Fast track review guidance for COVID-19 studies

How we decide which studies will be fast-tracked

COVID-19 studies are assessed by the HRA’s Director of the Approvals Service or their delegate to determine whether they will be accepted for fast-track review. New studies will be accepted for fast-track review if they fall into the following categories and will produce interim or final published results within one year.

• A study of a vaccine, prophylactic or early treatment, or diagnostic for COVID-19
• A study to understand transmission of COVID-19

Studies accepted for fast track review will be reviewed within 1 week of submission.

The criteria and timings of review have been amended from the original criteria to reflect the large quantity of research already underway, significant progress with the vaccine programme and enable restart and recovery of research in other health areas. Researchers are encouraged to check what research is already underway through the research summaries published on the HRA website.

All other research on COVID-19 will be managed through normal submission processes and timelines.

Please liaise with the proposed sites for all COVID-19 research to ensure that there is capacity to undertake the study.

How to apply for fast-track review

Before you start to develop your protocol, please check the list of approved COVID-19 studies to ensure that limited resources during this time are not wasted on unnecessary duplication of research. Please also review our guidance for COVID-19 studies that brings together relevant information to help you develop your study.

Please contact us to enquire about the fast-track process at an early stage in your study preparation and let us know when you plan to submit. This helps us to plan in enough committee meetings for fast-track studies.

For CTIMPs or combined IMP/device trials you will need to create and submit using combined review. You will need to create a project ID in the new part of IRAS.

For non-CTIMPs please create a project ID on the IRAS website.

When you have done this, please send us an email, copying in your research sponsor. Please include any documents that you have ready and any questions you may have. The full list of information required for a fast-track study can be found below. Your application will be triaged and, if approved in principle for fast-track review, we will follow up with you to let you know the timeline. Please ensure that you include your contact details.

We require:

• 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
• 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 Research & Development offices and clinical services that they have the capacity to support this study now
• 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:

• tell us if the study will include Adults Lacking Capacity
• tell us if the study is funded by the United States Department of Health and Human Services (USDHHS)
• tell us 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), and
• give us a predicted date when you may be able to start the study.

We will aim to publish your research summary together with your contact details within 3 days of approval, this is quicker than our standard timeline of after three months for non-COVID-19 studies. We are doing this because it’s important that the research community and wider public can see information about COVID-19 studies taking place.

We are also asking sponsors not to request deferral of the publication of these research summaries. However, should you wish to make a request to defer publication please email study.registration@hra.nhs.uk as soon as possible stating the period of time you are requesting a deferral for and the reason for the deferral request. We will postpone publication of your summary whilst your deferral request is under consideration. Find out more and view existing studies on our approved summaries page.

Public involvement is important and expected in COVID-19 research as much as it is for other research. It is also possible to involve patients and the public to the same rapid timescale that studies are being designed and set up. If you need advice on how to contact and involve people with relevant lived experience, contact our Public Involvement Team via fast.track@hra.nhs.uk. We can put you in touch with groups or networks who can arrange input rapidly and at short notice. You will usually receive a response on the same day or next working day.

If you intend to use confidential patient information without consent, please see our guidance.

We will consider requests for fast-track review as soon as possible. Please email us at fast.track@hra.nhs.uk

You will usually receive a response on the same day or next working day.

Please also contact:

• the NIHR Clinical Research Network and/or the national contact in Scotland or Northern Ireland as appropriate for the location of the sites
• other regulators, for example the MHRA, if the study requires clinical trial authorisation