From 1 April 2015 we are part of Public Health England

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Data Protection: confidentiality and consent

Data Protection and Confidentiality

SWCAR has a responsibility to maintain the confidentiality and security of all data held on the register. The collection and management of SWCAR data meets the requirements of the following guidelines and regulations:

We comply with the above by ensuring that:

In July 2004 BINOCAR gained MREC ethics approval on behalf of all UK Registers. See below for details.

Full details of our policies on confidentiality, data security and disclosure of information can be found in the SWCAR Code of Practice. See below for details.

Consent

All UK anomaly registers currently collect data without explicit patient consent under Section 251 of the NHS Act 2006.

Section 251 provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without obtaining the individual explicit consent of the patient. It is used to support medical purposes that are in the public interest where consent is not practicable but anonymised information will not suffice. It is reviewed annually.

Patient identifiable information is required by all UK anomaly registers to avoid duplication of cases and for validation of case information. Notifications are received from multiple sources and it is essential that new information is matched to the correct case and that each case appears only once in the data.

In June 2002, on behalf of all UK anomaly registers, BINOCAR (British Isles Network of Congenital Anomaly Registers) submitted an application for support for the collection of personal information without consent. This exemption was initially granted by PIAG (Patient Information Advisory Group) and was first enacted under Section 60 of the Health and Social Care Act 2001, and subsequently under Section 251 of the NHS Act 2006. PIAG had been established to provide advice on issues of national significance involving the use of patient information (data) and to oversee arrangements for its use. Its responsibility for administering Section 251 powers transferred to the National Information Governance Board for Health and Social Care (NIGB) from 1 January 2009, and has since transferred again to the Health Research Authority’s Confidentiality Advisory Group (CAG) since 1 April 2013. For further information about CAG, please see http://www.hra.nhs.uk/resources/confidentiality-advisory-group/.  BINOCAR registers have continued to be granted Section 251 support by CAG.

All UK anomaly registers have taken steps to ensure that information about congenital anomalies registers is in the public domain. Leaflets and posters are available in health care settings used by pregnant women and parents: antenatal clinics, GP surgeries, ultrasound departments, maternity wards, neonatal units, paediatric wards and clinics. Contact information is included so that parents can request the removal of identifiable information about their pregnancy/child or request a copy of information held.

SWCAR Code of Practice and Approvals

Help with downloads page

PDF file: SWCAR Code of Practice (2.9MB)

PDF file: Multi-Centre Research Ethics Committee (MREC) Approval (260K)
MREC approval letter covers for all British Isles National Network of Congenital Anomaly Registers (BINOCAR) registers. SWCAR is a BINOCAR Member.

PDF file: Patient Information Advisory Group (PIAG) Section 60 Approval (110K)

Word file: Section 251 Application (160K)

PDF file: SWCAR Patient Information leaflet (50K)

Related web sites

Confidentiality Advisory Group website

NHS Confidentiality Code of Practice website

The Information Commission website

NHS Act 2006: Section 251