UK wide consistency and IRAS developments

Transcription

1 UK wide consistency and IRAS developments Mary Cubitt Four Nations NHS/HSC Compatibility Programme Manager Operational Leads England, Northern Ireland, Scotland and Wales

2 Four Nations Policy Group Commitment Continuing to streamline processes To maintain compatible health research systems across the UK To increase the consistency of health research systems across the UK 16/05/2017 2

3 Researchers and patients are at the heart of why we do what we do 16/05/2017 3

4 Four Nations NHS/HSC Compatibility Programme Set up to increase consistency of processes and IT across UK from researcher perspective Programme Manager: Mary Cubitt All four nations involved in planning and designing 16/05/2017 4

5 Aims & Objectives AIMS To make it easier for all researchers to do research across the UK Researcher experience is the same across whole of UK A single ethics and R&D online submission from the Integrated Research Application System (IRAS) A consistent UK-wide approach to sharing local information between sponsor and sites An improved UK-wide approach to amendments 16/05/2017 OBJECTIVES 5

6 Combined Ethics and R&D Form Single combined Ethics and R&D Form in IRAS across UK Simultaneous e-submission to ethics and lead nation study-wide review Collaborative working between ethics and studywide review to support streamlined outcome 16/05/2017 6

7 Current Northern Ireland, Scotland and Wales REC Form and documents E-submit to REC R&D Form and documents Down load, attach and 16/05/2017 7

8 IRAS Form Submission England Existing simultaneous e- submitted from IRAS Northern Ireland, Scotland and Wales e-submit from IRAS for ethical review then immediately download submitted form and with documents for study wide review 16/05/2017 8

9 Stage 1: Northern Ireland, Scotland and Wales IRAS Form and docu ments E-submit to REC IRAS Form and docum ents Down load, attach and 16/05/2017 9

10 IRAS Form Submission All nations Simultaneously e- submission from IRAS 16/05/

11 Stage 2: whole of UK IRAS Form and documents E-submit 16/05/

12 From researcher perspective Behaviour change Plan NHS/HSC delivery side of study before going to REC Benefits One set of documents to upload One set of authorisations Less amendments between REC Favourable Opinion and getting up and running Time between initial application and site set up has potential to shorten 16/05/

13 From study wide reviewer perspective Behaviour change Be comfortable ignoring REC only items No additional tasks Benefits Receiving simultaneous application with REC Same document versions Applications to participating countries automatically Applications should be properly prepared for the NHS/HSC Simplicity of advice provision to applicants 16/05/

14 IRAS Form Progress/Work to do Development in IRAS happening now Applicant guidance in IRAS happening now Study wide reviewer guidance in progress Communicate with all stakeholders (Researchers, sponsors, R&D management staff, Study Wide Reviewers, Research Ethics staff and members) initiated but more to do Build e-submission to each nation study-wide review system Communicate with all stakeholders 16/05/

15 Shared Local Information Pack

16 Shared Local Information Pack Building on and extending the collaboration between the NHS/HSC and sponsors Site set-up a two way conversation Joint agreement to run study Concept of site specific submissions removed 16/05/

17 Shared Local Information Pack Not submitted. Shared with NHS/HSC organisation and jointly agreed Shared with PI and local research team AND R&D at the same time, so all know what is happening Sponsor chooses time to share NHS/HSC organisations confirm agreement to take part in study 16/05/

18 How will it work? Local Information Pack = Local Information Template + documents Create Local Information Pack in IRAS May be more than one per study if different activities at different sites Link Local Information Pack to site listed in Part C Share Local Information Pack with R&D office and local research team from within IRAS Jointly agree 16/05/

19 Current local process in DAs DA Study wide review Transfer SSI Submit SSI PI Other R&D Site team supporting set up and delivery 16/05/

20 To be local process in DAs One document package One joint decision about site DA Study wide review PI NHS Other Site team supporting set up and delivery 16/05/

21 No change to local process in England CRN One document package One joint decision about site HRA Approval for the NHS in England PI NHS CRN Site team supporting set up and delivery 16/05/

22 From researcher perspective Behaviour change Plan NHS delivery side of study before submitting IRAS Form Be very clear what is happening at NHS/HSC organisation Be very clear about funding Be very clear about agreement to be used Share complete pack with R&D and local research team Have open conversations Benefits Consistent process across the UK Consistent approach from all UK NHS/HSC R&D offices Sponsor in control of their own study 16/05/

23 From R&D office perspective Behaviour change Prepare to align processes to be nationally consistent Prepare for dialogue rather than receiving a submission Actively facilitate site set up rather than check documents SOPs updated Benefits Consistent process and approach across all sites in the UK means less researcher confusion across borders Involved in the conversation doing with NHS/HSC rather than to the NHS/HSC 16/05/

24 Local Information Pack Progress/Work to do Principles and high level process agreed across the UK - done Define how it will work in IRAS good progress Confirm and agree across UK exact template wording good progress Develop in IRAS Develop applicant guidance Develop PI and local research team guidance Develop R&D management guidance Communicate with all stakeholders 16/05/

25 Amendments much work to do More work required to rethink/ streamline amendment handling What is an amendment? Which amendments are R&D interested in? Can amendments be simplified for applicants? E-submission is needed 16/05/

26 Amendments Work to do Engage with stakeholders Plan the work Develop e-submission of all amendments 16/05/

27 What is the change management plan? Developing change management plans for each nation UK wide processes Nation specific engagement Supporting testing Developing Comms plans UK wide messages Nation specific communication channels 16/05/

28 On the horizon in IRAS 16/05/

29 Future IRAS developments Part C selection of sites from pick list for all nations (in development) Improved document upload (in development) Checklist visible to sponsor authorisation process (in the future) Ongoing updates as changes are made to IRAS guidance and e-learning module 16/05/

30 Under the bonnet Infrastructure Robustness Terms of Reference Privacy statement 16/05/

31 16/05/

32 Questions?? Four Nations Compatibility Programme Mary Cubitt Operational Leads England - Matthew Harris Northern Ireland - Sally Doherty Scotland - Joanne Rodger Wales - Christopher Cotterill-Jones 16/05/