Page 1 of 63
HEALTH RESEARCH AUTHORITY BOARD MEETING
AGENDA PART 1 – PUBLIC SESSION
Date: Tuesday 24 July 2018
Time: 1.30pm – 3.15pm
Venue: etc venues, Avonmouth House, 6 Avonmouth Street, London SE1 6NX
Item Item details Time Attachment Page (mins) no 1. Apologies Verbal -
Janet Messer Janet Wisely
2. Conflicts of interest Verbal -
3. Minutes of the last meeting 10
- 16 May 2018 A
4. Matters arising Verbal -
Including: - HRA Annual Report and Accounts 2017-18 published
5. Update from Chair 5 Verbal -
6. Chief Executive update 10 To be tabled -
7. HRA Directorate update 5 To be tabled -
8. Transformation Programme update 10 B
Including: - SIP Proportionality project 10 C
9. Update on progress of research transparency work 5 Verbal -
10. Pilot proposal for an HRA Accountable Centre Model for 15 D improvement evaluations
Page 1 of 2 HRA Board Meeting Agenda – Part 1 (2018.07.24) Page 2 of 63
11. Finance report: April – June 2018 10 E
Items for information 12. Annual Freedom of Information Report (2017/18) F
13. Annual Complaints Report (2017/18) G
14. Summary of 06.06.2018 Audit & Risk Committee meeting H
15. Out of session business conducted / External areas of Verbal interest since previous meeting 10 - Update regarding recruitment of Nick Hirst to support Research System Programme circulated 07 June 2018 - Statement issued by NIHR regarding Improving Performance in Initiating and Delivering Clinical Research circulated 07 June 2018 - Update regarding two studies to be published circulated 17 June 2018
16. Any other business 5 Verbal - (Any AOB items should be notified to the Head of Corporate Governance no later than 24 hours prior to the Board meeting barring exceptional circumstances)
17. Questions from the public 5 Verbal -
18. Date of next meeting
19 September 2018
19. Resolution to exclude members of the public
Members of the board are invited to resolve that representatives of the press and members of the public be excluded from the remainder of the meeting as any publicity would be prejudicial to the public interest by reason of the confidential nature of the business
Part 2 – Confidential session
The remainder of the HRA Board meeting will be deliberated in private due to the confidential nature of the business to be transacted. Papers and minutes will not be published for this part of the meeting.
Page 2 of 2 HRA Board Meeting Agenda – Part 1 (2018.07.24) Page 3 of 63
HEALTH RESEARCH AUTHORITY BOARD MEETING
PART 1 – PUBLIC SESSION
Draft Minutes of the Health Research Authority (HRA) Board meeting, held on 16 May 2018 at the London HRA Centre
Present Initials
HRA Non-Executive and Executive Directors
Teresa Allen Interim Chief Executive TA Graham Clarke Non-Executive Director GC Ian Cook Director of Transformation and Corporate Services IC Allison Jeynes-Ellis Non-Executive Director AJE Deirdre Kelly Non-Executive Director DK Jonathan Montgomery Chair JMo Nalin Thakker Non-Executive Director NT Karen Williams Director of Finance, Procurement and Estates KW
HRA Directors who attend the Board Janet Messer Director of Approvals Service JMe Juliet Tizzard Director of Policy JT
In attendance
Stephen Tebbutt Head of Corporate Governance ST
Observers Stergios Aidinlis, Member of the Public Katherine Guerin, HRA Christine Holmes, DHSC (in part items 1-7)
Item Item details Action 1. Apologies
Janet Wisely
2. Conflicts of interest
None to note
3. Minutes of last meeting
The Board agreed the minutes of the last meeting were a true and accurate representation of the matters discussed without amendment.
4. Matters arising
Page 1 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 4 of 63
July Board seminar on Board effectiveness update ST and AJE informed the Board the seminar would be external facilitated with the facilitator to hold individual phone calls with members of the Board prior to the seminar.
Future direction of travel for the Research Ethics Service Board seminar The Board noted this has been scheduled for early 2019.
Reasons for breaches and application of learning The Board noted this document had been circulated by JMe.
CEO update - TA to add benefit of meeting with stakeholders to future CEO updates The Board noted this would likely be ready for the July Board meeting. Action: Benefit of meeting with stakeholders to be added to CEO update TA
Staff survey – JMe to provide verbal briefing to Board on case studies for managing poor performance The Board agreed this would be added to the July P2 Board agenda Action: JMe to provide update at July P2 Board meeting JMe
Metrics – industry perceptions The Board noted this would be covered under the agenda timeline item.
R & D forum presentation The Board noted the forum had been successfully held earlier this week.
Transparency JT informed the Board that work continues to progress with a more detailed update to follow at the July meeting. The Board noted the report from the Select Committee is anticipated to be published in early June. Action: JT to provide update at July Board meeting JT
Research Systems team and Leadership Team to review systems risks The Board noted this would be covered under the agenda item on risk.
5. Update from Chair
CEO advert now published JMo advised the advert for the CEO position has now been released. JMo advised if any staff wished to discuss the role or had any concerns, he or Michele Ekins, Head of HR, would be happy to discuss further.
‘Research Integrity, Conflicts of Interest and the end of Expertise’ JMo advised he had recently given a lecture on ‘Research Integrity, Conflicts of Interest and the end of Expertise’ at the Research Institute for Ethics and Law event at the University of Swansea. JMo advised a draft of the presentation was available to Board members if they wished to read it.
Data JMo advised he had attended a number of events on data, including co-chairing
Page 2 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 5 of 63
a meeting of the AMS which discussed access to medical data and giving a talk on genomics at University of Kingston. The Board recognised the increased focus on data and expected this to continue.
Genome editing JMo advised he head recently attended an event on Genome editing at the Vatican and flagged the importance of the UK being positioned as an excellent place to conduct genome editing.
6. Update from Chief Executive
The HRA business plan for 2018 received sponsor approval at the end of March and now that the local elections have been completed is available on the HRA website. The annual report is in its final draft stage ready for the audit and approval stages over the next month and we have taken the opportunity to use advice from the National Audit Office to refresh the way that some of our performance information is presented. We anticipate that this will be ready for signoff by the auditors by the end of the month and by the Audit and Risk Committee on 06 June. Consistent with last year we will be requesting a chair’s action at the Board meeting on the 16 May to provide the Board sign-off of the accounts on 14 June. Karen will provide Jonathan with the ARC papers when they are distributed together with any adjustments agreed at the meeting to give him sufficient time to review and provide sign-off. This is consistent with last years’ approval timeline.
Following the development of the refreshed strategic aims last year we developed a planning grid which has helped us to directly align strategy, operational initiatives and personal objectives and this has been updated for the 2017/18 year. I am delighted to report that our performance across all areas last year was strong and that shortened timelines for our approval service continued to fall and were maintained throughout the year benefitting the wider research community with their study set up.
We continue to progress our service improvement programme and a number of projects are now entering the delivery stage. During April the new verification tool in IRAS went live. This should help to reduce the number of studies which are submitted that are incomplete, delaying study start up and generating extra non-added value work. Last year over 36% of study applications submitted were incomplete and we anticipate that we will start to see this reduce with new applications coming in now.
The HRA continues to provide guidance and support to the wider research community on the General Data Protection Regulations and have updated this on a regular basis ahead of the deadline of the 25th May. We have also developed our own implementation plans for readiness internally.
Our workforce project has now started and affects most of the approvals teams. This will be one of the most important pieces of work this year and will deliver a truly integrated service to our users. It will also identify the role changes which are needed to underpin other projects which are progressing around proportionality and amendments.
Page 3 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 6 of 63
The executive team and the transformation board are still developing a longer- term target operating model to ensure that we can help staff to visualise what we anticipate the HRA will look like over the next few years to assist our longer term workplans.
A team of over 20 HRA staff contributed to the success of our all staff day at the end of April. The organisation of the event and the selection of the external speakers resulted in a really engaging day and staff were then able to select from a series of 8 workshops on a range of topics from managing their own wellbeing to the changes to the Clinical Trials Regulations. Staff health and wellbeing is a key theme for the year following the feedback in the staff survey and we are using the survey outcome and feedback from the staff forum to ensure that we support both the physical and mental health of our most valued resource. During the event we were able to show a short animation celebrating the contribution and success of everyone during the last year.
The procurement process for the IRAS replacement is reaching its final stage and we anticipate that we will be able to confirm the preferred supplier over the coming weeks. This has been a particularly intense period of activity for a number of people across the HRA and our priority once a decision has been taken will be to ensure that we have adjusted our wider workplan to give this work priority over the coming months.
External visits/meetings
- Dame Sally Davies Commemoration Oration Kings College London (networking) - Christine McGrath R&D Direction University Hospital Southampton NHS Trust meeting to discuss new Research Leadership Organisation for R&D Directors and tour of research unit. - National Perinatal Epidemiology Unit, Oxford University. Visit to R&D team to learn about their work and have demonstrations of their approach to patient involvement and engagement. - Mark Walport CEO UKRI, Introductory meeting. - Nick Hirst NIHR CIO – external advice and assurance on planning for new systems implementation. - Digital Health, NHS London Digital Accelerator. Undertaking assessment of new technology from SMEs to inform HRA planning.
The Board noted there had been an increase in apps recently and expressed its concerns regarding the regulatory arrangements for these apps with some developers seemingly unaware or unclear on the necessary regulatory measures they must abide by. The Board noted the joint guidance on the regulation of software development developed by NHS Digital, MHRA, DHSC and the HRA however was unclear how easily locatable the guidance was. The Board recommended further cascading of the guidance, potentially by the Russel Group and Universities UK, and requested an update at a forthcoming meeting. Action: TA to provide update on regulation of new technology at future Board TA meeting
- Monthly catch up meetings Jonathan Sheffield CEO NIHR, Matt Cooper,
Page 4 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 7 of 63
NIHR. - Department of Health Clinical Trials Regulations Steering Group. - UKCRC Board Meeting MRC. - Universities UK - Research Integrity Forum to hear how universities plan to respond to the select committee hearing.
7. HRA Directorate update
General Data Protection Regulation – operational arrangements
The General Data Protection Regulation (GDPR) has less impact on health and care research than on other sectors due to the existing good practice already in place. Nevertheless, there is significant potential for confusion by stakeholders due to specific arrangements for research that do not apply to other activities of sponsors and sites. The HRA’s objective is to put in place simple, streamlined and standardised operational processes to support compliance and maximise consistency for sponsors and sites.
In addition to publishing ongoing updates to guidance for the UK health and care research community, we have put in place arrangements to manage queries from researchers and sponsors. The UK study-wide criteria are being updated so that new studies will be assessed for compliance against GDPR. Our guidance includes standardised wording to be used to support transparency requirements for existing and new studies. In recognition that many companies in the UK will have had wording stipulated by European or global headquarters, we have also put in place arrangements to review proposed wording for compliance at a sponsor level. With colleagues across the UK we are also finalising arrangements for organisations to update or put in place standard contractual arrangements between controllers and processors.
