Effective implementation of the Human Tissue Act

Abstract

5 tumultuous years of negotiation between scientists and politicians finally drew to a close on Sept 1, as the UK's Human Tissue Act (2004) came fully into force. Conceived in response to public outcry over two scandals of the 1990s—involving retention without adequate consent of organs harvested during postmortem examinations at two UK hospitals, Alder Hey in Liverpool and Bristol Royal Infirmary—the Act takes as its central tenet the principle of full consent. It sets out provisions for the “lawful storage and use of body parts, organs and tissue…for specified health-related purposes and public display”; regulates removal of tissues from dead people; and introduces several new offences (with corresponding penalties) for which researchers could end up in prison. Clinical diagnosis and treatment, the most common reasons why tissue samples are removed from individuals, are not covered; neither is tissue older than 100 years. Finding the delicate balance of regulation to ensure respect for individual autonomy, while minimising the bureaucratic burden for researchers, has taken a lot of fine tuning. The first draft of the Human Tissue Bill, the Act's predecessor, was widely criticised for being weighted too much in the favour of tissue donors. The 2003 consultation met with outcry from scientists who feared that the Bill's harsh penalties and strict regulations for tissue storage could criminalise legitimate clinical activities. The Wellcome Trust added its concerns about too-vague definitions of appropriate consent in various research scenarios and warned that the Bill could end up stifling research, especially in small centres. Others derided the lack of provision for individuals not competent to give informed consent. Two rounds of amendments have addressed some of these issues, but, from the point of view of scientists, some problems are still not fully resolved. A key requirement of the Act is the necessity to obtain a licence from the Human Tissue Authority, a new regulator, for several specified activities to do with tissue storage. These include: postmortem examination, storage of postmortem material, and storage of material from a living person for research. However, the administrative burden of licence application, the deadline for which was Aug 31, has troubled many in the UK medical research community. The cost—estimated at around £6000 per establishment—is not insignificant to cash-strapped research centres. And there remains a confusing grey area surrounding conditions under which a licence can be waived. Investigators do not need a licence if their work has been approved by a research ethics committee; however, when the specific project ends, it is not clear whether the waiver does too. If researchers keep their samples after finishing their ethics-committee-approved project, are they effectively banking tissue, for which a licence is necessary? Much of the uncertainty surrounding the Act's implementation will depend on the interpretations of research ethics committees, following guidance from the Human Tissue Authority. But these committees are not yet fully prepared for the deluge of requests the Act might bring. By introducing a statutory requirement for researchers to have ethics approval from a research ethics authority to work on anonymised tissue from living individuals without consent, and making it a condition of licence exemption that research has ethics approval, the Act could substantially increase the numbers of applications submitted to ethics committees. What is more, because university ethics committees are not recognised in the Act, ethics review boards within the NHS research governance system will be expected to do many more reviews. In a statement to The Lancet, the Central Office for Research Ethics Committees said it hopes the extra work will be minimised by two strategies. The first is a new set of procedures for fast-tracking applications that raise no material ethical issues. The second is broad ethics approval for classes of research using stored tissue that would eliminate the requirement for project-specific applications. New guidance and standard operating procedures for research ethics committees will be issued in October, 2006. Finalising the Human Tissue Act has been a difficult negotiation process, but what has emerged is a piece of legislation that grapples with fundamental questions about the ethical use of human samples in biological research. These are questions with which many other countries are also struggling due to the increasing popularity of large-scale, long-term genetic epidemiology studies, including the proliferating numbers of biobanks. The UK's experience is likely to shed more light on wider debates as the specifics of the Act are hammered out by research ethics committees.