Recently amended draft Human Tissue Bill remains confused and will endanger the continuation of vital medical research

The Royal Society today warned the UK Government that the recently amended draft Human Tissue Bill remains confused and will endanger the continuation of vital medical research. The warning comes ahead of the Bill’s second reading in the House of Lords later this week (Thursday 22 July 2004).

Lord May of Oxford, President of the Royal Society, said: “While the Government’s actions to amend the draft Human Tissue Bill are to be applauded, some parts of the proposed legislation remain confused and could lead to some current medical research becoming impossible. The amended Bill states that researchers must not possess any information that might allow identification of the individual from which a tissue sample originates. However, linkage information, such as the ability to cross reference with family members, is often a valuable part of a sample’s worth. Without it, genetic studies into the inherited factors of diseases such as cancer become difficult, if not impossible.”

Lord May added: “To avoid this situation the Bill needs further amendment to state that samples will be ‘appropriately anonymised’, allowing the option of access to additional valuable information. The judgement on what is deemed appropriate should be made by the Ethics Committee during the research project approval process but without placing additional bureaucratic burdens on researchers.”

Lord May said: “Another part of the Bill which still causes concern for researchers is the definition of consent. It is currently unclear whether researchers will be required to obtain further consent every time a new and unforeseen use of a sample emerges. This would make important work, such as that being done with the National Anonymous Tonsil Archive to establish the extent of new variant CJD, impossible.”

Lord May added: “The definition of consent needs to be sufficiently broad to allow for the fact that the scope of research programmes inevitably changes over time. Again, Ethics Committee approval of research projects should be deemed an appropriate measure to avoid this unworkable requirement.”

Lord May said: “We are also concerned by the lack of detail on the proposed Human Tissue Authority. Nowhere is there any guidance on who should be members of the Authority and, given the important role it will play once the Bill is passed, we would like to see assurances within the legislation that all key stakeholders will be adequately represented.”

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