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Payment of trial participants can be ethically sound: Moving past a flat-rate

Jennifer Koen, Catherine Slack, Nicola Barsdorf, Zaynab Essack

Abstract


The South African Medicines Control Council (MCC) policy that trial participants be paid a flat-rate of R150 per visit in clinical trials has been criticised in the press1,2; its affordability by non-industry funded trials questioned3; that it is an excessive or inappropriate reward4; or that it neglects critical factors like the design or nature of the study.3, 4 It might also be argued that this amount will act as an “undue inducement” for participants to enrol.

In our view the principal problem with the MCC policy is that it violates justice in that participants are paid the same amount but do not do the same things or make the same financial sacrifices.5 It has been argued that it would be more appropriate to have a broad contextualised policy6 and that participants should be paid for their time and expenses.4 However, these recommendations have not been specified in the South African literature. To take these recommendations forward we apply two theoretical models of payment (Wage Payment and Reimbursement models) to operationalise payments for time, inconvenience and expenses (TIE). We recommend that participants be paid for their time at a rate similar to national unskilled labour rates, with increments for inconvenient procedures (set nationally), and that they be refunded their direct expenses. This is operationally complex but ethically sound.

Our recommendations for stakeholders include that the NHREC assume control of payment norms and endorses payment for TIE.

A new payment approach will struggle to overcome the legacy of a flat rate because of community expectations and researchers who have enjoyed a simple administrative procedure.

Authors' affiliations

Jennifer Koen, HIV AIDS Vaccines Ethics Group (HAVEG); South African AIDS Vaccine Initiative (SAAVI)

Catherine Slack, HIV AIDS Vaccines Ethics Group (HAVEG); South African AIDS Vaccine Initiative (SAAVI)

Nicola Barsdorf, HIV AIDS Vaccines Ethics Group (HAVEG); South African AIDS Vaccine Initiative (SAAVI)

Zaynab Essack, HIV AIDS Vaccines Ethics Group (HAVEG); South African AIDS Vaccine Initiative (SAAVI)

Full Text

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Keywords

Payment; clinical trials; Medicines Control Council

Cite this article

South African Medical Journal 2008;98(12):926.

Article History

Date submitted: 2008-09-12
Date published: 2008-12-09

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