We are providing a large number of webinars that are proving very popular (currently 15 webinars with 700 people signed up), as well as supporting train- the-trainer workshops in collaboration with the NHS R&D Forum and the MRC Regulatory Support Centre.
The national data opt out is also being launched from 25 May, The Confidentiality Advisory Group have been liaising with team leading the programme to agree arrangements for affected research.
HRA Approval
A pilot of joined up outcome of review, with just one set of queries back to the applicant, is underway along with producing the final approval from both REC and assessment jointly. We have also begun testing the notion of setting a quality threshold for applications to proceed to REC review, so that the time of volunteer members is not wasted on reviewing and providing detailed and extensive feedback on poor quality applications.
The verification tool in IRAS has now gone live, ensuring that applicants have included key information and documents prior to submission to avoid delay and re-working. This includes a requirement to provide a funder reference number
Page 5 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 8 of 63
to improve tracking through the research journey for funders and HRA. Initially this caused a spike in enquiries as many applicants were unused to the check.
Historically, most applications were not valid for REC review, and even when valid to proceed to REC over 36% have still not been valid for assessment. With joined up validation now in place, this should reduce re-work and enable assessment to start sooner.
The model non-commercial agreement was held back from release to allow inclusion of updated clauses to reflect the requirements of the General Data Protection Regulation. The revised agreement is scheduled to be released in early summer.
As part of our project on Public Involvement in Ethics Review, the guidance in IRAS is being updated to help applicants better explain about the public involvement they have undertaken and what difference it has made.
NHS England Consultation on supporting research in the NHS
NHS England has published their response to the consultation on proposals to address ongoing issues across the NHS in England with Excess Treatment Costs for non-commercial studies and variability in contract value for contract commercial trials. We continue working with them and the NIHR Clinical Research Network to take forward implementation by NHS England and the Clinical Research Network.
UK-wide NHS/ HSC compatibility programme
We have supported Health and Care Research Wales (HCRW) as they took the step in April to align with HRA Approval as an interim step towards wider UK compatibility. Wales is using the same HRA Approval processes and we have supported their staff with training. England and Wales are issuing HRA Approval and HCRW Approval in one letter – one less step for cross border researchers.
Technical Assurance roll out
Radiation Assurance was opened to all oncology studies taking place in the NHS in England from 16 April 2018, with updated guidance in IRAS. Work is underway with experts across the UK to update wider guidance to support radiation review.
Learning and Development
For some time we have been working to develop an effective system for delivering webinars to members and the wider research community – commercial and non-commercial sectors. We launched the first webinar ‘Applying for HRA Approval – getting it right first time’ in February, followed by ‘Managing your Approval – 35 day no objection for amendments’. These are scheduled monthly throughout the summer in to October.
The webinars on GDPR (see above) are also being recorded to be posted on the HRA website. Although a few participants have experienced minor problems
Page 6 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 9 of 63
with the technology, initial feedback is extremely positive. We are evaluating the sessions and will continue to develop the content and the webinar series.
In addition, the team supported the planning and delivery of a successful All Staff Day.
Combined Way of Working with MHRA
The private pilot to test a combined way of working between MHRA and Research Ethics Committees opened to applications by invitation and prior agreement from the beginning of April. The first applications are expected towards the end of May, but regular calls have been held with the test sponsors to ensure they are suitably prepared. The RECs and staff involved have been trained on the process, including reviewing dummy applications.
The process involves a single submission of an application dossier which includes an application for a Clinical Trial Authorisation from the MHRA and to the REC. There will be a single validation undertaken by the MHRA and then the application will be reviewed by the MHRA and REC with co-ordinated communications to the applicant. This part of the pilot will remain invitation only and submission with prior agreement until we have received sufficient applications to effectively test the process and to develop the supporting guidance. Once we have reached this point, we will open the pilot to live submissions.
Collaboration & Development
The May meeting of the Collaboration & Development Forum heard about the Academy of Medical Science work on patient data and future data-driven technology, and explored issues around communicating to those involved in software and algorithms about regulating data.
Janet Messer external meetings/visits
- MHRA/RES project group - Four nations’ policy meeting - HRA Transparency Forum – presentation on potential new IRAS - IRAS Partners Board - UK Research Ethics Development Group - Information Commissioner’s Office – to discuss operational guidance on GDPR - Institute of Clinical Research – presentation on HRA activity - NHS Digital Research Advisory Group streamlining working group - NHS England Excess Treatment Cost working group - NHS England, NIHR Clinical Research Network and Association of UK University Hospitals – to discuss NHS England response to consultation on commercial clinical trials - NHS Digital Research Advisory Group - UK Caldicott Guardian Council – presentation on proposals for changes to approval applications to -support GDPR - Jo Burns NIHR Clinical Research Network – to discuss NIHR Digital Strategy and interoperability
Page 7 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 10 of 63
- Ministerial Industry Strategy Group Clinical Research Working Group - External Learning Reference Group – cross agency alignment on learning - Collaboration & Development Forum - David Newton UKCRIS – governance arrangements for biorepositories and databases - Experimental Cancer Medicine Centres Annual Conference – presentation on HRA approaches to platform trials - Clinical Practice Research Datalink 30th anniversary event - NHS R&D Forum – several staff presenting, chairing and supporting the stand
Social care research
We are planning a roundtable event on social care research in June to explore how we can best support this type of research. Drawing together key people in academic, voluntary sector and funding organisations, the roundtable will examine the specific ethical issues in social care research, determine the needs of participants and work with partners to agree further work in this area.
Electronic consent
Our work on collecting consent via electronic means is coming to fruition. We have agreed a joint statement with the MHRA which sets out the legal and ethical framework for both providing patient information and recording consent using digital formats. All studies can use provide patient information digitally and most studies can use simple electronic signatures. Only higher risk studies, such as phase I clinical trials, need use advanced forms of electronic signatures. We will publish the statement in June, along with advice to applicants about how to submit digital patient information and consent tools for HRA Approval. We will then update our website guidance for researchers on consent.
Public Involvement
Young patient advocates from the GenerationR initiative delivered a keynote presentation and two workshops at the HRA All Staff Day, facilitated by the Public Involvement Team. These workshops focused on the impact of Public Involvement; staff feedback from the day has been very positive. The team will be working with GenerationR and the NIHR CRN Patient and Public Involvement Priority Lead, Jenny Preston, to explore opportunities for further collaboration.
In April the Public Involvement Team launched supplementary guidance for applicants about what information about Public Involvement it is most useful to include in the current IRAS question on involvement (QA14-1) and five other main questions for the purposes of REC review. The guidance has been integrated throughout the IRAS Question Specific Guidance, and the team is now working with Comms to implement the rest of the dissemination plan for the guidance. This has included presenting at each of the regional Chairs’ Network Meetings and arranging visits to the RES Team meetings for REC staff in each office in order to reinforce stakeholder collaboration and engagement with the Public Involvement in Ethical Review (PIER) work programme. The Team has also redeveloped information about Public Involvement ahead of an
Page 8 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 11 of 63
update to the HRA website which will focus on user needs and on contextualising the importance of Public Involvement within the HRA’s core mission and values.
Communications
Have developed and delivered GDPR content on the website working with policy, Approvals and promoted the supporting webinars. They have been working with other stakeholders such as NIHR, and AMRC to identify opportunities to reach a wider audience with our guidance and materials in this area. Other headlines:
• Published the HRA business plan for 2018-19 • Prepared and delivered communications support for the NHS R&D forum conference • Developed an animation on HRA performance of the previous year for publication to the website soon • Agreed communications about combined ways of working pilot with MHRA • Responding to media queries • Delivering workforce related communications for the Approvals directorate • Delivering internal communications including the all staff VC and weekly newsletters and regular updates to the intranet • Planning ahead for international clinical trials day and developing our approach for NHS 70 • Equipping and developing the team to be able to make multi-media communications products quickly and effectively through use of mobile technology, recording and animations
2017/18 year-end accounts and audit
Year-end annual report and accounts process is on track to meet expectations and to date no significant issues have been raised. As previously reported, key the policy change for this year’s audit is our revision of the useful economic life for IRAS. Working with the communications team, we have also started to change the format of the report and accounts to help make the report more accessible, better reflecting our ‘house style’. This builds on the performance animation produced for this year’s all staff day.
Oracle: chart of account hierarchy and forecasting
We have changed our reporting hierarchy in Oracle to provide improved analysis and simpler reporting. Management information will reflect this changed structure for 2018/19. All staff have been updated of the changes at our recent all staff vc and finance are working with budget holders and our shared service providers to help roll out the new reporting.
Employee self service
Employee self-service for ESR (electronic staff record) has been rolled out to all staff, enabling better access to their own personal data and also providing our
Page 9 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 12 of 63
staff with the ability to update their personal data directly without the need for unnecessary form filing and sign off. Pilot supervisor self-service has also been rolled with approximately 35% of our managers being trained directly. Phase 2 is now planned so that supervisor roll out is complete by the end of this quarter. This will enable our managers to input sickness reporting and appraisal information directly into the ESR system without the need for shared service support nor duplication of entry – a streamlined, more efficient and accurate process.
Procurement
A number of activities continue to be supported by the finance team this quarter including:
• RS procurement • Learning management system – contracts and implementation • Printer sourcing for regional offices – Bristol and Manchester
We have also adopted the NAO contract management framework as the core document to support contract management at the HRA. Finance business partners will be using this document when supporting contract managers at their monthly / quarterly meetings.
Estates
Newcastle office move to NHS BT blood centre is complete and all snagging dealt with. We are also exploring opportunities to share space in our Manchester office. Following the organisational change process in finance we have created a new role with a focus on finance and estates contract management. We are now transitioning to this new approach and visiting all regional offices building on the good work performed the corporate SIP estates project team. Initial areas of focus include: confidential waste management, PAT testing and printer provision.
General Data Protection Regulations – corporate readiness
We are in the final stages of agreeing with NHS BSA that they will provide our Data Protection Officer function. Chris Gooday – who has recently led the NHS BSA GDPR project internally – will provide this service on our behalf. We are currently agreeing the contractually terms as well as the induction plan for the role. We anticipate that Chris will meet with Audit and Risk Committee in August (when the GDPR internal audit report is due to be discussed) and be a member of our information governance steering group.
All our information governance policies and procedures have been reviewed by independent legal advisors to ensure they meet GDPR requirements. Our approach to privacy for IRAS has been reviewed by our information governance steering group and is now being finalised on advice from our legal advisors. Our approach to GDPR readiness has been based on the ICO 12 steps methodology and has been led by the corporate secretary and information governance steering group.
