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

3 Relationship with participants3.1 Introduction20. This section outlines respondents’ views on aspects of the EGF concerning UK Biobank’srelationship with participants, namely:• Recruitment;• Understandings and consent; and• Confidentiality.3.2 Recruitment21. The Framework’s treatment of recruitment received a mixed response from respondents.The majority of respondents were ‘very satisfied’ or ‘satisfied’ with the general principles(n=16, 80%). However, in relation to the selection and approach of participants, 5respondents (25%) were ‘very unsatisfied’ or ‘unsatisfied’, with only 8 respondents(40%) being ‘satisfied’. Enrolment was thought to be ‘very satisfactory’ or ‘satisfactory’by 11 respondents (55%). Many respondents believed further development andclarification of concerns was needed in the EGF around issues relating to recruitment.22. Concerns around the selection, approach and enrolment of participants into the UKBiobank included:• selection bias of recruitment processes (Box 4);• whether GP participation was guaranteed (Box 5); and• data protection and clarity of data required from participants (Box 6).23. The recruitment of volunteers to UK Biobank was thought to be an area needing moreexplanation (Box 4). Many respondents were concerned about how UK Biobank wouldachieve a representative sample of the population and asked for further information on themethodologies that might be used to identify participants. There was praise and supportfor the outlined efforts to reduce barriers to participation. However, there were stillconcerns over how UK Biobank would ensure inclusion of under-represented groups insociety. This included concern that more information was needed on how people’scapacity to consent would be judged, so that claims of coercion or discrimination couldbe avoided.Box 4. Selection bias‘Reflecting specifically on the details of recruitment, we would look for further information as toprocedures to avoid an ascertainment bias favouring the more health conscious individual’ [O]‘...researchers should not approach people directly (as this would constitute a breach ofconfidentiality) and [we] would like consideration to be given to the idea of selecting participants via adifferent sampling frame. However, other possible sources (e.g. electoral register) are notoriouslyincomplete and use of these could lead to serious under-representation of certain groups. We wouldlike more detail about how UK Biobank plans to recruit potentially under-represented groups (e.g.travelling people and the homeless). If this aspect is not addressed the most under-researched groupsin terms of disease levels and health needs will be even more disadvantaged.’ [O]12