Help - Maintaining your approvals - Confidentiality Advisory Group (CAG)
Help
  • Using IRAS
  • Preparing & submitting applications
  • Maintaining your approvals
    • AmendmentsAmendments
    • Amendments for projects conducted in NHS/HSCAmendments for projects conducted in NHS/HSC
    • Confidentiality Advisory Group (CAG)Confidentiality Advisory Group (CAG)
    • HMPPSHMPPS
    • Radiation AssuranceRadiation Assurance
    • Pharmacy AssurancePharmacy Assurance
    • Examples of amendment typesExamples of amendment types
  • End of research
  • FAQs
  • Documentation
  • Reference
Confidentiality Advisory Group (CAG)

Confidentiality Advisory Group (CAG) - amendments and annual review



This page provides the following information:

Submitting amendments to the Confidentiality Advisory Group (CAG)

CAG should be notified of all amendments to the information provided in your original application. This is because support to process confidential patient information without consent is based on the precise details originally provided to CAG and so any change will not be covered by the existing support until a formal amendment is made and the amendment is supported.

You will need to complete and submit an amendment form to CAG where changes are intended to any of the following:
  • Data flows
  • Data items
  • Data sources
  • Purpose 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 and/or you need further guidance please contact the Confidentiality Advice Team (CAT; see Contact Us). 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 35 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 the review of the amendment are that the amendment is:
  • Fully supported
  • Conditionally supported
  • Not supported

Back to the top



CAG Annual Review

As part of the conditions for support, applicants are responsible for ensuring that the application is reviewed reviewed every 12 months to assess the need for continuing approval and to ensure that progress towards, or achievement of, any conditions of approval is in place. At this stage you should consider if it would be possible to reduce the amount of confidential patient information that you are processing.

This review is achieved through submitting an annual review report which should be submitted to the Confidentiality Advice Team by email using the annual review report template.

To allow sufficient time for processing, an annual review report should be submitted for review at least four weeks before the approval expires (i.e. no later than 11 months following the final approval date).

If the annual review is satisfactory, the Register of Approved Applications will be updated to reflect a suitable review has been provided. Applicants will not receive a letter confirming the annual review outcome and should refer to the Register of Approved Applications to check the update.

Back to the top



Page last updated: 18 December 2023



 
IRAS Integrated Research Application System, version 6.3.6, 09/01/2024, IRAS Dataset version 3.5.
The Health Research Authority (HRA) acknowledges the Integrated Research Application System (IRAS) partners in developing IRAS content. © Health Research Authority 2024.
Copyright and other intellectual property rights in the content of the Integrated Research Application System (IRAS) belong to the HRA and all rights are reserved. Terms & Conditions, Privacy Policy. APP-N