More for Reilly digestion – International standards for storing samples vary wildly

The Irish Times – Saturday, March 3, 2012

GENEVIEVE CARBERY

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.