Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop

Eloise Williams; Kathrine Craig; Christopher Chiu; Hugh Davies; Stephanie Ellis; Claudia Emerson; Euzebiusz Jamrozik; Monica Jefford; Gagandeep Kang; Melissa Kapulu; Simon E. Kolstoe; Katherine Littler; Anthony Lockett; Rey Elena Rey; Janet Messer; Helen McShane; Carla Saenz; Michael J. Selgelid; Seema Shah; Peter G. Smith; Naho Yamazaki

doi:10.1016/j.vaccine.2022.02.004

Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop

Eloise Williams^*, Kathrine Craig, Christopher Chiu, Hugh Davies, Stephanie Ellis, Claudia Emerson, Euzebiusz Jamrozik, Monica Jefford, Gagandeep Kang, Melissa Kapulu, Simon E. Kolstoe, Katherine Littler, Anthony Lockett, Rey Elena Rey, Janet Messer, Helen McShane, Carla Saenz, Michael J. Selgelid, Seema Shah, Peter G. SmithNaho Yamazaki

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.

Original language	English (US)
Pages (from-to)	3484-3489
Number of pages	6
Journal	Vaccine
Volume	40
Issue number	26
DOIs	https://doi.org/10.1016/j.vaccine.2022.02.004
State	Published - Jun 9 2022

Funding

In addition to the UK Specialist REC, the researchers\u2019 work was supported by a wide array of academics and experts via the pre-existing Human Infection Challenge for Vaccines (HIC-Vac) network (an international network of researchers who are developing human infection challenge studies to accelerate the development of vaccines, funded by the Medical Research Council (UK)), the UK MHRA (Medicines and Healthcare products Regulatory Agency), the HRA and the UK government. This broad coordination between researchers, policymakers and regulators is consistent with criterion four of the WHO Key Criteria, which states that COVID-19 challenge study research programmes should involve close coordination between researchers, funders, policy makers and regulators. This co-ordination of key stakeholders and research activities may arguably help to ensure that the potential public health benefits of the research are optimized [7] . Researchers reflected that this broad national support provided rigorous review and oversight, although the involvement of such a large collaborative group had trade-offs with regard to the rate of progress of the studies and the ability to rapidly share important findings of the research with the wider international community. For example, the involvement of public health agencies in such work requires that considerations must be made regarding how to incorporate the communication of preliminary research findings into the wider public health strategy and health promotion messages. E.W. is supported by a Postgraduate Scholarship from the Australian National Health and Medical Research Council (GNT2005380).

Keywords

COVID-19
Ethics review
Human challenge studies
SARS-CoV-2
Vaccines
Virology

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.vaccine.2022.02.004

Cite this

Williams, E., Craig, K., Chiu, C., Davies, H., Ellis, S., Emerson, C., Jamrozik, E., Jefford, M., Kang, G., Kapulu, M., Kolstoe, S. E., Littler, K., Lockett, A., Elena Rey, R., Messer, J., McShane, H., Saenz, C., Selgelid, M. J., Shah, S., ... Yamazaki, N. (2022). Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop. Vaccine, 40(26), 3484-3489. https://doi.org/10.1016/j.vaccine.2022.02.004

@article{ab3841a989bf4a909df68cf1d9b4b712,

title = "Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop",

abstract = "This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.",

keywords = "COVID-19, Ethics review, Human challenge studies, SARS-CoV-2, Vaccines, Virology",

author = "Eloise Williams and Kathrine Craig and Christopher Chiu and Hugh Davies and Stephanie Ellis and Claudia Emerson and Euzebiusz Jamrozik and Monica Jefford and Gagandeep Kang and Melissa Kapulu and Kolstoe, {Simon E.} and Katherine Littler and Anthony Lockett and {Elena Rey}, Rey and Janet Messer and Helen McShane and Carla Saenz and Selgelid, {Michael J.} and Seema Shah and Smith, {Peter G.} and Naho Yamazaki",

note = "Publisher Copyright: {\textcopyright} 2022",

year = "2022",

month = jun,

day = "9",

doi = "10.1016/j.vaccine.2022.02.004",

language = "English (US)",

volume = "40",

pages = "3484--3489",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd",

number = "26",

}

Williams, E, Craig, K, Chiu, C, Davies, H, Ellis, S, Emerson, C, Jamrozik, E, Jefford, M, Kang, G, Kapulu, M, Kolstoe, SE, Littler, K, Lockett, A, Elena Rey, R, Messer, J, McShane, H, Saenz, C, Selgelid, MJ, Shah, S, Smith, PG & Yamazaki, N 2022, 'Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop', Vaccine, vol. 40, no. 26, pp. 3484-3489. https://doi.org/10.1016/j.vaccine.2022.02.004

TY - JOUR

T1 - Ethics review of COVID-19 human challenge studies

T2 - A joint HRA/WHO workshop

AU - Williams, Eloise

AU - Craig, Kathrine

AU - Chiu, Christopher

AU - Davies, Hugh

AU - Ellis, Stephanie

AU - Emerson, Claudia

AU - Jamrozik, Euzebiusz

AU - Jefford, Monica

AU - Kang, Gagandeep

AU - Kapulu, Melissa

AU - Kolstoe, Simon E.

AU - Littler, Katherine

AU - Lockett, Anthony

AU - Elena Rey, Rey

AU - Messer, Janet

AU - McShane, Helen

AU - Saenz, Carla

AU - Selgelid, Michael J.

AU - Shah, Seema

AU - Smith, Peter G.

AU - Yamazaki, Naho

PY - 2022/6/9

Y1 - 2022/6/9

N2 - This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.

AB - This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.

KW - COVID-19

KW - Ethics review

KW - Human challenge studies

KW - SARS-CoV-2

KW - Vaccines

KW - Virology

UR - http://www.scopus.com/inward/record.url?scp=85125123922&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85125123922&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2022.02.004

DO - 10.1016/j.vaccine.2022.02.004

M3 - Article

C2 - 35210119

AN - SCOPUS:85125123922

SN - 0264-410X

VL - 40

SP - 3484

EP - 3489

JO - Vaccine

JF - Vaccine

IS - 26

ER -

Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this