BioWorld International Correspondent

LONDON UK BioBank, the world’s largest study of the links between genes and disease, has secured £45 million funding and the government’s approval to go ahead with collecting DNA samples and health and lifestyle information from 500,000 volunteers. Those individuals, aged 45 to 69 at the time of donation, will be tracked for 10 years, mainly through their National Health Service records.

The money (US$65.6 million) will fund a small number of regional centers that will be responsible for recruiting the volunteers, and the establishment of a coordinating center to manage and oversee the project.

The samples collected will be held in public ownership for public benefit. Pharmaceutical and biotechnology companies will have access, but no exclusive rights will be granted to any element of the data.

A separate body will be set up, independent of the users of the information and those involved in collecting it, to ensure that BioBank operates in the public interest and protects the rights of the volunteers. This body will ensure that samples and associated data are used responsibly and within the terms of the consent obtained from the donors.

The research charity the Wellcome Trust and the UK Medical Research Council are each putting £20 million into BioBank, and the remainder will come from the Department of Health.

GeneWatch UK, the leading independent genetics watchdog, criticized the decision to proceed with BioBank, accusing the government of pushing the project forward without a proper independent review of the science, the value for the money or the necessary safeguards for the public. GeneWatch believes the proposed scientific protocol is “hopelessly inadequate” and could lead to spurious links being identified between genes and diseases, and that the proper legal safeguards are not in place to protect the public from the misuse of genetic information.

Mike Dexter, director of the Wellcome Trust, said he would be willing to donate his DNA to the collection. “I may not reap the health benefits in my lifetime, but those of us contributing to the project rest assured that our involvement will provide a better life for our children and grandchildren.”

The backers of BioBank (previously known as the UK Population Biomedical Collection) are wary of public concerns about the exploitation of information and who will have access to the database. They have carried out three public consultation exercises to explore the concerns, and the final protocol for the study is being developed in light of this feedback.

Now that the funding is approved, bids will be invited to set up the national coordinating center and the regional centers, and it is expected that pilot projects will commence before the end of 2002.