Our new fast-track research ethics review pilot opens 4 January 2021 and will run until 31 March 2021. It will test a rapid research ethics review for global clinical and phase I trials for any disease area.
- Aims of the pilot
- Eligibility criteria
- When does the pilot begin and end?
- What is the application process/how can I book?
- Committee meeting dates
- Are there any other expectations of sponsors?
- Is there still availability for the pilot?
- How many studies can I put through the pilot?
- Where do I get updated about the pilot?
- What happens after the pilot?
- Validation criteria
The pilot will test whether the Health Research Authority, on behalf of the UK, can establish a sustainable model for providing rapid research ethics review.
It builds on our work providing fast-track ethics review for COVID-19 research.
Aims of the pilot
What are you testing through the pilot?
The pilot aims to test the demand for, and feasibility of a fast-track ethics review service. The service 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
Which studies are eligible for the fast-track review pilot?
The pilot 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 the pilot:
- 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
When does the pilot begin and end?
The pilot officially opens on Monday 4 January 2021, when you will be able to submit applications in IRAS. Please contact us before then to plan which Research Ethics Committee (REC) meeting you can attend. The first fast-track REC meeting will take place on Wednesday 13 January at 10am. Meetings will then be every Wednesday at 10am. The pilot will end on 31 March.
What is the application process/how can I book?
You will need to request entry into the pilot before applying.
Please do that by contacting our fast-track REC team on:email@example.com.
You can contact us now to register interest in a REC slot for January, February or March 2021.
Complete the normal clinical trial application in IRAS. This pilot is not using the Combined Ways of Working (CWoW) application.
You won’t be able to submit your application until Monday 4 January at earliest – depending on the date you are given for a REC.
Step 1: Register your trial application
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 firstname.lastname@example.org to confirm your readiness.
Committee meeting dates and submission periods can be found here.
|13/01/2021||04/01/2020 – 14:00 on 08/01/2020||full|
|20/01/2021||11/01/2020 – 14:00 on 15/01/2020||full|
|27/01/2021||18/01/2020 – 14:00 on 22/01/2020||full|
|03/02/2021||25/01/2020 – 14:00 on 29/01/2020||high interest|
|10/02/2021||01/02/2020 – 14:00 on 05/02/2020||high interest|
|17/02/2021||08/02/2020 – 14:00 on 12/02/2020||high interest|
|24/02/2021||15/02/2020 – 14:00 on 19/02/2020||high interest|
|03/03/2021||22/02/2020 – 14:00 on 26/02/2020||places available|
|10/03/2021||01/03/2020 – 14:00 on 05/03/2020||places available|
|17/03/2021||08/03/2020 – 14:00 on 12/03/2020||places available|
|24/03/2021||15/03/2020 – 14:00 on 19/03/2020||places available|
|31/03/2021||22/03/2020 – 14:00 on 26/03/2020||places 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 email@example.com 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.
Failure to meet these elements of the application will not make the application ineligible for the pilot. However, it is likely to result in queries and requests for changes that will delay issuing a favourable opinion.
We’d also like participants to help us to evaluate the pilot by completing a questionnaire about their experience of using the service.
Is there still availability for the pilot?
Yes. Pilot 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 pilot?
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 pilot.
Where do I get updates about the pilot?
Updates about the pilot will be added on this page.
What happens after the pilot?
We will use the pilot to determine the level of demand for a fast-track service, and to determine the resources required. We need to determine if this model is sustainable.
We are limiting this pilot solely to REC review, although we recognise that this is only part of the wider approval and study set-up process. We will also be exploring with partners what opportunities there are for fast-track options for other parts of the research journey.
Check your study will be valid before you submit
- all relevant sections and questions in the application form must be completed and all text must be in English and clearly legible
- check the project filter has been completed correctly
- check the study type has been completed correctly
- check the EudraCT number has been entered on the application form
- check the Chief Investigator is professionally based in the UK
- check the lead sponsor and sponsor's contact point has been provided
- check the Chief Investigator is an authorised health professional (for example a doctor, dentist, nurse or pharmacist)
- 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)
- written evidence of scientific critique must be uploaded or the free text box at describing the review process must be completed
- check details have been provided for who has reviewed the statistical aspects of the research
- 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)
- check the form been electronically authorised by the Chief Investigator
- check the form been electronically authorised by a representative of the lead sponsor
- 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
- 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.
- 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
- check the short curriculum vitae been uploaded for the Chief Investigator
- check a research protocol been uploaded
- 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
- if the study involves non-NHS/HSC sites, check the non-NHS/HSC Site Assessment form been completed along with the required supporting documentation