Volunteering for Infection: Participant Perspectives on a Hepatitis C Virus Controlled Human Infection Model

Abstract Ethical human subjects research requires participants to be treated safely and respectfully, yet much bioethical debate takes place without participants. We aim to address this gap in the context of controlled human infection model (CHIM) research. Based upon our own experience as study par...

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Published inClinical infectious diseases Vol. 77; no. Supplement_3; pp. S224 - S230
Main Authors Eberts, Jake D, Zimmer-Harwood, Paul, Elsey, James W B, Fraser-Urquhart, Alastair, Smiley, Thomas
Format Journal Article
LanguageEnglish
Published US Oxford University Press 14.08.2023
Subjects
Supplement
challenge
healthy volunteer
hepatitis C
controlled human infection model
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Summary:Abstract Ethical human subjects research requires participants to be treated safely and respectfully, yet much bioethical debate takes place without participants. We aim to address this gap in the context of controlled human infection model (CHIM) research. Based upon our own experience as study participants, and bolstered by a survey of 117 potential hepatitis C virus CHIM participants, we present ideas to inform efficient, ethical, and scientifically useful study design. We advocate for full protocol transparency, higher compensation, commitment to the rapid dissemination of study results, and proactive efforts to detail risk-minimization efforts as early as possible in the recruitment process, among other measures. We encourage researchers to proactively partner with volunteer advocacy organizations that promote collective representation of volunteers to maximize their agency, and guard against ethical issues arising from healthy human subjects research. The perspectives of former challenge study participants and a survey of other potential volunteers can inform the design of hepatitis C virus controlled human infection models, including on topics such as transparency, volunteer safety and risk, and compensation.
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Potential conflicts of interest . A. F.-U. reports being a part-time employee and a former full-time employee of 1DaySooner. J. D. E. reports being a full-time employee of 1DaySooner. They also report being the co-chair of the HCV CHIM Advisory Committee. J. W. B. E. reports having conducted paid survey work related to attitudes toward human challenge trials for 1DaySooner. P. Z.-H. reports the provision of transport and accommodation for working on script with co-authors from 1DaySooner, working on a contract to do independent research on behalf of 1DaySooner through Babbage Tech Ltd, and an honorarium payment for conference attendance from 1DaySooner. T. S. reports funding from 1DaySooner for co-authoring “Promoting Ethical Payment in Human Infection Challenge Studies.” All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciad350