4. UK Biobank s imaging application: Formulation of an EGC response

Transcription

1 UK Biobank Ethics and Governance Council Thirty-first Meeting Meeting at Wellcome Trust 215 Euston Road, London, NW1 2BE Monday 21 May 2012 at 10.30am Agenda 1. Apologies 2. Minutes of thirtieth meeting held on 5 March Matters arising (i) Tracking of requests to UK Biobank and update on recent activities (including a proposal for a December away day) (ii) Subgroup reporting as necessary: Feedback (iii) Subgroup reporting as necessary: Access (iv) Paper Advising on the interests of participants and the general public 4. UK Biobank s imaging application: Formulation of an EGC response 5. Closed discussion on topics to discuss under item 6 6. Update from UK Biobank (Professor Rory Collins, Chief Executive Officer, UK Biobank) (i) Report on access (ii) Data management and sharing plan (iii) IT and data security biannual report (iv) Participant and public involvement biannual report (v) Any other developments and outstanding recommendations from EGC30 7. Closed discussion of matters arising under item 6 8. UK Biobank s imaging application: Formulation of an EGC response 9. Communications activities (i) Upcoming meetings, conferences etc. (ii) External enquiries to the EGC 10. Report on meetings attended (i) Board of Directors meeting 16/03/12 (ii) Meeting with the Ethics and Governance Officer of INBANK 27/03/12 (iii) Launch of the Wellcome Trust and MRC commissioned report Assessing public attitudes to health related findings in research 03/04/12 (iv) Stakeholder workshop on the Expert Advisory Group on Data Access 03/04/12 (v) Conference call with Framingham Heart Study colleagues 25/04/ Any other business 12. Dates for March, 20 May, 9 September, 9 December 13. Date of next meeting 3 September Council meeting, London 1

2 UK Biobank Ethics and Governance Council Thirty-first Meeting 21 May 2012 Wellcome Trust, London Present: Professor Roger Brownsword (Chair), Professor Martin Richards, Dr Roger Moore, Dr Jonathan Hewitt, Mr Andrew Russell, Ms Tracey Phillips, Mrs Margaret Shotter, Dr Sheelagh McGuinness and Professor Søren Holm. In attendance from EGC Secretariat: Ms Adrienne Hunt. Observers: Ms Katherine Littler (Wellcome Trust) and Dr Sarah Dickson (MRC) for the whole day. Dr Catherine Moody (MRC) for items 1 7. Speakers: Professor Rory Collins (Principal Investigator and Chief Executive, UK Biobank), Mr Jonathan Sellors (Company Secretary, UK Biobank) and Mr Steve Garrett (Business Analyst, UK Biobank) for item Apologies Apologies were received from Professor Kate Hunt, Professor Paolo Vineis and Professor Heather Widdows. 2. Minutes of thirtieth meeting held on 5 March 2012 The Council approved the circulated minutes. 3. Matters arising Tracking of requests to UK Biobank and update on recent activities (including a proposal for a December away day) The EGC Chair updated members on a number of recent activities, including a report of his attendance at the March Board of Directors meeting. At its last meeting the EGC agreed to invite the new Chair of the UK Biobank Board of Directors, Sir Michael Rawlins, and the members of UK Biobank s Access Sub- Committee to attend a future EGC meeting. Sir Michael has accepted the invitation and will join the Council at its September meeting. The Access Sub-Committee has declined the invitation; the EGC has been advised of the Board s opinion that Professor Rory Collins should act as the EGC s conduit to the Access Sub- Committee. 2

3 The EGC has requested the right to observe meetings of the Access Sub-Committee on reasonable request. This will be considered by the Access Sub-Committee at its June meeting. Members agreed to hold an away day in December 2012 to discuss aspects of the EGC s remit and its relationship with various stakeholders. Mindful that the EGC s funding ends in September 2013, the discussion may inform a future submission for renewed funding. Subgroup reporting as necessary: Feedback Work on the subgroup s feedback report is ongoing. It is anticipated that the report will be discussed at the September EGC meeting. Subgroup reporting as necessary: Access A number of issues were discussed under this and item 7 (see Minute of item 7). Paper Advising on the interests of participants and the general public At the last meeting the EGC discussed its remit and what it understands by the phrase to advise on the interests of participants and the general public. The Secretary subsequently prepared a paper to reflect that discussion, which members reviewed at the present meeting. A number of amendments were proposed and the Council agreed to discuss the next draft at its December away day. 4. UK Biobank s imaging application: Formulation of an EGC response In April 2012 UK Biobank submitted a funding proposal to perform a range of imaging modalities on 100,000 members of its cohort. The Council has been asked to provide written comments as part of the funders formal review of UK Biobank s proposal and the EGC Chair has been invited to attend the September Review Panel meeting to speak to the EGC s views. Members discussed the imaging application with a focus on UK Biobank s proposed approach to the management of incidental findings made during the imaging assessment. 5. Closed discussion on topics to discuss under item 6 Members discussed a number of matters to raise with UK Biobank under item Update from UK Biobank (Professor Rory Collins, Chief Executive Officer, UK Biobank) Report on access At the end of March 2012 the UK Biobank resource opened for access by the research community. Members reviewed two papers: First, a high-level summary 3

