Consulting and involving the public in the first human COVID-19 human challenge study

How do you engage members of the public with medical research? Dr Emma Smith, HIC-Vac Network Manager, outlines how consulting the public was crucial during the world’s first COVID-19 human challenge study.

It is important that health and social care research aims to improve the overall well-being of the population, from advancing treatments for patients to helping us live healthier lives. People are at the heart of medical research and so engaging and involving them is an integral part of the research process and one that is mandated by most funders.

When we set up the world’s first COVID-19 human challenge study, acceptability of research to participants and society more broadly was particularly relevant because of the study’s ethically complex nature.

With volunteer participants being deliberately exposed to coronavirus (COVID-19) and the associated risk (albeit very small) of serious illness or death, the public’s perspectives were an important element of assessing if the study was acceptable and ethical (and was stated by the WHO1  as one of the key criteria for the ethical acceptability of COVID-19 human challenge).

A broad public consultation

In April 2020, our programme of activities to consult and involve members of public in this study began, around 10 months before the appointed Research Ethics Committee (REC) approved the COVID-19 human challenge study. Researchers based at the University of Southampton and University Hospital Southampton NHS Foundation Trust carried out a structured public consultation with 57 individuals aged 20-40 years to understand public attitudes a COVID-19 human challenge study2. In a series of small discussion groups, they posed a series of questions to probe whether attendees thought the concept of deliberately infecting people with coronavirus was acceptable, what concerns volunteers might have, and whether and how much they should be compensated for taking part. This found the overall response to be positive, and many attendees said they would like to volunteer to take part in such a study for altruistic reasons.

To build upon this work, HIC-Vac (an Imperial-led international network of researchers who are developing human infection challenge studies) funded a more extensive public consultation programme to include a larger, more diverse group of people across the UK. Our teams from Imperial College and the University of Southampton and University Hospital Southampton NHS Foundation Trust worked together to explore and capture public perspectives from different geographic regions which reflected a balance of ages, ethnicities and gender. The consultation activities included a survey of 2,441 UK adults (via an independent market research and data analytics company and networks linked to Imperial and Southampton) and several in-depth online focus groups (with 57 UK adults) to explore the survey findings in more detail.

We found the survey and focus group responses revealed overall agreement that a COVID-19 human challenge study should take place in the UK3. People taking part highlighted that in their view transparency of information about the study, trust and clear information on potential risks to study participants would be important. Our consultation also raised interesting points around the perceived risks of the study (including the mental health impact on study participants from being in isolation once exposed to the virus) and the need for clear information regarding the practicalities of taking part (for example the availability of WiFi and access to natural light and fresh air).

Involving the public in study design

Maria Piggin, Partnerships and Training Manager at the NIHR Imperial Patient Experience Research centre said:

“Public involvement is when members of the public, including patients, work alongside researchers to directly contribute to how research is designed, carried out and shared. It is considered a pre-requisite for high-quality medical research. It can help ensure research remains aligned with the needs and priorities of patients and the public, improves the practical experience of people participating in a study, and ensures that research findings are communicated clearly and to all those affected by the research. Public involvement can also help define what is likely to be acceptable to participants and society more broadly. We have excellent resources on public involvement as do the Health Research Authority and the National Institute of Health Research.”

Once the official partnership leading the COVID-19 human challenge study had been announced, our Imperial and Southampton teams involved a broad range of individuals (66 adults) across the UK for more specific discussions relating to perspectives and feedback on potential participation in this kind of study, study design, study information and consent4.

When our study was being designed, large UK data sets reported an increased risk of poor outcomes after contracting COVID-19 for ethnic minorities. One example of how public involvement informed the study design was a discussion with individuals from ethnic minorities about the potential inclusion or exclusion of people from ethic minority backgrounds based on their risk profile. Subsequently our study team decided that people from ethnic minorities should not be excluded from the study and a risk-assessment tool (QCOVIDTM) was utilised to help mitigate some of the extra risk to volunteers from ethnic minorities. A review of the study materials by members of the public led to the addition of new information, comparisons and visual aids to help volunteers consider the practicalities and risks involved before participating. Following the start of the national roll out of vaccines and the emergence of the COVID-19 Alpha variant (lineage B.1.1.7), a public involvement discussion explored the justification and benefits of carrying out a COVID-19 human challenge study in these circumstances, and concluded there was continued support for the study.

Presentation to the REC

The public consultation and involvement activities enabled public input into the concept and design of this human infection study at the initial stages and beyond.

Our findings from all these activities were discussed with the wider study team in order to implement changes where appropriate. We also submitted early insights to the REC as part of the ethics application to support their review of the study, and they were “pleased to note the detailed public involvement the research team had undertaken”5.


  1. Key criteria for the ethical acceptability of COVID-19 human challenge studies
  2. Exploring the acceptability of controlled human infection with SARSCoV2—a public consultation
  3. Welcome Open Research – Public attitudes to a human challenge study with SARS-CoV-2: a mixed-methods study
  4. The role of public involvement in the design of the first SARS-CoV-2 human challenge study during an evolving pandemic – ScienceDirect
  5. UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies

Dr Emma Smith is the HIC-Vac Network Manager at Imperial College London.

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