Med. 2002;136(5):368–73. 10.7326/0003-4819-136-5-200203050-00009
    1. Dualé C, Breysse G, Bories-Azeau B, et al. : French academic's views on financial compensation of participants. Eur J Clin Invest. 2016;46(7):619–26. 10.1111/eci.12638
    1. Permuth-Wey J, Borenstein AR: Financial remuneration for clinical and behavioral research participation: ethical and practical considerations. Ann Epidemiol. 2009;19(4):280–5. 10.1016/j.annepidem.2009.01.004
    1. Iltis AS: Payments to normal healthy volunteers in phase 1 trials: avoiding undue influence while distributing fairly the burdens of research participation. J Med Philos. 2009;34(1):68–90. 10.1093/jmp/jhn036
    1. Breitkopf CR, Loza M, Vincent K, et al. : Perceptions of reimbursement for clinical trial participation. J Empir Res Hum Res Ethics. 2011;6(3):31–8. 10.1525/jer.2011.6.3.31
    1. Burgess LJ, Sulzer NU, Hoosain F, et al. : Patients' motivations for participating in cardiovascular clinical trials: a local perspective. Cardiovasc J Afr. 2009;20(4):220–3.
    1. DasMahapatra P, Raja P, Gilbert J, et al. : Clinical trials from the patient perspective: survey in an online patient community. BMC Health Serv Res. 2017;17(1):166. 10.1186/s12913-017-2090-x
    1. Chen SC, Sinaii N, Bedarida G, et al. : Phase 1 healthy volunteer willingness to participate and enrollment preferences. Clin Trials. 2017;14(5):537–46. 10.1177/1740774517722131
    1. Wiener L, Viola A, Wilfond BS, et al. : Contrasting views of risk perception and influence of financial compensation between adolescent research participants and their parents. J Empir Res Hum Res Ethics. 2015;10(1):49–58. 10.1177/1556264614563249
    1. Jennings CG, MacDonald TM, Wei L, et al. : Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015;16:80. 10.1186/s13063-015-0582-8
    1. Mfutso-Bengo J, Manda-Taylor L, Masiye F: Motivational factors for participation in biomedical research: evidence from a qualitative study of biomedical research participation in Blantyre District, Malawi. J Empir Res Hum Res Ethics. 2015;10(1):59–64. 10.1177/1556264614559888
    1. Mtunthama N, Malamba R, French N, et al. : Malawians permit research bronchoscopy due to perceived need for healthcare. J Med Ethics. 2008;34(4):303–7. 10.1136/jme.2007.020461
    1. Njue M, Njuguna P, Kapulu MC, et al. : Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya [version 1; referees: 2 approved]. Wellcome Open Res. 2018;3:39. 10.12688/wellcomeopenres.14439.1
    1. Ripley E, Macrina F, Markowitz M, et al. : Why do we pay? A national survey of investigators and IRB chairpersons. J Empir Res Hum Res Ethics. 2010;5(3):43–56. 10.1525/jer.2010.5.3.43
    1. Grady C, Dickert N, Jawetz T, et al. : An analysis of U.S. practices of paying research participants. Contemp Clin Trials. 2005;26(3):365–75. 10.1016/j.cct.2005.02.003
    1. Bélisle-Pipon JC, Rouleau G, Birko S: Early-career researchers' views on ethical dimensions of patient engagement in research. BMC Med Ethics. 2018;19(1):21. 10.1186/s12910-018-0260-y
    1. Ripley E, Macrina F, Markowitz M, et al. : Who's doing the math? Are we really compensating research participants? J Empir Res Hum Res Ethics. 2010;5(3):57–65. 10.1525/jer.2010.5.3.57
    1. Essack Z, Koen J, Barsdorf N, et al. : Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa. Dev World Bioeth. 2010;10(1):11–21. 10.1111/j.1471-8847.2009.00254.x
    1. Molyneux S, Mulupi S, Mbaabu L, et al. : Benefits and payments for research participants: experiences and views from a research centre on the Kenyan coast. BMC Med Ethics. 2012;13:13. 10.1186/1472-6939-13-13
    1. Njue M, Molyneux S, Kombe F, et al. : Benefits in cash or in kind? A community consultation on types of benefits in health research on the Kenyan Coast. PLoS One. 2015;10(5):e0127842. 10.1371/journal.pone.0127842
    1. Gelinas L, Lynch HF, Largent EA, et al. : Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials. Ther Innov Regul Sci. 2018;52(3):268–74. 10.1177/2168479018770644
    1. Draper H, Wilson S, Flanagan S, et al. : Offering payments, reimbursement and incentives to patients and family doctors to encourage participation in research. Fam Pract. 2009;26(3):231–8. 10.1093/fampra/cmp011
    1. Faber M, Kruger HS: Nutrition research in rural communities: application of ethical principles. Matern Child Nutr. 2013;9(4):435–51. 10.1111/j.1740-8709.2012.00414.x
    1. Lowther K, Harding R, Ahmed A, et al. : Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya. AIDS Care. 2016;28 Suppl 1:60–3. 10.1080/09540121.2016.1146214
    1. Mngadi KT, Frohlich J, Montague C, et al. : Challenges with participant reimbursement: experiences from a post-trial access study. J Med Ethics. 2015;41(11):909–13. 10.1136/medethics-2013-101899
    1. Ballantyne A: Benefits to research subjects in international trials: do they reduce exploitation or increase undue inducement? Dev World Bioeth. 2008;8(3):178–91. 10.1111/j.1471-8847.2006.00175.x
    1. Moodley K, Myer L: Participant remuneration for research--how much is enough? S Afr Med J. 2003;93(9):677–8.
    1. Koen J, Slack C, Barsdorf N, et al. : Payment of trial participants can be ethically sound: moving past a flat rate. S Afr Med J. 2008;98(12):926–9.
    1. Africa NS: Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees.2012.
    1. McCallum AD, Nyirenda D, Lora W, et al. : Perceptions of Research Bronchoscopy in Malawian Adults with Pulmonary Tuberculosis: A Cross-Sectional Study. PLoS One. 2016;11(10):e0165734. 10.1371/journal.pone.0165734
    1. Mortimer K, Ndamala CB, Naunje AW, et al. : A cleaner burning biomass-fuelled cookstove intervention to prevent pneumonia in children under 5 years old in rural Malawi (the Cooking and Pneumonia Study): a cluster randomised controlled trial. Lancet. 2017;389(10065):167–75. 10.1016/S0140-6736(16)32507-7
    1. Boyce M, Walther M, Nentwich H, et al. : TOPS: an internet-based system to prevent healthy subjects from over-volunteering for clinical trials. Eur J Clin Pharmacol. 2012;68(7):1019–24. 10.1007/s00228-012-1231-8
    1. Gordon SB, Kanyanda S, Walsh AL, et al. : Poor potential coverage for 7-valent pneumococcal conjugate vaccine, Malawi. Emerg Infect Dis. 2003;9(6):747–9. 10.3201/eid0906.030020

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