Getting Started on a Study
Firstly, if it’s your idea, is it actually research or might it be better described as audit? Essentially “Research” is designed to generate new knowledge and “Audit” is designed to test whether an established service is meeting a defined standard. R&I can help you decide if your proposal is research and you can find further guidance on the Health Research Authority - Decision Tools website where you can also find out whether your study requires HRA Approval.
The Basic Approval Process
If you have a research idea then there are “approvals” you must have in place before you can start to approach patients about your study.
- HRA Approval (Permission for the study to go ahead in the NHS) this is the new approval that is now required for 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.
- Confirmation of capability and capacity from every participating Trust to indicate they can deliver the study in their organisation
You won’t be able to apply for these unless your study has a sponsor. This is the organisation that will be legally responsible for the organisation and management of the study – this is normally an organisation such as a NHS Trust, a University or a commercial company – often your employer.
Sponsored or Hosted Activity?
Do you have an idea for a research proposal that you want to develop and lead? If so your substantive employer (LTHT or UoL) will need to “sponsor” this activity with you as the chief investigator.
You may want to open a study in Leeds that is being sponsored by another organisation – we describe these studies as “hosted” in LTHT.
If you have a research idea then the R&I team will help you obtain the approvals you need to start your study. We can guide you through the regulatory approval process and signpost you to help in developing your study idea to a research protocol. At a minimum you will need to produce;
- A Protocol
- A Patient Information Leaflet/Sheet (PIL/PIS)
- A Consent Form
- A GP letter
These documents will form the MINIMUM data set to be submitted to the Health Research Authority for review. You can apply to HRA via an online application through the Integrated Research Application System (IRAS) as well as submitting electronically.
For help and support through this process please email the R&I team firstname.lastname@example.org or call 0113 20 60469.
Sponsored Clinical Trials of Investigational Medical Product (CTIMP)
If you have a proposal for a research study that will involve a drug you may be undertaking a Clinical Trials of Investigational Medicinal Product (CTIMP) or drug trial.
CTIMPS are governed by law and subject to inspection by the UK regulator – the Medicines & Healthcare Products Regulatory Agency – MHRA. There are several additional requirements associated with drug trial protocols including how to report safety events, how manage your drug and how to provide assurance on the quality of your study. The Trust and the University have set up a specific section of the R&I team to help you design your trial. Please contact the Quality Assurance (QA) team before you start writing you drug trial protocol.
The QA team will help you design your trial paperwork to ensure it is ethical and legal and help you with all aspects of your study design. QA can provide template to support you through the approval process and guide you once your trial is live.
In LTHT we expect all our researchers to have undergone some research training and for CTIMPs it is a condition of approval that you have undertaken GCP training in the last three years. Please see our training page for more details.
For help and support through the CTIMP approval process please contact mail to Louise Harris (Quality Assurance manager) email: email@example.com or call 0113 20 60440
Please also see our key support documents page for templates and guidance and section Governance and Good Clinical Practice.
If you wish to submit your study for Confirmation of capability and capacity and Leeds Teaching Hospitals NHS Trust (LTHT) will be the research governance sponsor, please contact the R&I Office and we will help you with your submission to the HRA and advise you on getting confirmation of capability and capacity at LTHT and in your participating sites.
If you wish to take part in a study which is being led by another organisation, the sponsor or chief investigator will provide you with a local study information pack which you will need to run the study here at LTHT.
The sponsor or chief investigator (CI) will submit these documents direct to the R&I Office or they may ask you to submit the documents to the R&I Office.
The study documents R&I require in order to start the local organisational approval process for your study are as follows:
- Protocol and any amendments
- Patient information sheet and consent form
- IRAS form (combined REC and R&D form) in PDF and .xml format as submitted for HRA Approval
- *LTHT draft statement of activities (SoA) and draft schedule of events (SoE) (non-commercial studies only)
- Optional - *model/modified draft LTHT non-commercial agreement.
- *model/modified draft LTHT commercial research agreement (commercial studies)
- *NIHR costing template (validated) and delegation log (including known research team names) (commercial studies only)
- HRA initial assessment letter and (when issued) HRA approval letter
- Research passport application for non-LTHT staff only
- Evidence of GCP training within last 2 years for CTIMP investigators only.
*We will work with you and liaise with the sponsor to finalise draft documents during the assessment process.
Assessing capacity and capability
First, your CSU (R&I Lead or CSU management team) will need to undertake a capacity and capability (feasibility) assessment for the study (formerly known as CSU approval), that is, consider carefully if the Trust has the capacity and capability to deliver the study safely and effectively, meeting all governance requirements and performance targets.
You must complete the LTHT Research Study CSU Capacity and Capability Assessment Form and submit to your CSU for review and approval.
A completed and signed copy of this form must be submitted to LTHT R&I as evidence of CSU confirmation that there is capacity and capability within the CSU to deliver the study. Supplementary CSU specific feasibility paperwork may still be used locally to aid decision making but only this form will be accepted by LTHT R&I.
Names and contact details of CSU Research Leads can be found here.
Arranging key service support approval
Next, you will 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 here.
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 approved 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.
Research agreement completion (commercially sponsored studies) arranging key service support
If your study is commercial the sponsor of your study will have prepared a model/modified draft LTHT commercial research agreement. Review of Confidentiality and research agreements will usually be undertaken by Research & Innovation Coordinator’s, they will review, liaise with the sponsor and finalise the agreement.
Once we have finalised the agreement we will sign it off on behalf of LTHT when we issue the LTHT Confirmation of capability and capacity email (see below).
LTHT Confirmation of capability and capacity
A study cannot proceed without LTHT Confirmation of capability and capacity. Once all the above stages have been completed (feasibility review, arrangement of key service support approvals, SoA and SoE or agreements finalised) R&I will issue an LTHT Confirmation of capability and capacity email (along with a fully executed/signed agreement, and an authorised SoA and SoE). This email signals that the study can begin at LTHT.
Further guidance and information please contact the R&I Team: firstname.lastname@example.org