Impact of legislation and Human Tissue Authority regulation on research

29 October 2009

One of the concerns expressed when the Human Tissue Act was enacted in the UK in 2004 was that the legislation would have a stultifying effect on research. The Human Tissue Authority has commissioned some research to test the veracity of this claim and assess the effect of the legislation on researchers working with human tissue. The research carried out by Opinion Leader consisted of a questionnaire survey of 295 members of the research community supplemented by ten in depth interviews with a range of stakeholders (together with a literature review and stakeholder meeting).

The results, published in September 2009 in a report - The Impact of legislation and Human Tissue Authority regulation on research suggested that respondents found it difficult to distinguish between the effects of the Human Tissue legislation and Human Tissue Regulation generally (including research ethics and research and development (R&D) governance). Moreover, the respondents were often sharply divided in their opinions. Those appointed as designated individuals pursuant to the Human Tissue Act licensing regime were less likely to be negative about the impact of the legislation, but pathologists and those working in the NHS were more likely to be negative. Indeed the majority of those questioned (59%) believed that the Human Tissue legislation and subsequent regulation by the Human Tissue Authority had a negative impact on research. 68% of respondents believed that the legislation resulted in samples being more difficult to get hold of, and 61%, that potentially valuable samples were being disposed of.

On a positive note, 70% of all respondents agreed that the legislation and HT regulation had helped to ensure that informed consent is given by donors, and more participants agreed than disagreed that the combined effect of the HT legislation and regulation had resulted in increased public confidence in what happens to donated tissue.

Comment: It is unsurprising that those with a positive attitude to governance generally were more likely to be positive about the HT Act particularly as pathology was one of the sectors most critical of the legislation as it passed through Parliament. The complexity of governance in this area is confirmed by the findings of a survey of pathologists and pathology carried out by onCoreUK, in collaboration with the Pathological Society, in response to the National Cancer Research Institute Task Force on the role of pathology in cancer research. This also highlighted the need for guidance to be consolidated into an accessible, authoritative and consistent multi-regulator resource. As a result of these findings, the Medical Research Council has announced that their excellent Data and Tissues Tool Kit is to be strengthened by providing links to guidance from relevant regulatory and governance bodies, and more widely disseminated via a range of stakeholders to provide an authoritative resource in this area.

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