The Health Research Authority protects and promotes the interests of patients and the public in health and social care research. We make sure that research taking place in the NHS is ethically reviewed and approved. Researchers who want to start a study apply to us for permission to do so, which usually involves attending a Research Ethics Committee (REC).
Our review process is designed to provide the right amount of scrutiny in the shortest time possible. This ensures that health and social care research is safe, legal, ethical and fair.
During a public health emergency, time is of the essence. When faced with a new adversary, such as pandemic flu or coronavirus, health research studies enable us to understand more about the condition. They help to generate better diagnoses, test new treatments and can help to prevent and manage the spread of disease. Recently the National Institute of Health Research (NIHR) and UK Research and Innovation (UKRI) announced that £20m was available for new studies which could help with the coronavirus outbreak.
To ensure that this kind of research can start as soon as possible, in some cases the HRA and devolved administrations are able to fast-track the review of a study. This means that researchers receive approval to begin much more quickly than the usual timelines, sometimes in a matter of hours. The full process for fast-track reviews is set out in the Standard Operating Procedures for Research Ethics Committees.
If a researcher has a study which they think needs fast-track review they should contact the Director of the Approvals Service as soon as possible. If the research is taking place in the NHS, they also need to contact the NIHR Clinical Research Network or the equivalent operations lead in the relevant devolved nation. Information on how to do this is available in the emergency approvals section of our website. These senior staff quickly consider the potential impact of any delay on public health and give the researcher, or sponsor, permission to submit an urgent application. The researcher will also be advised to contact other regulators, for example the Medicine and Healthcare products Regulatory Agency (MHRA) if the study requires clinical trial authorisation.
Emergency applications are still subject to a robust ethics review. The Director of the Approvals Service can either arrange for an existing Research Ethics Committee (REC) to hold an extraordinary meeting, or for a new REC to be formed to consider a particular application. Specialists can be invited to join, but the committee should contain the same mixture of lay and expert members as would usually be the case, to ensure that the quality of review is the same. More information about this process is set out in the Standard Operating Procedures for Research Ethics Committees (SOPs).
At all points in the process, the HRA will keep the research team informed, letting them know the outcome as soon as possible.
This fast-track approach relies on the heavy involvement of key individuals. It’s expensive, and only possible in a very small number of cases where a delay to the study start would, for example, prevent any learning from the outcomes. It’s expected that almost all of the 6000 studies reviewed each year by the HRA will use the standard process.
As worldwide cases of coronavirus pass 100,000, and funders work quickly to commit money to studies in this area, it is crucial that the HRA, working with partners in the devolved administration, is ready and able to facilitate high-quality research quickly if needed.