Britain is to establish a national database correlating genetic information with medical histories and lifestyle data on 500,000 volunteers. The £45 million ($65 million) BioBank project is intended to provide a resource that will help researchers unravel the origins of a variety of illnesses.

However, its launch coincides with reports that researchers face increasing difficulties in obtaining samples of diseased human tissue—material that will be vital for studies complementary to the BioBank data to determine which genes and proteins are abnormal in a given disease state.

The drop in available samples was thought to be due to public outcry over events such as that at Alder Hey hospital near Bristol, where surgical staff had been removing organs from children who had died and preserving them for future research, without consulting the children's parents. But the fall-off in donations was relatively small and only temporary. It seems instead that the problem lies with the medical intermediaries, ranging from pathologists to ethical review boards, involved in the collection and distribution of such material.

“At present, the proportion of those we ask who give their consent to tissue removed during surgery being used for research is more than 99%,” says Neil Grey of the Peterborough Hospital Human Research Tissue Bank, one of Britain's leading suppliers of human tissue for research purposes.

A spokesperson for Pharmagene, a private company engaged in securing human tissue samples for drug research, agrees: “In fact, the events at Alder Hey and elsewhere have yielded a positive outcome in that there has been an increase in public awareness of the potential for the use of human tissue for research purposes. Whilst we did experience a temporary reduction in the frequency with which tissue was made available, this resulted not from patients refusing to give consent for the tissues to be used for research, but from those people involved in the supply...of tissues.”

Removal of a piece of tissue during surgery requires that informed consent be obtained from the patient, that an independent research ethics committee approve the supply of tissue to researchers and companies, and that patient confidentiality be maintained. Although this system may be working for private companies, academic researchers are having difficulties with the flow of material.

Scientists are finding the new regulations and monitoring practices introduced in the wake of public concern over the events at Alder Hey to be cumbersome and restrictive to work with. “There has recently been a tremendous sea-change in the availability of human tissue for research,” says Anne Bishop, a senior lecturer who specializes in lung tissue repair and regeneration at the Tissue Engineering Centre at the Imperial College of Science, Technology and Medicine in London. “The new regulations and practices have tied the hands of people who need to be much freer.”

Bishop quotes the example of a team of researchers who failed to obtain a particular sample they had been promised because the administrator responsible for overseeing the deal could not be found at the moment that the tissue was extracted from the patient during surgery.