Human Genetics Alert
For immediate release 29th April 2002
HGA says: sort out ethics BEFORE you fund BioBank
Human Genetics Alert (1) today criticised the Wellcome Trust and Medical Research Council's decision to fund BioBank UK as premature. A workshop on ethical issues held last Thursday showed that crucial ethical foundations of the study are still being decided, and the Human Genetics Commission has not been properly consulted. Yet in January, the Health Secretary, Alan Milburn, pledged that the study would not be given the go ahead until the ethical issues had been fully addressed (2).
HGA Coordinator, Dr David King, said: "Unless the ethics are sorted out before the study is agreed, they are building a house of cards. They seem to think that ethics is just window dressing. There has been no serious public consultation or Parliamentary debate on this project. After the Alder Hey scandal and the GM food fiasco, they should have learned that this kind of arrogance is no longer acceptable."
Amongst the key ethical problems raised by the MRC/Wellcome Trust proposals are:
· The risk of breaches of confidentiality: although the funders insist that patients' medical data and samples will be held securely, the Information Commissioner has admitted that the Data Protection Act may fail to protect donors against 'inappropriate disclosure' from the BioBank (3). HGA calls for clear legislation to protect medical privacy and prevent genetic discrimination; the current lack of such legislation means that there is little redress for individuals if leaks do occur. In fact, the government is currently seeking to make it easier for researchers and NHS staff to access patients' medical data without their consent, using regulations under section 60 the Health and Social Care Act (4).
· The relationship between BioBank UK and industry: the proposals lack any clear regime to govern access to patients' samples by industry. Such a regime would specify what type of research industry can do, rules preventing doctors' conflict of interest, and how the NHS will be compensated. The MRC appears ready to let its own scientists, and companies using the Biobank, patent genes derived from patients' samples, yet is unwilling to inform patients that this may happen. HGA calls for a clear ban on the patenting of genes discovered through the BioBank.
· Consent: The project documents show that the funders view sample donors merely as useful sources of DNA, rather than as real participants in the project. There are no clear guidelines, preventing, for example, research in behavioural genetics or on other non-disease characteristics, which as recent articles in the British Medical Journal have shown (5), is a major focus of research for pharmaceutical companies. Instead, the MRC and Wellcome Trust will require sample donors to give unconditional consent for the use of their samples, and do not plan to ask donors for fresh consent in the future if new, unforeseen research is proposed.
For further information, contact Dr David King: 020 7704 6100.
Notes for editors
1. Human Genetics Alert is an independent watchdog group, funded by a leading British charity.
2. Speech given by Rt Hon Alan Milburn MP at international conference 'Genetics and Health - a Decade of Opportunity',16 January 2002.
3. Information Commissioner's submission to Human Genetics Commission, cited in HGC 'Comments to inform the Government response to the House of Lords report on Genetic Databases', June 13th 2001.
4. Draft regulations can be found at http://www.doh.gov.uk/ipu/confiden/index15.htm.
5. BMJ Theme Issue 134 April 2001, 'Too much medicine?'