The Health Research Authority. Janet Wisely. April 2015

Transcription

1 The Health Research Authority Janet Wisely April 2015

2 The HRA as an organisation A Non-Departmental Public Body January 2015 Public sector employees on NHS terms Volunteer members of committees A Special Health Authority 2011 NRES COREC COREC - MREC NHS RECs scattered

3 HRA Non-Departmental Public Body Status January 2015 Care Act clauses align to our business plan Places our functions on a statutory footing Greater authority and policy responsibility Extends remit to adult social care Gives duties to the HRA and to others

4 The Health Research Authority Research policy ( governance ) Research Ethics Committees Collaboration and Development projects HRA assessment and Approval programme (NHS) Research transparency Public involvement and engagement Systems, including IRAS, TOPS and HARP Advice, guidance, training, quality assurance Communications Confidentiality Advisory Group and Team

5 A new UK policy framework for health and social care research (draft) research governance UK wide steering group with ambition to issue a UK wide policy framework (which would enable the current frameworks to be withdrawn) Draft policy out for comment in each country RGF (s) withdrawn when the new policy framework consulted on and adopted

6 Regulation, legislation, policy and operations EU directive EU regulation UK regulations UK legislation Other legislation MCA, Tissue, data etc Research Governance Policy (each country, HRA - England) Governance Arrangements for Research Ethics Committees (harmonised) REC Standard Operating Procedures (UK - HRA) Standards, guidance, advice, training, decision tools (HRA)

7 HRA public involvement and engagement Public involvement strategy Commitment to engagement all

8 Views on health research Differences in views - public versus patients Differences in sources of confidence - expert versus patient Regulation is part of that confidence Lack of understanding about clinical research and who could participate Trust in the NHS (further work this year, identification of patients and consent)

9 Case study clinical trial of statins in primary care Good support for simplified consent Some concerns about whether patients might feel pressurised into taking part, with suggestions about how more thinking time could be built-in The opt-in model was preferred, since this kept the patient-doctor relationship intact with patients maintaining agency Participants generally supported the HRA proposals for what should be included on a patient information sheet.

10 Case study zero consent Zero consent supported for a mattress example Posters advising patients of the trial did not receive strong support Difference of opinion about using zero consent in other cases: Some felt it could be used more often if there was no difference between treatments Others were concerned to ensure there was no scope creep Reassurances included: low risk, no evidence, impractical to seek consent, equipment based and non-invasive

11 Research Ethics Application Form: 'QA14-1: In which aspects of the research process have you actively involved, or will you involve, patients, service users and/or their carers or members of the public? Design of the research Management of the research Undertaking the research Analysis of results Dissemination of findings None of the above Give details of involvement, or if none please justify the absence of involvement (free text box) INVOLVE (2014) Public involvement in research applications to NRES

12 Figure 1: All studies (non-commercial and commercially funded combined): responses to question on public involvement 2010 (N=646) 2012 (N=1169) % % % % % % No involvement box ticked Involvement box ticked, not confirmed by free text Involvement box ticked, confirmed by free text INVOLVE (2014) Public involvement in research applications to NRES

13 Patients will be involved during the research as subjects I will be asking my patients to take part in my study patients will be asked to carry the sampling storage equipment (bottles and paper) and present them to staff at delivery participants will be offered a copy of the results of the study. I will be giving talks about the research I see patients all the time, I know what their views are on this INVOLVE (2014) Public involvement in research applications to NRES

14 patient information sheets were written by a patient advisory group service users helped develop the research topic and what research questions should be asked named members of the public as co-applicants who will continue to be involved in the study we have invited patients on the trial steering group/ management group the study was conceived, designed and being led by a patient group who have led the application for funding and will be involved in all aspects including undertaking the research and dissemination INVOLVE (2014) Public involvement in research applications to NRES

15 Public involvement and REC outcome Involvement ticked & confirmed Involvement ticked, not confirmed No involvement Favourable 39.7% 38% 23.6% FI Favourable 52.9% 56.3% 72.3% Not favourable 7% 5.7% 4.1% Total % 100% 100% 100% Total no Accepting it may be an indicator of quality more broadly

