Press releases issued after 1 April 2013 can be found on the Public Health England website.
This page sets out to explain:
- What the Newborn Blood Spot Screening Programme is for
- How parents are informed
- Why samples are stored securely
- How possible future research use is explained to families
- How families can express an opinion about research
- The Code of Practice
- The very limited set of circumstances in which the cards are released to third parties (outside of research a court order is required)
- Research is either completely anonymised or individually consented
- Benefits of the research
The Newborn Blood Spot Screening Programme
The Newborn Blood Spot Screening Programme is a very successful and important NHS screening programme that tests all newborn babies so that those with rare but serious conditions can be identified. This allows babies to be referred immediately to specialist paediatricians so they can benefit from starting treatment and other management as early as possible to enable them to lead full and healthy lives.
In England last year (2011-2012), approximately 698,800 babies were screened and approximately 1,290 babies were identified with one of the five conditions for which screening is offered.
How parents are informed
Mothers-to-be receive written information about the screening tests offered during pregnancy and again after their child's birth with opportunity to discuss with their midwife and ask questions during pregnancy as well as before the test so that they can make an informed choice about screening.
Blood is collected from a heel prick and dried as blood spots on filter paper cards. Parents are informed that, after testing, these cards must be stored for at least five years for quality control of this nationwide screening programme. They are stored securely by the NHS newborn screening laboratories responsible for the tests.
Research and public health uses of cards
At the time of the test, the midwife explains the research and public health uses of the blood spots to the mother and gives her an opportunity to decide whether she wishes to receive information about future research studies. Her decision is recorded on the card.
Use of the cards for research or public health studies is governed by a strict Code of Practice published in 2005. This Code of Practice was developed following a wide public and open consultation and is published on our website along with more detailed information.
Blood spot cards are not released to commercial companies or to insurance companies.
Cards can only be released to the police on receipt of a court order for a specific dead or missing person. The card of a person who is alive and not missing is not released.
Approval for research and public health studies
Research is carried out on completely anonymised cards. If not anonymised - consent has to be sought from parents or with approval obtained from the National Information Governance Board Ethics and Confidentiality Committee. Blood spot cards are only released by the laboratories for research that has been approved by a research ethics committee and, if appropriate, the National Information Governance Board.
Benefits of research
The use of blood spots for research has benefitted countless children with rare or uncommon conditions. Major advances include the development of tests to identify MCADD, a life threatening condition that is now offered as a screening test to all babies born in England.