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Fast-track research ethics review

Last updated on 25 Oct 2021

Our fast-track research ethics review provides a rapid review for global clinical and phase I trials for any disease area in roughly half the time of a usual ethics review. This page has all the information you need about how to apply.

The fast-track ethics committee accepts applications submitted through combined review. Our combined review service brings together a single Clinical Trial of Investigational Medicinal Products (CTIMPs) application for both Clinical Trial Authorisation and Research Ethics Committee opinion. It will apply to all CTIMPs from 1 January 2022.

If you would like to talk to us about fast-track ethics review within combined review, please contact the fast track team by emailing: fasttrack.rec@hra.nhs.uk.

Introduction

The fast-track research ethics review was initially piloted between January and March 2021 to test whether the Health Research Authority, on behalf of the UK, could establish a sustainable model for providing rapid research ethics review.

It builds on our work providing fast-track ethics review for COVID-19 research.

The fast-track research ethics review involves:

  • a shorter time period between submission and the REC meeting
  • review by a dedicated fast-track committee, with one paid chair and experienced members drawn from a panel
  • faster turn-around of correspondence with applicants.

Eligibility criteria

Which studies are eligible for the fast-track review?

Fast-track ethics review is open to global clinical trials and phase I trials, whether the sponsor is commercial or non-commercial. This includes:

  • any Clinical Trial of an Investigational Medicinal Product (CTIMP) led from UK with at least one other country participating
  • any CTIMP led from outside the UK which could be placed in any country and the UK is competing for participation (including any only taking place in the UK)
  • any phase I or phase I/II CTIMP in healthy volunteers or patients

The following are not eligible for fast-track ethics review:

  • any CTIMP involving a gene therapy medicinal product
  • any CTIMP funded by the US Department of Health and Human Services
  • any other type of clinical trial or research study.

What is the application process/how can I book?

You will need to request entry into the fast-track research ethics review before applying.

Please do this by contacting our fast-track REC team on:fasttrack.rec@hra.nhs.uk.
Applications via fast-track without combined review are completed via IRAS (Integrated Research Applications System).

Applications submitting via the combined review process should complete in the new part of IRAS.

For specific queries about combined review, please visit the combined review guidance page.

Step 1: Register your trial application and book your meeting date

Contact fasttrack.rec@hra.nhs.uk

You will need to provide the following details (where possible):

  • trial title
  • IRAS ID
  • EudraCT number
  • phase of the trial
  • is the trial taking place in the NHS/HSC
  • which UK nation the trial is led from (trials taking place in the NHS/HSC only)
  • name and contact details of the sponsor
  • how your study meets the eligibility criteria for the pilot
  • whether it involves participants under 16
  • whether your study involves adults lacking capacity
  • the fast-track REC meeting date you want to book for

Committee meeting dates and submission periods can be found here.

Fast-track REC meetings are on Wednesdays, starting at 9am. We highly recommend applicants attend the meeting.

Meeting Submission window Availability
15/09/21 06/09/21 to 12 pm on 10/09/21 Full
22/09/21 13/09/21 to 12 pm on 17/09/21 Full
29/09/21 20/09/21 to 12 pm on 24/09.21 Full
06/10/21 27/09/21 to 12 pm on 01/10/21 Full
13/10/21 04/10/21 to 12 pm on 08/10/21 Full
20/10/21 11/10/21 to 12 pm on 15/10/21 Full
27/10/21 18/10/21 to 12 pm on 22/10/21 Full
03/11/21 25/10/21 to 12 pm on 29/10/21 Places available
10/11/21 01/11/21 to 12 pm on 05/11/21 Places available
17/11/21 08/11/21 to 12 pm on 12/11/21 Places available
24/11/21 15/11/21 to 12 pm on 19/11/21 Places available
01/12/21 22/11/21 to 12 pm on 26/11/21 Places available
08/12/21 29/11/21 to 12 pm on 03/12/21 Places available
15/12/21 06/12/21 to 12 pm on 10/12/21 Places available

Once we have confirmed your booking and the application has been allocated to a REC meeting, you will be issued with a REC reference number. You do not need to use the online booking system.

Step 2: Submit application

All applications via combined review with fast-track are submitted via a new part of IRAS.

Applications via fast-track without combined review are submitted via IRAS (Integrated research Application System).

