All applications, except those reviewed via the Precedent Set process are considered at a full CAG meeting.
On receipt of the application, the first validation stage will determine whether there is sufficient information for the application to be presented to CAG.
At this stage the Confidentiality Advice Team (CAT) may advise that further information is required prior to presenting the application to CAG. CAT may also advise on potential alternatives to the use of patient identifiable data without consent and, if necessary, applicants will need to speak to other parties potentially involved in the activity about the application. If further information is required before the application can be confirmed as valid, the applicant will be informed within one week of submitting their application.
It is the applicant’s responsibility to ensure that queries are responded to within the given timescales, normally one week, to enable the application to progress. In some instances applicants may be asked to revise their application form to ensure the information presented is clear.
Following validation the applicant will be advised by email whether their application is valid, whether it will be submitted for full CAG review or processed via precedent set review and be given details of the timescales involved.
CAG review of applications
If your application requires full CAG review then it will be considered at a monthly CAG meeting. In some circumstances, the CAT may advise you to attend the meeting. Where applications are reviewed at a CAG meeting applicants can expect to receive a decision with 60 days.
If your application is being reviewed via the Precedent Set process then it will be reviewed by a sub-committee. Where applications are reviewed via precedent set applicants can expect to receive a decision within 30 days. In some cases this review may refer the application to a full CAG review.
After CAG review
CAG will provide advice to the Health Research Authority (HRA) or Secretary of State (SofS) who in turn make a decision on the application. The Confidentiality Advice Team will inform you of the decision, in writing, within 10 working days of the review.
The possible HRA/SofS decisions are:
- An application is approved
- An application is conditionally approved
- An application is provisionally approved pending further information from the applicant
- A decision is deferred, further information is required from the applicant to determine if the requirements of the Regulations are met
- A decision is deferred, further information is required from a third party to determine if the requirements of the Regulations are met
- An application is not approved
- Approval under the Regulations is not considered to be required.
Where your application is approved, this is for a period of 12 months, or as otherwise specified as part of the approval letter, and is conditional on your compliance with the CAG standard conditions of support.
Please see the next section for information on the annual review process for all approvals.
If your application is not approved and you can address the reasons given for this that were set out in the outcome letter from CAG then you may resubmit your application. In this situation, you should revise your application and supporting documents if required accordingly and submit the application with a covering letter detailing the amendments made and how these address the issues raised. The normal booking and submission process should be followed when resubmitting the application for review.