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Fast-track research ethics review

Last updated on 12 Apr 2021

Our fast-track research ethics review provides a rapid research ethics review for global clinical and phase I trials for any disease area. Following a three-month pilot period between January and March 2021, we are extending the fast-track research ethics review until at least June while we complete our evaluation. We will also explore how a fast-track ethics review can be incorporated into wider rapid approval and study set-up processes. This includes integration into the combined review with the Medicines and Healthcare products Regulatory Agency, which offers a single application, combined review and decision for a clinical trial.

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 service has now been extended into April, May and June while we complete the evaluation our initial pilot.

Fast-track 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 that by contacting our fast-track REC team on:fasttrack.rec@hra.nhs.uk.
You can contact us now to register interest in a REC slot for April, May or June 2021.
Complete the normal clinical trial application in IRAS. This fast-track research ethics review is not using the Combined Ways of Working (CWoW) application.

Step 1: Register your trial application

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
  • approximate submission date

Step 2: Confirm your submission date

When you are confident that you will be able to submit your application within a particular time period (REC meeting submission period), please contact fasttrack.rec@hra.nhs.uk to confirm your readiness.

Committee meeting dates and submission periods can be found here.

From April fast-track REC meetings will be on Wednesdays starting at 9am. We highly recommend that applicants attend the meeting.

Meeting Submission window Availability
24/03/2021 15/03/2020 – 2pm on 19/03/2020 full
31/03/2021 22/03/2020 – 2pm on 26/03/2020 full
14/04/21 05/04/21 – 12pm on 09/04/21 full
21/04/21 12/04/21 – 12pm on 16/04/21 full
28/04/21 19/04/21 – 12pm on 23/04/21 high interest
05/05/21 26/04/21 – 12pm on 30/04/21 available
12/05/21 03/05/21 – 12pm on 07/05/21 available
19/05/21 10/05/21 – 12pm on 14/05/21 available
26/05/21 17/05/21 – 12pm on 21/05/21 available
02/06/21 24/05/21 – 12pm on 28/05/21 available
09/06/21 31/05/21 – 12pm on 04/06/21 available
16/06/21 07/06/21 – 12pm on 11/06/21 available
23/06/21 14/06/21 – 12pm on 18/06/21 available
30/06/21 21/06/21 – 12pm on 25/06/21 available

Once you have confirmed your submission 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 3: Submit application

All applications 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.

Step 4: 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 14:00 on the Friday before your REC meeting in order 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 submission.

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?

Yes. Fast-track ethics review slots may fill up over time, but we have availability at the moment. Depending on the number of applications, we may not be able to book your application into the first available fast-track REC meeting. Please see: what is the application process/how can I book?

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) been named, and that evidence 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 been electronically authorised by the Chief Investigator
  13. check the form been electronically authorised by a representative of the lead sponsor
  14. if the research involves the use of ionising radiation, check the form 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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