UK BIOBANK Ethics and Governance Framework ... - Wellcome Trust

• relationship of UK Biobank with participants and society, particularly the project’saims and the expectations the project has of participants;• the value of biobanks;• plans for income generation and handling of property rights; and• level of and controls on commercial access.14. Respondents called for the remit, roles and potential impact of UK Biobank to be clearlyexplained to all stakeholders, particularly participants.‘Nowhere in the document is there a statement of either the expected benefits or the potential harms ofthe Biobank project both for participants and for the wider society. Such a statement is essential tomeaningful public consultation.’ [O]15. The role of biobanks was questioned by one respondent, as were the risks involved insuch projects:‘There is considerable controversy regarding whether or not UK Biobank can generate scientificallyvalid and useful results (see eg. The Lancet, Vol 361, p1734-1738). Concerns include both the broaderissue of the relevance of this type of study to reducing the incidence of common diseases and thenarrower issue of whether the biobank is optimally designed to minimise the chances of makingspurious and misleading conclusions about the role of genes in health. It is wrong to imply toparticipants that long-term participation will lead to health benefits until these issues have beendemocratically debated and resolved. Arguments in favour of participating are critically dependent onthe claimed benefits of the project (see eg. John Harris, 2003, Ethical Biobanking, HGC03/19 AnnexB).’ [O]‘We would, however, be interested in hearing about whether or not a risk analysis has been conductedfor the overall project. If so, and in line with the recent recommendations by the House of CommonsScience and Technology Committee on openness and transparency, we would support publication ofsuch analyses, and indeed the overall business plan, to allow wider scrutiny.’ [O]16. Access to the data contained in the UK Biobank was also a concern:‘I would still be a bit concerned about the short, throw-away sentence about access by the police or thestate as a whole. There has been considerable concern about this in other countries with databases ofthis type and I am not sure whether this statement will be reassuring enough. I think many members ofthe public will be worried that this is simply a back-door way into the widely discussed concept of abroad national DNA database and it seems to me that a database which is being held purely formedical research should be better protected than this.’ [P]17. There was conflicting opinion about the value of commercial involvement, with a numberof respondents requesting further information about the possible nature of UK Biobank’srelationships with commercial entities, some noting that it may endanger individuals’willingness to participate (Box 2).Box 2. Commercial involvement‘Concerns raised in past consultations (particularly regarding the science, poor prospects for healthbenefits and lack of controls on commercial access) have not been addressed.’ [O]‘The vision of a user community that, in principle, includes commercial entities is to be warmlywelcomed and strongly supported. Such diversity of eventual use promises maximal returns from UKBiobank in terms of scientific discovery and improved healthcare, both in the UK and globally.’ [O]‘Our main concern is that the great utility of Biobank for UK researchers might be undermined by thepossibility that it will be of use to pharmaceutical and biotechnology companies. We think its very10