Page 10 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 13 of 63
Emergency incident response exercise
Senior managers took part in a simulation incident exercise which tested our response to a ransomware attack on our research systems. The simulation was observed by members of the Business Continuity Team at NHS BT. The findings from the exercise will be considered in due course by the Audit and Risk Committee.
8. HRA Business Plan 2018/19
The Board noted the HRA Business Plan for 2018/19 has now been published following the end of purdah.
9. Timelines to first patient recruited performance update
JMe presented the latest timelines from application submission date to date first participant recruited into the trial, using combined data from several sources. JMe gave a caveat regarding the quality of some of the data however advised it was a fairly large data set and should still give a good indication of the current timelines.
The Board noted 100 days from submission to first patient recruited is a key target for industry and the data showed this target being met from September 2017 for a sub-set of trials, illustrating what was possible with well-prepared studies.
The Board noted the timelines for NHS permission of first site to first recruit had remained relatively constant during the reporting period at approximately 30 days and the Board noted this is higher than other countries. The Board noted some of the delays related to the negotiation of costs for each site.
The Board agreed it is important this information is used more widely to demonstrate the current timelines and highlight the issues which are preventing the timelines from being further reduced. The Board agreed text is needed to support the graphs and further consideration required regarding how the HRA can deliver this information and engage with particular audiences and opinion formers to support further improvement to the system. Action: JMe to finalise presentation including explanatory text JMe
10. Service Improvement Programme update
IC presented the latest update on the Service Improvement Programme to the Board flagging the programme remains green and on track. Key progress to note includes agreement to move to the Windows 10 operating system by the end of the calendar year and the development and implementation of the IRAS verification tool. ESR employee self-service has also been implemented with supervisor self-service in the process of being rolled out.
The Board recognised the ongoing workforce pressures and risk of insufficient ‘people’ resource to deliver the programme.
Page 11 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 14 of 63
11. Performance Report Quarter 4 2017/18 including Finance report
The Board received the quarter 4 performance report for 2017/18 report and agreed it had been a great year with considerable achievements made over the last 12 months. The Board expressed its thanks to all staff for their hard work over the last year.
KW highlighted the amber reporting for IT and ensuring staff have the tools to enable them to perform well. KW flagged the recent decision to move to Windows 10 and Office 365 would hopefully support the improvement to the service over the coming year.
The Board noted the sickness absence was higher than the target number of days lost to sickness (1500) at 2517. KW flagged wellbeing is a key focus for 2018/19 and there had been well attended and well received wellbeing sessions held at the all staff day last month.
The Board noted the final finance report for the year with an end of year underspend position of £4K (0.03% of total budget). KW advised close monitoring of our forecast and nimble investment decisions to best meet our strategic objectives have ensured we have fully utilised our available resources this year.
KW flagged the HRA has reduced its cash position in year to better reflect our annual requirements. Our cash position at the end of the year was £965k compared to £3,485k at 31 March 2017.
12. Corporate Risk Register Quarter 4 2017/18
The Board reviewed and noted the Corporate Risk Register for Quarter 4. The Board noted the Audit and Risk Committee had reviewed the register at its last meeting and had been assured the risks were being appropriately managed. The Committee had requested management consider the risk of the expectations of the HRA’s stakeholders, both internal and external, not being met in relation to the functionality of the new IRAS. The Board was assured this risk would be considered by the Research Systems team.
The Board noted the decrease in the score of the transparency risk and queried if the score was appropriate. JT advised, since the last quarter, there had been considerable work to understand the issues and how these could be addressed however recognised the risk was still a high one and the score would likely change again following the publication of the report from the Select Committee.
13. Summary of 14.02.2018 Audit & Risk Committee meeting
The Board noted the summary of business conducted at the last Audit and Risk Committee meeting. GC highlighted the substantial rating received for the key financial controls audit, with no recommendations, which was an excellent result.
GC advised a deep dive had been held considering GDPR; both the HRA’s internal readiness and the HRA’s external responsibility in providing guidance
Page 12 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 15 of 63
and training to the research community. GC advised there are a few things still outstanding for the internal readiness however the Committee was assured there were no major issues anticipated. KW flagged confirmation had been received regarding the HRA’s Data Protection Officer, with an experienced individual from NHS BSA to provide two days a month support to the HRA.
14. Out of session business conducted / External areas of interest since previous meeting
The Board noted the following out of session business / external areas of interest since the last meeting:
- R & D Forum held on 14 & 15 May 2018 - Update on research systems procurement timeline and shortlisting circulated for information - HRA Approval directorate proposed changes FAQ and presentation circulated to Board for information - Pre-election period ‘purdah’ guidance on conduct circulation for information - Statement from the House of Lords debate (18 April 2018) on the European Union Withdrawal Bill in relation to the EU Clinical Trials Regulation circulated for information - Medicines & Healthcare products Regulatory Agency 5 year Corporate Plan published https://assets.publishing.service.gov.uk/government/uploads/system/u ploads/attachment_data/file/702075/Corporate_Plan.pdf
15. Any other business
None to note
16. Questions from the public
None to note
17. Date of next meeting
24 July 2018, London
Page 13 of 13 2018.05.16 HRA Board Minutes – Part 1 (Management in confidence) Page 16 of 63
Agenda item: 8
Attachment: B
HRA BOARD COVER SHEET
Date of Meeting: 24 July 2018
Title of Paper: Transformation Programme Update (now includes update on implementation of ‘new’ IRAS) Purpose of Paper: To update the Board on current progress of the programme
Reason for To offer the Board assurance that satisfactory progress is Submission: being made
Lead reviewer: Senior Leadership Team
Details: Contained in slide set.
Suitable for wider Yes. circulation? Time required for item: 10mins Recommendation / To Approve Proposed Actions: To Note Yes For Discussion Yes Comments
Name: Ian Cook
Job Title: Director Transformation and Corporate Services Date: 19 July 2018
Page 17 of 63
Transformation Programme Report - SIP and Research Systems Programme (RSP) – July 2018
• Overview • Intended benefits • Headlines • Progress report • High level plan – to be distributed at meeting • Key risks
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 18 of 63
Overview
• Primary focus remains on process improvements, though KPI’s indicate that benefits are being realised (contained in 17/18 performance report) Indicative ‘progress ‘ line Deliverables Benefits Ambition • Predictable (quicker) timelines Better service • Increased customer satisfaction
Process
Improvements • Invest in additional capability Reduced Costs • meet challenge of reducing
budget Research Better Health
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 19 of 63
Intended Benefits – Snapshot Benefit Business Change Benefit realisation ‘target date’ Enhanced analytical capability which will enable data to be more effectively used in both Development of ‘new’ ‘IRAS and further Initial results towards end Q4 improving operational performance and offering key intelligence to the research community developments in HARP 2018/2019, then more pronounced during 19/20 Providing transparency for researchers, stakeholders, patients and the public by offering As above As above greater access to data A process that offers the applicant a more precise timetable to allow them to plan subsequent Delivering an integrated process and KPI’s already indicate a greater level of activity. restructuring of approvals directorate consistency and predictability Less time and resource spent on re-working applications following initial submission (i.e. SIP – ‘Getting it right first time’ IRAS KPI’s suggest gradual decline in number reduction in work needed between applicant and operational teams to get initial application verification tool of missing document s to valid) Shorter elapsed time from application to HRA Approval providing opportunity for improved SIP Approval Workstream and Timelines have remained steady for all speed of study set-up will improve potential for researchers to recruit to target and complete development of ‘New’ IRAS types of study during 17/18 – potential studies to schedule. for further improvement with new ‘IRAS’ High rates of satisfaction will potentially increase attractiveness of UK as place to carry out SIP Approval and Customer Service % of applicants who responded to the research and enhance reputation of HRA. Sharing positive news enhances staff morale. Workstreams survey rating the service 7/10 or above was 83% in June 2018 The application of a proportionate approach to HRA Approval will make it easier for SIP Proportionality Workstream Commence January 2018- April 2018 – researchers to set up studies. subject to recommendations proposed and the agreement to implement. Improved consistency in how Research Ethics Committees (RECs) address and consider public SIP PIER Workstream – development of Towards end Q4 18/19 involvement in applications for ethical review. standards (working with REC’s) Improvement in the quality and relevance of the information that researchers provide on SIP PIER Workstream – development of Towards end of Q3 18/19 public involvement in applications for ethical review clearer guiidance to researchers
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 20 of 63
Headlines
• SIP and RSP Programme remains green • ‘New’ IRAS build commenced 16/7/18 • Restructuring of Approvals Directorate – senior appointments made, – full organisational change programme, affecting around 60% of workforce, will formally begin in Autumn 2018 • Additional programme resources secured • Challenges of delivering financial benefits • Customer support discovery report completed (more detail follows)
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 21 of 63 Transformation Date: 18th Budget: 40k Programme July Forecast outturn: 40k RAG
Workstream Status Commentary – RSP Development began on 16 July initial signs are that Pega and HRA team are working very effectively together HRA Approval - Integrated Process Proceeding as planned
HRA Approval - Proportionality Proceeding as planned
HRA Approval - Get it right first time Quantification of benefit from IRAS verification tool still being assessed HRA Approval - Amendments Will require dedicated resource to take forward – exploring possible solutions Priority actions for the next few months include: Publishing interview dates for the next financial year – 30 June 2018 - complete Interviewing all those in the current ‘backlog’ – 31 July 2018 – has begun We also intend to establish two small working groups by the end of June: HRA Approval – Volunteer recruitment and management - one to look at communication activity (promotion, advertising etc.) o small scale targeted at Liverpool area to test in June o wider HRA profile, website, HRA Board involvement in Sept - and the other to ascertain how the end-to-end process can be improved. Some timelines reprogrammed now that realistic planning in place PIER: Public involvement in the ethical review process Test bed (organisations who are testing the new Public Involvement guidance in leading to more favourable opinions and improved IRAS) process/protocol finalised health research Corporate: Development of an effective and efficient Proceeding as planned corporate support and infrastructure model that results in a business model that secures the best value ‘mix’ of in-house, third party and shared ALB resourcing.
