This time last year, the British research community was fuming over a piece of draft legislation that was, in the general view, a potential disaster for science. The Human Tissue Bill had been drawn up quickly in the wake of public outcry about the removal and storage of deceased children's organs at hospitals. It aimed to put consent at the heart of any situation where human tissue was being removed or retained.
But the bill as originally written would have threatened vital research, because it lacked clarity over issues relating to consent and anonymity of samples said many, including Robert May, president of the Royal Society, and Nick Wright, president of the Pathological Society of Great Britain and Ireland. Mark Walport of the Wellcome Trust called the bill "a confusing mix of contradictions and ambiguities, which could result in an unworkable, bureaucratic system that stifles legitimate research." Wright's take was no more complimentary: "I have no idea who drafted it, but it's a terrible pig's breakfast," he said last summer.
What a difference a year can make. This month, with the bill now officially enshrined in law as the Human Tissue Act, the British science world is looking on with much less trepidation. "We're quite pleased with it now, actually," says James Underwood, president of the Royal College of Pathologists.
That's because, in the face of repeated and vociferous lobbying from scientists, the House of Lords took a hard look at the bill and changed or expunged many of the contentious passages. As Alison Hall from the Cambridge Genetics Knowledge Park wrote in a report, "Many of the amendments made in the House of Lords were a response to the concerns of the genetics, research, and academic communities as to the Act's potentially burdensome effects. What has resulted is a more balanced piece of legislation."
Walport says that the final law, unlike the earlier bill, managed to achieve its goals without hindering science. "The Human Tissue Act strikes a balance between protecting the rights of patients and their families and safeguarding vital medical research which brings health benefits to all of us," he said.
Underwood says that the science community achieved a real victory because the bill was changed, but he points out that the true winner is society at large. "What we were doing was arguing the case for the bill to serve the public interest," he says.
With the Act in good shape, the next step is for the Human Tissue Authority, which the bill established, to put in place codes of practice. Overseeing that task will be the authority's chair, Helene Hayman, who first needs to appoint 16 or so members of the authority, most of whom will be nonscientists. It is expected that those appointments will be made by next month, with the codes of practice issued when the Act comes into force in April 2006.
When asked whether he expected to be named to the Authority, Underwood said, "I don't know. I've applied and had an interview. It was the most dreadful experience. It was the first time I'd been interviewed for a post in years."
Meanwhile, up in Scotland, Jeanne Bell from Edinburgh's Western General Hospital has put consent at the center of a new brain and tissue bank that she and colleagues established in early March. Funded by the Medical Research Council, the project aims to collect postmortem brain tissue and other organ tissue with the aim of investigating sudden death. A central feature of the setup will be the appointment of full-time staff to ensure good communication with families of the deceased, she said.
Both normal tissue and diseased samples from the children who die of sudden death will be collected in a bank that will be available for the wider scientific community to use. "Pathologists desperately need normal tissues for comparison," says Bell. "We specifically want to help the research community ... with a whole lot of things that are not well researched at present."