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

‘As UK Biobank will have the role of 'sponsors' of research , what indemnity arrangementsare in place?’ [P]‘When UK Biobank will act as a sponsor for a research project, are there any additionalrequirements or safeguards to ensure compliance with the legal and ethical framework?(Could be perceived as a sensitive issue since UK Biobank is also the key holder to personaldata).’ [O]• The legislative framework within which UK Biobank will operate –‘Indicate what other audit/monitoring process will take place as required by law in England(besides the MREC). For instance: - The Charity Commission for England and Wales/TheData Privacy Commissioners.’ [O]5.7 Benefit sharing102. Respondents had mixed views on the EGF’s treatment of benefit sharing, with 50%(n=9) of respondents finding the framework ‘very acceptable’ or ‘acceptable’, and 22%(n=4) finding the framework ‘very unacceptable’ or ‘unacceptable’.103. A number of comments were made by respondents concerning the dissemination ofknowledge from UK Biobank, including:‘Whilst these proposals are broadly acceptable, they must also include prior publication (for wideconsultation and review) of research hypotheses and protocols (see above). Otherwise thedissemination of misinformation is much more likely than the dissemination of information.’ [O]‘In addition, it is stated that results will be allowed to remain confidential for limited periods, but thedefinition of 'limited' is important, as this could potentially be a big problem for commercialresearchers.’ [O]104. Some respondents suggested that the Framework should go further than reinvestingincome from fees in the resource, by acquiring and returning a share in any profits to theresource, or to the NHS:‘We suggest that UK Biobank gains a share of any commercial benefit derived from research byresearchers/commercial companies. We agree that such profits must be ploughed back into UKBiobank.’ [P]‘Income should be reinvested in the NHS and not in Biobank, since it is from the NHS that patients arebeing recruited, through NHS facilities and doctors' time.’ [P]‘Given the investment of tax payers' money and the altruistic involvement of participants, the publicwill expect that there is a proper return/reinvestment in UK Biobank and/or the NHS in terms of feesand/or profits from patents etc., especially when there is access from private companies ororganisations from outside the UK.’ [P]105. One respondent was concerned by the lack of detail in the EGF concerning incomegeneration:‘We note in general the lack of detail surrounding strategies within UK Biobank for income generationand would actively seek dialogue between stakeholders better to define such detail.’ [O]38