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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.

COVID-19

UK Government

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

Response to Department of Health and Social Care consultation on ‘Making vaccination a condition of deployment in older adult care homes’
Dr Isra Black (University of York) and Dr Lisa Forsberg (University of Oxford)
Link to written evidence:  PDF
Link to Consultation: https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-older-adult-care-homes (14 April 2021)

Written evidence to the Public Administration and Constitutional Affairs Committee on 'Covid 19 Vaccine Certification'
Dr Lisa Forsberg (University of Oxford), Dr Isra Black (University of York), Professor Thomas Douglas (University of Oxford)
Link to written evidence:  PDF
Call for evidence: https://committees.parliament.uk/committee/327/public-administration-and-constitutional-affairs-committee/news/153049/call-for-evidence-in-covid19-certification-inquiry/ (23 March 2021)

Written evidence from Dr Lisa Forsberg, Dr Melanie Collard, Dr Isra Black, Dr Henrique Carvalho and Dr Anastasia Chamberlen (COV0004)
'COVID-19 and the criminal law' (21 April 2021)
Link to report: COV0004 - Covid-19 and the criminal law

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/

Written evidence from Dr Stephen Rainey (LBC0005)
'Following the Science: to emergency governance, and back again'
Link to report: https://committees.parliament.uk/writtenevidence/8370/pdf/

Other

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

Report commissioned by 1Day Sooner (March 2023), 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.
Link to 1Day Sooner: https://www.1daysooner.org/
Link to report: https://ukpandemicethics.org/wp-content/uploads/2023/03/The-ethics-of-controlled-human-infection-model-studies-for-mitigating-pandemic-risks-Report.pdf 

World Health Organization Policy Brief 'COVID-19 and mandatory vaccination: Ethical considerations and caveats' (13 April 2021) cites Alberto Giubilini's open access book
Giubilini, A., (2019), 'The Ethics of Vaccination', (Palgrave Macmillan)
Link to policy brief COVID-19 and mandatory vaccination: Ethical considerations and caveats
Link to open access book The Ethics of Vaccination

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.

THIS Institute Report  'Pandemic Ethics: Testing times: An ethical framework and practical recommendations for COVID-19 testing for NHS workers' expert group including Alberto Giubilini (21 July 2020)
The report sought to identify and characterise the ethical considerations likely to be important to the testing programme, while recognising the tension between different values and goals. The project was guided by an expert group and by an online consultation exercise held between 27 May and 8 June 2020 to characterise the range and diversity of views on this topic. The 93 participants in the consultation included NHS workers in clinical and non-clinical roles, NHS senior leaders, policy-makers, and relevant experts. The project report emphasises that getting the COVID-19 swab testing programme for NHS workers right is crucial to support staff and patient safety and broader public health. It also recognises that COVID-19 does not affect all population groups equally. People who are socio-economically disadvantaged or members of Black, Asian and Minority Ethnic (BAME) groups may face distinctive issues in relation to testing.
Link to report: https://www.thisinstitute.cam.ac.uk/research-articles/testing-times-ethical-framework/

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

Neuroethics

Maslen, H., Savulescu, J., Levy, N., Cohen Kadosh, R. and Douglas, T., (2014), 'Mind Machines: The Regulation of Cognitive Enhancement Devices', Oxford Martin School Policy Paper [freely available]

Abortion

Savulescu, J., (2013). UK Parliamentary Inquiry into Abortion on the Grounds of Disability (UK House of Parliament). Submitted written evidence on invitation from Fiona Bruce MP. Download report here https://dontscreenusout.org/wp-content/uploads/2016/02/Abortion-and-Disability-Report-17-7-13.pdf 

Savulescu, J. and De Crespigny, L. (2007), Submission to Victorian Law Reform Commission. The Law of Abortion

Human Embryo & Stem-Cell Research

Katrien Devolder (July 2023) Public dialogue on early human embryo research, two workshops commissioned by the Human Developmental Biology Initiative, with funding from Wellcome, UKRI and Sciencewise.
Link to dialogue webpage: https://hdbi.org/public-dialogue
Link to full report: https://hdbi.org/s/HVM-HDBI-public-dialogue-report.pdf

Savulescu, J., Donovan, P., Faden, R., Harris, J., Lovell-Badge, R. and Mathews, D., (2008 ). Hinxton Consensus Statement: Science, Ethics and Policy Challenges of Pluripotent Stem Cell-Derived Gametes.

Reproducibility and research integrity

September 2021: Written evidence to UK Parliament's Science and Technology Committee on 'Reproducibility and research integrity'.

As the UK seeks to recover from the pandemic, research and innovation has the ability to drive economic growth, with UKRI estimating that every £1 spent on research and development delivers £7 in economic and social benefit. However, the integrity of research, especially medical and social science research, is at risk from what is known as the ‘reproducibility crisis’ (i.e. it being very difficult or impossible to replicate a scientific study).

As early as 2005, the issue of reproducibility was identified in Ioannidis’ paper, ‘Why Most Published Research Findings Are False,’ and since then a large number of surveys or replication studies have been conducted that show the prominence of the issue.

So far, Government policy has focused on the overall theme of ‘Research Integrity,’ including asking UKRI to establish a national research integrity committee as recommended by our predecessor Committee, but the specific issue of reproducible research has been overlooked.

For OUC's submission, see document RRE0076 

Witnesses: Dr Aksel Sterri (Hosted Researcher at Oxford Uehiro Centre for Practical Ethics, University of Oxford), Dr Rebecca Brown (Senior Research Fellow at Oxford Uehiro Centre for Practical Ethics, University of Oxford), Brian Earp (Research Fellow at Oxford Uehiro Centre for Practical Ethics, University of Oxford), and Professor Julian Savulescu (Uehiro Chair in Practical Ethics; Director, Oxford Uehiro Centre for Practical Ethics; Co-Director, Wellcome Centre for Ethics and Humanities University of Oxford at Oxford Uehiro Centre for Practical Ethics.

Medical Ethics

British Association of Perinatal Medicine Report 'Recognising uncertainty: an integrated framework for palliative care in perinatal medicine. A BAPM Framework for practice'. July 2024.
Multiple authors, including Dominic Wilkinson
This new palliative care framework has been developed as a joint venture in conjunction with the Association of Paediatric Palliative Medicine (APPM). In this version, we move away from a list of specific conditions, and instead propose a model that recognises the inherent uncertainty present in the care journey for so many babies and their families. 
Link: https://www.bapm.org/resources/palliative-care-in-perinatal-medicine-framework

 

Submission to Nuffield Council on Bioethics: Inquiry into disagreements in the care of critically ill children 'The role of clinical ethics advice in disagreements about the care of critically ill children'. Report published by Department of Health and Social Care, September 2023

Wilkinson D, Harrop E, Shoulder R, Turnham H.

Link: https://assets.publishing.service.gov.uk/media/651597336a423b000df4c579/...
Report of the independent review on the causes of disagreements in the care of critically ill children by the Nuffield Council on Bioethics.

From:

Published
18 September 2023