NextCOVE, how the HRA handles complaints and concerns raised

Last updated on 3 Nov 2023

The Health Research Authority (HRA) has received a number of questions and concerns about NextCOVE, a clinical trial of a new Covid vaccine for adults and children over the age of 12. The study, sponsored by the pharmaceutical company Moderna, intends to recruit more than 8000 people to take part across sites in America and Canada, as well as the UK.

Last week, some of these concerns were raised in the Houses of Parliament as part of the second reading of a bill proposing a review of the compensation offered to people disabled by Covid vaccinations. Comments in parliament were then picked up in the media.

The HRA is one of a number of bodies responsible for the regulation and governance of health and social care research in the UK. Our primary role is to protect and promote the interests of patients and the public in research.

Research projects involving people, their tissue of their data need a number of approvals before they can go ahead. This may include an independent opinion from a Research Ethics Committee (REC).

The HRA is the appointing authority for RECs in England. We are responsible for setting up and running RECs as well as appointing members, and it is the members’ responsibility to consider the ethics of a research application.  RECs are made up of a mixture of people with different skills and experiences including healthcare professionals and lay members who are not current healthcare professionals. This balance of members is a legal requirement for studies involving medicines, including vaccines.

RECs protect the rights, dignity and wellbeing of those taking part in health research and help high quality research to start quickly. They consider the ethical issues presented by an individual application – which vary depending on each study – but all RECs work within the same review principles.

The NextCOVE study received a favourable ethics opinion from South Central – Berkshire B Research Ethics Committee earlier this year.

When concerns are raised with us about a study which has had REC review, they are overseen by a group of senior staff which looks at whether this is a complaint about the HRA, or about a study. If it’s the latter, then we need to make sure that the concerns raised are within the remit of the HRA. If not, we will signpost people to other organisations. If so, we investigate concerns either in line with our Complaints Policy or our third party complaints procedure. We publish these policies and procedures on our website so that people communicating with us know what to expect.

Our investigation might include reviewing the documents submitted by the study team and that the REC used to make its ethics decision. We may talk to staff and the volunteer REC members involved in the review, and usually contact the study team to ask questions about the concerns raised. Depending on the type of study and the type of complaint, we may also need to work with other regulators.

At all stages, we keep in touch with the people who have raised complaints with us to let them know what we’re doing and what happens next.

As an arm’s length body of the Department of Health and Social Care, and with a statutory function set out in the Care Act, we can only review issues raised that are within our remit, and act within our powers. The HRA doesn’t have any authority to audit or inspect studies when people tell us about breaches of the research protocol, conditions of research approval or where they’ve heard about activity which doesn’t comply with the principles of good clinical practice. However where we have serious concerns or new information comes to light, the REC can suspend or withdraw its favourable ethics opinion, meaning the study would need to be paused until a new opinion is in place. Our remit does not extend to sanctioning researchers, sponsors or funders.

For that reason, sometimes people raising concerns with us may also be encouraged to raise the same issues with other regulators, or other organisations involved in the research such as the sponsor, the funder, and any research sites.

We continue to review the concerns raised with us about the NextCOVE study and are in conversation with the study team. We will update this page when we have completed our investigation in line with the policy and process set out above.

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