NHS ethical review

Submission to a NHS Research Ethics Committee (NHS REC) is governed by the Governance Arrangements for NHS Research Ethics Committees. The Health Research Authority has developed a decision tool to clarify where ethical review is required by a NHS REC under UK legislation and as directed by policy. Any research that involves NHS patients and carers, a Clinical Trial of an Investigational Medicinal Product, device, human tissue or invasive research involving prisoners or adults lacking capacity will require an ethical review by a NHS REC. If your study does not fall within these areas it will still have ethical implications and require review by a University research ethics committee.

Since 31 March 2016, NHS ethics review is sought as part of an application for HRA Approval. An application for HRA Approval is made and submitted on the Integrated Research Application System (IRAS). Please note: the HRA Approval process covers both NHS ethics review and the R and D element.

If you only wish to apply for NHS REC review (i.e. your study does not involve the NHS) there is still the option to do so on IRAS. 

Study set-up

During study set-up you will need to undertake the following: 

Engagement with participating NHS organisations

Statement of Activities and Schedule of Events

Contractual arrangements

How do I apply?

How do I submit my application?

The booking and submission of your application needs to take place on the same day.

The IRAS Form and supporting documentation must be electronically submitted from IRAS to the HRA.  

N.B. You will need to request all authorisations again if any changes are made after this stage, as the authorisations will be invalidated.

Once your application has been submitted you will receive a validation letter containing details of the NHS REC meeting at which your study will be reviewed; it is recommended that you attend this meeting. Communications with the NHS REC will take place directly between you and the REC.

At the same time the HRA will undertake an initial assessment of your study to ensure that your application is valid. The outcome of this initial assessment will be communicated to you and the NHS REC.

Progress of your application can be tracked via the e-submission tab on IRAS.

Once both HRA assessment and NHS REC review (where required) are complete you will receive notification of the outcome from the HRA in the form of a letter and guidance on what you should do next.

If your study involves NHS sites please refer to further guidance.

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What other permissions do I need?

Examples of other permissions which you may need before you can start your study:

We can provide advice and guidance in obtaining these permissions.

Portfolio adoption and support from the NIHR Clinical Research Network

If you wish to apply to have your study included in the NIHR CRN portfolio, you should answer yes to question 5b in the IRAS project filter and complete and submit a Portfolio Application Form in IRAS to the NIHR CRN. A decision on portfolio eligibility will be made by NIHR CRN.

HRA Approval replaces the current NIHR Coordinated System for Gaining NHS Permission (CSP). For studies where the project filter indicates that you are applying for support from the NIHR CRN, the HRA will provide the NIHR CRN with information from the application to the HRA to determine portfolio eligibility.

When can I start my study?

The recruitment of research participants at a site must not start until all permissions are in place and we have issued a full sponsorship letter.

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Does HRA Approval apply to studies that pre-date HRA Approval?

Studies which have already applied for NHS REC review but have not applied for NHS R and D review, or need to add new NHS sites in England, or have new amendments, will be brought under HRA Approval so that NHS sites can work with sponsors in the new way.

Study amendments

If you plan to make an amendment to your study please contact the Research Governance Team before you submit this to the NHS REC and/or HRA to ensure that we can offer continued sponsorship. We will help you determine whether the amendment is substantial or not. Definitions of substantial and non-substantial amendments can be found on the NRES website.

You are expected to notify both substantial and/or non-substantial amendments.

Substantial amendments:

Notice of Substantial Amendment forms are created in IRAS but they cannot be electronically submitted from IRAS. Submission of these forms continues to be via email, contact details can be found on the NRES website.

Other (non-substantial) amendments:

For all amendments the HRA Assessment Team will categorise the amendment according to the UK amendments process and inform you within 5 days. Once received you should send the amendment and the categorisation information to participating NHS organisations (a template for this e-mail is available).

Study extensions

If you plan to extend your study you can do this at the same time as making an amendment (as above). Alternatively, if an amendment is not planned and you wish to extend the study, the new end date should be detailed in a Progress Report which can be submitted at any time. The reason for the study extension should be detailed and no other changes should be made to the study. If any changes are required this should be dealt with as an amendment (see above).

Annual reporting

An annual progress report should be submitted to the NHS REC and HRA, 12 months after the date on which the NHS REC favourable opinion and/or HRA Approval was given. Progress reports should be sent to the NHS REC and/or HRA by e-mail with a copy to us. 

There are separate forms for use in CTIMPs and non-CTIMPs. The appropriate forms and further information are available from the NRES website.

End of study

You should notify the NHS REC in writing of the conclusion or early termination of a study using the appropriate form, and send us a copy of the report.

Where a project has HRA Approval only, you will need to tell HRA when the project has ended. You should send this notification by email to hra.approval@nhs.net, including your IRAS ID and your contact information (phone and email), with a copy to us. 

There are separate forms for use in CTIMPs and non-CTIMPs. The form should be sent within 90 days of the end of the study.

You are also required to send a summary of the final research report to the NHS REC within 12 months of the end of the study. The appropriate forms and further information are available from the NRES website.

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