West Anglia Primary and Community Care Centre
Flowchart for Coordinated System for NHS Permission- NIHR Studies:
Set up and REC-NHS R&D Permission processes
Funding
Funding should be agreed in principle. You need to evidence this to secure NIHR adoption. A confirmation letter is needed for all regulatory approvals
Planning stage-Key points to remember
· Research sponsor
The Sponsor is legally responsible for the project. A sponsor letter is required for all regulatory approvals. For University staff, please speak to the Cambridge Research Office at an early stage http://www.admin.cam.ac.uk/offices/research/ . In order for the University to act as a sole sponsor for a project, University staff are advised to complete a sponsorship checklist form to be reviewed by the research office. Trusts may agree to sponsor. Contact the Trust R&D offices at an early stage as there may be cost implications.
· Peer review
For University research, the sponsor is responsible for the peer-review, please speak to the Cambridge Research Office. Take care if the project is part of a programme grant as you may need to evidence external peer reviews as detailed in the eligibility section above.
· Indemnity/Insurance Arrangements
If you rely on university insurance, please speak to the Cambridge Research Office. Indemnity cover should be in place and a confirmation letter is needed for all regulatory approvals. For commercial studies ABPI applies. NHS indemnity may apply for NHS staff and those holding honorary contracts.
· Grant Contracts hosted by the NHS
Liaise early with NHS R&D office to set these in motion.
· Feasibility
Liaise early with the Trust and if applicable the Primary Care Research Network (PCRN). The NHS R&D office use the Research Support Services Planning tool to make an early assessment of risk and mitigations NIHR Research support services Planning Tool.
· Commercial studies charges
There is a charge per site for commercial NIHR CRN studies to recoup R&D costs. Please provide an invoice name and address and contact the R&D office for more details.
· Service support costs
For studies involving NHS staff or GPs recruiting patients, you need to apply for reimbursement of NHS service support costs at an early stage as West Anglia Comprehensive Clinical Research Network (CLRN) takes 2-3 weeks to consider service support costs applications.
If the study is Primary Care Research Network (PCRN) adopted, we advise researchers to discuss primary care input with Helen Macdonald, (PCRN Manager Tel: 01223725458, Mob: 07852766182) Email: ) or Camilla Croucher (PCRN Research Study Delivery Officer T:01223725459Email: ) using the PCRN costing template http://www.pcrn-eoe.org/default.asp?id=181 to agree on costing then apply to the West Anglia CLRN via http://www.crncc.nihr.ac.uk/about_us/ccrn/west_anglia/funding, download the NHS infrastructure support form application and follow instructions on the website.
· Identification of Principal Investigator/Local Collaborator
A principal Investigator (PI)/Local collaborator must be identified for research sites.
· Letters of access/Honorary Research Contract
If the study team have direct/indirect contact with NHS service users or NHS staff and/or have access to participants identifiable data or health records
1. Non NHS researchers (university) will need to apply using a Research Passport form. The key requirements are indicated in the PCT guidance on completing and submitting a Research Passport form document below.
2. NHS researchers need to complete an NHS to NHS confirmation of engagement checks form. The key requirements are indicated in the PCT guidance for NHS researchers below.
The research passport algorithm helps researchers to identify the type of research activity that they will be conducting and assesses whether they need a letter of access or honorary research contract in place.
NB: It is important to have an up to date CRB clearance where indicated as this could delay research passport applications.
Getting started with Integrated Research Application System (IRAS) applications
NB: There is a new IRAS document handling functionality that is critical to your submissions. Detailed information about this functionality is found here https://www.myresearchproject.org.uk/Help/Help%20Documents/PdfDocuments/IRAS%20Guidance%20for%20documents_July11.pdf
Contact the R&D office if your project started before IRAS v3.4 as we may need to facilitate the research governance submission.
