The use of these blood spots is governed by a Code of Practice, available from your midwife
or via www.newbornscreening-bloodspot.org.uk
In the future there is a small chance researchers may want to invite you or your child to
take part in research linked to the blood spot programme. If you do not wish to receive
invitations to take part in research please let your midwife know.
> Storage of blood spot cards is regulated
Newborn screening laboratories are responsible for testing newborn blood spots for the
screening programme. The laboratory directors become ‘custodians’ of the blood spot cards,
storing them, and ensuring guidelines about their storage and use are followed. There is
strict guidance about who is allowed to access these blood spot cards and how the cards
can be used.
> Use of blood spot cards is regulated
Laws cover the use of the blood spot cards, in particular the Human Tissue Act 2004, the
Data Protection Act 1998, and the Health and Social Care Act 2001. The specific guidance
relating to the management of the blood spot bank has been developed with careful
reference to these laws. These Acts are not described in detail here, but further information
can be accessed via the Office of Public Sector Information at www.opsi.gov.uk/legislation/
In 2004 the UK Newborn Screening Programme Centre consulted parents and health
professionals about the screening programme and stored blood spot cards. Taking into
account their views, the Centre developed guidance for laboratory directors on the storage,
use and release of blood spot cards. This guidance can be found in ‘The Code of Practice
for the Retention and Storage of Residual Spots’ available from
www.newbornscreening-bloodspot.org.uk/
One of the requirements of both the Code of Practice and the Human Tissue Act described
above is: blood spot cards can only be used in research projects if they have approval from
a committee that considers the ethics of the research (a Research Ethics Committee). More
information about research ethics committees is available from the Central Office for
Research Ethics Committees at www.corec.org.uk/
The Code of Practice also requires that only research that makes good use of blood spot
cards by addressing important questions with high quality methods can be allowed to use
blood spots. All potential research projects must therefore be reviewed by other scientists
before they can be approved. This process is known as ‘scientific peer review’.
Practical procedures (often called Standard Operating Procedures) are currently being
developed by newborn screening laboratories, in consultation with the UK Newborn
Screening Programme Centre. These procedures will ensure that both the blood and the
information stored on the blood spots cards are stored securely and can only be accessed
by authorised members of staff.
The UK Newborn Screening Programme Centre also provides advice to newborn screening
laboratories about the use of blood spot cards, and will record the use of the blood spot
cards as part of an annual report.