Evidence map›Paper›PMID 36088739›Full record

ArticleEpidemics2022

The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic.

Maria Piggin, Emma Smith, Peter Mankone, Leah Ndegwa, Diane Gbesemete, Philippa Pristerà, Michael Bahrami-Hessari, Halle Johnson, Andrew P Catchpole, Peter J M Openshaw and 4 more

Abstract read
In one paragraph

Article in Epidemics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Ethical approval for controlled human infectious model clinical trial protocols - A workshop report.Biologicals : journal of the International Association of Biological Standardization · 2024
    Article
  5. 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.

Maria PigginNIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK. Electronic address: publicinvolvement@imperial.ac.uk.
Emma SmithNational Heart and Lung Institute, Imperial College London, London W2 1NY, UK.
Peter MankonePublic Contributor.
Leah NdegwaPublic Contributor.
Diane GbesemeteNIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; School of Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton General Hospital, Mailpoint 806, Level D, Southampton SO16 6YD, UK.
Philippa PristeràNIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK.
Michael Bahrami-HessariNIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK.
Halle JohnsonNIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK.
Andrew P CatchpolehVIVO Services Limited (Part of Open Orphan), UK.
Peter J M OpenshawNational Heart and Lung Institute, Imperial College London, London W2 1NY, UK.
Christopher ChiuDepartment of Infectious Diseases, Imperial College London, London W2 1NY, UK.
Robert C ReadNIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; School of Clinical and Experimental Sciences, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton General Hospital, Mailpoint 806, Level D, Southampton SO16 6YD, UK.
Helen WardNIHR Imperial Biomedical Research Centre, Patient Experience Research Centre, Imperial College London, St Mary's Campus, Norfolk Place, Paddington, London W2 1NY, UK.
Caroline BarkerNIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, SO16 6YD, UK; NIHR Applied Research Collaboration Wessex, University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton SO16 6YD, UK.

Funding

Medical Research Council MR/R005982/1
6 · The paper itself

Abstract

High quality health care research must involve patients and the public. This ensures research is important, relevant and acceptable to those it is designed to benefit. The world's first human challenge study with SARS-CoV-2 undertook detailed public involvement to inform study design despite the urgency to review and establish the study. The work was integral to the UK Research Ethics Committee review and approval of the study. Discussion with individuals from ethnic minorities within the UK population supported decision-making around the study exclusion criteria. Public review of study materials for consent processes led to the addition of new information, comparisons and visual aids to help volunteers consider the practicalities and risks involved in participating. A discussion exploring the acceptability of a human challenge study with SARS-CoV-2 taking place in the UK, given the current context of the pandemic, identified overall support for the study. Public concern for the wellbeing of trial participants, as a consequence of isolation, was identified. We outline our approach to public involvement and its impact on study design.

Indexed as

COVID-19SARS-CoV-2HumansPandemicsEthicsHuman challenge studyPublic involvementSARS-CoV-2

Identifiers

PMID36088739
PMCPMC9434955

What OpenQuestion holds

Textmetadata
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.