4 report, provided by Mr Steve Garrett, giving details of the number of approved registrations and submitted Applications (by institution type e.g. academic, governmental etc. and institute location e.g. whether UK-based or international). Second, a report containing details of the individual Preliminary and Main Applications, including their lay summaries. Members noted that there were 25 Preliminary and 2 Main Applications in UK Biobank s access system. During the development of the access procedures UK Biobank advised that the intention was for application lay summaries to be structured in such a way as to provide sufficient information about any particular proposed study (including its methodology) in order to facilitate the various oversight responsibilities that the Ethics and Governance Framework (and the Access Procedures) place on the EGC. In discussion with UK Biobank colleagues, it was agreed that the Preliminary Application lay summaries received to date were of variable quality in terms of the information provided. Quite apart from the matter of its own oversight responsibilities, the EGC considers an informative lay summary to be a key aspect of UK Biobank s public accountability so that the research community, the participants and the general public can gain a reasonable understanding of the health-related research being done using UK Biobank. As such, the Council fully supported a proposal by Professor Collins that more detailed guidance should be provided to Applicants and that prompts could be inserted into the application forms requiring Applicants to provide specific information as part of a more structured lay summary. Professor Collins welcomed the EGC s advice on which prompts might be included. Even with the proposed improvements to the lay summaries, and with the benefit of having now seen the first tranche of applications, the EGC expressed its view that having access to the lay summaries of applications only will not suffice for the Council to fulfil its oversight role. The Council requested routine access to the methodology sections of all applications. Professor Collins advised that the EGC pursue this request with the Board of Directors. The Council and Professor Collins agreed on the need for clarity regarding the respective roles and responsibilities of the parties involved in access, in particular those of the EGC and the Access Sub-Committee. The EGC supported Professor Collins proposal to develop a Memorandum of Understanding to address this. Mr Jonathan Sellors and Ms Adrienne Hunt will liaise on the development of the Memorandum. Data management and sharing plan Members noted UK Biobank s data management and sharing plan which, once finalised, will be a public document. IT and data security biannual report Members were pleased to receive the biannual report on IT and data security, in particular the update on the security provisions in relation to the access systems. 4

5 UK Biobank s IT infrastructure, including the new access systems, underwent external penetration testing at the beginning of May. The testing was performed by a third party company from a remote location, with no special access and no prior knowledge of the system. The testing was focussed on what information can be obtained from the system, rather than load testing/performance testing. UK Biobank is awaiting the full results of the report, however there were no high or critical issues discovered and nothing that would lead to a compromise. In order to assure itself about the risk assessment process undertaken by UK Biobank, the EGC requested sight of UK Biobank s access systems risk register. Professor Collins agreed to provide this documentation. Participant and public involvement biannual report Members congratulated UK Biobank in particular, Mr Andrew Trehearne for the excellent coverage on the launch of the resource. The biannual update on Communications provided a valuable summary of the work that has been undertaken by UK Biobank in recent months. In future it will be important for UK Biobank to have a process and system in place for more organized user involvement. To this end, and now that access is open, it may be time for UK Biobank to look again at the outcomes of the EGC s 2009 workshop on public involvement. In addition, UK Biobank might want to consider the Patient and Public Involvement initiatives of other organisations, such as the National Institute for Health Research. The Council would welcome more information in future biannual reports about UK Biobank s plans for participant involvement. Any other developments and outstanding recommendations from EGC30 Imaging Professor Collins advised that, prior to the autumn funding decision, UK Biobank aims to develop the imaging visit participant materials. An invitation to tender will also be prepared for work that will assess attitudes to feedback (e.g. participants views on the imaging assessment and feedback processes and the opinions of various constituents GPs in particular on the impact of feedback). The Council offered support to UK Biobank in the development of these materials. In particular, a number of EGC members have experience of performing public attitude surveys and will be keen to advise UK Biobank. Re-contact UK Biobank has received research ethics committee approval for the information materials of two initiatives that require participant re-contact. First, 20 25,000 participants will be invited to attend a repeat of the baseline assessment visit. Beginning in August 2012 and taking place at the co-ordinating centre in Cheadle this process is expected to take about a year. Second, UK Biobank participants will be re-contacted and asked if they are willing to wear an accelerometer for a week, before returning it to the project. A pilot will be undertaken with the first invites being 5