Note: If you will not complete the above process by the date agreed in Step 1, contact fasttrack.rec@hra.nhs.uk to rearrange your REC review as soon as possible. We reserve the right to exclude applications from organisations which repeatedly do not meet the submission date and do not cancel with sufficient notice.

Step 3: Validation Process

Validation checks will be completed on your application. This will involve checking that all required documents have been submitted and that the documents can be opened and are readable. If the application is not valid, and there is time before the meeting, you will be given the opportunity to correct this. The application will need to be valid by 2pm on the Friday before your REC meeting to be able to proceed the following Wednesday.

Are there any other expectations of sponsors?

To maximise the chance of a favourable opinion, we expect sponsors to submit applications of a high quality which meet the expectations of the REC. We will use standard validation criteria to check the completeness of the application. Failure to meet any of the validation criteria will delay your application being valid for REC review. Failure to meet the criteria by 2pm on the Friday of your submission window will mean you will not be able to proceed to your REC meeting, and you will have to rebook.

We will also scrutinise the following elements of the application:

  • whether the participant information sheet (PIS) is suitable for a UK audience (such as uses UK English and does not make references to the US healthcare system)
  • whether there is a short summary of the PIS to aid understanding by prospective participants
  • whether there is evidence of public involvement and a description of how it helped address the ethical aspects of the study
  • whether there is a description of how the results will be communicated to participants.

Please read our one-page guidance for applicants: helping to ensure public involvement informs ethical review.

Failure to meet these elements of the application will not make the application ineligible for the fast-track ethics review. However, it is likely to result in queries and requests for changes that will delay issuing a favourable opinion.

Is there still availability for fast-track ethics review?

Slots fill up quickly. Please follow the guidelines under what is the application process/how can I book? to request a place.

How many studies can I put through the fast-track ethics review?

As long as there is a slot available at the meeting date of your choice, you are welcome to submit as many studies as you wish through the fast-track ethics review.

Where do I get updates about the fast-track ethics review?

Updates about the fast-track ethics review will be added on this page.

Validation criteria

Check your study will be valid before you submit

  1. all relevant sections and questions in the application form must be completed and all text must be in English and clearly legible
  2. check the project filter has been completed correctly
  3. check the study type has been completed correctly
  4. check the EudraCT number has been entered on the application form
  5. check the Chief Investigator is professionally based in the UK
  6. check the lead sponsor and sponsor's contact point has been provided
  7. check the Chief Investigator is an authorised health professional (for example a doctor, dentist, nurse or pharmacist)
  8. if the sponsor is based outside the UK or EEA, check a legal representative based in the UK or European Economic Area (EEA) has been named, and that evidence has been provided that this person or body is established within the UK or EEA, and has accepted the role of legal representative (for example a copy of relevant correspondence)
  9. written evidence of scientific critique must be uploaded or the free text box at describing the review process must be completed
  10. check details have been provided for who has reviewed the statistical aspects of the research
  11. check that insurance or indemnity arrangements to meet potential liabilities relating to the management, design and conduct of the research have been provided (except where NHS indemnity will apply)
  12. check the form has been electronically authorised by the Chief Investigator
  13. check the form has been electronically authorised by a representative of the lead sponsor
  14. if the research involves the use of ionising radiation, check the form has been electronically authorised by a Lead Medical Physics Expert and Lead Clinical Radiation Expert
  15. all documents listed in the checklist must be uploaded (including those for study-wide review for studies in the NHS led from England or Wales). Remember to check for all the supporting documentation required based on the study type and participant population like participant information sheets for different age groups.
  16. check supporting documents have been marked with version numbers and dates in the case of the research protocol, information sheets, consent forms, letters to participants or others with an interest in the research, and any other documentation to be used in the research that is not already scientifically validated and referenced
  17. check the short curriculum vitae been uploaded for the Chief Investigator
  18. check a research protocol been uploaded
  19. if a similar application has previously been submitted for review and rejected, check a copy of the unfavourable opinion letter is uploaded with a covering letter or explanation in the application form (at A6) of how the new application addresses the reasons given for the unfavourable opinion, and with highlighting of any changes to study documentation, and documents given revised version numbers and dates where applicable
  20. if the study involves non-NHS/HSC sites, check the non-NHS/HSC Site Assessment form been completed along with the required supporting documentation

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