As announced by the Department of Health on 20 September 2012, all functions that advise on the use of confidential patient information without consent, according to regulations made under section 251 of the NHS Act 2006 will transfer from the National Information Governance Board (NIGB) to the Health Research Authority (HRA) on 31 March 2013.
Responsibility for approving applications will lie with the Health Research Authority from April 2013 for research applications; the Secretary of State for Health will retain the approval function for all other non-research applications. Please see the FAQs
for details on this change.
Progress has been good since the original announcement and the following key decisions have been made:
- The HRA has agreed to convene a Confidentiality Advisory Group (CAG) which will take on responsibility which lies currently with the Ethics and Confidentiality Committee (ECC)
- Six current members of the ECC will transfer to the CAG on 31 March 2013 to support the establishing chair and ensure a strong level of continuity – these posts will be re-advertised towards the end of 2013 and appointed to by March 2014
- Recruitment of a further ten CAG members will be completed by January 2013 (advert due to go out at the beginning of December)
- Current staff associated with the function will transfer on or before the 31st March 2013
The next key step is to appoint the ten CAG members. The HRA will make these appointments, working closely with colleagues from the NHS Commissioning Board Authority, Public Health England, the Information Commissioners Office and others from the Health and Social Care Sector.
Work also continues on ensuring that the advisory and decision making functions are wholly transparent and fit for purpose. A range of meetings will be set up with key stakeholders before the end of the calendar year to discuss the developing design work.
The engagement work will continue in the new-year where it’s planned to hold two wider stakeholder events. More information to follow
For media enquiries, please contact Eileen Phillips on 0207 210 5224.
A number of FAQs are also attached. If you do have any further questions please contact:
Establishing Chair, Confidential Advisory Group
NIGB Approvals Manager,
Tel: 0207 003 3012
Assistant Director – Business Partner
s251 – Transition Project Manager
Tel: 0207 972 2550
Frequently Asked Questions
How does the process to access confidential patient information without consent currently work?
Applicants currently submit applications to the Ethics and Confidentiality Committee (ECC). The ECC carries out an expert advisory function through consideration of these applications. It advises the Secretary of State for Health (SofS) on whether applications/amendments/annual reviews should be approved and whether conditions are required. The SofS currently takes all decisions on whether an application (covering both research and non-research medical purposes) should be approved.
This process of approval is managed by the advice team supporting the ECC, so the applicant receives a streamlined outcome that incorporates both the ECC advice and the decision taken by the SofS.
What does this mean for existing approvals?
There is no change to the status of existing approved applications. Data controllers are assured that approvals continue as per details on the Register, and applicants should continue to submit annual reviews and extension requests in line with the usual process.
There will be a change in contact details when the staff and advice function transition to the Health Research Authority (HRA) and these will be communicated to the contacts held on the Register of approved applications nearer the time. Existing applicants are advised to check their Register entry and ensure it is up to date.
Is ‘section 251’ being abolished?
No, approvals are made under the authority of Section 251 of the NHS Act 2006 and the Health Service (Control of Patient Information) Regulations 2002 (‘section 251 support’). These legal provisions have not changed and approval will continue to provide a legal gateway to enable data controllers, if they choose, to disclose information without being in breach of the common law duty of confidentiality.
Is the NIGB ECC being abolished?
The ECC is currently a sub-committee of the National Information Governance Board (NIGB). The NIGB will be abolished on 31 March 2013 along with the ECC. The function of the ECC will be taken on by the CAG from 31st March 2013. As the mechanism for seeking ‘section 251 support’ continues, changes need to take place to ensure the effective administration of the process for requesting approval.
Do I need to apply for approval if I need to access confidential patient information without consent for a secondary use from 01 April 2013?
All instances of accessing confidential patient information without consent for defined medical purposes require a legal basis, such as consent or via ‘section 251’ support. If all alternatives have been exhausted then applicants are advised to seek approval (please see website [link] for further details on when an application is advised).
When the HRA take over approvals for research, what is the situation for non-research applications?
From the applicant’s perspective, there will be no changes to those seeking support for relevant non-research activities. The Confidentiality Advisory Group (CAG) will continue to consider applications covering both research and non-research. Non-research includes national clinical audit, confidential inquiries, health and service management, service evaluation and surveillance activities.
The Secretary of State will continue to take the final approval decision for any non-research applications.
Will the process change from 01 April 2013?
The process will not change immediately, however the HRA is looking at how further improvements and changes to the processes may be implemented. The HRA is hosting to stakeholder events in January to inform these plans.
It is assumed that contact details will change – where can I find these?
All existing applicants (based on details given in the Register) will receive an email in March providing updated contact details.
It is important to tell us now of any changes to contact details on the Register as the email contact will receive this email.
Will there be staff who are aware of my application history?
Yes, the existing advice team that has supported approvals considered by the ECC is intended to transfer to the HRA by 01 April 2013, therefore providing assurance that corporate memory is not lost and there will be familiarity with existing applications.
Further advice If you have questions about your existing approval please contact the NIGB office on 020 7004 1539