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

and access to medical records to researchers who are working towards the common good and itsanother to do this for companies that are seeking to make a profit with work that may benefit the publicin the future.’ [P]5.8 Transfer of assets, or closure108. Respondents had divergent views on the EGF’s proposals for the transfer of UKBiobanks assets or closure, with 30% (n=5) of respondents finding the framework ‘veryacceptable’ or ‘acceptable’ and 30% (n=5) finding the framework ‘very unacceptable’ or‘unacceptable’. Many respondents requested further details on the strategy to allow themto make a more informed judgement:‘More details are required. For example, what will happen if UK BioBank becomes insolvent? Whowill own the data? Will they be bound by the same terms.’ [O]109. Many respondents believed that greater transparency will be needed regarding financingand ownership of the resource to ensure participation by the general public:‘This is a particularly important consideration given the concerns evoked by the sale of the Icelandicdatabase to a private company. Many people may be willing to provide samples, and allow access totheir medical records for a public venture, but would feel less committed to a private company. Itshould be agreed that, in the event of any change in the ownership or control of the database, allparticipants will be informed of the change and given the option to withdraw.’ [O]‘Financial transparency as to future revenue will ensure stakeholders and participants are best placedto adjudge the likelihood of closure or substantial transitions in sample holdings or control of such and(sic) must be assured.’ [O]‘DNA samples and associated data are now of considerable commercial value. The majority ofbiobanks (existing or proposed) are also suffering financial difficulties and UK Biobank has not yetpublished a fully transparent budget or convincing evidence that it will be financially viable once it hasbeen set up. This means there is a very real prospect of bankruptcy and receivorship. It is unclearwhether in such circumstances the terms of consent ('soft law') would carry any weight in relation tothe financial requirements which may necessitate sale of samples to the highest bidder. UK Biobankshould provide transparent information both on its anticipated future budget and the legal situationshould bankruptcy occur. The implications of a more gradual decline in financial viability should alsobe considered - eg. will the biobank need to compromise its ethical standards if it becomes increasinglydependent on commercial funders, and what safeguards could be developed to prevent this?’ [O]110. Many respondents noted that they did not believe that the UK Biobank resource shouldever be sold:‘It was previously stated that DNA resource would not be sold. This is a principle which should beagreed and adhered to. Subjects have gifted the samples to UK Biobank and they should not be soldonto a third party.’ [O]‘UK BioBank should consider whether a lack of intent to sell or make other substantial transitions inthe holdings or control of the resource should be part of the consitution of UK BioBank.’ [O]‘We all believed that under no circumstances should samples or data contained within UK Biobank besold.’ [P]111. Finally, a number of respondents suggested how the contents of the resource should betreated in the event of the UK Biobank’s closure:40