16 The new policy framework Ambition is to simplify the approval process and support good quality research in the UK Sets out responsibilities and sources of assurance Informed by individual projects that have already been issued for specific comment, including educational research, risk in research, perception of risk in research, social care scoping study Informed by other HRA projects and programmes, including the collaboration and development programme

17 The new policy framework and the Clinical Trial Regulations Research policy is a statutory function for the HRA Some of the detail required in UK legislation to implement the EU regulation can be included in HRA policy, and avoid the detail on the face of the UK legislation Existing MHRA HRA MoU

18 Research ethics service 69 RECs in England Working to standard operating procedures within a managed, supportive and responsive service Includes the Social Care REC Independent ethical opinion, volunteer membership Committed to continued improvement Reduced cut off timelines for Phase 1 Expedited review (public health emergency) Will be a component of HRA Approval for the NHS

19 Time to complete review, all application types, England

20 Distribution of review times for Phase 1 studies Data from April 2014 January 2015

21 Transparency Key issue with respect to public confidence Identified as a priority for the HRA as a NDPB Care Act gives the HRA specific duties HRA signed up to AllTrials HRA expectations and HRA requirements EU clinical trial directive and future EU clinical trial regulation

22 Transparency HRA approach Transparency as a global issue Pragmatic and proportionate approach to support UK competitiveness RGF REC question on IRAS since 2008 Registration identified as a specific REC condition Deferral option for early trials as a solution for Europe? Using the sponsor declaration as a compliance check point 2014, extended 2015

23 Transparency elements Registration all clinical trials, with deferral to recognise issues of commercial confidence Registration other studies Findings and reporting results (including participants) Access to data, tissue HRA decision making including REC and CAG Public confidence

24 HRA assessment and Approval NHS Site selection & feasibility Site set-up ready to deliver Site set-up ready to deliver HRA Single application Application to HRA Single validation HRA Approval Assessment REC opinion

25 Key messages One application, one assessment and one Approval for research in the NHS England UK wide compatibility Single application form provided by IRAS IRAS and current HRA ethics database (HARP) to be updated to provide required system platform UK wide Single platform in place to manage the system interface - Clinical Trial Regulations

26 Key principles Agreeing standards and templates is key so HRA can provide clear, consistent expectations for assessment Assessors will be a dedicated HRA staff resource Expertise for technical assurances will be coordinated by the HRA and provided by NHS staff Individual components/ standards will deliver early improvement HRA Approval will be rolled out by study type; ambition for all study types by end of 2015

27 Work completed All assessment components underway IS procurement and staffing framework complete Local research support functions paper published Q&A updates published Technical assurances roll out started Model non-commercial agreement published for comment Recruitment to operational roles ongoing

28 Controlled roll out - cohorts First cohort go live announced for May 2015 Release and early testing Review, refine, announce, test etc Therefore not a set of dates now, the timing of the move to the next cohort will depend on the uptake and success of the previous one Enables process to drive system specification Notice given to enable preparation for each step Ambition remains end of December 2015 Staff research, health services research, clinical (primary care first)

29 Clinical Support Assurances Pharmacy single technical review as part of HRA assessment instead of duplicate review at sites Radiation revised technical review prior to HRA application to assure REC and sites Started roll out in collaboration with CRUK and ECMCs Coordinates and supports NHS expertise Ambition to extend to all studies: Summer (Pharmacy) Autumn (Radiation)

30 Clinical Support Assurances - Pharmacy It s a really positive step forward for Pharmacy staff Lead Pharmacist for Clinical Trials, University Hospitals Birmingham

31 Latest data March 2015 Pharmacy: From August 2014 (7 months) 37 reviews requested 28 reviews completed For the 28 completed reviews there were 132 duplicate reviews avoided Radiation First study received 25/2/15 7 studies in progress as of March, no complete reviews.

32 Collaborative Working Representation from NIHR CRN on programme boards UK wide collaboration NHS Research Support Champions Team of regional change leads supporting local activities Collaboration & Development Forum funders, sponsors, investigators Proactive stakeholder engagement Phase 1 Advisory Group

33 Benefits realisation Quality Consistency Challenge and feedback Whole system approach New approach Metrics line of sight where they don t directly translate Metrics and benefit

34 Thank you, questions?