Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations

116 Pages Posted: 16 Aug 2020

See all articles by Holly Fernandez Lynch

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

Thomas Darton

University of Sheffield

Emily Largent

University of Pennsylvania - Perelman School of Medicine

Jae Levy

Independent

Frank McCormick

Bank of America

Ubaka Ogbogu

Faculty of Law & Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta

Ruth Payne

University of Sheffield

Alvin E. Roth

Dept. of Economics, Stanford University; National Bureau of Economic Research (NBER)

Akilah Jefferson Shah

University of Arkansas for Medical Sciences - College of Medicine

Thomas Smiley

Independent

Date Written: August 14, 2020

Abstract

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, this report offers an expert analysis of ethical approaches to paying research participants in these studies, as well as HICS more broadly. The report first provides an overarching ethical framework for research payment that divides payment into reimbursement, compensation, and incentive, focusing on fairness and promoting adequate recruitment and retention as counterweights to ethical concerns about undue inducement. It then describes variables relevant to applying this framework to any type of study, including the prospect of direct medical benefit, early participant withdrawal, study setting and location, pandemic circumstances, study budget, and participant perspectives. We conclude that there is no need for a unique payment framework specific to HICS or SARS-CoV-2 HICS, but that there may be features of particular relevance to ethical payment for these studies. Participants have varied motivations for enrolling in HICS, including financial considerations, altruism, and other interests, but undue inducement does not seem to be a significant problem based on available evidence. Payment in these studies should reflect the nature of participant confinement, anticipated discomfort from induced infection, risks and uncertainty, participant motivations, and the need to recruit from certain populations, as relevant. Where HICS involve significant risks and highly contingent social value, special review confirming the ethical permissibility of these studies can help promote confidence in the ethical permissibility of offers of payment to participate in them. We do not propose specific payment amounts for potential SARS-CoV-2 HICS, as these will be highly variable based on the relevant factors described in the report. Instead, we note that it is reasonable to start from payments offered in other similar studies, while adopting a systematic approach based on the ethical framework herein, as reflected in a pragmatic payment worksheet describing goals, coverage, factors to consider, and potential benchmarks.

Keywords: human infection challenge study, challenge trial, SARS-CoV-2, COVID-19, coronavirus, research, payment

Suggested Citation

Lynch, Holly Fernandez and Darton, Thomas and Largent, Emily and Levy, Jae and McCormick, Frank and Ogbogu, Ubaka and Payne, Ruth and Roth, Alvin E. and Jefferson Shah, Akilah and Smiley, Thomas, Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations (August 14, 2020). Available at SSRN: https://ssrn.com/abstract=3674548 or http://dx.doi.org/10.2139/ssrn.3674548

Holly Fernandez Lynch (Contact Author)

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Thomas Darton

University of Sheffield ( email )

17 Mappin Street
Sheffield, Sheffield S1 4DT
United Kingdom

Emily Largent

University of Pennsylvania - Perelman School of Medicine ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

Jae Levy

Independent ( email )

Frank McCormick

Bank of America ( email )

100 North Tryon Street
6th Floor
Charlotte, NC 28255
United States

Ubaka Ogbogu

Faculty of Law & Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta ( email )

Edmonton, Alberta T6G 2H5
Canada
7804929055 (Phone)
7804924924 (Fax)

Ruth Payne

University of Sheffield ( email )

17 Mappin Street
Sheffield, Sheffield S1 4DT
United Kingdom

Alvin E. Roth

Dept. of Economics, Stanford University ( email )

Landau Economics Building
579 Serra Mall
STANFORD, CA 94305-6072
United States

National Bureau of Economic Research (NBER)

1050 Massachusetts Avenue
Cambridge, MA 02138
United States

Akilah Jefferson Shah

University of Arkansas for Medical Sciences - College of Medicine ( email )

4301 W. Markham St.
Little Rock, AR 72205
United States

Thomas Smiley

Independent ( email )

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