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Very excited that our paper on promoting ethical payment in human infection challenge studies is out today, open access, in the American Journal of Bioethics @bioethics_net
https://www.tandfonline.com/doi/full/10.1080/15265161.2020.1854368?src=
https://www.tandfonline.com/doi/full/10.1080/15265161.2020.1854368?src=
If you couldn't make it through our 100+ page report that we posted over the summer, this new and improved version is for you! https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3674548
We start by ? if there's a need for a distinct framework for ethical payment in challenge studies (esp. w/ SARSCoV2), compared to other research w/ healthy individuals. After considering public trust, risk level, social value, + susceptibility to financial influence, we say no.
We then introduce the "payment funnel," a series of general to specific factors relevant to ethical payment for participation in human infection challenge studies:
The funnel starts with the basic framework for ethical payment in clinical research: reimbursement and compensation to meet fairness obligations, incentives to encourage participation in otherwise important and ethical research.
Next, we add some more specific considerations to the basic framework related to the prospect of direct medical benefit, impact of early withdrawal or termination, study location, study budget, and participant perspectives.
Finally, at the base of the funnel, we consider key factors that are particularly relevant to challenge studies: participant isolation/confinement, anticipated discomfort, risk of lasting harm, participant motivations, and a few other things - especially ethics review capacity.
The funnel won't spit out a specific dollar amount, but it should help investigators, research ethics committees, and participants understand what amounts are reasonable - ideally with far less concern on the part of those overseeing research that payment is too high.
We also offer a "worksheet" that investigators can use to justify their payment proposals to ethics reviewers and others.
Although our focus was on payment for SARS-CoV-2 challenge studies, we don't take a position on whether those studies are ethical to proceed at the moment - we just discuss payment IF other ethical standards are satisfied.
There is still a very live discussion about whether SARS CoV 2 challenge studies would be useful, especially given new variants and vaccine dosing questions. https://blogs.bmj.com/bmj/2021/01/08/human-challenge-trials-of-covid-19-vaccines-still-have-much-to-teach-us/
And there are plans to proceed in the UK: https://www.gov.uk/government/news/expert-partnership-to-explore-and-establish-human-challenge-studies-of-covid-19-in-the-uk
And in the Netherlands: https://www.reuters.com/article/health-coronavirus-challenge-virus/dutch-researchers-preparing-for-human-challenge-covid-19-vaccine-trial-idUSKBN2852VM
It was fabulous to work with this interdisciplinary team (ethics, medicine, science, economics, law, participants): @emily_a_largent @UbakaOgbogu @DrAkilahJ @TomDarton1 @paynero_shef Al Roth, Frank McCormick, Thomas Smiley, + Jae Levy. Thanks @1daysooner for kicking us off.
This project is the culmination of several years of work with @emily_a_largent and others on paying research participants. We have more work to do, but this paper summarizes our thinking on ethical payment more broadly - it's not applicable exclusively to challenge studies.
The last thing I'll say is that we got fantastic and insightful peer commentaries and I'm looking forward to sharing those as soon as they're posted.
