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Data protection
Ethics

In July 2004 BINOCAR gained MREC ethics approval on behalf of all UK Registers.  REC: 09/H0405/48.

The approval of research projects not only involves approval of the resources requested and financial implications of the research, but also of any ethical issues involved in the research.  NHS Research Ethics Committees (REC) have been established throughout the UK for many years to provide independent ethical review of all health and social care research to safeguard the rights, dignity and welfare of those participating in research in the NHS.

The REC is entirely independent of the researcher and the organisations funding and hosting the research.  The members of a REC are specially trained in research ethics and are required to review and give opinion on the ethical aspects of a research proposal.  These include patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background.  Research projects cannot proceed without REC approval.  The REC’s task is to advise the NHS body under which the research is intended to take place but it is the NHS body that has responsibility to decide whether or not the project should proceed, taking into account the ethical advice of the REC.

For more information on REC, visit www.hse.gov.uk/research/ethics/index.htm.

Section 251

In June 2002, on behalf of all UK Registers, BINOCAR submitted an application for the support for the collection of personal information without consent. 

This exemption was initially granted by PIAG (the Patient Information Advisory Group), and was first enacted under Section 60 of the Health and Social Care Act 2001.  Section 251 of the 2006 Act permits the common law duty of confidentiality to be set aside in specific circumstances for medical purposes.

PIAG was established to provide advice on issues of national significance involving the use of patient information and to oversee arrangements for its use.  It was formally wound up on 31 December 2008, and replaced by the National Information Governance Board for Health and Social Care (NIGB) under Section 158 of the Health and Social Care Act 2008.

Responsibility for administering Section 251 powers transferred to the NIGB on 1 January 2009.

For further information about the NIGB, please see www.nigb.nhs.uk.

The NDSCR aims to provide timely, accurate and easily accessible information for health professional and parents, to help them make informed decisions about current and future pregnancies and the care of their children. Ongoing surveillance and the monitoring of anomaly occurrence to check for varying trends or changing patterns of distribution are also very important public health activities.

Identifiers are required to avoid double counting and for the validation of cases, ensuring accurate matching between antenatally diagnosed anomalies and postnatal notifications. Since it is currently impractical to obtain explicit parental consent for the inclusion of a case to the NDSCR, NDSCR as part of BINOCAR therefore applied for and was granted exemption under the terms of the 2001 Health and Social Care Act. Permission has to be reviewed annually, and has been granted for the following reasons:

  1. Many reliable and valuable notification sources used by registers involve little or no contact with parents; for instance cytogenetic laboratories and pathology departments
  2. There would be unique and irreconcilable difficulties in matching anonymised antenatal diagnoses is a fetus with similarly anonymised postnatal notifications of a child, often received some months or even years after delivery
  3. Parents understandably become distressed when asked for consent from multiple notifiers
  4. Discussions of congenital anomaly notification may not be appropriate during the period when parents have first been informed about a potential problem, especially prenatally.  Assessing the likely outcome of an affected pregnancy is usually very difficult, and properly ‘informed’ consent is therefore impossible to obtain
  5. The potential for sensitivities surrounding terminations of pregnancy for congenital anomalies may prevent discussions for notification to a register
  6. Anonymisation is impossible in those cases where the fetus does not reach 24 weeks’ gestation and therefore does not acquire an NHS number.  This includes almost all terminations of pregnancy for fetal anomaly reasons
  7. It is the experience of many studies that health professionals do not request consent for notification of congenital anomalies during consultation and that this leads to long delays in notification or failure to notify.
 
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NDSCR logo: links to NDSCR home page
Updates
BINOCAR Annual Report 2010 (BINOCAR site)
J. Morris and E. Alberman, Trends in Down's syndrome live births and antenatal diagnoses in England and Wales from 1989 to 2008: analysis of data from the National Down Syndrome Cytogenetic Register, British Medical Journal, 2009:339;b3794, doi:10.1136/bmj.b3794
by Wolfson Institute Website Manager © Queen Mary, University of London 2013
Centre for Environmental and Preventive Medicine, Wolfson Institute of Preventive Medicine, Barts and The London, Charterhouse Square, London EC1M 6BQ Tel: 020 7882 3850 Fax: 020 7882 6270