RESEARCH & INNOVATION
GUIDANCE FOR RESEARCHERS
CONFIRMING CAPACITY AND CAPABILITY
TO UNDERTAKE RESEARCH - WHERE LTHT IS A PARTICIPATING SITE
(FORMERLY RESEARCH APPROVAL PROCESS)
1 Scope of guidance
This guidance is for research studies where Leeds Teaching Hospitals NHS Trust (LTHT) is a participating site and the research is led (sponsored) by an organisation other than LTHT. If you wish to lead a research study and LTHT will be the research governance sponsor, please contact the R&I Office for advice. We will help you with your submission to the HRA and advise you on getting the study assessed at LTHT and in any participating sites.
2 The Health Research Authority (HRA) Approval
HRA Approval is required for all research to commence in the NHS in England. It comprises an assessment of study compliance with applicable regulations and standards and includes review by an NHS research ethics committee.
It allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study within their organisation.
HRA approval is mandatory for all new research studies.
3 How do I get confirmation of capacity and capability to start my research study at Leeds Teaching Hospitals NHS Trust?
If you wish to take part in a study which is being led by another organisation, the sponsor or chief investigator will provide a local study information pack to set up the study at LTHT. The sponsor or chief investigator (CI) will submit these documents direct to the R&I Officeor they may ask you to submit the documents to the R&I Office. Please use the following email .
The study documents (local information pack) R&I require in order to begin assessment of LTHT capacity and capability for your study are listed below.
Commercial studies
· IRAS application form (combined REC and R&D form) in PDF format as submitted for HRA approval
· Protocol and any amendments as submitted for HRA approval
· Participant information and consent documents (without local logos/headers)
· Relevant model agreement
· NIHR costing template (for NIHR portfolio studies the template should be validated by the lead Clinical Research Network (CRN) for the study)
· Delegation log (including known research team names but not signatures)
· HRA initial assessment letter (if issued) or HRA approval letter
Non-commercial studies
· IRAS application form (combined REC and R&D form) in PDF format as submitted for HRA approval
· Protocol and any amendments as submitted for HRA approval
· Participant information and consent documents (without local logos/headers)
· Statement of activities (SoA) and schedule of events (SoE). These must be validated by the HRA (ie date and version number added by HRA)
· Relevant model agreement
· HRA initial assessment letter (if issued) or HRA approval letter
*Please note the 70 day initiation metric starts the day the sponsor sends to either R&I or the research team, all the documents that make up the local information pack as listed above.*
We also require the following documents:
· HRA approval letter (when issued)
· Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study at this Trust.
4 What happens next?
On receipt of the local information pack your study will be allocated to a member of the R&I Team who will be your point of contact throughout the LTHT capacity and capability process.
S/he will issue you with an R&I reference number - please quote this in any communication with the R&I Department.
S/he will review the study documents and advise you on what you need to do next to obtain confirmation to run the study at LTHT, that is,the process to assess local capacity and capability and arrangement of local key service support approvals, finance and contract reviews.
5 Assessing capacity and capability
Your CSU (R&I Lead or CSU management team) will need to review the study and issue CSU approval, that is, confirm that there is capacity and capability within the CSU to deliver the study safely and effectively, meeting all governance requirements and performance targets.
To ensure a thorough review of the study, your CSU may wish to use the R&I capacity and capability assessment guidance and template at http://www.leedsth.nhs.uk/research/information-for-researchers/key-documents/ These documents and process are currently “draft in use” and we welcome your feedback.
6 Arranging key service support approval
You will also need to obtain local key service support approvals from any service departments you may require to support your research, including R&I finance approval. R&I is happy to support you in obtaining these local approvals if required. Please see department contact details below.
Department / Name / Email addressR&I Finance / Caryn Lomax (commercial studies)
Simon Revesai (non-commercial studies) /
Pharmacy / Caroline Bedford/Paula Smalley /
Radiology / Mark Harrison /
IRMER / Peter Howells /
ARSAC / Rebecca Cain /
ECG / Sarah Taylor /
ECHO / Sarah Deakin
Julie Corrigan (ECHO Service Manager) (Adults)
Jan Forster (Children’s) /
Labs / Clare Leeming /
Histopathology / Olorunda Rotimi /
Cytogenetics/DNA / Miranda Squires /
Ophthalmology / Jen Green
Ian Simmons /
HMDS / Sharon Barrans /
Phlebotomy / Mary Simpson /
7 New Interventional Procedures Group
If your study will involve the testing or use of an interventional procedure which is new to LTHT (including new interventional procedures involving an implantable medical device) you must obtain the approval of the New Interventional Procedures Group (NIPG). Details and application form are available from Jason Dunne, secretary to NIPG, telephone 0113 - 206 6951 or email The NIPG policy and application form are available at NIPG policy and application form . Please note that finance sign off is required for NIPG approval and this should be obtained from the R&I Finance Team (contact details in section 7 above) and not the CSU accountant.
If the study will involve an interventional procedure which is new to the investigator as an individual (but not to LTHT) the individual must ensure s/he has discussed it and gained the agreement of the CSU clinical director or clinical lead and general manager.
As NIPG approval is a new requirement for research there may be current studies involving a new interventional procedure that have not been reviewed by NIPG. If you have such a research study, please inform Jason Dunne as soon as possible so that this can be assessed and agreed by the group as per new requirements.
8 GCP Training
GCP training is a mandatory requirement for all staff undertaking clinical trials of investigational medicinal products (CTIMPs) at LTHT. The principles of GCP state that each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). You will need to provide evidence that you have undertaken GCP training within the last 2 years. If you have not had any GCP training you must complete a comprehensive introductory course either on line or face to face. Training is provided by the NIHR Clinical Research Network Yorkshire & Humber (CRN Y&H). Once you have had your initial full training you will need to undertake refresher training every 2 years.
9 Research passport
Non-LTHT staff will need to complete a research passport application to obtain an honorary contract or letter of access to undertake research activities at LTHT.
10 Completing the statement of activities and schedule of events (non-commercial studies)
If your study is non-commercial, the sponsor of your study will have prepared a statement of activities (SoA) and schedule of events (SoE) to capture all the information around study activities to be undertaken at a local level. A template SoA and SoE will be reviewed and assessed by the HRA for the each type of participating site to ensure that there is clarity on the resource implications for participating NHS organisations delivering research within an NHS organisation. This then needs to be finalised during the Trust level assessment process with all the local requirements for LTHT. The sponsor is responsible for completing these documents in discussion with you. R&I can support you in this process.
11 Research agreement completion (commercially sponsored studies)
If your study is commercial, the sponsor of your study will have prepared a model/modified draft LTHT commercial research agreement and R&I will review, liaise with the sponsor and finalise this agreement. Once we have finalised the agreement we will sign it off on behalf of LTHT when we issue the LTHT confirmation of capacity and capability email (formerly R&I/organisational approval) (see below).
12 Confirmation of Capacity and Capability
A study cannot proceed without LTHT confirmation of capacity and capability (formerly R&I/organisational approval). Once all the above stages have been completed (CSU approval, arrangement of key service support approvals, SoA and SoE or agreements finalised) R&I will issue an email confirming that LTHT has the capacity and capability to undertake the study (along with a fully executed/signed agreement, and an authorised SoA and SoE). This confirmation email signals that the study can begin at LTHT.
For further guidance and information please contact the R&I Team:
See the HRA website for more information about the HRA process:
http://www.hra.nhs.uk/about-the-hra/our-plans-and-projects/assessment-approval/
HRA Guidance for Researchers v11.0 15/03/2017
15 March 2017