Customer Support: Delivering an integrated approach Report received by Transformation Board in June – see separate slides for further to managing the customer relationship, ensuring that all detail queries are managed effectively and that feedback is effectively used in improving service provision
Page 22 of 63
SIP – Customer Support
‘Delivering an integrated approach to managing the customer relationship, ensuring that all queries are managed effectively and that feedback is effectively used in improving service provision’
For purpose of this workstream: • “Customer” defined as anyone (individual or organisation) who is involved in, seeks to be involved in, or who has an interest in health and social care research in the UK. This does not mean that the individual or organisation has to be based in the UK. It includes, but is not limited to: applicants, sponsors, funders, participants, and members of the public. • In scope: queries/feedback about what we do, processes, committees and services, content we have published, general questions about research landscape and suggestions for improvement • Out of scope interactions as part of: processing applications, pro-active communications with stakeholders, ongoing activities to develop and improve guidance etc. www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 23 of 63
SIP – Customer Support Key findings from initial discovery report – presented to Transformation Board in June 2018: 1. Numerous routes in – incl. mainline phone, generic email addresses (~ 50), webform, direct contact with individuals (email / phone / incidental contact), social media . . . 2. Management of interactions • No organisation-wide systems or processes for recording/managing interactions • managed by numerous teams/HRA Directorates • Majority receive mix of queries and feedback; some overlap in topics handled • Some have formal policies/procedures; others use informal or ad hoc processes • Many use escalation and/or referral routes • Timelines do not exist across all; unique ‘case reference’ systems are not used • Widespread use of generic email addresses and shared outlook accounts • Not all log activity; if they do then requires other software and manual transfer of data • Change in research environment usually leads to incr demand across all points of contact www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 24 of 63
SIP – Customer Support Transformation Board discussed short and longer-term opportunities to deliver: • Better experience for customers (e.g. clearer routes of contact, service standards, consistency) • Greater efficiency in managing interactions, reduce risks and make better use of data from all this interactions
Next steps: • Draft implementation plan identifying short and longer term deliverables (expect to submit to Transformation Board, August 2018)
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 25 of 63
SIP – Customer Support Development of HRA Customer Charter: • Customer Support SIP Deliverable • Originated from staff suggestion and issue raised by Staff Forum • Aim: • To develop organisation-wide charter setting out what individuals can expect from HRA and what we expect from them in return (note v1.0 not intended to include service standards but will focus on “terms of engagement”) • Activity to date: • Review of customer charters published by other organisations; identification of applicable themes (complete) • Themes tested with staff via survey (in progress) • Next steps: • Results of staff survey will be used to inform an initial draft of the Customer Charter (expected to be submitted to Transformation Board, August 2018)
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 26 of 63
Key Risks
Research Systems Programme Mitigation 1 Future running costs cannot be Currently developing financial models for 19/20 accommodated in HRA spending review against a number of possible scenarios allocation 2 The complexity of managing two supplier Both suppliers are now engaged on programme and relationships whilst developing new IRAS, positive relationships are developing. The maintaining current IRAS and developing management of the relationship and the associated and maintaining HARP will increase capacity and capability to manage the work going pressure on team and potentially impact forward is being considered by the DD Research on level of service Systems and our Implementation partner 3 Unable to deliver critical functionality Scheduled in meetings with MHRA, Appian, Pega and and/or connectivity with MHRA necessary BGO to consider and develop technical solutions for CTR
www.hra.nhs.uk | @HRA_Latest This presentation is designed to provide general information only. Our website terms and conditions apply www.hra.nhs.uk
Page 27 of 63
Agenda item: 8
Attachment: C
HRA BOARD COVER SHEET
Date of Meeting: 24 July 2018
Title of Paper: SIP Proportionality project update: Taking a proportionate approach to approving research studies
Purpose of Paper: To provide a high level summary of the outcome and actions planned as a result of the SIP HRA Approval – Proportionality work stream.
Reason for Submission: To update Board on how we have progressed so far with the Proportionality which is part of the SIP work – for information only.
Details: The debrief paper is aimed at aimed all those with an interest in the work of the Proportionality work stream so far including the Board and the senior stakeholders who took part in a series of interviews conducted by Amanda Hunn in late 2017 to look at different ways in which the HRA handle applications more proportionately. Feedback from stakeholders on receiving the briefing has been positive.
The work has been extremely useful in providing time and space to think through the issues. Further work has been identified in order to test or operationalize in order to make things easier and quicker for researchers, and more efficient for us.
Time required for item: 10
Recommendation / To Approve Proposed Actions: To Note x For Discussion Comments
Name: Amanda Hunn/Juliet Tizzard
Job Title: Joint Head of Policy
Date: 20.6.2018
Board Cover Sheet (July 2017) Page 28 of 63
Taking a proportionate approach to approving research studies
June 2018
At the Health Research Authority, we review a wide range research in health and social care – around 5000 studies each year. Whilst it is right for some studies – such as drug trials - to go through a rigorous process of ethical review and research governance assessment based on a full set of information, this approach is not necessary for all research. Some studies are low risk and therefore need a lighter-touch review.
We have already introduced some processes to make HRA Approval more proportionate, but we know we can go further. As part of our service improvement programme, we have been looking at ways in which we can extend that proportionate approach to research regulation. We want to make it as straightforward as possible for new studies to obtain approval and focus our attention and resources where they are most needed.
In late 2017, we carried out interviews with 31 senior stakeholders in the research community and analysed our own data about research applications to inform our thinking about where we could enhance proportionality. We looked at the following types of research:
• Staff research • Research using anonymised tissue and/or data • NHS premises • NHS-sponsored single-site studies.
Extending proportionate review One aspect that we have considered is whether we can speed up HRA Approval for some types of study.
We already have a process for proportionate ethics committee review which provides an accelerated, proportionate review of research studies which raise no material ethical issues (ones which have minimal risk, burden or intrusion for research participants). Each year, we consider around 1500 studies through our proportionate review process (about a third of all applications), in which studies are assessed by a subgroup of Research Ethics Committee (REC) members outside a REC meeting.
We have looked at developments in the USA and considered whether a fast-track review of low-risk studies by an appropriately trained staff member, rather than a member of the REC, would be appropriate here. This approach was popular with stakeholders.
We agree that we can take a more proportionate approach and that studies with no material ethical issues should not need review by an ethics committee. We have decided to pilot a Page 29 of 63
refined process of this approach that involves both ethical review and assessment of low-risk studies being carried out by a member of staff. This desk-based approach would include:
• Staff-only studies • Low risk data and/or tissue studies • Basic science studies • Surveys and questionnaire studies using a validated questionnaire with the intended audience • Surveys with genuinely anonymised responses. We are working up potential algorithms to quickly and easily identify studies that can reliably be categorised as having no ethical issues.
A proportionate application package Besides considering whether we could reduce the level of review or assessment needed for some studies, we have also looked at whether we can reduce the amount of information we ask for in support of an application for HRA Approval. Stakeholders were very supportive of this approach for low-risk studies. It would mean that applicants could complete a shorter IRAS form with a reduced dataset, tailored according to study type.
We agree that there is scope to reduce the amount of information collected in application forms for some types of studies. We are taking this idea forward in a pilot approach for staff studies, as described below. We will also keep this in mind for other study types as we review more generally how applications are made.
A parameters approach: student research We receive around 1800 applications for student research each year. Student projects are often of poor quality, have very tight timescales and receive inadequate support from supervisors.
We have been considering whether we can change the way we approve student research by exploring the concept of a parameter approach. This would involve a batched application made by the course leader where the research could fit within an agreed set of parameters:
• the students will do an identical research exercise (for example, all analysing the same dataset), or • the students are expected to conduct similar research activity within an agreed set of parameters which can be deemed to be low risk (for example, students might have access to a range of identifiable tissue). In each case, the course leader or supervisor would act as the Chief Investigator. This could be part of an extended proportionate review system for low-risk research and it would seem to lend itself to studies involving either data, tissue or simple questionnaires.
We are developing a communication plan targeted at supervisors so that best practice on the handling of student studies is widely understood.
2 Page 30 of 63
A parameters approach: platform trials The parameters concept lends itself well to platform trials too. These are designed to be more efficient, testing multiple therapies and/or multiple diseases in one clinical trial and targeting treatment using advanced screening methods. The treatments or disease areas may change over time based on interim analysis.
In the past, researchers running platform trials had to submit many amendments to their approval to accommodate the changes made during the trial. We have been working with the MHRA to address this and have agreed that if researchers are clear upfront about what types of changes they intend to make during the trial – provided the single aim and endpoint is unchanged – this will reduce the number of amendments required. This approach reduces the administrative burden on both the applicant and the regulators.
Work with REC members and stakeholders has shown this to be an acceptable approach and we are testing its feasibility using current systems and processes. We are taking this forward with stakeholders to ensure a system wide approach to ensure end-to-end benefit.
Research on NHS premises We receive around 50 applications each year for studies which take place on NHS premises but do not meet any other criterial for approval. This is despite the fact that we do not require these studies to have HRA Approval.
We have decided to maintain this position and to clarify our guidance to make it clear that researchers carrying out this kind of research do not need to seek HRA Approval.
Staff research We receive almost 500 applications each year for research in which the participants are NHS staff. Staff research projects do not need ethical review, but they do come to us for assessment against NHS standards. We considered whether we need to continue to assess staff research, or whether this type of study could fall out of HRA scope altogether.
Following stakeholder feedback and consideration of the impact of removing staff research from HRA scope, we have decided to continue to assess staff research.
This approach will maintain an assurance for local NHS R&D and make it easier for researchers to set up and run staff research in a consistent way across lots of NHS organisations. We know that it helps researchers when we clearly indicate that the study complies with NHS standards and whether or not NHS organisations are required to provide formal confirmation of capacity and capability, particularly because in most cases we can provide a clear message that NHS R&D offices do not need to undertake any local activity. We were concerned that, without HRA assessment, there could be a temptation to set up local systems, retaining R&D staff for this purpose and resulting in variation between sites.
However, we know that we could take a more proportionate approach to the application package that we require for academic-led funded research involving senior NHS members of staff. We are currently piloting an approach using a very much reduced question set, relying more on the protocol to make an assessment.
3 Page 31 of 63
Research using anonymised tissue and/or data We receive around 350 applications each year for anonymised tissue, tissue and data or data-only studies. These studies do not need ethical review, but they do come to us for assessment against NHS standards. We considered whether we need to continue to assess anonymised tissue and data research, or whether this type of study could fall out of HRA scope altogether.
We agree that we can take a more proportionate approach. We are exploring the possibility of assessing biorepositories at an organisational level, rather than project by project. For example, assessment could give approval to the arrangements and compliance of a single tissue bank rather than the individual studies seeking to use anonymised tissue and data derived from the tissue bank.
We are working with stakeholders to agree standards for the assessment of biorepositories. In the meantime, there is no change to our current practice of assessing individual projects.
NHS-sponsored single-site studies We receive over 1100 applications (excluding clinical trials) each year for NHS-sponsored single-site studies. Stakeholders suggested that our assessment duplicates the assessment conducted by the NHS sponsor and we could remove this duplication. However, variation in the quality of local sponsor review means that it would be risky for us to stop the assessment of these studies, as the assurance provided to patients by consistent national standards is important.
