Confidentiality and Consent
Identifiers are required to avoid double counting and for the validation of cases. Currently it is not possible to obtain explicit consent for the BINOCAR Registers. BINOCAR therefore applied for and was granted Section 60 Class Support under the Health and Social Care Act 2001 for the collection of personal information without consent.

PIAG class support was granted for the following reasons:

(i) many reliable and valuable notification sources involve little or no contact with parents, for instance, cytogenetic laboratories and pathology departments;
(ii) parents may become distressed when they are being asked for consent from multiple notifiers;
(iii) discussions of congenital anomaly notification may not be appropriate during the period when parents have first been informed about a congenital anomaly, especially prenatally;
(iv) the potential for sensitivities surrounding terminations of pregnancy for congenital anomalies may prevent discussions for notification to a register; and
(v) 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.

We have, however, taken steps to ensure that information about congenital anomalies registers is in the public domain by producing leaflets and posters to inform all women about congenital anomalies registers when they book for antenatal care. These leaflets and posters will be available in all health care settings used by pregnant women and parents e.g. antenatal clinics, GP surgeries, ultrasound departments, maternity wards, neonatal units, paediatric wards and clinics etc. Information provided on these leaflets and posters provides contact information so that parents can request that identifiable information about their pregnancy and/or child be removed from the register.

All BINOCAR registers aim to provide timely, accurate and easily accessible information for health professionals, and thus parents, to help them make informed decisions about current and future pregnancies and the care of their children.

IT Security
All registers are sited in institutions with robust IT security policies. All BINOCAR registers have to fulfil these requirements.

Patient Information Advisory Group (PIAG)
Congenital anomaly registers achieve high levels of ascertainment and completeness by collecting information from multiple sources. For data validation purposes, and to prevent cases being counted more than once, personal information about the mother and baby is required. NHS patients provide information about themselves in confidence and where information is held in confidence, informed consent from the patient is required for use of the information in a way that could identify the patient. The Government recognises and is committed to the protection of patient rights regarding disclosure of their personal information. At present congenital anomaly registers do not obtain consent to be included on the registers.
The Health and Social Care Act (2001) set out clearly this commitment. However, there are certain situations where it is not possible to obtain informed consent from patients. In recognition of these situations, Section 60 of the Health and Social Care Act 2001 was established to provide a means by which patient identifiable information needed to support essential NHS activity could be used without the consent of patients. This can only be used in circumstances where the medical purpose is in the interests of patients or the wider public, where consent is not a practicable alternative and where anonymised information will not suffice. It is intended that consent or anonymisation procedures will be developed, and to ensure this each use of section 60 is reviewed annually. The Patient Information Advisory Group (PIAG) was established to provide advice on issues involving the use of patient information and to oversee arrangements created under Section 60 of the Health and Social Care Act 2001. Its membership is drawn from patient groups, healthcare professionals, and regulatory bodies.

For more information on PIAG click here

BINOCAR Patient Information Leaflet

Click here to access the generic patient information leaflet for BINOCAR registers