International standards for storing samples vary wildly


BACKGROUND:The issue of retaining ‘heel-prick’ samples has sparked controversy in many countries

THE HEEL-PRICK test on newborns has been carried out in most western countries since the 1960s, but the policies on use and retention of the blood samples has been anything but uniform.

The issue has sparked controversy in many jurisdictions. Medics advocate the research and individual health benefits of such information in the rapidly growing area of genetics. Areas of potential benefit include Sudden Adult Death Syndrome and cystic fibrosis.

Civil liberties groups raise concerns about DNA databases being gathered and used without consent.

In Ireland, more than a million such samples were held without consent until the Data Protection Commissioner found this was not legal. Ten-year-old samples will be destroyed in six months and samples will no longer be kept past 10 years.

There is “no agreed practice standard internationally” on retaining the cards, the Health Service Executive report recommending the destruction said. “In Europe this varies . . . from one month to indefinitely.”

It said retaining the card goes against an EU data protection directive, under which explicit consent must be given for processing health information. It also says information should not be processed for a purpose it was not gathered for, or kept longer than needed.

Ethically the “international consensus clearly favours seeking the individual’s consent” for use of material for research and other purposes, the report said.

In the UK, samples are used for public health research and parents are informed of this. There is a storage guideline of five years for hospitals; some store them for 20 years or more. The UK department of health said such research had led to medical advances and the strictest safeguards were in place.

Genewatch UK warned about misuse of samples if stored indefinitely without consent.

New Zealand last year legislated to retain its 40-year archive of samples but to improve safeguards. It decided potential benefits of permanent retention were “significant”.

Policies vary across the US. In January, Minnesota began destroying more than a million samples after a court ruling and in 2009 a case taken in Texas saw five million tests destroyed.

The American Civil Liberties Union said parents have the right to know before the blood is stored and used by researchers.

The HSE paper said samples could be useful for research but this “poses a risk to the individual in terms of information flow”.

Cardiologist Dr Joe Galvin of the Mater family heart-screening clinic says there is a “real urgency” for these samples to be used to help diagnose Sudden Adult Death Syndrome and reduce cases of the genetic disease cystic fibrosis.