HEALTH RESEARCH AUTHORITY BOARD MEETING

Transcription

1 HEALTH RESEARCH AUTHORITY BOARD MEETING Minutes of the Health Research Authority (HRA) Board meeting, held on 26 th November 2014 from 12.30pm 2.30pm via videoconference from HRA 1 Skipton House / Manchester HRA Centre / Jarrow HRA Centre / Nottingham HRA Centre Present Initials HRA Non-Executive and Executive Directors Sally Cheshire Debbie Corrigan Allison Jeynes-Ellis Jonathan Montgomery Julie Stone Janet Wisely Non-Executive Director Director of Finance Non-Executive Director Chair Non-Executive Director Chief Executive SC DC AJE JMo JS JW HRA Directors who attend the Board Joan Kirkbride Janet Messer Tom Smith In attendance Director of Operations and Approval Director of Systems and Development / Programme Director HRA Approval Director of Quality, Standards and Information JK JMe TS Shaun Griffin Communications and Strategy Advisor Stephen Robinson Corporate Secretary (in part items 1 7) Stephen Tebbutt HRA, Board Secretary and CE Business Manager SG SR ST Observer Sue Cartwright Emyr Harries Christine Holmes DH Sponsor team KPMG DH Sponsor team SCa EH CH Item Item details Action 1. Apologies Hugh Davies, HRA Ethics Advisor Ian Cook, Director of Corporate Services 2. Conflicts of interest None to note 3. Minutes of last meeting Page 1 of 9

2 The minutes of the previous meeting were accepted as a true and accurate record of the matters discussed without amendment. 4. Matters arising Shaun Griffin The Board noted the previous Board meeting had been SG s last meeting as an Executive Director and SG would be leaving the HRA in January for the Terence Higgins Trust. The Board thanked SG for his work at the HRA in particular his role as Executive Director on the Board. Off-Patents Drug Bill The Board noted the second reading was scheduled to take place on 7 November however this had been cancelled as the meeting was not quorate. Arrangements to reschedule the second reading are currently taking place. 5. Update from Chair HRA All-Staff Day 2014 JMo advised the 2014 All Staff Day on 13 November was a very successful event, with a well-balanced programme combining informative, inspiring and fun sessions to help HRA staff meet each other, take pride in achievements, explore the challenge ahead and draw out ideas about how to meet these challenges. The Board noted its congratulations and gratitude to Sue Nunn and the team who brought the day together and made it run so smoothly. Positive feedback The Board noted there was positive feedback on our work on transparency from the EU Forum of National Ethics Committees (20 Nov) and also from a panel session at the EU Conference on Science Innovation and Society - Responsible Research and Innovation (21 Nov). There was also particular interest in our systems for training and accrediting research ethics committees and assuring consistency and quality through the shared ethical debates. The latter has previously been identified as good practice by UNESCO. Non-Executive Director Interviews JMo advised interviews were held for the None-Executive Director (NED) positions on the Board of the new Non-Departmental Public Body (NDPB) on 7 and 14 November and the names of a number of candidates who were identified as appointable have been submitted to Government for consideration. JMo flagged the appointments are made by the Minister and not by the interview panel with the outcome expected shortly. The NDPB will be established from 1 January 2015 with the first formal meeting of the new Board scheduled for 21 January. JMo advised the NED induction programme will begin before this with ST leading this piece of work with input from current NEDs. Final Board meeting as Special Health Authority JMo advised this is expected to be the last formal meeting of the Special Health Page 2 of 9

