David Neal

Deputy Director (Policy), National Research Ethics Service

“I am the Deputy Director (Policy) of the National Research Ethics Service (NRES). NRES comprises 80 Research Ethics Committees (RECs) in England and their management support. We also work closely with colleagues in Wales, Scotland and Northern Ireland to provide a coordinated system of ethical review across the UK.

“Right from when the HTA was established, it was clear that NRES and the HTA shared a common aim to balance the Protection of the rights of research participants and tissue donors with encouraging research using donated tissues for the benefit of science and society. We shared key values in seeking a proportionate, facilitative and transparent approach
to research regulation. The licensing and ethical review functions needed to work together without unnecessary duplication. Consistent interpretation of the Human Tissue Act (HT Act) was essential to avoid uncertainties among researchers, sponsors and RECs themselves. For NRES it was also important to ensure that ethical review of research involving tissue operated in a legal framework supported by the HTA.

“It was therefore crucial to establish close links from the outset. A great deal of progress has been made. We have a formal Memorandum of Understanding, and we meet and correspond regularly, for example on complex enquiries. We work with the HTA to agree consistent guidance and signpost researchers to our respective websites. As a result of our joint efforts, there is greater clarity, and we now receive fewer enquiries; on what types of tissue are regulated under the HT Act or when ethical
approval must be obtained. NRES and the HTA have also collaborated effectively on a joint training programme for RECs and the research community to increase understanding, particularly around consent issues.

“We streamlined the approval process whereby research ethics committees can give generic ethical approval for a research tissue bank’s arrangements for the collection, storage and release of tissue – providing the bank’s tissue is stored on HTA-licensed premises. This has resulted in more than 200 tissue banks being approved.

“We believe this coordinated approach is reassuring to researchers and has been of benefit in encouraging research within the framework of the HT Act.”