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Research & Development Website

How do I get R&D and Research Ethics Approval?

A step by step guide

Please click on the links in the Flow Chart for further guidance on each section

You may find it useful to refer to RDInfo Process Flowchart

Useful links:

 Is your project likely to meet the eligibility criteria for the NIHR Portfolio?

This is important to access NIHR funding and support.

NIHR - National Institute for Health Research

Eligibility Criteria for the NIHR Portfolio

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There must be a protocol.

Is there one already? Are you collaborating in ongoing research?

Start completing your IRAS online form.

It is beneficial to start this form early.

This is one from for all of the applications you will need to make.

www.myresearchproject.org.uk

For guidance on completing your IRAS form, click here

Guidance on

how to develop a research protocol.

Is it Audit, Service Evaluation or Research?

www.myresearchproject.org.uk

Click here for a Flow Chart of the development process developed by RDDirect

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Has it been peer reviewed?

Essential for all research in the NHS.

Guidance document for requirements for peer review with checklist for reviewers.

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Will your research need support from other Trust Departments?

It is essential to liaise with support departments and resolve and capacity or financial issues at this stage.

Are arrangements in place for the research team to access results and support to deliver the research?

Contact names and details for:

Pharmacy - Application

Radiology - Guidance for researchers

Form 1

Form 2

Form 3

Form 4

Pathology - Application

Directorate Finance Managers

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Who is the research sponsor?

All research in the NHS must have a Sponsor who takes on responsibility for the Research Governance. The Sponsor is legally responsible for the project.

The Sponsor needs to agree to any research BEFORE your project will be accepted by REC

Guidance on how to identify your

Research Sponsor.

Is your Sponsor LTHT?

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What are the Indemnity/Insurance Arrangements?

This must be clear for all research involving patients. It must be explicit in any Clinical trial Agreement (for industry sponsored research) or Agreements with external Sponsors
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Complete the online applications for Ethics and R&D Approval

  • If you are the Chief Investigator for a project only taking place at this site OR the CI for a multicentre project fill in IRAS.
  • If you are the Principal Investigator for this site in a multicentre project led by another organisation, fill in the Site Specific information form for the Leeds Site (transferred to you by the CI).
  • COMING SOON...If accepted for funding in principle by the NIHR the lead CLRN will liaise with you to finalise your IRAS Application.
  • If not accepted in principle carry on with you application in the normal way. (LTHT R&D Approval)

Fill in IRAS www.myresearchproject.org.uk

Guidance on how to go about this is available here

WHAT DO I SUBMIT TO R&D

Refer to Checklist for how and what to submit to LTHT R&D Department for R&D Approval.

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Submission to the Research Ethics Committee

  • If LTHT is the Research Sponsor, you must get written confirmation of ‘agreement in principle' to sponsor the research BEFORE Research Ethics will accept the submission (leave adequate time for Sponsorship in principle review by R&D)
  • If externally sponsored, does the project need Site Specific Assessment by a Leeds REC (Chief Investigator will confirm this)? If so, you will send the SSI and local investigator CV to REC

How to submit your project to the Research Ethics Committee

National Guidance on how to apply to a Research Ethics Committee.

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Ethics Review Completed

Once ethical review is completed and you have a letter

‘confirming a favourable opinion':

Make a valid R&D Application (follow the process on the R&D website)

NB Failure to submit all the require document will result in a delay in review. The ‘valid application' MUST include the final versions of all documents eg protocol, PIS, consent form as approved by the REC.

Refer to Checklist for how and what to submit to LTHT R&D Department for R&D Approval.

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R&D Review

R&D will review the valid application within the agreed time.

If you are the CI undertaking the project in another NHS Trust you must contact that Trust's R&D Department to obtain local R&D approval.

List of national R&D contacts.

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R&D Review completed satisfactorily

R&D will issue letter of confirmation of approval
  

Back to R&D Approval Page

 

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