As outlined in Section 1, the laboratory directors are ‘custodians’ of the blood spot cards,
storing them, and ensuring guidelines about their 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
As described in Section 1, the management of the storage and use of the blood spot cards is
guided by laws, a code of practice and standard practical procedures.
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. The 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 research must make good use of blood spot cards
by addressing important questions with high quality methods. 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.
Steps are taken to keep private any personal information contained in, or linked in any way
to, the UK newborn blood spot bank. This is done in different ways, depending on what the
spots are used for, and is guided by the Code of Practice and Research Ethics Committees
described above. Individuals’ identities are protected by removing identifying information
from the blood spots before they can be used.
3.2 Public involvement in managing the UK newborn blood spot bank
The public are currently represented in the management arrangements for the UK newborn
blood spot bank in a number of ways. These have included:
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