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

‘Biobank has probably considerably underestimated the level of re-contact necessary in order to obtainthe data needed to test the relevant hypotheses. An assessment of the likelihood of recontact isnecessary before participants can be informed about it.’ [O]‘It is unlikely that recontact will be a regular event, thus it would be feasible for the Ethics andGovernance Council to be involved in and approve all decisions to recontact participants.’ [P]‘We suggest that you indicate that consideration will be given to the possible “over-solicitation of agiven sub-population” in decisions to recontact participants. A registry should be set to keep track torecontacts with any given individual.’ [O]3.3.6 Right to withdraw51. The majority of respondents found the EGF’s proposals around the right to withdraw‘very acceptable’ or ‘acceptable’ (n=14, 70%). The main issues concerning the right towithdraw were to what extent participants should be given the freedom to make decisionsabout continuing to be a participant in UK Biobank and how withdrawal would beoperationalised. Examples of respondents’ views are included in Box 11. The EGFproposed three possible options:• Complete withdrawal;• Discontinued participation; and/or• No further contact requested.52. A number of respondents believed that all three levels of withdrawal should be available.However, it was recognised by respondents that the value of UK Biobank as a resourcefor research would be limited if many participants withdrew and chose to have their dataremoved from the database. Furthermore, it was highlighted that there could be difficultyin tracing and destroying distributed samples for anonymised data sets.53. Despite its potentially limiting impact on the value of the resource, a number ofrespondents still felt that it was absolutely necessary to give participants the option ofbreaking the link with their medical record and having their identifiable informationdestroyed, as this was crucial to make the project “ethical”. On the other hand, a numberof respondents suggested that the most practical and acceptable way forward wasdiscontinued participation.Box 11. Right to withdraw‘Ideally, we would like to see patients being given the option of the three levels of withdrawal. It wouldbe a shame to lose the information already collected, and that available from maintaining an ongoinglink, if the patient simply does not want to be contacted again. We believe it is essential, however, thatthe option of breaking the link with the medical record and of destroying identifiable information isavailable to all participants.’ [O]‘A possible solution would be to offer participants who withdraw the choice of the three optionsoutlined in the Framework document. However the Complete withdrawal option risks significantlylimiting the value of UK BioBank for research if large numbers of participants take this option.Furthermore the fact that it may not be possible to trace and destroy all distributed sample remnantscould cause difficulty. Therefore Discontinued participation may be the best practical option althoughthis should be clearly stated in the original consent process.’ [O]‘Since right to withdraw may not be feasible for at least some research using anonymised data sets, itis critically important that there is prior agreement on what types of research are publicly acceptable.’[O]22