Help - Preparing & submitting applications - Ethical review (REC)
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Ethical review (REC)

Preparing and submitting applications for ethical review in IRAS




IMPORTANT: Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).

The way in which applications for CTIMPs and IMP/Device trials are made is changing to a combined MHRA and ethics review. From 01 January 2022 applications for all new CTIMP and IMP/Device trials must be made via the combined review service, which can be accessed using the new part of IRAS.

  • If you planning to start a new CTIMP or IMP/Device trial application, please see the guidance on how to apply for combined review.
  • If you already have an existing application in progress, please ensure you complete all your approval applications promptly.



IMPORTANT: Eligibility Criteria for Student Research

Undergraduate Level: Health and social care research applications from students working at undergraduate level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland.

Master's Level: Applicants should complete the Student Research Toolkit in the first instance, to check eligibility. Some health and social care research applications from students working at Master's level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland.

Doctorate Level: Health and social care research applications from students working at doctorate level are being accepted for Research Ethics Committee (REC) review; HRA and HCRW Approval; and/or Research and Development (R&D) study-wide review in Scotland and Northern Ireland. Applicants may find it helpful to complete the Student Research Toolkit.

Please visit the Health Research Authority (HRA) website – Student Research for further guidance. For student research below doctorate level, it is very important to complete the Student Research Toolkit before proceeding with your application form.




This page provides the following information:

Research Ethics Committee (REC) reviews in IRAS


Research Ethics Committees (RECs) review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical.

Requirement for ethical review of research may be under:
  • Legislation applying to the UK as a whole or particular countries of the UK;
  • Policy of the UK Health Departments, where research relates to the services for which they are responsible.

IRAS provides the mechanism to apply for ethical review by RECs within the UK Health Departments’ Research Ethics Service (NHS/HSC RECs). NHS/HSC RECs safeguard the rights, safety, dignity and well-being of people participating in research in the NHS/HSC. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. Some types of research require NHS REC review by law whether or not they take place within the NHS or involve NHS patients or other service users. To help you decide whether your project needs NHS REC review, please refer to the HRA’s decision tool.

There are other types of REC that may review research applications but their applications are not within IRAS. These include:
  • Ministry of Defence Research Ethics Committee (MoDREC), which is responsible for the ethical review of research funded by or sponsored by the MoD, including research involving the UK Armed Forces, is carried out by MoDREC .
  • Higher Education Institution (HEI) Research Ethics Committees. Researchers in Higher Education Institutions (HEIs) are advised to check whether, under their institution’s policy and internal arrangements, ethical review is required by their HEI REC.

IRAS is used to apply for ethical review for project based research, research databases and research tissue banks.

Types of ethical review, REC types and REC flags

The Research Ethics Service provides two types of ethical review:
  • Proportionate Review (PR) – this provides an accelerated, proportionate review of research studies which raise no material ethical issues. Proportionate Review applications are reviewed via email correspondence, teleconference or at a face to face meeting by a sub-committee rather than at a full meeting of a REC. A PR review is as rigorous as a full REC review. Eligibility of an application for PR is assessed when booking in your application for ethical review based on your answers to the questions. In some instances applications reviewed in PR may need to be referred to a Full Committee Review. More information about PR is available on the HRA website.
  • Full committee review – if the application is not eligible for PR then it will be considered at a full REC meeting. Information about Full Committee Review is provided on the HRA website.

Depending on your planned research activity it may be a requirement or in some instances a recommendation to seek review from a particular type of REC:
  • ‘Recognised RECs’ are recognised by the United Kingdom Ethics Committee Authority (UKECA) for the review of CTIMPs, in accordance with The Medicines for Human Use (Clinical Trials) Regulations 2004.
  • ‘Flagged RECs’ are RECs which have expertise in reviewing particular types of research.
When you book your application for review you will be offered a choice of RECs with appropriate flags based on your answers to the questions. However, you may find it helpful to review the further detailed information on the HRA website and/or refer to the REC Directory to find out which RECs are likely to be suitable to review your research.


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How to apply for ethical review


Research projects involving the NHS/HSC – apply for ethical review by completing the ‘IRAS Form’, which is selected at filter question 4. The IRAS Form is a combined form, which replaces the previous separate application forms for ethical review and for NHS R&D. This route should be used when the project involves the NHS/HSC as well as if it involves both NHS/HSC and non-NHS sites. You will need to complete the application form, upload supporting documents, obtain electronic authorisations and book your application in before you electronically submit it. For further tips on making a successful application please refer to our tips section below.

