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New guidelines have been drawn up to protect the identity of people who volunteer to donate samples to the UK Biobank, the project that aims to collect half a million DNA samples for future medical research.
There will also be a ban on the sale of any DNA samples to private or commercial interests, and access to data will only be granted once research proposals have undergone stringent checks.
The plans, announced on Wednesday, are set out in the UK Biobank Ethics and Governance Framework, a document designed to ease concerns in some quarters that sensitive genetic data gathered by the gene bank could fall into the hands of companies that will abuse its use.
The bank, funded by £45 million (approximately $51.5 million) from the Medical Research Council, the Wellcome Trust, and the Department of Health, is a long-term project intended to improve the diagnosis and treatment of illnesses.
But it has attracted its fair share of criticism, both from lobby groups that have expressed concerns about the potential for confidential patient information to slip into the wrong hands and from members of Parliament on the House of Commons Science and Technology Committee, who earlier this year branded it "a politically driven project".
Supporters hope the new framework will alleviate these concerns. The framework says a special code will be used to link DNA samples with "sensitive" information such as health and lifestyle data and identification details.
"Only those with access to the 'key' to the code will be able to relink the participants' identifying information with the data and samples," the framework says. The number of people with access to this key will be kept to a minimum.
The framework also states that although UK Biobank will have the right to sell data, it will not do so. "Rather, UK Biobank will serve as the 'steward' of the resource, maintaining and building it for the public good in accordance with its purpose."
But it rules out barring any particular research group or industry from having access to the database, mainly because it can't anticipate all the research uses to which it will be put. Instead, research proposals will undergo a process of ethical review before getting the go-ahead.
UK Biobank Chief Executive John Newton said in a press statement that the guidelines put the interests of the public at the heart of the gene bank project.
"The safeguards being proposed go well beyond what is required by law in a number of cases, and they set a new standard for ethics and governance in this area."
But Ian Gibson, a member of Parliament with Britain's governing Labour party and chairman of the House of Commons Science and Technology Committee, said he still has concerns that sectors like the insurance industry—which could have a strong interest in the bank's database—would eventually get hold of the information.
"I welcome the fact that this problem has been addressed, but I still think we need some kind of regulatory body in place to make sure the information remains sacrosanct," he told The Scientist.
Helen Wallace, from the lobby group GeneWatch, expressed similar concerns.
"The major problem is how this all relates to commercial companies and commercial interests, and this document sidesteps the issue," she told The Scientist. "It's no good making decisions on a case-by-case basis; we need to have ground rules from the start."
References
| 1. | | [http://www.mrc.ac.uk/index/public-interest/public-news/public-news_archive/public-news_archive_1_2002/public-biobank_uk.htm]
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| | | "The UK Biobank study gets funding go-ahead," Medical Research Council news, January–June 2002.
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| 2. | | [http://www.ukbiobank.ac.uk/ethics.htm]
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| | | UK Biobank Ethics and Governance Framework
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| 3. | | [http://www.mrc.ac.uk/]
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| | | Medical Research Council
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[1]
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| 4. | | [http://www.wellcome.ac.uk/en/1/hme.html]
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| | | The Wellcome Trust
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| 5. | | [http://www.doh.gov.uk/index.htm]
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| | | UK Department of Health
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| 6. | | [http://www.the-scientist.com/news/20030408/02/]
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| | | P. Hagan, "Biobank debate heats up," The Scientist, April 8, 2003.
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| 7. | | [http://www.parliament.uk/parliamentary_committees/science_and_technology_committee.cfm]
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| | | House of Commons Science and Technology Committee
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| 8. | | [http://www.wellcome.ac.uk/en/1/awtprerel0303n285.html]
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| | | "UK Biobank chief executive officer appointed," Joint press release from the Wellcome Trust, Medical Research Council, and the Department of Health, March 31, 2003.
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| 9. | | [http://www.norwich-labour-mps.org.uk/ian-house.htm]
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| | | Ian Gibson
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| 10. | | [http://www.genewatch.org/]
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| | | GeneWatch
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