An update from the Health Research Authority (HRA) on 6 April 2020 regarding COVID-19: Regulatory Approval and Transparency
Research is central to understanding, treating and preventing COVID-19. We all want research to start as quickly as possible and to maintain high standards of research practice.
Research Ethics Committee review is a vital component of COVID-19 research. It cannot be done retrospectively, so it is important to get this before you start your research. Studies without a favourable research ethics opinion may not be published by a journal and may not confirm to research governance standards.
Applying for ethics review of your COVID-19 study does not take long and we can provide support throughout the process.
If you are not sure whether your project is classed as research, please use our decision tool.
Fast-track review of COVID-19 studies
The HRA is working with the rest of the research system to provide a coordinated process so that COVID-19 research can progress quickly. We are using a fast-track review process with bespoke advice and support for researchers. The average review timeline is 5 days, with many completed within 24 to 72 hours.
We have updated the information on our website about the fast-track review process, guidance for researchers, sites and sponsors, guidance about using confidential patient data without consent and information about how we are handling other types of research.
Our review takes place in parallel with the Chief Medical Officer’s prioritisation process for COVID studies.
COVID-19 research transparency
Research transparency is even more important at this time. It ensures researchers and sponsors know about other studies taking place across the UK and creates important visibility for the public, health and social care professionals and policy makers.
We have introduced an additional step in our normal transparency arrangements, on behalf of the four nations, to ensure that information about COVID-19 related research is made public as quickly as possible. Summary information about each COVID-19 research project is on our website.
Jen Harrison
HRA Approval Change Manager
Health Research Authority