During 2017 we worked with a large NHS sponsor to pilot a system where the sponsor provided assurance that the project met the standards. As a result of the pilot the NHS organisation strongly indicated that having two different pathways for single and multicentre sponsored studies would be unhelpful at the sponsor end.
We have therefore decided to continue to consider these studies for HRA Approval, but to also support sponsors to do a better job in ensuring the quality of their applications, so that we can reconsider the potential for a more light-touch assessment in the future. We are exploring with stakeholders (such as the MRC Regulatory Support Centre, the NIHR Clinical Research Network, the NHS R&D Forum and others) how this can best be achieved. We are reconstituting our non-commercial sponsor group to provide a forum for oversight of this work.
Summary By taking the approaches described above, we will be able to streamline the approval process for many types of research study, making it easier and quicker for researchers, and more efficient for us. This will mean that we can focus our resources and attention on higher- risk research, allowing low-risk research to start more quickly.
Our work to make regulation of health and social care research more proportionate is ongoing and we will publish further updates in future. If you have any ideas or feedback, please send them to [email protected].
4 Page 32 of 63
Agenda item: 10
Attachment: D
HRA BOARD COVER SHEET
Date of Meeting: 24 July 2018
Title of Paper: Proposal for Pilot of HRA Accountable Centre Model for improvement evaluations
Purpose of Paper: This proposal provides an overview for a new model for the governance of evaluations of healthcare improvement activities, to be piloted by The Healthcare Improvement Studies (THIS) Institute, University of Cambridge.
Reason for Submission: Proposal to pilot a new model for Board consideration and approval
Details: THIS Institute proposes a new governance model designed to serve improvement evaluations as a distinct class of activity.
Time required for item: 15 minutes
Recommendation / To Approve x Proposed Actions: To Note For Discussion x Comments
Name: Teresa Allen
Job Title: Interim Chief Executive
Date: 18 July 2018
Board Cover Sheet (July 2017) Page 33 of 63
Proposal Pilot of HRA Accountable Centre Model for improvement evaluations
Draft 0.2 2018-07-16
This proposal provides an overview for a new model for the governance of evaluations of healthcare improvement activities, to be piloted by The Healthcare Improvement Studies (THIS) Institute, University of Cambridge. Contents
1 Background ...... 2
Improvement evaluations as a distinct category of activity ...... 2
2 Accountable Centre model ...... 4
2.1 The Accountable Centre ...... 4
2.2 Evaluation Study Framework ...... 5
2.3 HRA approvals ...... 5
2.4 Recruitment of evaluation sites ...... 6
3 Advantages of the Accountable Centre Review Model ...... 6
4 Operational considerations ...... 7
Page 34 of 63
1 Background
The UK Health Research Authority (HRA), established in 2011, is responsible for the governance of all types of research that take place within the National Health Service (NHS). Approvals are based on an assessment of both governance and legal compliance, and where applicable includes ethical review by an independent NHS Research Ethics Committee (REC).
The classification of a project as research activates specific requirements for ethical and regulatory review. The distinction between health research and other related activities is guided by an online decision tool (the Heath Research Authority Decision Tool[1]). The tool categorises projects according to the binary classification of research or non-research.
If a project is deemed research, it must obtain HRA approval, NHS ethical review (where required) and confirmation of capacity and capability from each participating NHS organisation in England. If a project is deemed non-research, no further HRA or ethical review is required – though projects may be registered as a service evaluation, service improvement project or audit with the relevant NHS organisation(s). However, the research/non-research classification does not adequately address the specificities of a third category of activity: improvement evaluation. This proposal is directed towards piloting a new model for facilitating proportionate governance for this important category of activity.
Improvement evaluations as a distinct category of activity
Improvement evaluations are a type of study that focuses on evaluating improvement activities in healthcare. Such studies are undertaken with a goal of learning from a service change or improvement activity in a healthcare system where the primary goal of that activity is to make improvement (e.g. through pathway redesign, changing appointments systems or supply chains etc.). From the perspective of healthcare organisations, the impetus for such improvement activity may arise externally (e.g. in response to policy or contractual changes, opportunities to work in national programmes etc.), or internally (e.g. in response to discovery of a problem or CQC finding, through the service improvement agendas of the teams and boards etc.). In all of these instances, producing knowledge is not the primary goal of organisation: the changes will be occurring anyway. But done well and systematically, studies of those improvement activities are a very valuable way of obtaining “extra juice from the squeeze” that may serve the interests of patients, the public and the health care system by producing systematic knowledge. Thus:
Improvement evaluations study programmes where the primary aim of the participating organisations is to make improvement (e.g. in their systems and processes), and, for those organisations, knowledge production is a secondary aim or by-product. Improvement evaluations are systematic studies of whether those programmes work and how they work.
Improvement evaluations play an important role in the health system: they can assist with identifying what works well and what does not, may enable insight into the influences on
2
Page 35 of 63
effectiveness of a quality improvement intervention or other improvement or service change effort, may support replication and scaling of successful programmes, and may reduce waste and costs associated with unsuccessful programmes by demonstrating what should not be supported in the future. As an example, 24 organisations across the NHS participated in the Health Foundation’s Safer Patients Programme, starting in 2004. Those organisations took part in the programme in order to improve their systems, practices and culture – not to produce knowledge. The evaluation study that was “wrapped around” the programme did not change anything that the organisations were going to do anyway, but it did show that those organisations did not improve more than organisations that were not participating in the programme, those producing valuable learning about whether the programme was a suitable candidate for investment by the NHS. [2, 3] Another example is the evaluation of stroke reconfiguration in London and Manchester. The evaluation study again was “wrapped around” a programme that was happening anyway, and produced very important learning about centralised models, showing that they can reduce mortality and length of stay.[4]
A large number of initiatives continue to be launched every year from which much important learning could be gained if evaluation were bundled with the programmes. Current examples include the Getting it Right First Time programme, which seeks to reduce unwarranted clinical variations through £60m funding from the Department of Health (http://gettingitrightfirsttime.co.uk/what-we-do/), and the roll-out of national Early Warning Score system (https://www.england.nhs.uk/nationalearlywarningscore/). In these cases, NHS organisations will be initiating improvement efforts anyway, and evaluations “wrapped around” them could advance knowledge about programme design, implementation, mechanisms of change, and outcomes. It might reasonably be argued that improvement programmes should include evaluation as standard.
The challenge for improvement evaluations is that they may not comfortably fit the current definitions of research or service evaluation. Improvement evaluations do have some features of research, including the systematic approach to knowledge generation. Typically, however, in contrast to many research projects, those studying the improvement control relatively few aspects of the change under study: the evaluators do not deliver the programme of interventions or other changes. They may sometimes, however, help those leading a programme to implement it in such a way that evaluation is facilitated – for example though wait-list, stepped wedge or cluster randomised designs in situations where use of such strategies is consistent with the goals of the programme.
The specificities of improvement evaluations means that current research governance and ethics requirements may be problematic or ill-suited to the goals either of evaluation or to organisations seeking improvement, since they often assume that the evaluator is controlling many more aspects of the programme than is usually the case in improvement evaluations. This may lead to inappropriate suggestions about study design, to delays in approval which may be highly consequential for real-time improvement programmes, to queries at trust level about cost recovery (because of the difficulties of distinguishing programme activities from evaluation activity), and to inappropriate requirements for local collaborators/principal investigators.
On the other hand, when improvement evaluations are classed as service evaluations (which HRA Defining Research Table [5] specifies as comprising projects which are “designed and
3
Page 36 of 63
conducted solely to define or judge current care.”, they may not have sufficiently robust governance or ethical oversight and are subject to widely varying local arrangements. A further important problem is that where improvement evaluations are not classified as research, the ability to publish findings and accumulate knowledge is undermined, and the impact of the evaluation on practice and policy is weakened.
Further, the ambiguities about where improvement evaluations “sit” can lead to some studies being classed as research and others as service evaluations even when apparently similar. The latest definition included in the UK Policy Framework for Health and Social Care Research[6] has further clarified which activities are considered as research, but it does not fully address the particularities of improvement evaluations since it still requires a binary decision about research/non-research.
The issue is not simply one of further clarifying the boundaries of research and service evaluation, but one of recognising that improvement evaluations may constitute a distinct category of activity for which there is not currently an appropriate governance structure.
In order to address the challenge that governance of improvement evaluations present, THIS Institute proposes to pilot a new model.
2 Accountable Centre model
THIS Institute proposes a new governance model designed to serve improvement evaluations as a distinct class of activity. The proposal is based on the principle of licensing, whereby centres demonstrate that their policies and infrastructure are consistent with the principles outlined in the UK Policy Framework for Health and Social Care and that they have a suitable framework in place for the governance and conduct of high quality studies that pose minimal risk.
2.1 The Accountable Centre
An accountable centre is an organisation or unit that seeks to conduct activities categorised as ‘improvement evaluations’. These centres are accountable to the HRA for proposing, agreeing, and then complying with an Evaluation Study Framework. The Framework will identify what counts as improvement evaluation activity and specifies governance arrangements for improvement evaluation. It will be reviewed and signed- off by the HRA to authorise a unit/organisation as an Accountable Centre. An Accountable Centre may recruit evaluation sites who may be invited to take part in current or future studies on the basis of the agreement.
4
Page 37 of 63
2.2 Evaluation Study Framework
Under this licencing model, an Accountable Centre would produce an Evaluation Study Framework for approval by the HRA. It will include, for example, an account of the Centre’s: o Planned categories of activities and projects that should be recognised as Improvement Evaluation o Research governance procedures including, but not limited to, informed consent o Information governance procedures o Standard operating procedures, including those relating to staff training, obtaining and storing of consent forms, anonymization, file-naming etc. o Quality Assurance methods o Procedures for recruiting evaluation sites o Procedures for agreeing assessments of capacity and capability with the sites.
The draft Evaluation Study Framework will be submitted for review to the HRA. Once approved by the HRA, the Accountable Centre is responsible for ensuring that its projects are compliant with the Framework and for demonstrating compliance.
2.3 HRA approvals
Projects that the Accountable Centre proposes as Evaluation Study Framework- compliant will be submitted to the HRA and will be automatically tracked to Proportionate Review for ethics purposes. The submission will include a document explaining how it is compliant with its agreed Evaluation Study Framework including a notice that activities are within the scope of those referenced in the Framework. The proportionate review subcommittee (who may be tagged as having specialist expertise in improvement evaluations) will assess whether the project is Framework- compliant. The sub-committee will have the option of escalating to full review if a) they determine that it is non-compliant or b) have concerns that cannot be dealt with through proportionate review. However, the presumption is that ethical review of Framework-compliant proposals will normally be complete within the 21 days allowed for proportionate review. A letter of approval would be issued by the HRA providing individual sites with assurance that the study will be conducted in a safe, ethical and legal manner. For specific classes of project or activity agreed as part of the Evaluation Study Framework, the HRA will also issue a letter indicating that evaluation sites do not need to undertake assessments of capacity and capability.
