Which review bodies need to approve or be notified of which types of amendments

Sections on this page:

NHS R&D review of amendments

For information on preparing and submitting amendments for studies conducted in the NHS/HSC in England, Scotland, Wales, and Northern Ireland, please refer to the amendments for projects conducted in the NHS/HSC guidance on the IRAS website.

For studies where the lead NHS R&D office is based in England a flow chart outlining the amendment process and an example template email for sponsors to share amendment information with sites is available in the Training Resources section of the HRA website. A template email for sponsors to share information is available.

 

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NHS Research Ethics Committee review of amendments

Flow diagrams setting out the process of ethical review of substantial amendments (CTIMPs and non-CTIMPs) are provided in the Resources section.

Any valid amendment submitted as a substantial amendment will be accepted for review. If the sponsor is satisfied that an amendment is not substantial, there is no requirement to notify the REC. Sponsors and CIs may seek advice from the REC on whether an amendment should be considered substantial.

Please note that Notice of Substantial Amendment forms submitted to REC must be electronically authorised in IRAS; this will be checked at validation. Notice of Substantial Amendment forms generated from Minimal Dataset studies (i.e. function used for projects that pre-date IRAS) are currently exempt from this requirement.

For studies taking place in the NHS/HSC, please refer to the guidance located on the IRAS website.

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MHRA (CTIMPs) review of amendments

For general information about notification of substantial amendments to the MHRA, what to submit and associated fees please refer to the MHRA website.

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MHRA (Medical Devices) review of amendments

The following guidance only applies to amendments to clinical investigations of medical devices subject to regulation by the Competent Authority (i.e. those that have a Notice of No Objection from MHRA).

You must notify MHRA Devices of all proposed changes to the investigation (not only those classified as substantial amendments for the purposes of ethical review) and await a letter of no objection from MHRA Devices before you implement them. This includes changes made at the request of the REC. Failure to notify proposed changes could result in the manufacturer being liable to prosecution.

For details of how to notify MHRA refer to the MHRA website.

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ARSAC

A research certificate can be extended if the subject numbers in the original application have not been met or if some of the originally specified investigations for individual subjects will fall outside the duration of the certificate. Such a request should be submitted by letter, containing all relevant information, rather than by a new application form.

Where a material change to the original application is minor, an application for variation of a certificate can be made by letter. This should include a full justification for the variation. Major changes will require an application for a new certificate.

All certificates relate to the appointment and facilities quoted in the application, and the ARSAC should be informed promptly of any material change in these circumstances since the certificate may need to be varied.

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Confidentiality Advisory Group (CAG)

An amendment to your application should be made using the CAG amendment template. Where necessary your completed amendment form should be accompanied by revised/additional documentation. Please see guidance from the Confidentiality Advice Team if you are unsure what to provide.

You will need to submit an amendment to CAG any changes are made to the following:

  • Data flows
  • Data items
  • Data sources
  • Purposes of application
  • Data controller (please note that an amended application form and supporting documents setting out the new data controller arrangements will be required, you are advised to contact the Confidentiality Advice Team prior to submission)
  • Data processor
  • Duration amendment

If you are unsure whether an amendment needs to be submitted after reviewing the template please contact the Confidentiality Advice Team. The CAT may advise that you submit the amendment for information only at this stage.

Once you have submitted the completed amendment form the Confidentiality Advice Team will confirm if the amendment contains sufficient information, whether it is valid and the process and timelines for its review. You may be asked to provide further information prior to confirmation that your amendment is valid.

If the amendment can be reviewed outside a full CAG meeting an outcome should be provided within 30 days of receipt of a valid amendment, if the amendment is referred to a full CAG meeting an outcome can be expected within 60 days of receipt of a valid amendment. The Confidentiality Advice Team will inform you if your amendment is referred to a full CAG meeting as soon as possible. Please note that final approval for the amendment will not come into effect until a final approval letter is issued. The possible outcomes of review of the amendment are that the amendment is:

  • Fully supported
  • Conditionally supported
  • Not supported

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National Offender Management Service (NOMS)

The National Research Coordinator should be notified of all amendments to the information provided in your original application. Amendments to the scope or nature of an approved research project must not be made without prior agreement.

You should be aware that it is not necessary to submit a Notice of Substantial Amendment form for this review body.

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