Thursday, October 29, 2020

Paying participants in challenge trials of Covid-19 vaccines, by Ambuehl, Ockenfels, and Roth

 Here's a new short paper in Journal of Medical Ethics: (it's ungated, you can read it all at the link): 

Payment in challenge studies from an economics perspective 

by Sandro Ambuehl, Axel Ockenfels, and Alvin E. Roth

published online early, Oct 28, 2020. http://dx.doi.org/10.1136/medethics-2020-

"Participants in medical studies perform a service. Outside the domain of research participation, there is nearly universal agreement that workers providing a service should be compensated fairly, and that work involving more discomfort and risk should be compensated more generously. Accordingly, labour regulations impose floors (minimum wage laws), not caps on compensation. Caps, even if intended to protect against undue inducement, also raise concerns about illegal price-fixing that disadvantages workers. Such limits on payment for egg donors have successfully been challenged in court.

...

"Payment caps can lead to attempts to circumvent the regulation. For example, many countries that prevent payment for the donation of blood plasma instead import it from the USA where payment is legal—the volume of the US export market for plasma products approaches $20 billion per year.ii Similarly, restrictions on CHIM trial payments may lead to an increase in trials in countries with less stringent regulation.

...

"we note that increasing hourly pay by a risk-compensation percentage as proposed in the target article provides compensation proportional to risk only if the risk increases proportionally with the number of hours worked. (Some risky tasks take little time; imagine challenge trials to test bulletproof vests.) To ensure that equal consequences are compensated with equal amounts across a wide variety of studies, we instead recommend a three-part contract consisting of: (1) salary for time involvement that is adjusted to account for the amount of discomfort experienced during participation, (2) insurance against ex post adverse outcomes and (3) ex ante compensation for risks that cannot be compensated ex post (such as death). Such a scheme also increases transparency about what is requested from participants and thus contributes to high-quality participation decisions."

...

"The current discussion about payment in challenge trials is important because the potential benefits of well-designed challenge trials that could accelerate the development of safe and effective vaccines are enormous. Overall, economic research has shown, first, that ethical concerns over high payments may rely on intuitive predictions about behavioural effects that find little or no empirical support, and that the dangers of underpayment are at least as real as those of overpayment. Second, a part of the ethics literature attaches significantly more weight to concerns of undue inducement than the general population. Accordingly, it appears to us that there is sufficient public support for preparing for challenge trials, with paid participants, without a need for excessive ethical concern that payments might inadvertently become too generous to trial participants."

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Our article is an invited commentary on

Related comments appear in

  1. Compensating for research risk: permissible but not obligatory
    Holly Fernandez Lynch et al., J Med Ethics
  2. Payment of COVID-19 challenge trials: underpayment is a bigger worry than overpayment
    Jennifer Blumenthal-Barby et al., J Med Ethics, 2020
  3. How much money would it take for you to be infected with COVID-19 for research?
    By Olivia Grimwade and Julian Savulescu., JME blog, 2020

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