Nuffield Council of Bioethics Responds to the Announcement of UK COVID-19 Human Challenge Trials

|| Wednesday: November 11: 2020 || ά. On October 20 the UK Government announced that it would work with partners to develop a COVID-19 human challenge study model. This will include the manufacture of the challenge virus and will be the first in-human characterisation study for COVID-19. In human challenge studies, participants are deliberately infected with the virus in question in order to gain knowledge in controlled circumstances about how the virus behaves or, in order to see, if, an investigational vaccine provides protection.

In response to this Nuffield Council of Bioethics has said the following: Given the scale of the global challenges, that COVID-19 poses, challenge trials could, potentially, play a useful role alongside the many other studies, currently taking place. However, they come with their own unique set of ethical considerations and risks, that must be addressed by all those, involved in the study, a properly constituted ethics committee, researchers and funders.

The World Health Organisation:WHO has published guidance on the issues, that such a committee should consider and, also, recommended that any proposed COVID challenge study should be reviewed by a specialist ethics committee with the necessary scientific and ethical expertise. We understand that the Health Research Authority has established such a specialist ethics committee in order to be prepared for any applications to run a challenge trial in the UK and we warmly welcome the establishment of this committee.

Today’s announcement highlights an early stage of the human challenge trial process and will require ethical approval before it goes ahead. Those, involved in the developing the study model and in any specific research proposal, must, now, consider the following:

::: Scientific justification: is a challenge study the most appropriate approach? Can the same benefit be gained for lower risk in a different kind of study?

::: Engagement with the wider public. Researchers and funders must consult and engage with the wider public from the beginning. They must make sure that public concerns are properly understood and addressed and that anxieties based on misconceptions can be avoided.

::: Assessment of risks and benefits: potential benefits must outweigh risks, taking into account the interests of three groups: participants, society in general and third-party contacts of participants. Researchers and funders must consider what actions must be taken to minimise risks, such as, finding an appropriate dose of the challenge virus and mitigate those risks, that remain, for example, by determining which volunteers are highly unlikely to develop serious disease, how volunteers will be monitored and ensuring that they have access to the best possible care.

::: Informed consent: There are significant challenges in ensuring volunteers thoroughly understand the risks and the uncertainty of any benefit. Volunteers will, also, be committing to stay within a bio-secure facility until they are no longer infectious.

The Council hopes that this process will involve a wide range of voices in considering how this might go forward.