Fast-track research ethics review

1. Eligibility criteria for fast-track ethics review
2. What is the application process/how can I book?
3. Are there any other expectations of sponsors?
4. Is there still availability for the fast-track research ethics review?
5. How many studies can I put through the fast-track research ethics review?
6. Where do I get updated about the fast-track ethics review?
7. Validation criteria
8. Questions and answers

Eligibility criteria for fast-track review

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 need to contact one of the RECs participating in the fast-track service directly to arrange your review. This will be a Type I REC which accepts seven-day submission and is recognised to review CTIMPs in healthy volunteers.

These RECs are listed on this web-page along with instructions.

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: Select a REC

One of the key benefits of our fast-track service is that you can reserve a slot for your research ethics review ahead of time and submit up to seven days prior to the meeting. To book your review click on the links below to check when each REC meets and to get their contact details. Then contact the REC to book your preferred date.

The current RECs are accepting fast-track applications:

• London - Riverside
• London – West London & GTAC
• London – Westminster
• Wales REC 1
• Wales REC 2
• East of England – Cambridge Central
• London – Brent
• London – Chelsea
• London – Hampstead
• London – Harrow
• London – London Bridge
• London – Surrey Borders
• North East – York
• North West – Greater Manchester (GM) Central
• South Central – Berkshire B
• South Central – Berkshire
• South Central – Oxford A

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

• Study title
• IRAS ID
• Phase of the trial
• Confirm how your trial meets the eligibility criteria for fast-track research ethics review
• Is the trial taking place in the NHS/HSC?
• Which UK nation is the trial being led from? (trials taking place in the NHS/HSC only)
• Name and contact details of the sponsor
• Does the study involve participants under 16?
• Does the study involve adults lacking capacity?
• Does the study hold funding from the US department of health?
• Does this study involve the review of a gene therapy trial?
• Do you intend to apply for radiation assurance or pharmacy assurance as part of this submission?
• Chosen REC
• Chosen REC meeting

We highly recommend applicants attend the meeting.

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). Applications should be submitted at least seven-days before the REC meeting.

If you intend to use our Radiation or Pharmacy Assurance services alongside fast-track ethical review, submissions for Radiation or Pharmacy Assurance must be made 40 calendar days before the cut-off date for your chosen REC meeting.

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 seven days before your REC meeting by 12pm.

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.

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?

We expect our updated service to remain very popular. Please select your REC as early as possible.

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

As long as there is a REC available, you are welcome to submit as many studies as you wish through the fast-track ethics review. Each study will need to be submitted as a separate application.

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. You are no longer be required to add a EudraCT number in the combined review system when making your initial application, but if you already have a EudraCT number for a global trial you should include it
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

Fast-track Research Ethics Review questions and answers

What if we’d already requested a slot with the current fast-track REC?

Reservations for fast-track REC meetings in August and beyond have already been placed on other REC meetings. We will contact the Chief Investigator and the Sponsor for each specific study in a separate email to let you know your new REC.

What do we do if we want to submit a fast-tracked research ethics review?

From 1 August, you will be able to contact one of the RECs participating in the fast-track research ethics review service directly to arrange this. These are listed on the HRA website along with instructions.

What will happen to my study if it is still pending a final REC decision?

Studies still awaiting a REC decision will be transferred to one of the existing Type I and Type III RECs recognised to review CTIMPs during July and they will review any further responses to the REC and be able to make the final decision. We will support the receiving REC with expertise from the fast-track REC that is familiar with the initial review of the study.

What will happen to my study if it has already been approved?

Studies without any open amendments will be transferred to one of the existing Type I and Type III RECs recognised to review CTIMPs and they will review any future post approval activity including amendments and safety reports for these studies. We will contact the Chief Investigator and the Sponsor for each specific study in a separate email during July to let you know your new REC.

What does this mean for amendments?

Amendments already submitted to the standalone fast-track REC which have not yet received a final ethics opinion will be reviewed by the fast-track REC. For future amendments, you will be provided with the details of the specific REC which will be reviewing the amendments going forward.

Will applications being transferred to REC meetings after 1 August have the same submission deadline and meeting date?

Applications booked for a meeting after 1 August will have to submit at 12pm seven days before the REC meeting date.

Will there be a choice of weekly meeting slots from the RECs offering a fast-track research ethics review service?

You will be able to reserve a slot at a range of upcoming meetings directly with the RECs supporting the fast-track research ethics review service. Subject to availability, we anticipate there will be a choice of at least one or two RECs each week. This is an increase in our current capacity. We will monitor how this works and continue to hear your feedback as we go through this transition period.

Will there now be more fast-track slots available?

Yes as there will now be more fast-track research ethics review slots available with 17 RECs accepting fast-track applications submitted seven days before the REC meeting. We anticipate these will be popular and advise you to book your slot as soon as possible.

Will the RECs offering a fast-track research ethics review service provide early feedback after the meeting? Will they be able to match the timelines we’ve seen from the fast track REC (two to three days after the meeting)?

Yes RECs will continue to offer early feedback after the meeting. These should be available five days after the meeting on average, which is much earlier than applications submitted through the normal route and will allow us to continue to deliver the key benefits of fast-track whilst also making sure this is sustainable for the future.

Fast-track research ethics review used to allow submission by 12pm on Friday for a meeting the following Wednesday (ie a 5-day submission deadline). Will the RECs offering a fast track research ethics review service also operate a 5-day submission deadline?

Submission will be required by 12pm seven days before the REC meeting date. This will allow us to continue to deliver the key benefits of fast-track whilst also making sure this service is sustainable for the future.

Will we be able to select a REC familiar with our processes and documents that has reliable and favourable review timelines?

All fast-track research ethics review applications will be given priority and have faster research ethics review timelines than applications submitted through the normal route.

You will be able to choose from one of a number of fast-track research ethics review service RECs available and can continue to opt for this REC going forwards

Are the REC meetings offering a fast-track research ethics review service spread evenly through the month?

The REC meetings are spread through the month with at least two RECs offering a fast-track research ethics review meeting each week, but often between three to seven.