Please note that:
  • if your project is led from England or Wales then when you electronically submit your application it will be submitted for HRA and HCRW Approval (see the IRAS Help page for more information). The application for HRA and HCRW Approval includes the REC review.
  • If your project is led from Northern Ireland or Scotland please refer to further information provided in IRAS Help page


Research projects that do not involve the NHS/HSC – apply for ethical review by completing NHS REC Form, which is available at filter question 4. This option becomes available when you select the option to indicate that the project does not involve the NHS at filter question 3a.

You will need to complete the application form, upload supporting documents, obtain electronic authorisations and book your application in before you electronically submit it. For further tips on making a successful application please refer to our tips section below.

Research tissue banks and research databases – apply for ethical review by selecting the Research Tissue Bank form or Research Database form at filter question 4. These form options become available if you select Research Tissue Bank or Research Database category at filter question 2. If you are establishing a collection of tissue and an associated database then you should select the Research Tissue Bank application to apply for ethical review of the tissue and data collection.

You will need to complete the application form, upload supporting documents, obtain electronic authorisations and book your application in before you electronically submit it. For further tips on making a successful application please refer to our tips section below.

Tips for successful REC application:


There are a number of errors that are seen in applications for ethical review. These usually delay the progress of an application and in some instances may lead to the application being rejected. Below are some tips to avoid some of the common application errors:
  1. Project filter
    • Make sure that you completed all questions in the project filter and that your selections accurately represent your project. Incomplete or inaccurate selections will mean that the dataset you generate is not appropriate for your research.
  2. Dataset
    • Make sure that you complete all fields in the form. You can review the form page by page online or create a pdf of your draft form.
  3. Supporting documents
    • Make sure that you upload your supporting documents to the Checklist tab for the form. Documents uploaded in either Project Documents or My Documents areas are not automatically added to the form checklist.
    • The checklist provides a list of the documents that are normally expected to support the application. Use this as a guide to the documents you should include although those that are marked as mandatory are expected in all cases. Where you are not including a document that is listed, enter a reason in the “reason not supplied” box. If you want to include a document that isn’t listed then add a row to include it by using the add row function at the bottom of the checklist.
    • When you upload documents make sure you enter the correct file title, version number and date.
  4. Authorisations
    • Make sure you have electronic authorisations in place for all declarations in the form and that they are shown as valid.
    • Do not add electronic authorisations until you are certain the application is complete. Any changes made to the dataset (except adding the REC Reference number and date after booking) will invalidate any authorisations that are already in place.
    • If your form requires multiple authorisations be aware that if one of the authorisers changes the form before they authorise it then any authorisations that were already in place will be invalidated and will need to be sought again.
  5. Submitting for ethical review
    • You must book your application before you electronically submit it. If you do not book the application it will be rejected and the submission history will show that your submission was invalid as no booking was made.
    • The REC cannot access the form or the documents until the application has been booked and electronically submitted.
    • If you change the content of the form and/or the documents in the checklist after submission then these changes are not sent to the REC. You will need to liaise with the REC to submit these updates.
    • Ensure you or someone else familiar with the research is available to be contacted in the days after submission. This will enable quicker resolution of any queries about the application.


In addition to the tips above you may wish to check whether your application is likely to meet the relevant validation criteria by referring to the Research Ethics Service Standard Operating Procedures. The SOPs are publicly available on the Health Research Authority website.


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After you have submitted your application


When the application is submitted it will be validated by a member of staff. At this stage the completeness of the application will be looked at and any initial queries raised. Therefore it is helpful if someone familiar with the research is available to be contacted so that any points can be resolved quickly.

If your application is being considered at a full REC meeting, you should attend the meeting, if possible. The details for the meeting will be emailed to you once your application is valid. Guidance for applicants attending a REC meeting is provided on the HRA website.

After ethical review you will be notified of the RECs decision in writing. Ensure that you carefully read this correspondence as it will contain information about any revisions or clarifications that are needed as well as any conditions associated with the opinion given.

If you receive a provisional opinion from the REC then you will need to respond to the issues that have been raised before a final opinion is given. The provisional opinion letter will provide information about the issues that have been raised. To respond to these points you may need to submit an updated version of your application form and/or supply further supporting documents (this may include revised versions of documents you have previously supplied and/or new documents). Your response to the REC must be electronically submitted from IRAS by following these instructions.

If you have any issues, wish to appeal an unfavourable opinion, raise concerns about the ethical review of your research or provide feedback then please refer to the HRA website for further information about what to do.


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Page last updated: 14 September 2021




 
IRAS Integrated Research Application System, version 5.21, 14/09/2021, IRAS Dataset version 3.5.
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