By Laura Donnelly, Health Correspondent
Published: 9:00PM BST 12 Sep 2009
New rules coming into force next
month will give scientists working on stem cell research access to samples of
blood and tissue collected by NHS hospitals during biopsies and treatments, as
well as to giant "tissue banks" which built up stores of material
before the legislation was introduced.
Ethics experts, patients' groups
and churches described the change as "absolutely frightening" and
liable to destroy trust among thousands who donate, whatever their views on the
use of hybrid embryos for stem cell research.
While scientists will have to try
to gain explicit consent before using cells from such stores, if the samples
were collected before 1st October and the donor cannot be tracked down, the
experiments will be allowed to go ahead regardless.
In an article for The Lancet,
leading ethical experts yesterday warned of a risk of a public outcry similar
to those over scandals at Alder Hey and Bristol Royal Infimary hospitals, when
children's body parts were kept without parental consent.
Joyce Robins, co-director of
pressure group Patient Concern warned that most people had "not an
inkling" that fundamental changes were about to be introduced.
She said: "This is
absolutely frightening. People who have donated for medical research may well
not agree with human/animal hybrids, which are one of the most controversial
ideas out there.
"Scientists know how hard it
would be to get consent for these kinds of experiments – this is an attempt to
get around the obstacles".
Author Professor David Jones,
director of the Centre for Bioethics and Emerging Technologies at St Mary's
"That tissue could be used
to clone an embryo, and you would not even be told it was happening."
The rules governing the use of
donated human tissue are set out in the Human Fertilisation and Embryology Act
which became law last year.
Although certain aspects of the
legislation, such as changes which made it easier for lesbians to have IVF
treatment, provoked fierce debate as it made its way through Parliament, the
amendment on body tissues was passed almost unnoticed.
Prof Jones said he was not
reassured by insistence from regulators that efforts would be made to trace
donors. A study of couples who stored human embryos at fertility clinics found
that 50 per cent could not be tracked down after just five years.
Jim McManus, from the Catholic
Bishops Conference of England and
He said: "Whether or not you
object to your personal DNA being mixed with animal matter, the ethical
consequences of this are so great that express consent should be obtained on
every occasion, with no exceptions. I am really alarmed about this".
The Lancet article criticises the
decision by UK Biobank, a major research study which has already collected
samples from 363,000 people, to refuse to provide any undertaking that it would
only hand over its samples for hybrid embryo creation if explicit consent for
that had been given.
Jones and fellow author Dr Calum
McKellar, director of research at the Scottish Council on Human Bioethics,
contrasted the approach taken by UK Biobank with its counterpart project in
The mass study Generation
Scotland has said it would not pass on samples for hybrid creation without
explicit permission.
Meanwhile, dozens of NHS clinics
and research trials across the
Dr McKellar said: "Many
thousands of altruistic individuals, whose leftover tissue was kept after
surgery or who gave cells or tissue in the past to biomedical collections for
research, would now be aghast if they realised [the material] could now be
cloned using animal eggs".
Prof Graeme Laurie, Chair of UK
Biobank's ethics and governance council said that although the body had refused
to commit to obtaining explicit consent, it might still take that decision once
specific requests for samples to use in trials were made.
He said: "
We don't want to pre-empt scientific or social views that might change
radically by the time there is an application".
A spokesman for the Human
Fertilisation and Embryology Authority said the circumstances under which
researchers wished to create hybrid embryos were "very specific" and
the likelihood of doing so without explicit consent "very small".
Such licences would only be
granted if they met legal criteria, including approval from an ethics committee.