3 Authority Board and expressed his gratitude to all Board members for their work to ensure the success of the organisation. We were established in response of the challenge from the Academy of Medical Sciences to streamline the research approvals system, particularly in relation to the difficulties in securing NHS R&D approvals that were outside our formal controls. The support for the business case for HRA Approval demonstrates that we responded effectively to that challenge and won the confidence of Government and key stakeholders. We are regarded as a well-managed organisation that can be trusted to deliver, with strong accountability, risk management and audit arrangements. The Board's early commitment to openness and transparency, especially in seeking and responding to patient and public views, was an important part of building that confidence. Our approach to this has been widely commended and was said to be exemplary at an APBI meeting of Patient Organisations that JMo attended on 17 November. Our decision to sign up to the AllTrials campaign gave a significant signal about the robustness of our commitment to patient and public interests and was commended by Sile Lane of Sense About Science in her presentation to the All Staff Day. We have maintained the confidence of industry stakeholders, gained strong support from the Academy of Medical Sciences and also from Parliamentarians (expressed in the debates on the Care Bill, and leading to cross-party support for the establishment of the NDPB). Our strong internal performance has been maintained through this process of change and we are seeing the UK regain some of the ground it had lost in relation to its attractiveness for clinical trials. This has all been achieved without diluting the protections for research participants. The Health Research Authority can be proud of its achievements and JMo expressed his appreciation to Janet Wisely and her executive team, JMo s nonexecutive colleagues, the volunteers on the HRA s Research Ethics Committees and to all HRA staff for their commitment and essential contributions to its work. 6. Update from Chief Executive Meetings to highlight JW advised the Communication team hold a full list of the extensive set of meetings attended and presentations made by the HRA senior team. JW highlighted the following meetings which had taken place since the last Board meeting: - Jonathan Emms, the Association of the British Pharmaceutical Industry (ABPI) President introductory meeting with JW and JM. This included discussions on transparency and EU legislation with expressed commitment to the transparency agenda. - Medicines and Healthcare Products Regulatory Agency (MHRA) and Department of Health (DH) to discuss the legislation required to implement the clinical trial regulations. Page 3 of 9

4 - United Kingdom Ethics Committee Authority (UKECA) and four nations. UKECA business included a focus on quality assurance and the REC accreditation scheme as well as early discussions on development of the UK legislation that will be required to implement the EU clinical trial regulations. - UK policy framework steering group at which a very early draft of the framework was discussed to establish key areas for content. The project is on target to submit to the first Board meeting of the NDPB in January ahead of issuing the framework for comment. - NIHR Trust and CRN Leaders conference attended by JW, JMa and Mary Cubitt as invited guests of the conference with excellent opportunities to network and promote work of the HRA. - HRA workshop held in Cardiff this week to complete the set across the devolved administrations. Business plan The Board noted SR is the lead for this work and plans are in place to deliver the first draft version to DH by the requested December deadline. As previously advised much of the plan will be a roll over and build on last year given the established work programmes and success in starting work this year that will ensure the HRA is well placed to take the additional responsibilities for the HRA as a NDPB. Early trial registration JW advised good progress had been made in working with Clinical Research Organisations (CRO s) to develop a position statement and proposals to take through MHRA to EU negotiations. The proposals will set out the UK model of deferral as a basis for wider management of registration and the balance against commercial confidence for these early phase trials. AllTrials JW flagged the campaign is to be taken to USA which is a very positive move and help work towards a global position on transparency. World Health Organisation (WHO) consultation In response to recent consultation by the WHO on the Statement on Public Disclosure of Clinical Trial Results, supporting the disclosure of clinical trial results to enhance transparency for the public ( the HRA responded to confirm it supported the consultation by the WHO on a world platform, highlighting the steps that were in place in the UK regarding registration of clinical trials since Sep 2013 and noting that the HRA looks forward to the next steps and proposals by the WHO following the consultation. JW advised the we also noted our position that all research, not only clinical trials, should in due course be published /reported, balanced with the protection for researchers and their innovations with the need to reduce waste on duplicate research and the need to continually assure public confidence in health research. Page 4 of 9