Start completing your IRAS online form as early as possible. As a NIHR portfolio study, this needs to be submitted via the Co-ordinated System for NHS permissions. Question 3a must be “England” and question 5b must be “yes” in the IRAS project filter. If the lead R&D office is not in England, please contact for advice.
The Help section in IRAS contains all the guidance. The IRAS manual is also a useful resource for researchers https://www.myresearchproject.org.uk/Help/Contents/IRASHelp_UserManual.pdf. Ane-learning module has also been addedto the IRAS website to help new users familiarise themselves with the application process.
Concurrently
NIHR Adoption
Is your project likely to meet the eligibility criteria for the NIHR Portfolio?
This is important to access NIHR funding and support.
Once you have secured funding, Please submit your Portfolio Application Form before you submit your REC application. Do not wait until the project has been approved by the REC as this will result in unnecessary delays.
· Apply to the NIHR Portfolio by completing the Portfolio Application Form (PAF) via IRAS. The PAF is a separate form on IRAS listed as one of the project forms. Only some of the questions are populated from the integrated data set. This form will only appear if question 5b is ticked yes in the project filter.
· The Chief Investigator (CI) fills in Portfolio Adoption Form, submit this in IRAS, selecting the CLRN that will support you through the NIHR CSP process. A list of CLRN can be accessed via the PAF E-submission tab.
· Submit your application by pressing the ‘PAF E-Submission' button.
The application form will be sent electronically to NIHR CSP in England. You will be able to track the progress of your Portfolio Application Form submission through updates to the status in the submission history. The Portfolio Adoption Form will be validated and a confirmation email will sent to you and will also give you an indication of eligibility.
NB: Evidencing external peer review is critical for adoption-please check the eligibility criteria
Adoption by NIHR Topic Networks
Speak to the Network managers at an early stage. Local network managers contact details:
· Cancer- Dr Roy Harris Tel: 01223 256193 E-mail:
· Diabetes- Sandra Mulrennan Tel: 01223 769169 E-mail:
· Mental Health- Angela Browne Tel: 01223 746 135 E-mail:
· PCRN- Helen Macdonald Tel: 01223 725458, Mob: 07852766182 Email:
· Dementias & Neurodegenerative Diseases Research Network-Ann Luck Tel:01603421826 Mob:07770598322 E-mail:
Useful links
http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_eligibility
Submission to the Research Ethics Committee (REC)
For University research make sure that the Cambridge Research Office have seen your REC form in draft before you submit
Complete your NHS REC application form via IRAS and if at any stage you experience difficulties completing the form, please contact the NHS R&D office. Please secure sponsor signature (part D of the REC form). The submission tab on IRAS gives detailed instructions on REC submission.
When you are sure that the REC form is complete and is accurate, book a meeting with the appropriate REC.Bookings can be done via the NRES central allocation system (CAS) Tel: 0845 270 4400 (9.30am 4.00pm weekdays)Email: The East of England also runs a local booking system for submissions in the East of England. Contact details: Tel: 01223 596907. For individual REC within the region, details can be found at http://www.nres.nhs.uk/contacts/nres-committee-directory/. NB: The contact details change periodically, so we advise researchers to use the REC directory link to get up to date contact details http://www.nres.nhs.uk/contacts/nres-committee-directory/
REC instructions on booking and submissions can be found at http://www.nres.nhs.uk/applications/booking-and-submitting-your-application/ or https://www.myresearchproject.org.uk/Help/Help%20Documents/PdfDocuments/SubmissionGuidance.pdf
For low risk research studies, (i.e qualitative, student projects) ethics review via the proportionate review service http://www.nres.nhs.uk/applications/proportionate-review is now available. It is a fast track review process for studies which present minimal risk or burden for participants. To submit a proportionate review application in England, please contact the local REC office. This takes on average 14 to 21 days subject to full submission. In IRAS, where the responses to the project filter questions indicate that a study may be suitable for proportionate review by a REC sub-committee, a new question A6-3 is enabled in the dataset.
