COVID-19 studies submitted to the Health Research Authority for fast track review are currently being approved in as little as 24 to 72 hours.
The timelines reflect the significant public health interest in studies to learn more about the spread of Coronavirus, or to test new treatments.
process for fast-track reviews is set out in the Standard Operating Procedures for Research Ethics Committees. If agreed
that your application is a priority, we can arrange for it to be reviewed at a
scheduled meeting, for an existing REC to hold an extraordinary meeting, or for
a new REC to be formed to review the study. Fast-track studies are overseen by
the Director of the Approvals Service who will liaise with colleagues in
Scotland, Wales or Northern Ireland if applicable. The process supports and aligns with the prioritisation process put in place by the Chief Medical Officer.
Researchers who have a study that they would like to be considered for fast-track review should contact us using the telephone numbers at the bottom of this page. We’ll take some basic information and ask you to send us an email copying in your research sponsor. Your application will be triaged and, if approved in principle for fast-track review, we will follow up with you by phone for more information.
Please register the proposed study on the IRAS website and be ready to discuss:
- A brief summary of the study (if you have a protocol or one-page summary already please let us know)
- Your current working title, and IRAS ID if available
- When you expect you will be able to submit the full study via IRAS
- Whether the study involves the NHS and, if so, if you have agreement in principle from the relevant R&D offices and clinical services that they have the capacity to support this study now
- Whether you have applied for prioritisation of this project from the Chief Medical Officer
- Whether the study is a Clinical Trial of an Investigational Medicinal Product (CTIMP). If so then you will also need submit to the Medicines and Healthcare products Regulatory Agency (MHRA). We will liaise with them to expedite the review. If it is a CTIMP, our Pharmacy Assurance process can support site set up.
- Whether the study involves ionising radiation. If so, our Radiation Assurance process can support site set up
We will also ask you to:
- Confirm if the study will include Adults Lacking Capacity
- Confirm if the study is funded by the United States Department of Health and Human Services (USDHHS)
- Confirm which nations the study will include (if this is Scotland, Northern Ireland or Wales please also contact the research operations lead in the relevant nation
- Give us a predicted date when you may be able to start the study
If you intend to use confidential patient information without consent, The Confidentiality Advisory Group can also provide fast-track review.
We will consider requests for fast-track review as soon as possible. During office hours please contact the HRA Mainline on 020 797 22545. Out of hours please contact 020 710 48322.
More than 40 COVID-19 studies have now been submitted to the Health Research Authority, and you can read more about how we are working with partners across the UK to ensure that this research can be prioritised in our news story. We are grateful to study teams for their support in helping the HRA to work as effectively as possible at this time.