Evidence map›Paper›PMID 33341309›Full record

GuidelineVaccine2021

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.

Euzebiusz Jamrozik, Katherine Littler, Susan Bull, Claudia Emerson, Gagandeep Kang, Melissa Kapulu, Elena Rey, Carla Saenz, Seema Shah, Peter G Smith and 4 more

Abstract readPractice Guideline
In one paragraph

Guideline in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed.

  1. Ethical Frameworks for Conducting Social Challenge Studies.Journal of empirical research on human research ethics : JERHRE · 2026
    Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. The Case for Human Challenge Trials in COVID-19.Journal of bioethical inquiry · 2024
    Article
  14. Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.Biologicals : journal of the International Association of Biological Standardization · 2024
    Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Ethics of Controlled Human Infection Studies With Hepatitis C Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Euzebiusz JamrozikThe Ethox Centre & Wellcome Centre for Ethics and the Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK; Monash Bioethics Centre, Monash University, Clayton, Victoria, Australia; Royal Melbourne Hospital Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.
Katherine LittlerGlobal Health Ethics Unit, World Health Organization, Geneva, Switzerland.
Susan BullThe Ethox Centre & Wellcome Centre for Ethics and the Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.
Claudia EmersonInstitute on Ethics & Policy for Innovation, Department of Philosophy, McMaster University, Hamilton, Ontario, Canada.
Gagandeep KangThe Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Melissa KapuluKEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research-Coast, Kilifi, Kenya; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Elena ReyCentro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM. Cali, Colombia; Universidad Icesi. Cali, Colombia.
Carla SaenzDepartment of Health Systems and Services, Pan American Health Organization, USA.
Seema ShahLurie Children's Hospital & Northwestern University Feinberg School of Medicine, Chicago, USA.
Peter G SmithLondon School of Hygiene and Tropical Medicine, London, UK.
Ross UpshurDivision of Clinical Public Health, Dalla Lana School of Public Health, Toronto, Canada.
Charles WeijerDepartments of Medicine, Epidemiology & Biostatistics, and Philosophy, Western University, London, Canada.
Michael J SelgelidMonash Bioethics Centre, Monash University, Clayton, Victoria, Australia.
WHO Working Group for Guidance on Human Challenge Studies in COVID-19

Funding

Medical Research Council MR/R010161/1Wellcome TrustWorld Health Organization 001
6 · The paper itself

Abstract

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.

Indexed as

Antiviral AgentsBiomedical ResearchCOVID-19COVID-19 Drug TreatmentCOVID-19 VaccinesEthics Committees, ResearchHealthy VolunteersHuman ExperimentationHumansInformed ConsentPatient SelectionSARS-CoV-2VaccinationWorld Health OrganizationAntiviral AgentsCOVID-19 VaccinesBioethicsClinical trialsControlled human infectionCoronavirusCovid-19EthicsHuman challenge studiesResearch ethics

Identifiers

PMID33341309
PMCPMC7598752

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.