5
Page 38 of 63
2.4 Recruitment of evaluation sites
Accountable Centres may invite NHS sites or other participating organisations to agree to work with the Accountable Centre within the HRA-approved Evaluation Study Framework as evaluation sites. Evaluation sites may be of different types (e.g. care homes, NHS trusts etc.). The Framework will indicate classes of activity and projects where a default confirmation of capacity and capability for Framework-compliant projects would be the norm. It will also make explicit that the HRA may issue letters indicating that no assessment of capacity and capability will be needed for some classes of activity/project. When projects are available, evaluation sites that have expressed interest and agreed to the Study Evaluation Framework will be invited to express interest in taking part. Those who agree to take part will be given notice of the HRA approvals and any letters and will have two weeks to raise any issues; after that point, the prior confirmation of capacity and capability will be assumed to apply to the particular project. Formal agreement will then be sought to participate in the project.
3 Advantages of the Accountable Centre Review Model
The new system will take advantage of the existing excellent infrastructure for research governance but supports more proportionate processes for improvement evaluations in the public interest. It provides clarity about a form of study that currently falls between two stools in terms of governance: it is enough like research to require proper oversight, but it is also typically low-risk activity and sites where it is conducted are appropriately considered as evaluation sites rather than research sites. It provides a more facilitative environment for the conduct of improvement evaluations, which are very valuable to the NHS, its patients and staff, and maximises opportunities for systematic learning for improvement. It is likely to reduce costs and burden on all parties. The model is consistent with the principle of proportionality but builds in sufficient checks and balances to manage risks.
6
Page 39 of 63
4 Operational considerations
The Accountable Centre model will require careful design and testing to ensure feasibility, operational effectiveness and efficiency, acceptability among multiple stakeholders, and appropriate risk management. To achieve these goals, THIS Institute at the University of Cambridge will resource and conduct a pilot of the model, supported by RAND Europe (a partner organisation of THIS Institute) and working closely with the HRA at all times to test the processes and share learning. THIS Institute will propose a draft Evaluation Study Agreement to the HRA for review in Autumn 2018. Scoping of how best to manage both ethical review processes and research governance (including capacity and capability assessment) will be undertaken beginning August 2018, with particular attention to operational design and risk management. At the same time, THIS Institute will recruit a small number of NHS organisations that are prepared to work with us to provide feedback on the Framework and optimise workflow and processes. A test project will be taken through the system in late 2018. Some process evaluation will be undertaken (e.g. a small number of formative interviews with key stakeholders, data on processing times etc). The resource impact of the pilot on HRA will be relatively minimal. An officer of HRA will be needed throughout the pilot as a contact point and cooperation will be needed by selected HRA Research Ethics Committees. No direct costs will be involved.
THIS Institute (The Healthcare Improvement Studies Institute)
At THIS Institute we aim to strengthen the evidence-base for improving the quality and safety of healthcare.
Co-created by two exceptional organisations - the University of Cambridge and the Health Foundation – THIS Institute is founded on the guiding principle that efforts to improve care should be based on the highest quality evidence.
THIS Institute is made possible by the Health Foundation.
7
Page 40 of 63
References
1. Health Research Authority, Decision tool: Is my study research? online: http://www.hra- decisiontools.org.uk/research/ [acessed 28/02/2018]. Updated October 2017. 2. Benning, A., et al., Multiple component patient safety intervention in English hospitals: controlled evaluation of second phase. BMJ (Clinical research ed.), 2011. 342: p. d199. 3. Benning, A., et al., Large scale organisational intervention to improve patient safety in four UK hospitals: mixed method evaluation. BMJ (Clinical research ed.), 2011. 342: p. d195. 4. Ramsay, A.I.G., et al., Effects of Centralizing Acute Stroke Services on Stroke Care Provision in Two Large Metropolitan Areas in England. Stroke, 2015. 46(8): p. 2244- 2251. 5. Authority, H.R., Defining Research table. online: http://www.hra- decisiontools.org.uk/research/docs/DefiningResearchTable_Oct2017-1.pdf [accessed 28 February 2018]. October 2017. 6. Health Research Authority, UK policy framework for health and social care research 2017, Health Research Authority: London.
8
Page 41 of 63
Agenda item: 11
Attachment: E
HRA BOARD COVER SHEET
Date of Meeting: Board: 24th July 2018
Title of Paper: Finance report - for the 3 months ended 30 June 2018
Purpose of Paper: To enable an informed understanding of our financial performance for the 3 months to 30 June 2018.
To improve decision making by increasing financial literacy particularly in relation to our 2018/19 financial plan and future financial strategy.
Reason for Submission: The Board, Accounting Officer and Leadership Team have a key governance role in the financial stewardship of the HRA.
This report supports this aspect of the governance framework, providing the Board, Accounting Officer and senior management with essential financial information to inform strategy, inform decision making and ensure robust financial management.
Lead Reviewer: Steve Tebbutt
Details: Main points to note:
• No significant variances at this stage of the year • Our confirmed GIA revenue allocation for 2018/19 is £12,110k, £200k (1.7%) reduction on previous year (2017/18 £12,310). • £1,752k one-off additional funding for the research systems transformation has been approved by DoHSC finance (£1,500k from research funds; £252k from Brexit funding). • Capital and depreciation resource limits have yet to be confirmed from DoHSC finance – we anticipate that
1
Page 42 of 63
these will be confirmed as part of the June consolidation process. • £500k additional cash requirement has been agreed with DoHSC to address cash drawdown shortfall in 2017/18 • Additional funding for Agenda for Change pay proposals (c£120k) is being discussed with DHSC finance colleagues – likely to be confirmed by the end of the month • In year savings target will be confirmed as part of the quarter1 reforecasting process and is anticipated to be in the region of £100k - £200k. This is tough but achievable. • Year to date financial performance reports a small underspend position of £19k (0.6%) (2017/18: £46k (1.5%) on revenue expenditure and £1k (0.9%) (2017/18 £7k (4%)) underspend on capital expenditure • A new enhanced accounting hierarchy has been introduced, providing greater analysis within the coding structure. • Work is now underway to develop improved reporting and financial analysis based on this new hierarchy • The HRA continues to meet its regulatory requirements in paying invoices quickly.
Suitable for wider Yes circulation?
Time required for item: 10 minutes
Recommendation / To Approve Yes Proposed Actions: To Note
For discussion
Comments
Name: Karen Williams
Job Title: Director of Finance, procurement and estates
Date: 18th July 2018
Page 43 of 63
Finance Report - Financial Year 2018/19 Health Research Authority as at 30 June 2018
Executive Summary – Headlines • The HRA 2018/19 outturn for the first 3 months of the year was £3,389k (2017/18: £3,124k) and £106k (2017/18 £166k) capital. On revenue expenditure this represented an small underspend of £19k, 0.6% (2017/18 £46k, 1.5%) and on capital expenditure a £1k, 0.9% underspend (2017/18 £7k, 4.0%).
• Senior leadership team and the workforce board are now focused on developing a target operating model to support our strategic ambition and also meet spending review requirements. Our financial plan this year is dependent on confirmation pf funding for Agenda for Change pay award c£120k and achieving savings of up to £200k on business as usual activities.
• Funding has been secured for 2018/19 research systems transform programme (£1,752k). The framework contract has been signed and the first phase of the programme planned. Contractual discussion with the incumbent supplier has commenced. To date requests for GIA funded reserves programmes are at £523k. £298k has been released to the ledger, with £26k available to be allocated, leaving £199k unfunded.
• The HRA continued to meet its regulatory requirements in paying invoices quickly
Revenue financial performance for the 3 mths-ended 30 June 2018 2018/19 3 Months ended 3 June 2018 Latest Budget Actual Variance Variance Income Budget £000 £000 £000 % £'000 Grant in Aid confirmed inc RS Prog 13,862 3,208 3,189 -19 -0.6% HRA income 195 0 0 0 0.0% Non cash revenue resource limit 1,000 200 200 0 0.0% Total Income 15,057 3,408 3,389 -19 -0.6% Latest Budget Actual Variance Variance Expenditure Budget £000 £000 £000 % £000 Approvals - Operational 5,083 1,270 1,270 0 0.0% Approvals - Programme and Guidance 746 191 183 -8 -4.2% Approvals - Member Support 552 138 151 13 9.4% Research systems 915 227 226 -1 -0.4% Confidentiality Advisory Service 295 72 43 -29 -40.3% Total Services Expenditure 7,591 1,898 1,873 -25 -1.3% Chief Exec and Board 377 118 117 -1 -0.8% Policy 457 107 101 -6 -5.6% Governance ( inc. Quality) 323 98 99 1 1.0% Training 447 128 129 1 0.8% Corporate Services ( inc IT Services) 1,238 325 333 8 2.5% Transformation 2,002 59 63 4 6.8% Premises 888 322 323 1 0.3% Finance, Procurement & Estates 709 153 151 -2 -1.3% Reserves 26 0 0 0 - Depreciation 1,000 200 200 0 0.0% Total Non-Services Expenditure 7,466 1,510 1,516 6 0.4% Total Expenditure 15,057 3,408 3,389 -19 -0.6% 3
Page 44 of 63
Highlight report:
Overall
No significant issues on business as usual activities at this early stage in the year. Salary costs tracking just below expectations and no significant additional budget pressures identified on non-pay activities.
Transformation costs include research systems replacement programme £1,752k, future services programme (to replace our pc infrastructure and support contract) £192k and service improvement programme activity £40k.
Quarter 1 reforecasting cycle will help determine the level of savings required to fund key strategic reserves activities this year. The savings target is anticipated to be in the region of £100k - £200k once existing organisational change activity has been taken into account.
Key variances:
Confidentiality advisory team: £29k, 40%. Underspend predominantly related to vacant posts. The majority of this underspend to date is a permanent saving although not anticipated to continue at this pace once one post has been filled.
Member support costs: £13k, 9%. Overspend due to phasing only and is not expected to generate a permanent variance.
Corporate Services (incl. IT services): £8k, 2%. Overspend due to vacancy factor, anticipated to be reversed in the later months of the year once planned vacant posts materialise.
2018/19: financial risks:
1. Agenda for change pay award - £120k budget pressure. Discussions are ongoing with DHSC finance to agree funding for A4C proposals. Confirmation due by the end of July. Not included in above analysis.
2. Fixed timeframe for research systems delivery and available funding - risk of not effectively utilising funding for best effect to the sector given tight timescales and fixed window for funding. Further bid for 2019/20 Brexit funding and potentially SRE funding will be submitted later this year to secure funds to complete the programme in 2019/20 once more is known of current programme and future requirements.