6 circulated in June. It is anticipated that 1,000 participants will be re-contacted in the first 4 6 weeks. It is apparent that a number of re-contacts are planned for the year ahead. Professor Collins confirmed that UK Biobank will develop a report on re-contact that will help the project and other interested parties, such as the EGC to track the range of actual and proposed re-contacts. The Council welcomed this confirmation, considering such a report to be timely. Biomarker proposal In February 2012 UK Biobank submitted a grant application proposing that a wide range of biochemical markers are measured in samples collected at baseline from all 500,000 of its participants. A funding decision is expected in July. 7. Closed discussion of matters arising under item 6 Access EGC access to information The Council agreed to ask UK Biobank s Board of Directors to consider and respond to the EGC s request for routine sight of the methodology section of all applications. In writing to the Board the EGC will make clear that it has absolutely no intention of conducting a parallel review of the merits of particular applications 1. The formal process for reviewing and approving access applications rests clearly and firmly with UK Biobank s access management team and the Access Sub-Committee in a process managed by Professor Collins. The EGC s interest (in line with its remit under the Ethics and Governance Framework) lies primarily in reviewing the process and, on occasion, the decisions made by UK Biobank. EGC standard operating procedures In addition to the development of a Memorandum of Understanding (see item 6), the EGC agreed to develop a standard operating procedure for how it will exercise its oversight and reporting function with respect to the access process. Lay summaries Members were invited to contact the EGC Secretary with their views on what guidance should be provided to Applicants, and what prompts could be included in the application process, to encourage the submission of more informative lay summaries. 1 Except where so required under the Ethics and Governance Framework e.g. the EGC s advice must be sought on all applications that request re-contact with participants. 6

7 Review of the access process It was noted that UK Biobank intends to review the access system in light of the first batch of applications within the first 3 to 6 months of access. The Council would be keen to provide input during this review process, for example, by reviewing and commenting on the adjudication process and outcomes for a set of applications. Re-contact Noting UK Biobank s intention to prepare a report on re-contacts (see item 6), the Council agreed to offer a few thoughts on how such a report might be structured. For example, the report could list specific re-contacts against a timeline, including recontacts that have already taken place (e.g. in the last 18 months) and anticipated re-contacts (e.g. for the next 18 months). The report might list the specific recontacts under a number of category headings (e.g. re-contacts for UK Biobank s own purpose invitations to contribute new data via questionnaires or to have new face-to-face contact via a further assessment visit or re-contacts for an Applicant s purpose as part of a research project). 8. UK Biobank s imaging application: Formulation of an EGC response The Council agreed on the key points to include in its submission to the funders review of UK Biobank s imaging application. 9. Communications activities The Secretary reported on a number of upcoming meetings and conferences including: Professor Søren Holm s attendance at the Council of Europe Symposium Biobanks and biomedical collections (19 20 June); the Chair, Vice Chair and Secretary s visit to the Framingham Heart Study (17 18 July) and the ALSPAC Ethics and Law Committee (21 August); the Vice Chair s attendance at UK Biobank s International Scientific Advisory Board meeting (13 14 September). 10. Report on meetings attended Board of Directors meeting 16/03/12 The Chair had provided an update on his attendance at the Board meeting earlier in the day. Meeting with the Ethics and Governance Officer of INBANK 27/03/12 The Secretary recently met INBANK s Ethics and Governance Officer, Ms Hawys Williams. An initiative of Arthritis Research UK, INBANK is a centralised, diseasebased resource linking clinician- and patient-reported data with biological samples and routinely collected patient outcome data from NHS and related sources from other devolved administrations. 7

8 This central resource will provide access for recruitment to studies of both early and late stage inflammatory arthritis, the opportunity to access samples for biomarker development and testing and the facility for linking to follow up morbidity data to assess both clinical benefit and adverse events following treatment. 2 Launch of the Wellcome Trust and MRC commissioned report Assessing public attitudes to health related findings in research 03/04/12 A number of Council members and the Secretary attended the launch of the Wellcome Trust and MRC commissioned report Assessing public attitudes to health related findings in research. The report 3 forms one part of a broader project aimed at developing a set of principles to be considered in the development of any feedback policy. The final project report will be published towards the end of the year. Stakeholder workshop on the Expert Advisory Group on Data Access 03/04/12 The EGC Chair and Secretary attended a workshop aimed at informing the workplan of the new Expert Advisory Group on Data Access (EAGDA). Formed by the Wellcome Trust, Medical Research Council, Economic and Social Research Council and Cancer Research UK, EAGDA will hold its first meeting in June. Conference call with Framingham Heart Study colleagues 25/04/12 In preparation for the planned July visit, the Chair and Secretary held a conference call with Framingham Heart Study (FHS) colleagues to discuss the EGC s areas of interest in relation to FHS s feedback policy and practice. 11. Any other business There was no other business. 12. Dates for March, 20 May, 9 September, 9 December 13. Date of next meeting 3 September Council meeting, London 2 For more information see from which these quotations are derived. 3 Accessed on 24 August 2012 at: 8