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Confidentiality Advisory Group (CAG) – considerations and application guidance

The following should be used by potential applicants and applicants to CAG to determine the issues that CAG will consider when reviewing an application.

CAG principles

The document ‘Principles of Advice’ was originally authored in 2012 during the time of the NIGB Ethics and Confidentiality Committee. Following review of the current guidance on the website it has been agreed this document will be specifically reviewed by the CAG as part of its developing business improvement programme around guidance. This item has been withdrawn in the interim and a new version will be published once developed and approved.

Reducing the disclosure of confidential patient information

For all applications, CAG will consider whether the information requested is the minimum necessary to achieve the purpose and whether there are any alternatives to the processing of confidential patient information. We have developed new guidance in this area. This guidance should be consulted by all applicants intending to submit a new application to CAG or completing an annual review for CAG in order to ensure that methods for reducing the disclosure of confidential patient information have been considered and that this is evidenced within the application form/annual review submitted.

Non-response guidance

Support under section 251 cannot be recommended if there is a practicable alternative to the use of confidential patient information without patient consent. Therefore, careful consideration should be given, before submitting an application, to the feasibility of conducting the study with patient consent. If consent is not considered to be a practicable alternative, then this needs to be explained within any application. One of the reasons that consent might not be a practicable alternative is the possibility of non-response from those approached. This document provides guidance to potential applicants on the relevance of non-response.

Pre-submission advice

The Confidentiality Advice Team offers advice on draft applications prior to formal submission. Applicants are strongly encouraged to contact the Confidentiality Advice Team (CAT) to explore this option prior to formal submission.

The application form will need to be fully completed before contacting the CAT, who will then be in a position to advise on whether there are areas that are likely to raise issues with the Group and how to resolve them. Applicants should arrange an appointment directly with the Advice team, noting that requests for pre-submission advice must be made no later than 2 weeks before they intend to make a submission.