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.