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:

Data Protection Act 1998
Health & Social Care Act 2001
Caldicott Guardian Principles 1997
The NHS Confidentiality Code of Practice
Information Sharing Agreement, Avon IM&T Consortium
University of Bristol Department of Clinical Sciences South Bristol IT Policy Document
SWCAR Code of Practice

We comply with the above by ensuring that:

all staff are trained in confidentiality and consent issues and are bound by a confidentiality agreement covering storage and transfer of information
all computer systems have controlled access
database and electronic storage of data are always password protected
data collection is relevant, not excessive and is used for legitimate medical purposes in the public interest.
data is stored for a limited period
policies on security and confidentiality are regularly reviewed
access to data is strictly controlled and on a need to know basis and all requests for patient identifiable information are referred to the SWCAR data controller
any research making use of SWCAR data requires independent ethical approval
patients have access to information about SWCAR and are able to obtain copies of their data on request.

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 60 of the Health and Social Care Act 2001.

Section 60 provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without obtaining explicit consent of the patient. It is used to support medical purposes that are in the public interest where consent is not practicable and anonymised information will not suffice. It is intended as a transitional measure and is reviewed annually.

Patient Identifiable Information is required by all UK anomaly registers to avoid duplication and for validation of case information. Notification is 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 Section 60 Class Support for the collection of personal information without consent. This was granted by the Patient Information Advisory Group (PIAG) in July 2002 for the following reasons:

many reliable and valuable notification sources involve little or no contact with parents, for instance, cytogenetic laboratories and pathology departments
parents may become distressed when they are being asked for consent from multiple notifiers
discussions of congenital anomaly notification may not be appropriate during the period when parents have first been informed about a congenital anomaly, especially antenatally
the potential for sensitivities surrounding terminations of pregnancy for congenital anomalies may prevent discussions for notification to a register
it is the experience of many studies that health professionals forget to ask about consent for notification of congenital anomalies during consultation and that this leads to long delays in notification or failure to notify.

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

SWCAR Code of Practice (main text only) (220K)
Confidentiality, Security and Disclosure of Patient Information
SWCAR Code of Practice (includes all appendicees) (4.7M)

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.

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

Section 60 Application (50K)

SWCAR Patient Information leaflet (50K)

Related web sites

Patient Information Advisory Group (PIAG) web site

The NHS Confidentiality Code of Practice web site

The Information Commission web site