For REC submission accompanying documents are NOT uploaded to IRAS. A checklist is generated and hard copies of documents are sent to REC. It is essential that the REC submission code in the footer is the same as the R&D form.
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 e.g. Checklist, protocol, participant information sheet (PIS), consent form as prepared in line with REC guidance.
Alternatively, for studies taking place in NHS settings with NHS patients or staff where the approach uses social science or qualitative methods, provided that the research does not involve any change in treatment or clinical practice, the researchers can submit via Social Care Research Ethics Committee http://www.screc.org.uk Please contact Barbara Cuddon Social Care REC Coordinator Tel: 0207 024 7660 Email: . The Social Care REC accepts electronic submission. This takes on average 60 days.
Useful links
National Guidance on how to apply to a Research Ethics Committee.
REC Application Process Flow Diagram
http://www.nres.npsa.nhs.uk/applications/
R&D submission (in parallel with REC submission)
Applicants are encouraged to apply to NHS R&D offices whilst REC review is underway-
Please discuss timing with the NHS R&D office
The Speeding up research governance approval guidance covers key issues for researchers to consider for a fast R&D approval process.
Complete your NHS R&D form and decide whether the study will involve research sites or participant identification centres (PICs). Please factor in that local recruitment (sites) result in a positive effect on Network-related activity based funding (resources). PIC recruitment does not strengthen research infrastructure for the Trust directly. The link below gives a brief overview on PICs.
http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/PICs%20leaflet_DL_FINAL.pdf PCRN have specialist expertise helping with PIC sites, logistically naming a PCT as a PIC on an RD Form alone is not enough, work up on the practicalities with PCRN is needed see http://www.pcrn-eoe.org/documents/Publication/PCRN-EoE_PIC_Referral_v1_for_Websites.pdf?preventCache=12%2F01%2F2012+10%3A35
Part C of the RD form- Overview of research sites has been amended. Researchers have to go to Part C of the RD form, tick NHS sites and click on organisation search to add the appropriate organisation. NB Primary Care Trusts are listed as PCTs. We advise researchers to type Cambridgeshire PCT to add it as a site. If you type NHS Cambridgeshire for example, no organisation will come up.
Contact the R&D office if your IRAS forms (PAF & RD form) started before IRAS v3.4 as we may need to facilitate the submission.
Secure both the CI and the sponsor signatures (part D of the R&D form). The R&D form needs the same submission code as the REC form. If you are in any doubt, please let the R&D office see the form before you press the E-submission button. Supporting documentation must be uploaded to the checklist associated with this application form BEFORE you submit the RD form. You MUST follow the guidelines on electronic submission of supporting documentation https://www.myresearchproject.org.uk/help/Help%20DoIRAS guidance on electronic submission of documents July11.pdf before submitting your RD application. Instructions for attaching documents to the checklist are available on the checklist tab. Note pdf and xml versions of RD form are required. It is likely applications will be rejected if documents are missing. You will receive a message when your RD submission is valid.
SSI Submission for research sites
Ring the NHS RD Office to discuss timing of the submission
Once you have worked up logistics for the site (i.e. named PI/local collaborator, site documents, CVs, Clinical Trial Agreement (CTA) if applicable, feasibility and costing discussions for PCRN projects) then you are ready to progress SSI submission.
The Site Specific Information (SSI) submission provides the R&D office with specific details of the resources involved in the research project at a specific site.Within IRAS, the Chief Investigator/study coordinator sends the SSI form to Principal investigators (PIs) to complete and submit. PIs need an IRAS account to sign the SSI form.
For projects happening in Cambridgeshire Community Services NHS Trust , please liaise at an early stage with Emily Li Primary Care Research Network (PCRN) Research Support Officer Tel: 01480 308203 Email: regarding authorisation on the SSI form.
