Policy, Reports & Advice

 
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'The Ethics of Controlled Human Infection Model Studies for Mitigating Pandemic Risks'

Report commissioned by 1Day Sooner (March 2023)

Authors: Bridget Williams, Josh Morrison, Dominic Wilkinson, Julian Savulescu

This report provides guidance on when it may be appropriate to conduct CHIM studies and the requirements for their ethical conduct. This includes guidance on conducting CHIM studies prior to an outbreak and at the beginning of an outbreak with a known PPP or novel pathogen that may have pandemic potential. The report has been developed for the context of the UK. It aims to inform UK policymakers, researchers, regulators, and members of research ethics committees.

View/download full report 

1Day Sooner aims to reduce the global burden on infectious disease and avert future pandemics by working to accelerate the development and implementation of vaccines, treatments, and mechanical interventions. They do so as advocates for people who want to be in high-impact medical studies, including human challenge studies.

Highlights

UK Government

Members of OUC have submitted evidence to Parliamentary committees on COVID-19: 

Written evidence from Dr Jonathan Pugh, Dr Lisa Forsberg, and Dr Thomas Douglas (COV0255)
'Restrictions of Liberty in Public Health, Medical Treatment, and Human Rights in The COVID-19 Pandemic'
Link to report: https://committees.parliament.uk/writtenevidence/9404/pdf

Written evidence from Dr Lisa Forsberg, Dr Isra Black, Dr Thomas Douglas, Dr Jonathan Pugh (COV0220)
'Compulsory vaccination for Covid-19 and human rights law'
Link to report: https://committees.parliament.uk/writtenevidence/9253/pdf/

Written evidence from the Wellcome Centre for Ethics and Humanities (COV0156)
On maintaining public health whilst upholding human rights 
Contributors from OUC include Dr Jonathan Pugh, Dr Stephen Rainey and Joseph Nguyen
Link to report: https://committees.parliament.uk/writtenevidence/8681/html/

Other

Report commissioned by 1Day Sooner (March 2023)
'The Ethics of Controlled Human Infection Model Studies for Mitigating Pandemic Risks'
Authors: Bridget Williams, Josh Morrison, Dominic Wilkinson, Julian Savulescu
Link to report 
1Day Sooner aims to reduce the global burden on infectious disease and avert future pandemics by working to accelerate the development and implementation of vaccines, treatments, and mechanical interventions. They do so as advocates for people who want to be in high-impact medical studies, including human challenge studies.

Exit Statement 'COVID-19: Ethical guidelines for the Exit Strategy'Alberto Giubilini and Julian Savulescu (1 October 2020).
"The UK “Exit Strategy”, which aims at safely easing the restrictions introduced in March 2020 to contain the COVID19 epidemics in the UK, needs to balance different values and priorities, beyond protecting the population from the virus. The task will be made even more difficult by the fact that Exit Strategy will have to be responsive to likely new spikes of COVID-19 cases, if not by an actual second wave of the virus."
Link to Exit Statement PDF.

World Health Organization Report 'Key criteria for the ethical acceptability of COVID-19 human challenge studies' cites papers by Julian Savulescu, Tom Douglas, Hannah Maslen and Alberto Giubilini (6 May 2020)
Controlled human challenge studies involves the deliberate infection of healthy volunteers.  They are particularly useful for testing multiple vaccine candidates quickly and efficiently, as well as providing data on the processes of transmission, infection and immunity. Aimed at scientists, policy-makers and regulators, the report outlines the criteria that would need to be met for human challenge studies on COVID-19 to be ethically acceptable.
Link to report: https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV-Ethics_criteria-2020.1-eng.pdf?ua=1

Cited papers

  1. Schaefer G, Tam CC, Savulescu J, Voo TC. Covid-19 vaccine development: time to consider Sars-Cov-2 challenge studies? SSRN Electronic Journal. January 2020. Link to paper on SSRN.com  - SSRN REGISTRATION REQUIRED (FREE)
  2. Bambery B, Douglas T, Selgelid MJ, Maslen H, Giubilini A, Pollard AJ et al. Influenza vaccination strategies should target children. Public Health Ethics. 2018;11(2):221–34. Link to paper on OUP website   - OPEN ACCESS
  3. Bambery B, Selgelid M, Weijer C, Savulescu J, Pollard AJ. Ethical criteria for human challenge studies in infectious diseases. Public Health Ethics. 2015;9(1):92–103. Link to paper on OUP website  - FREE