Health Research Authority (HRA) What do you need to know?

Health Research Authority (HRA) What do you need to know?

Background why another change?

Cohorts Cohort Type of Study Live date 1 Health services research not requiring REC review 11 th May 2015 2 Studies in primary care only 10 th August 2015 3 Studies which are not clinical trials or clinical investigations 4 Clinical trials and clinical investigations in secondary care 30 November 2015 March 2016 5 Single site, site sponsored studies March 2016 6 Studies solely for educational purposes March 2016 Fully implemented from 31 st March 2016

The Benefits One application One set of authorisations One set of documents to upload HRA accepts responsibility for their assessment NHS sites in England must have regard for HRA guidance Allows NHS sites to focus on set up and delivery

Should now be default option for new studies IRAS

Still have the function to create an SSI-but should not be used IRAS

HRA Review and Conclusion Initial Assessment An initial assessment is performed to confirm is the study eligible? If so an initial assessment letter is issued. Letter will clarify arrangements for different site types Flags issues to be resolved so sites don t replicate Review The HRA assessment will assess for compliance and other related matters and liaise with the sponsor of nominated individuals Conclusion Once assessment is completed, HRA conclusion- Approved or Not Approved -will be issued in the form of a letter HRA approval letter will state whether a model agreement is to be used for contracting MHRA approval is currently separate, but HRA approval is only issued when MHRA approval is in place

Statement of Activity & Schedule of Events NON COMMERCIAL TRIALS ONLY Download from HRA website Sponsor and study team should complete Attach to IRAS http://www.hra.nhs.uk/resources/hra-approvalapplicant-guidance/statement-activities-hraapproval/

Statement of Activities Acts as an agreement for simple studies A template per site type should be submitted to the HRA for review Sites will complete as part of the set up process

Schedule of Events Details activities and cost attribution at site A template per site type should be submitted to the HRA for review HRA approval will not be conditional on correct attribution of costs

Local submission NUH will be informed by the sponsor or HRA they have been selected as a site (NUH listed on IRAS). No need to submit to NUH via email If study is awaiting HRA approval, if appropriate Assess Arrange Confirm can begin If study is open already, AAC will begin immediately For studies where the HRA have said confirmation of capacity is not required, NUH will still look at the documents to ensure there is no risk of burden to staff or patients You should not start recruiting until NUH have confirmed you are OK to do so.

NUH review- Assess, Arrange, Confirm Study milestones- recruitment, start and end dates, follow up information, regulatory approvals Capacity- support departments, staffing resource Capability- do we see these patients, is the trial deliverable? Study action plan documentation to be completed by RPM/RM&G reviewer. Only when this has been completed is CAPACITY & CAPABILITY CONFIRMED

Local Information Pack In order to begin Assess, Arrange, Confirm we need the following from the sponsor:

Site set up stages

Studies involving Devolved English led Nations HRA will share the study-wide review SSIs submitted to Devolved Nations sites Led from Devolved Nations Ethics service shares their review with the HRA HRA will conduct their assessment and issue approval Have to accept SSI s at site, but still only confirming capacity and capability

Amendments Historic Studies When CSP is switched off amendments will go through the HRA Applies to ALL amendments for ALL studies (adopted and non adopted) Addition of new sites Will go through HRA via a light touch assessment Send e mail to hra.approval@nhs.net with study documentation For non commercial- schedule of events and statement of activities should also be completed

Amendments REC Approval Those requiring approval, continue to submit to REC that initially reviewed the study and info will be shared with HRA internally Non substantial amendments (not requiring REC) submit to hra.amendments@nhs.net Categorisation HRA assessment staff will categorise as A, B or C and inform the applicant of the categorisation. This will be completed within 5 working days A or B requires consideration by site- can be implemented 35 calendar days after sponsor provides information unless concerns/objections raised C does not require consideration by site so can be implemented immediately

Timelines Timelines are in calendar days with no clock stop

The future No SSI No governance review- NUH will confirm capacity and capability No CSP system Radiation and pharmacy technical assurance will be centralcurrently in final stages before roll out For further information please visit http://www.hra.nhs.uk/ Slides can be downloaded from http://nuhrise.org/training/ Contact R&I if you have further questions