The Approval Processes – IRAS, HRA, REC & C&C!

Jess Bisset

Research Operations Manager UH Bristol

Research and Innovation http://www.uhbristol.nhs.uk/research-innovation University Hospitals Bristol NHS Foundation Trust Level 3 Education Centre Upper Maudlin Street Bristol BS2 8AE Tel: 0117 342 0233 Fax: 0117 342 0239 e-mail: research@uhbristol.nhs.uk

Is it research?

• UHBristol R&I website: http://www.uhbristol.nhs.uk/research-innovation/information-for-researchers/is-your-study-research,-audit-or-service-evaluation/

• Check the ‘tool kit’ http://www.hra-decisiontools.org.uk/research/

What is a Sponsor?

• RGF: Sponsor: “Individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study”

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdf • Clinical Trials Regulations: “sponsor” means, in

relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) or that trial.

http://www.legislation.gov.uk/uksi/2004/1031/regulation/3/made

Does my project need a sponsor? If you are planning on carrying out research within the NHS – YES under the Research Governance Framework

Who should be my sponsor? Usually the organisation that employs you or where the

funding for the research will be held (i.e. a grant). For research undertaken as part of a qualification, the

university at which the student is registered should act as sponsor

Is there an application process? Yes. Each organisation has a different application process. Either refer to the relevant website or R&D department

for information on the process.

Obtain funding & sponsorship

Complete IRAS form & supporting documents

Write protocol

IRAS form authorised by sponsor & CI

Submit IRAS form and all supporting documents to Health Research Authority (HRA)

REC review (if applicable to study type)

HRA review (all NHS studies)

REC approval HRA approval

Submit request for capacity and capability confirmation from all participating sites. C&C issued Sponsor green light to

begin recruitment!

Disclaimer: Not an exact replica of study start up!

If other regulatory bodies required (e.g. MHRA/GTAC) will need to be completed at same time

Integrated Research Application System (IRAS): https://www.myresearchproject.org.uk/Signin.aspx

IRAS…

Applications to relevant regulatory bodies for all research involving the NHS need to be made through IRAS:

Non NIHR Grants

How to apply for HRA approval

o Once a new project is created in IRAS it is important to complete the filter questions correctly o For studies led from England click ‘IRAS form’ on filter question 4 to enable HRA

application o Prepare your study documents. Please include the IRAS ID on your PIS and ICF, the

HRA will reject the application if you don’t! o PIS needs to incorporate GDPR related statements. Guidance can be found on the

HRA website. o Send your documents to sponsor for review prior to submission (they will also need

to authorise your IRAS form) o Book your application in through the Central Booking Service o E-submit your applications in IRAS o HRA publish Assessment Standards and Criteria which may help – guidance also

available in IRAS

You must speak to your sponsor for guidance on application forms and processes!

Further information on the HRA website: https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/hra-approval/

• All done through IRAS at the same time as HRA (1 form!) • Passed to REC committee (if applicable)* • REC review will look at justification of the research,

patient approach and consent , study equilibrium, study design and ethical issues!

• REC will contact you via email with an initial ‘application valid’ email and details of the REC meeting

• Encouraged to attend REC meeting so that you can answer their questions in person and speeds up the review!

• Will send a ‘favourable opinion’ letter via email if successful.

REC application

http://www.uhbristol.nhs.uk/research-innovation/our-research

Previously when research involved the NHS R&D approval was always required. Now all research involving the NHS in England must be sent to the HRA for

approval. The HRA will then confirm in their Assessment Letter whether confirmation of

capacity and capability is required at participating sites. Where confirmation of capacity and capability is not required the sponsor should inform participating sites and they will either: Have 35 days to review and object to the study No action required – study sent for information only Examples: Research looking at a tool that clinicians use for patient management, survey link sent to staff members only, questionnaires to staff only.

When is Capacity & Capability (C&C) confirmation required?

Example of where C&C not required

Example text from an HRA assessment letter where capacity and capability review is not required.

Research that will require C&C review

Where there are any implications on capacity at a Trust (i.e. personnel time/support, access to patients) C&C review will be required

The HRA assessment letter will confirm this. However, if you are confident C&C is required you

can approach the R&D department & local team early to start feasibility (assessment stage)

Local Information Pack

Submit the local information pack via email to the appropriate R&D inbox at the participating site. For UH Bristol it is ResearchApprovals@UHBristol.nhs.uk

For contact details of R&D offices: http://www.rdforum.nhs.uk/content/contact-details/

• Copy of IRAS Form as submitted for HRA Approval • Protocol and amendments • Participant information and consent documents (without local logos/ headers) • Relevant model agreement • Commercial studies only – NIHR Costing template (validated) and delegation log

(including known research team names but not signatures) • Non-commercial studies only – statement of activity and schedule of event

templates (including known information) • Any other documents that the sponsor wishes to provide to the site to support

the set up and delivery of the study • Copy of HRA initial assessment letter (if one is issued) and (when issued) HRA

Approval letter and final documents.

Statement of Activities

• One per site type • Is the Statement being used as the contract with the study

sites. If not what will be used instead? • Identify whether a local person (Principal Investigator (PI)) will

be appointed at sites or not (Q9)? • Have the schedules been correctly completed (finance, tissue

and data)?

• Guidance available on the HRA website

Schedule of Events

• One per site type • Does the Schedule list all of the activities that will take place at

each study visit (either at the NHS site or by NHS staff)? • Are timings for these activities included and details of who will

undertake the activities? • Have cost attributions been provided for each activity? • Guidance available on the HRA website

For single site studies it can be agreed prior to submission to HRA that no Statement of Activities or Schedule of Events is required for the participating site. Contact the R&D office in the participating site to discuss this.

What the R&D office does

• Document Check (everything received and sufficient information available to complete C&C) • Staff Capacity - Research Unit (how many other studies are team working on) • Staff Capacity – PI • Finance arrangements suitable including excess treatment costs and clear invoicing

arrangements • Contract review • Impact on Service (e.g. additional beds required/increase in use of MRI scans) • Support department approval (e.g. pharmacy/labs/radiology/medical illustrations etc) • Additional Capacity Issues (e.g. require framework agreement with NBT?) • Staff Capability – CVs and GCP training, student research supervision arrangements adequate • HR arrangements for any staff members required • Any other training required (e.g. Investigator Oversight for CTIMPs) • Adequate facilities and emergency arrangements in place? • Recruitment targets realistic? Burden on patients? Trust is performance measured by DoH

and Clinical Research Networks • Service cross overs (e.g. TYA) • Any Trust monitoring required