UK: optimism over new regulator

British researchers hope the new Human Tissue Authority won't hinder vital research

Apr 27, 2006
Stephen Pincock
The Human Tissue Authority (HTA), a new regulatory agency in Britain, announced this week that the rules governing live kidney donation would be relaxed. But for the research community, the new watchdog's most significant impact won't be felt for another four months, when it begins regulating research aspects of human tissue use. The new kidney transplant rules allow more flexibility in who can donate to whom. They were announced at the same time as the HTA issued its first ever licenses, to banks storing tissue for transplants.But for the research community, the key date is September 1, when HTA will begin regulating other areas, including the storage of material from a living person for research. Scientists will be able to apply for a license for these activities on the HTA's Web site from July this year, a spokesman told The Scientist. In the meantime, the agency has published a series of codes of practice after consulting with professional bodies.The HTA was established a year ago, under the Human Tissue Act, to regulate the removal and use of human bodies and tissues. It was set up in the wake of public outcry about the removal and storage of deceased children's organs at hospitals.During the Act's drafting, scientists expressed grave concerns that it would hinder vital medical research. After sustained lobbying, the wording of the law was changed in the House of Lords, with a result that was more generally acceptable.James Ironside, who is now deputy chairman of the HTA, is also head of the National CJD Unit in Edinburgh. He told The Scientist his main motivation for joining the agency was to ensure medical research could be carried out in an environment that was comfortable for scientists. "Actually it has been a great pleasure to realize that all the members of the committee feel the same way, including the lay members," he said.The HTA has been developing the codes of practice through a consultation process with professional bodies, he said. "That's allowed us to develop the codes in a way that will be workable professionally." The central tenet of the codes of practice is consent. The rules under which scientists will be operating make it clear when consent is required and in what form, Ironside said. At an introductory meeting for researchers this week, HTA members fielded a lot of nervous questions, Ironside said. But he added that the authority is planning to hold a series of workshops to help clarify any unresolved issues. "We want to facilitate research and support people within the framework of the act."Adrian Newland, president of the Royal College of Pathologists, said that the authority had been responsive to the needs of the scientific community during the process of consultation. "I think we've been quite lucky over the past few months in that they've taken in a lot of what we've had to say," he told The Scientist. While not all the minor issues have yet been ironed out, he said, the research community has appreciated the authority's "light touch" when it comes to licensing premises, as well as its level of engagement. "They seem to have gone out of their way to talk to the relevant bodies."Stephen Pincock spincock@the-scientist.comLinks within this articleHuman Tissue Authority"Strangers allowed to give organs," BBC News Online, April 25, 2006. Mayor, "Researchers fear shortage of brain tissue," The Scientist, May 16, 2003. Pincock, "UK law threatens research," The Scientist, January 27, 2004. Pincock, "A better UK human tissue bill," The Scientist, March 28, 2005. CJD Unit Newland