3. Organisational and technological systems changes need to create £600k (approx 5%) economies to meet spending review requirements in 2019/20 and provide funds to support policy and external engagement strategic objectives. 2017/18 savings initiatives including organisational change, costs sharing (estates), closure of Exeter office and further digitalisation of ethics committees have generated efficiencies but more needs to be done to keep within funding envelope. Strategic priorities in 2019/20 mean significant financial pressures due to requirement to deliver on transformation agenda and achieve spending review requirements.
4. Our current business model will not sustain our strategic and operational objectives and yield real terms reductions in funding as required by the spending review. To address this we are developing a target operating model and associated financial strategy to create a revised business model that enables us to deliver on our requirements within our allocated GIA. This will be presented to the Board in the Autumn. Page 45 of 63
Staff costs (3 mths-ended 30 June 2018)
2018/19 Variance % 2018/19 2018/19 budget vs budget Variance vacancy 2018/19 budget net of net of net of factor actual Service YTD vacancy vacancy vacancy YTD factor factor factor £000 £000 £000 £000 £000 £000 Approvals Directorate 0 (48) (48) 0 48 - Approvals - Member Support 1 0 1 1 0 0.0% Approvals - Operational 1,261 0 1,261 1,216 (45) (3.6)% Approvals Programme and Guidance 176 0 176 172 (4) (2.3)% Confidentiality advisory service 61 0 61 37 (24) (39.3)% Training 56 0 56 55 (1) (1.8)% Total Services Staff Costs 1,555 (48) 1,507 1,481 (26) (1.7)% Chief Executive and Board 103 0 103 103 0 0.0% Corporate Services (8) (8) 0 8 -
Corprate Services (inc IT Services) 215 0 215 211 (4) (1.9)% Research systems 122 0 122 121 (1) (0.8)% Transformation 52 0 52 53 1 1.9% Finance, procurement and Governance (4) (4) 0 4 -
Finance and Procurement 123 0 123 116 (7) (5.7)% Governance (inc. Quality) 93 0 93 95 2 2.2% Policy 99 (2) 97 96 (1) (1.0)% Total Staff Costs 2,362 (62) 2,300 2,276 (24) (1.0)%
The decision to continue investing in additional agency administrative support based in our Manchester office to release pressure in operational teams has proven to be affordable. This arrangement will continue under regular review by recruitment panel for the foreseeable future. The Approvals directorate remains within budget, net of vacancy factor.
For the first three months’ staff costs were slightly underspent by £24k, 1.0%, due mainly to vacant posts that are being actively recruited to or have already been filled. Recruitment panel continues to closely monitor vacancies and potential strategies to ensure frontline services are protected and strategic programmes have sufficient capacity. Future target operating model discussions and operational change processes are monitored by workforce board.
Non-staff costs
No significant variances to report at this stage of the year. Our refined approach to finance business partnering has been implemented to enable the right level of focus on costs / activity proportionate to our internal assessment of risk.
Estates related costs have been pulled out of the Approvals directorate and are now reported separately as a corporate cost. Cost sharing arrangements for SKH with NHS BSA continue to help mitigate the costs of our London office (£72k/annum) while we wait confirmation of the new lease costs (due from DoHSC imminently). We are also exploring sharing space in our Manchester office with the Government Property Agency on behalf of another government agency.
5
Page 46 of 63
Reserves
Requests for GIA funded reserves programme are currently at £523k. This is in addition, to our fully funded RS transformation programme, £1,752k (funded by DoHSC Research funding and Brexit funding).
A number of these GIA funded projects have been deferred while we understand better our forecast financial position for 2018/19. Our financial plan is currently over-subscribed by £199k which means that some of the reserves projects will need to be deferred / curtailed and further savings identified in order to achieve our grant in aid allocation.
Reserves:
Programme Requested Committed Deferred
£000 £000 £000
Future services programme (1) 192 192 0
Windows 10 upgrade (2) 58 0 58
Service improvement programme 40 40 0
PIER additional capacity 43 18 25
Website development 18 8 10
Technical assurance (3) 60 0 60
EU clinical trials (4) 40 0 40
CRM system (5) 30 0 30
Chief Executive recruitment 40 40 0
Totals 523 298 225
Released to ledger (298) (298) 0
Funding required 225 0 225
Funding available 26 148 26
Shortfall / in year savings target 199 0 199
(1) Future Services Programme: £192k is our commitment to the programme for 2018/19. Early signs are that this amount may not be fully utilised this year due to delays in achieving the necessary government approvals. Some of this commitment might therefore be available to reinvest in other reserves programmes – particularly Windows 10 upgrade, reducing the net requirement here. (2) Windows 10 upgrade: HRA uses Windows 7 operating system which requires updating to a more resilient, supported and secure system. NHS Digital have negotiated a deal with Microsoft for the health sector to enable this to happen unilaterally. The upgrade will involve all laptops being rebuilt with the new operating system, some infrastructure changes as well as an organisational change programme. Costs are likely to be in the region of £60k plus some capital costs. The upgrade will enable HRA to improve toolset provided to staff, enhance Page 47 of 63
collaboration functionality and better utilise Cloud services. Costs may be covered by slower than planned implementation of FSP and associated cost deferral (above). (3) Technical assurance: Planning process identified the need to increase capacity in this team following the launch of the technical assurance process. To date no additional capacity has been released to support this new service with developments being led by BAU capacity. (4) EU clinical trials: Again planning process identified the need to invest in this area to ensure we meet tight timescales and align with partners. Investment in RS systems development capacity, as well as changes proposed in the Approvals team, go some way to address this however more may be required. (5) CRM system: Service improvement programme identified the need to invest in CRM tools to support the customer support work-stream. Investment in capacity in this work-stream is being explored to ensure it aligns with other transformation programme activities. £30k capital allocation has been provisionally provided within the capital budget.
Capital expenditure
2018/19 2018/19 2018/19 2018/19 plan full budget actual var ytd Plan initiative year ytd ytd £0 £0 £0 £0 HARP Developments 215 54 54 0 IRAS Developments 285 71 71 0 BGO Contract 500 125 125 0 IS Team – capitalised salaries 143 36 35 (1)
BGO Contract and Capitalised salaries position as at 30 June 643 161 160 (1) 2018 Future Services Programme 27 0 0 0 ICT infrastructure 100 0 0 0 CRM 30 0 0 0 Total Capital 800 161 160 (1)
Confirmation of our capital GIA allocation has yet to be received from DoHSC finance for 2018/19. The capital programme has been budgeted on the assumption that we will receive funding in line with last year’s budget and consistent with requests submitted to DoHSC finance.
Investment in IRAS and HARP developments are in line with the budget for P1, reflecting activity supporting the 28th June IRAS release. As development and implementation of the new IRAS system progresses, it is anticipated that development will be diverted to system improvements for HARP and migration requirements for new IRAS.
There has been provision made within the programme for the implementation of the Future Services Programme, the CRM system, and also additional laptops that will be required for the roll out of Windows 10.
Better payments performance The HRA has continued to meet the duty to pay 95% of invoices in 30 days, also maintaining the internal stretched target of paying 60% of suppliers in 10 days.
Number Value (£)
7
Page 48 of 63
Benchmark 95% 95% 2018/19 99% 100% 2017/18 98% 98% 2016/17 98% 98%
Recommendations The Board is asked to review and approve the finance report for the 3 months to 30 June 2018.
Karen Williams Director of Finance, Procurement and Estates 18 July 2018
Page 49 of 63
Health Research Authority 2018-19 Annual Cash Flow Profile Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Total £'000s £000 £000 £000 £000 £000 £000 £000 £000 £000 £000 £000 £000 £000
Opening Balance 957 929 846 1,459 1,648 1,246 1,063 914 842 811 874 895 957 Receipts
Debtors 33 17 44 - - 18 - - 18 - - 213 342
Revenue cash limit 1,000 1,000 2,000 900 800 1,000 1,100 1,200 1,150 1,150 1,100 1,462 13,862
Capital cash limit - - - - 100 100 100 100 100 100 100 100 800
Additional Cash allocation - - - 500 ------500
Total Receipts 1,033 1,017 2,044 1,400 900 1,118 1,200 1,300 1,268 1,250 1,200 1,775 15,504 Payments
Staff - payroll 443 793 820 776 767 770 771 768 759 753 745 1,036 9,198
Non-payroll payments 558 278 534 382 481 476 524 524 460 355 354 505 5,432
Capital payments 60 30 77 54 54 54 54 80 80 80 79 78 780
Total Payments 1,060 1,100 1,430 1,211 1,302 1,300 1,349 1,372 1,299 1,188 1,179 1,619 15,410
Closing Balance 929 846 1,459 1,648 1,246 1,063 914 842 811 874 895 1,051 1,051 Notes and Assumptions (1) Includes additional £500k cash cover confirmed by DHSC
9
Page 50 of 63
Agenda item: 12 Attachment: F
HRA BOARD COVER SHEET
Date of Meeting: 24/07/2017
Title of Paper: HRA FOI Summary for LT & Board 2017/18
Purpose of Paper: To provide the LT & Board with an overview of Freedom of Information requests received during the period 01 April 2017 – 31 March 2018.
Reason for Submission: For information
Details: An anonymised version of the register is available upon request.
Suitable for wider Yes circulation? Time required for item: 5
Recommendation / To approve Proposed Actions: For information / to note X For discussion Comments
Name: Stephen Tebbutt
Job Title: Head of Corporate Governance & Risk
Date: 26/06/2018
Page 51 of 63
Summary of FOI requests received 2017/18
Stephen Tebbutt Head of Corporate Governance & Risk
SAMPLE IMAGE INSERT YOUR OWN IMAGE HERE OR CONTACT COMMS TO ACCESS THE IMAGE LIBRARY. MAXIMUM WIDTH: 25.4 CM MAXIMUM DEPTH: 10.3 CM Page 52 of 63
Total number received
• A total of 65 FOIs were received in 2017/18, a 20% increase in comparison with 2016/17
Number of FOIs received in 2017/18 in comparison with 2016/17 70
60 65
50 54
40
30
20
10 Number of FOIs received FOIs of Number 0 2016/17 2017/18 Year
This presentation is designed to provide general information only. Our website terms www.hra.nhs.uk | @HRA_Latest and conditions apply www.hra.nhs.uk
Page 53 of 63
Breakdown of requests received by category • The following charts show the types of FOI requests received In 2017/18 in comparison with the previous year
Breakdown of FOI requests Breakdown of FOI requests received by category 2016/17 received by category 2017/18
0 RES RES 1 5 IT 10 IT 3 HR HR 2 3 22 CAG 2 CAG Corporate 2 Corporate 4 Estates 3 33 Estates Finance 2 Finance 1 3 5 Policy Policy Comms Comms 0 8 10 Other Other
This presentation is designed to provide general information only. Our website terms www.hra.nhs.uk | @HRA_Latest and conditions apply www.hra.nhs.uk
Page 54 of 63
Breakdown of requests received (cont.) • For 2017/18 the greatest proportion of FOI requests received related to the Research Ethics Service (33). These can be broken down further as follows: Breakdown of FOI requests received (2017/18) relating to RES Request for documentation regarding a 1 1 particular study e.g. protocol / application form 6 Requests for approval documentation regarding a particular study e.g. minutes / letter from REC 14 Broader requests for information or statistics e.g. total number of clinical trials approved for a given period Request for the findings of a particular study
11 Request for REC member information (job titles of members)
This presentation is designed to provide general information only. Our website terms www.hra.nhs.uk | @HRA_Latest and conditions apply www.hra.nhs.uk
Page 55 of 63
Breakdown of requests received (cont.)
