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

5.6 External governance100. The majority of respondents (n=14, 78%,) thought that the arrangements for externalgovernance as laid out in the framework were ‘acceptable’. Respondents welcomed theembedding of the external governance of UK Biobank within existing governancestructures in the UK:‘We strongly support the employment of traditional and proven mechnisms of external oversight andgovernance to assure such privacy and informed consent. We consequently welcome the provisonwithin the Framework of structures of external governance reflecting existing standards within UKconstituent nations, thereby best to support the endeavours of UK Biobank.’ [O]101. Respondents commented that a number of areas concerning external governance neededfurther clarification or caused concern. These included:• How MRECs would be used –‘Which MREC? Will one be established specifically for this role, or will the various existingMRECs pick up the extra burden?’ [P]• The involvement of GPs and local healthcare organisations –‘The framework puts certain responsibilities on participants’ GPs and on primary care trustsand other healthcare organisations to be aware of the research being undertaken and toensure that the arrangements for the research meet the governance standards. It is unclear,at this stage, what information will be provided to doctors to enable them to undertake thisrole. More information is therefore needed before we can say whether this is an acceptableexpectation. GP involvement should also be both voluntary and properly resourced.’ [O]‘The involvement of the recruiting GPs in fully understanding the principles of researchgovernance is very important, both for the project, and for capacity and capability buildingwithin the GP workforce.’ [O]‘How are local healthcare organisations going to be informed of research involvingparticipants who are patients under their care?’ [P]• Conflicts of interest –‘MREC review and RGFs do not generally cover important issues such as conflicts of interestor the scientific validity or usefulness of the research. These issues are currently covered(albeit inadequately) in other research studies by the process of informed consent andscientific peer review. Biobank's proposed governance processes appear to weaken thesesafeguards without putting alternative systems in their place. This is critically importantbecause commercial conflicts of interest are particularly extensive in biomedical research,and because the majority of genetic association studies to date have given false or misleadingresults.’ [O]• Equity of assessment processes –‘In assessing applications, all of them should be treated equitably ie those from academia andindustry.’ [O]• The role as ‘sponsor’ of research –37