To complete an SSI:
· Select R&D form on the left hand panel on the Navigate page
· On the main window, select the Add SSI tab
· Select either NHS-SSI (for NHS sites) or non NHS SSI (for non-NHS sites)
· The required form can be selected and populated by clicking on the name
· Complete the additional information required in the SSI form, preferably secure electronic signatures (or wet ink)
· You MUST follow the guidelines on electronic submission of supporting documentation https://www.myresearchproject.org.uk/help/Help%20DoIRAS guidance on electronic submission of documents July11.pdf. The checklist tab has instructions on how to attach files including pdf and xml version of the SSI form plus all local CVs and local documents on headed paper.
· Press the E-submission button and you will receive a message when your SSI submission is valid.
Contact the R&D office if your project started before IRAS v3.4 as we may need to facilitate the submission.
Trust R&D Review
The NHS R&D office will review the application in parallel to Ethics. The local review process leading to permission will take approximately 30 days when we have received a valid submission subject to CSP process and REC approval.
Once REC positive opinion and other regulatory approvals are in place NHS R&D will issue the research governance permission letters. If you need to contact individual NHS R&D offices, a full list of contacts can be found here Contacting NHS R&D Offices.
Adding new sites or participant identification centres (PICs)
For projects started before IRAS v3.4 follow the instructions below as the R&D office may need to facilitate the submission manually
· Go to your NHS R&D form and add the new site/PIC to part C of the form
· Resubmit your R&D form, email , copying or your lead CLRN if different and . You need to be clear in the email text that there are no changes to the RD form other than the addition of new sites/PICs. You will also need to attach pdf and xml RD form and provide an SSI valid submission as applicable.
For projects started post IRAS 3.4, please follow the instructions below
· Go to your NHS R&D form and add the new site/PIC to part C of the form
· Resubmit your R&D form in IRAS email , copying or your lead CLRN if different and . You need to be clear in the email text that there are no changes to the RD form other than the addition of new sites/PICs. You will receive an email to confirm validation.
· For sites only, Please follow the SSI submission section above and you MUST follow the guidelines on electronic submission of supporting documentation https://www.myresearchproject.org.uk/help/Help%20DoIRAS guidance on electronic submission of documents July11.pdf. The checklist tab has instructions on how to attach files.
Amendments
REC: Follow REC instructions for amendments at:
http://www.nres.nhs.uk/applications/after-ethical-review/notification-of-amendments/
For non Clinical Trial of Investigational Medicinal Products, you do not need to notify REC about new sites or PICs.
Examples of substantial and non-substantial amendments can be found at http://www.nres.npsa.nhs.uk/applications/after-ethical-review/notification-of-amendments/examples-of-substantial-and-non-substantial-amendments/
R&D
Projects started before IRAS v3.4: The NHS R&D office will facilitate the amendment submission where necessary. Please send us all the documents electronically including the notice of substantial amendment (if applicable), notice of non substantial amendment (if applicable), a copy of all amended documents, MHRA approval (if applicable), REC approval (when available), REC acknowledgement for minor amendment (when available) and other REC/MHRA correspondence available relevant to an amendment
Projects started post IRAS 3.4, please follow the instructions below
Amendments are submitted electronically to the CSP module via IRAS E-submission tab. Please follow the instructions on IRAS for submitting substantial amendments and non substantial amendments.
Amendments to the research projects should be notified to REC and the NHS R&D offices. The standard timing for Trusts to approve amendments is 35 days subject to REC and all regulatory approvals. Please refer to the NIHR amendment process guidance http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/Amendments%20Guidance%20for%20Researchers_1.0.pdf.
Trusts will let you know if they cannot meet this timescale. The submission for R&D must include:
· Notice of substantial amendment (if applicable)
· Non substantial amendment (if applicable)
· A copy of all amended documents (track and clean) –this helps review
· MHRA approval (if applicable)
· REC approval (when available)
· REC acknowledgement for minor amendment (when available)
· Other REC/MHRA correspondence relevant to an amendment
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