5 HRA news JW advised all new starters and other important updates have been included in HRA news with messages for staff reinforced through the all staff video / teleconferences which continue to be well attended. JW advised she was particular pleased to report that we have now successfully recruited to the Information System team which was a key dependency for successful further progression of HRA Approval. All staff day JW echoed JMo s earlier comments to advise the event was a great success, and has evaluated very well. 7. Transition to NDPB status SR tabled an update on the work to transition the HRA to NDPB status. SR thanked CH and DH colleagues for their help and support. SR flagged the following key updates Commencement Order 2014 No (C.111) Completed and published 31 st October 2014 The Health Research Authority (Transfer of Staff, Property and Liabilities) and Care Act 2014 (Consequential Amendments) Order 2014 Completed and published 18 th November 2014 Framework Agreement (DH / HRA) 1 st Draft has been submitted and after HRA meeting on 10 th November, comments returned to DH. DH is now working on it and draft to be returned shortly. To be ready in advance of 21 st January Board meeting. Staff Consultation Document with Q&A Completed and approved. Key Issues and Actions Appointment of Chair Completed. Appointment of Chief Executive Letter of appointment by Una O Brian, Permanent Secretary at the Department of Health being prepared to be ready for 1 st January Appointment of Non-Executive Directors A submission to George Freeman, Parliamentary Under Secretary of State (Life Sciences), providing him with a panel report which includes the recommendations of the selection panel (Russell Hamilton, Jonathan Montgomery and Moira Rankin) for candidates has been made. No decisions have been announced as yet. Full induction programme being devised and led by Stephen Tebbutt, Board Page 5 of 9

6 Secretary. Appointment of Executive (voting) Members of the Board To be undertaken at Board meeting on 21 st January. 1 st Meeting of New Board Arranged for 21 st January Agenda to be finalised but will concentrate on requirements for formal constitution matters of HRA as a NDPB. Accounts, Audit and Annual reports The Transfer Order confirmed the requirement to submit Accounts and Audit Report until 31 st December The Department of Health is stating that the next set of Accounts and Audit Report can be submitted for the period 1 st January 2015 to 31 st March Clarification is still being sought on the implications and specific requirements. An Annual Report will be prepared for the period to 31 st December An Annual review will be submitted for the period 1 st January 2015 to 31 st March An Annual report will be submitted for the period 1 st January 2015 to 31 st March Staff Consultation The consultation document and Q&A was issued to all staff Wednesday 19 th November Timetable as follows: Date Week beginning 27 October th November th November 2014 Action Information on change to NDPB status and staff transfers included in HRA News and during All Staff Videoconference Issue of Staff Information paper to Staff Partnership Forum and managers Issue of Staff Information paper to all staff Start of one-month opportunity for staff to ask questions, raise concerns or make comments End of one-month period for staff to comment 19 th December 2014 December 2014 Issue of individual staff transfer notification letters date tbc 1 st January 2015 HRA as SpHA ceases to exist. HRA established as NDPB on this date No comments / observations have been received to date. Key Staff Issues - Staff will continue to retain access to the NHS Pension Scheme from 1 st January All transferring permanent and fixed term staff will do so without a break in their statutory continuity of service. Page 6 of 9

