If you intend to access confidential patient information without consent in England and Wales you should apply to the Confidentiality Advisory Group (CAG). You will need to apply whether your project is managed as research or non-research.
Before completing your application, refer to our application guidance and information on CAG considerations when undertaking a review of an application
Application forms and supporting documentation
- All research applications should be prepared on the Integrated Research Application System (IRAS). Supporting document requirements are set out in the checklist for the form.
- All non-research applications should complete the section 251 form. Refer to the annex to the form for supporting document requirements.
All documents should be provided in black and white and labelled appropriately with a clear title, version number and date. Application forms should not include embedded documents.
We are currently training new staff and preparing for the COPI notice transition. As such we are temporarily pausing our pre-application advice service until mid July 2021.
Please continue to submit your application through the usual processes described below, making sure you have read all guidance.
The Confidentiality Advice Team offers pre-application assessment prior to formal submission of an application. This assessment of content aims to:
- indicate any areas that may be queried further by the CAG;
- advise where greater clarity may be required;
- highlight key aspects specific to your application; and
- signpost to specific contacts to address points raised where necessary.
To use this service:
- A request must be submitted no later than 10 days prior to the date the assessment is required. We cannot guarantee to provide an assessment if the output is required sooner than 10 working days from receipt. If a response is required earlier than 10 working days, a request will be accepted only at the discretion of the team. Applicants are advised to plan accordingly and to make contact at an early stage; and
- a completed draft application is required. Advice cannot be provided against protocols or briefing papers alone as the questions in the form are necessary for a pre-application assessment to be undertaken. Patient leaflets and supporting information should also be provided so an assessment with the full context can be undertaken.
Additionally, for complex or novel applications, the team is happy to meet to discuss initial proposals as we have found it significantly aids submissions if consideration of CAG issues takes place at an early stage. If the view is that the application raises significant issues, complex or novel issues and a conversation would be helpful, please contact the confidentiality advice team.
Precedent set pathway
If your application falls into one of 11 agreed precedent set categories your application will be processed under this pathway. The categories describe commonly-arising situations which have been identified and discussed at meetings of the CAG, where the expertise of a broad range of members is applied to the establishment of precedent advice. Find out more about the precedent set pathway.
Booking and submitting an application
Applications to CAG must be booked for review prior to submission. You should only contact the team to book once an application is ready for submission as the application must be submitted within 24 hours of booking. If the application is not submitted within 24 hours the booking will be cancelled. We are unable to reserve spaces for future meetings to prevent delays to applicants who are ready to submit.
The process to book an application is:
- Review the precedent set criteria prior to booking to determine if any apply to your application.
- Check the meeting and cut off dates for scheduled meetings and the corresponding dates by which valid bookings must be received to be considered for that meeting.
- Call the confidentiality advice team (0207 104 8100 – available 9am-5pm) to book the application into the next available meeting.
- Email the fully completed application (for research applications please include .pdf and .xml versions of the IRAS form) and all supporting documents to the team within 24 hours of booking. If the application is not submitted within this time period it will automatically be removed from the meeting agenda.
If you have any questions in relation to the process, please contact firstname.lastname@example.org