Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Aug 14;77(Suppl 3):S224-S230.
doi: 10.1093/cid/ciad350.

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

Jake D Eberts  1 , Paul Zimmer-Harwood  1   2 , James W B Elsey  3 , Alastair Fraser-Urquhart  1 , Thomas Smiley  1
Affiliations

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

Jake D Eberts et al. Clin Infect Dis. .

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.

Keywords: challenge; controlled human infection model; healthy volunteer; hepatitis C.

PubMed Disclaimer

Conflict of interest statement

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.

References

    1. Stunkel L, Grady C. More than the money: a review of the literature examining healthy volunteer motivations. Contemp Clin Trials 2011; 32:342–52. - PMC - PubMed
    1. Hoogerwerf MA, de Vries M, Roestenberg M. Money-oriented risk-takers or deliberate decision-makers: a cross-sectional survey study of participants in controlled human infection trials. BMJ Open 2020; 10:e033796. - PMC - PubMed
    1. Kraft SA, Duenas DM, Kublin JG, Shipman KJ, Murphy SC, Shah SK. Exploring ethical concerns about human challenge studies: a qualitative study of controlled human malaria infection study participants' motivations and attitudes. J Empir Res Hum Res Ethics 2019; 14:49–60. - PubMed
    1. Marsh AA, Magalhaes M, Peeler M, et al. . Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials. PLoS One 2022; 17:e0275823. - PMC - PubMed
    1. Fisher JA, McManus L, Kalbaugh JM, Walker RL. Phase I trial compensation: how much do healthy volunteers actually earn from clinical trial enrollment? Clin Trials 2021; 18:477–87. - PMC - PubMed

Publication types