• ‘Other’ was the next highest category (10). These included requests for: – Contact details of particular roles (4) – Vehicle / fleet information (1) – Label supplier (1) – Airfare details (1) – Requests unable to be categorised further (3)
• IT requests were the next highest (8) with all requests relating to contract information including end of contract dates for software and hardware suppliers.
This presentation is designed to provide general information only. Our website terms www.hra.nhs.uk | @HRA_Latest and conditions apply www.hra.nhs.uk
Page 56 of 63
Breakdown of requests received (cont.)
• The following requests may be of interest for LT and the Board to note from the remaining categories:
– A request for the contact details of the HRA’s GDPR lead and how many subject access requests have been received – Requests for the CAG minutes / correspondence in relation to particular studies (3) – A request for the details of the communications team social media usage – A request for details regarding the amount spent on consultancy by the HRA between 2011-2017
• The anonymised FOI register for 2017/18 is available on request.
This presentation is designed to provide general information only. Our website terms www.hra.nhs.uk | @HRA_Latest and conditions apply www.hra.nhs.uk
Page 57 of 63
Agenda item: 13
Attachment: G
HRA BOARD COVER SHEET
Date of Meeting: 24 July 2018
Title of Paper: Complaints Register 2017/18
Purpose of Paper: To provide the LT & Board with details of complaints received during 2017/18. If the Board require further detail regarding a specific complaint please contact the Head of Corporate Governance & Risk prior to the meeting.
Reason for Submission: For information
Details: A total of 9 Complaints have been received during the 2017/18 year. This represents a decrease of 11 over 2016/17 when 20 complaints were received.
Of the 9 complaints: • 1 (11%) were upheld; • 8 (89%) were partially upheld;
By far the majority of complaints (5 or 56%) were regarding difficulties associated with HRA approval processes. Of these 5 were partially upheld.
3 (33%) were about treatment either in a REC or by HRA staff (1 upheld and 2 partially upheld).
The last concerned the volunteer recruitment processes and was partially upheld.
The HRA encourages the local resolution of concerns before they become a complaint but none were recorded during the year. It is however likely that concerns will be resolved locally without being formally recorded.
The HRA also works hard to support individuals that have a complaint that involves a third party i.e. complaints about treatment in a research project. 5 were received in 2017/18 Page 58 of 63
and it should be noted that one in particular was linked to a Parliamentary review and research into ME/Chronic Fatigue Syndrome (CFS).
It should be noted that appeals against Research Ethics Committee (REC) decisions are handled under operational Standing Operating Procedures (SOPs) and not classified as complaints.
Please see the Board Complaints Register 2017/18 for more detail. If further detail is required, the Head of Corporate Governance & Risk would be happy to provide these.
Suitable for wider Yes circulation?
Recommendation / To Approve Proposed Actions: To Note Y Comments
Name: Stephen Tebbutt
Job Title: Head of Corporate Governance & Risk
Date: 26/06/2018
Page 59 of 63
SUMMARY COMPLAINTS REGISTER 2017 - 18
Working Date Ref Category Nature of complaint days to Outcome Action resulting from the complaint received respond
Making some changes to our tracking arrangements to make it Ops/HRA Time taken for the HRA to respond to their Partially 17.C.01 19.05.17 12 easier to have visibility of the progress of applications and help Approval IRAS application Upheld them to support applicants. The combination of the absence of the Chief Investigator, the quality of the application, and the misunderstanding over the questions led to an uncomfortable review. The regional manager has taken the opportunity to remind the REC Manager of the option to prompt the Chair to intervene and Hostility and lack of professionalism shown Partially 17.C.02 Ops/REC 03.08.17 17 take a different approach should a similar impasse arise in by REC Chair Upheld future reviews. He will also speak directly to the REC Chair, reminding that where the Chief Investigator is absent and matters cannot be easily resolved in the meeting, the concerns should be raised in correspondence directly to the Chief Investigator. Several issues with the submissions process Reminder for staff to re-enable e-submission when a that reinforce an impression of a system Partially 17.C.03 Ops/IRAS 04.09.17 24 provisional or favourable opinion with conditions is given. that is unwieldy, unresponsive and which Upheld Improvements to research systems in train. encourages error. Due process not followed by the HRA Understand that there may have been confusion about the resulting in direct contact by the MHRA and 36 Ops/HRA Partially body responsible for liaison with MHRA. Have written to 17.C.04 the HRA appears to have no limit on the 01.09.17 (Kept Approval Upheld confirm to them that MHRA would expect to liaise directly with time allowed to reach a decision once it informed) the applicant and not the HRA. approaches the MHRA for advice. The guidance used to communicate to sponsors could be Complaint about application handling which 27 clearer. Will ensure that changes are considered as part of the Ops/HRA Partially 17.C.05 raises concerns in regards to transparency 02.11.17 (Kept current Service Improvement Programme and in particular ‘Get Approval Upheld in the way administrators operate. informed) it Right First Time’ to help reduce number of applications with documents missing or incorrect signatures.
Page 60 of 63
Working Date Ref Category Nature of complaint days to Outcome Action resulting from the complaint received respond Website updated to remove misleading reference to the ‘National’ Social Care REC. The HRA now hosts several Cannot be considered for the National committees with responsibility for reviewing social care studies Partially 17.C.06 SCREC social care REC due to living away from 01.12.17 123 However as REC is based in London, members are recruited upheld London. from relevant geographical area in line with all RECs. Apologies given for considerable delay in responding to complaint due to management oversight.
Chief Investigator was most disappointed as Fed back importance of being more patient with applicants Ops/HRA Partially 17.C.07 to how she was spoken to by a member of 12.12.17 20 who may not be familiar with the application process and of Approval Upheld the HRA team. remaining calm to be more helpful.
Several issues: HRA giving perceived wrong Broad description given in the application which did not make advice on interpreting IRMER guidelines on clear that the focus of the research is not the radiation itself radiation exposure, communication from but the comparison of images resulting from radiation which researcher diluted, expert opinion is resulted in the wrong advice being given. Ops/HRA ignored, and nobody advises on questions 47 Approval / Partially 17.C.08 needed to be asked of MPE or RPO. 31.01.18 (Kept Reviewed and revised our internal guidance, and will take Guidance Upheld informed) forward wider revision of external guidance with input from & Advice radiation professionals. Staring to roll out new radiation technical assurance process which should assist in getting clear guidance for individual studies without the delays described.
Treatment in a REC. The general attitude 64 Requested the Chair to ensure this behaviour does not reoccur and unprofessional manner of the 17.C.09 Ops/REC 21.02.18 (Kept Upheld and to ensure members conduct themselves in a professional committee members left us feeling very informed) manner. dejected.
2 | P a g e
Page 61 of 63
Agenda item: 14
Attachment: H
HRA BOARD COVER SHEET
Date of Meeting: 24 July 2018
Title of Paper: Audit and Risk Committee meeting summary – 06 June 2018
Purpose of Paper: A summary of the key items discussed at the last Audit and Risk Committee meeting for Board to note.
Reason for Submission: For information
Details: See summary
Time required for item: 0-5 minutes
Recommendation / To Approve Proposed Actions: To Note x For Discussion Comments
Name: Stephen Tebbutt
Job Title: Head of Corporate Governance & Risk
Date: 18 July 2018
Board Cover Sheet (September 2017) Page 62 of 63
AUDIT AND RISK COMMITTEE MEETING SUMMARY
Key summary points from the HRA Audit and Risk Committee meeting held on 6 June 2018
COMMITTEE 02 May 2015, HRA 1, Skipton House GOVERNANCE - Quorate - Attendance (membership) – 3/4
KEY BUSINESS Final HRA Internal Audit Plan 2018/19 CONDUCTED The Committee reviewed and approved the final Health Group Internal Audit Plan for 2018/19.
Annual Report Accounts 2017/18
The Committee reviewed the Annual Report and Accounts for 2017-18 and agreed, in general, the report was clear with the formatting changes improving the design compared with previous years.
The Committee reviewed each section in turn with the report updated with the Committee’s recommendations prior to being laid before Parliament and subsequent publication.
The Committee expressed its thanks to the communications team for its work in developing the format of the report at short notice and noted this format would be further refined and improved for next year.
Audit Completion report
Audit Completion Report The HRA’s external auditors, Mazars, presented the Audit Completion Report highlighting that no issues were identified with regard to the management override of controls risk.
The Committee expressed its thanks to NAO, Mazars, the finance team and all in the organisation for an excellent year with well controlled expenditure. The Committee was confident public money has been appropriately used at the HRA over the last year.
Deep Dive into Research System Procurement
A discussion was held regarding the recent research system procurement exercise.
The Committee noted three suppliers submitted tenders and the executive had confirmed it was satisfied by the three bids which allowed appropriate consideration and comparison.
The Committee noted the confusion at the recent Board meeting regarding the uncertainty of whether Board were being asked to approve the decision for the particular supplier. The Committee noted the Board had already reviewed and approved the
2018.06.06 Audit and Risk Committee meeting summary Page 63 of 63
business case therefore no further Board approvals were required in choosing the specific supplier.
The Committee discussed how other stakeholders’ needs would be met with regard to new IRAS. The Committee noted, ahead of the procurement process, a significant exercise had been undertaken to collect user stories which could be built into new IRAS. Feedback had been sought from a range a stakeholders and PwC had also attended an IRAS Board meeting.
The Committee noted the process has strengthened the HRA’s understanding of the whole business case process and how the funding model works in DHSC which should help with any future business cases required.
The Committee expressed its thanks to the research systems team for working professionally during the exercise in an environment of uncertainty.
UPCOMING - Review Audit Committee manual and terms of reference MEETING - Review emergency incident scenario final report TOPICS - Review declaration of interest register 2017/18 - Risk deep dive - workforce pressures and assessment of progress from staff survey action plan
2018.06.06 Audit and Risk Committee meeting summary