Payment in challenge studies: ethics, attitudes and a new payment for risk model

Abstract

Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated.

Payment in challenge studies from an economics perspective

“…Sandro Ambuehl , 1 Axel Ockenfels , 2 Alvin E. Roth 3 We largely agree with Grimwade et al's 1 conclusion that challenge trial participants may ethically be paid, including for risk.…”

Payment of COVID-19 challenge trials: underpayment is a bigger worry than overpayment

“…Grimwade et al's survey of investigators involved in 25 challenge trials for diseases other than COVID-19 found that the maximum payment offered was $4446 and the average amount was $1770, with an average hourly payment of $13.77. 5 Among the investigators surveyed, 84% believed that the amount their trial paid was appropriate-only 16% believed the amount was too low. While that amount is more than the US current federal minimum wage ($7.25/hour), it is less than the suggested fair minimum wage of $15/hour.…”

Should practice and policy be revised to allow for risk-proportional payment to human challenge study participants?

“…Euzebiusz Jamrozik , 1,2,3 Michael J Selgelid 1 Human infection challenge studies (HCSs) provide illuminating case studies for several ongoing debates in research ethics, including those related to research risks and payment of participants. Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics.…”

“…Euzebiusz Jamrozik , 1,2,3 Michael J Selgelid 1 Human infection challenge studies (HCSs) provide illuminating case studies for several ongoing debates in research ethics, including those related to research risks and payment of participants. Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics. [1][2][3][4][5][6][7][8] The authors advocate revision of research payment policy and practice based on their main finding that members of the public endorse ex ante payment of participants proportional to research-related risk exposure, in addition to post hoc compensation for any lasting harms that occur.…”

“…Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics. [1][2][3][4][5][6][7][8] The authors advocate revision of research payment policy and practice based on their main finding that members of the public endorse ex ante payment of participants proportional to research-related risk exposure, in addition to post hoc compensation for any lasting harms that occur. 1 Although 'payment for risk' would diverge from most current research ethics guidelines, it is noteworthy that the difference in payment to participants that their framework would allow might only be small, at least in the case of currently accepted studies.…”