7 - Staff will remain employees of the HRA and will continue to be public sector employees on full NHS terms and conditions of service. The HRA will continue to use NHS terms and conditions of service and its existing policies for existing staff and for new appointments post transfer for the foreseeable future. The HRA will continue with its policy harmonisation programme in accordance with our agreed consultation procedures involving the Staff Partnership Forum. - Staff benefits are non-contractual although contribute to the HRA being an Employer of Choice. The HRA offers a range of benefits to staff currently including childcare vouchers, interest free season ticket loans, eye care support, an Employee Assistance Programme and flexible working. These benefits will continue following the transfer. - The HRA will, for the time being, continue using the NHS Branding (see below) so staff will continue to access NHS benefits. Branding An amendment in our Establishment Order was required that states: In article 1(2) (citation, commencement and interpretation) of the National Health Service Litigation Authority (Establishment and Constitution) Order 1995 (b), in the definition of NHS body, after clinical commissioning group insert the Health Research Authority. Similar is required for the NHS Clinical Negligence Scheme, NHS Liabilities to Third Parties Scheme and NHS Property Expenses Scheme. HRA is therefore considered as an NHS Body. Similar applied to Health Education England. HRA will consult staff and stakeholders in the new year on branding moving forward. Internal Audit of NDPB Transition This has been undertaken by PricewaterhouseCoopers (PwC) Auditors on behalf of DH Internal Audit. No report has been submitted as yet. Miscellaneous Under the Transfer Order all property (although the HRA has none), assets, rights and liabilities of the HRA as Special Health Authority transfer to the HRA as a NDPB. The implications of this are that all contracts, including shared services and those with REC Chairs and Vice Chairs, leases, liabilities (such as complaints or claims)etc. transfer. The HRA continues as a legal entity with all implications thereof. Novation of all agreements, memorandums of understanding and prior commitments also occur i.e. UKECA. It has also been confirmed that the HRA can continue to use the NHS Mail service. The handover process for the Audit and Risk Committee is in place and will take place prior to the first Board meeting. Page 7 of 9

8 The Board queried what would happen if the new NED appointments were not in place by 1 January JMo sought comment from DH colleagues as it is a DH process. CH advised the risk has been mitigated as all parties involved in the process are fully aware of the timescales and that urgency had been stressed to ensure the appointments are made on time. 8. Corporate Risk Register The Board received the Corporate Risk register and noted the risks largely related to the HRA Approval Programme and the Confidentiality Advisory Group. The Board noted the reputational importance of HRA Approval and the external interest hence the large number of risks relating to HRA Approval on the register. The Board noted a review of communications vs information would take place once the new Deputy Director for Corporate Services is in post (likely December 2014) who has a strong background in communications. The Board noted IT remains a risk to the organisation however ATOS and DH are fully aware of the issues. The Board noted there has been a small improvement in the recent service. 9. Finance report October 2014 The Board noted there are no new matters of significant concern at this stage of the financial year in terms of the overall position. DC highlighted the main points from the report: - Year to date under spend of 201k - Increase in early forecast underspend from 1.57m (Financial Plan) to 1.668m. Range of forecast now declared to DH of 1.7million to 2million. This is largely due to delays in recruitment, vacancies arising and the cancellation of a small number of REC Meetings. DC flagged the continued need for approvers to review their invoice workflow on a daily basis. DC advised good support had been received from the DH finance team and sponsor team. SC seconded this as Audit Chair. The Board approved the finance report for October HRA Approval Programme Plan The Board noted the plan had been shared for information to provide assurance regarding the approach taken to the planning of the HRA Approval Programme as detailed as one of the recommendations from the gateway review. The Board noted the Programme Board governs the programme and the HRA Board would receive reports for information on an exception basis. JMe advised a Gantt chart will be developed to highlight progress and any risk areas to the Board and allow any concerns relating to interdependencies to be raised. Page 8 of 9

9 The Board noted a gateway review would be scheduled for March 2015 with the intention still for HRA Approval to be rolled out for all types of studies by end of Breach report (01/04/ /03/2014) JK presented the Breach report for 2013/14 to the Board. JK flagged it was reassuring that most of the breaches had been self-reported. JK advised Frank Wells, Lead Advisor (honorary) to the HRA on Integrity, Fraud and Misconduct, had attended a conference in Belgium and will attend one in Brazil to highlight the importance of collecting this information so lessons can be learned as our understanding is that the UK is the only country which collects this information. JK advised the Operations team would analyse the data further to identify trends. The Board agreed it is important to maximise this data to help build public confidence. 12. HRA Appointing Authority updates (November 2014) The Board noted the latest appointing authority update. 13. Any other business JMo thanked members of the Board again for their contribution to the HRA as a Special Health Authority in driving forward the health research agenda in the UK. 14. Date of next meeting: 21 January 2015 Page 9 of 9