Abstract
1. How to obtain local NHS Permission for a National Portfolio study
The scenario
Following informal discussion with the study’s Chief Investigator at BAUS you are keen to recruit patients under your care to a study comparing two interventions for overactive bladder.
How to prepare
Before you start the local approval process you should review the protocol and conduct a simple but realistic feasibility assessment of the study. This will help you to determine if you can comply with the requirements of the study, identify how many potentially eligible patients you may see and calculate how many of these patients you could realistically recruit. If your department conducts review meetings of potential studies then you will need to get the study reviewed and approved at that meeting before going any further.
In preparation for your submission for approval by your Trust’s Research and Development (R&D) Department, you will also need to have completed Good Clinical Practice in Research (GCP) training in line with your Trust’s requirements and have prepared a relevant CV which should be no more than 2-pages long 1 . You will need to be a registered user on the Integrated Research Application System (IRAS) at www.myresearchproject.org.uk as the Trial Manager will transfer the Site Specific Information (SSI) form to you as named site Principal Investigator (PI) within the IRAS web system.
What to do next as PI?
As PI you must liaise with your Trust’s R&D Department and any relevant support departments that may be involved in the study (e.g. medical imaging if the study requires CT scans). R&D will register the study on their system, allocate it a reference number and provide support to help you through the process of obtaining NHS Management Permission (R&D Approval). You should also begin completing the SSI form with the local study information in preparation for submission. If you have access to a Trial Coordinator in your department or the Trust’s research team, they may be able to help you with completing the SSI.
What other help may be available?
When working on a NIHR Portfolio study you will be able to access NHS service support. The form that this support takes will vary greatly from Trust-to-Trust and you will need to be precise about your needs and persistent in your approach. Your R&D team can let you know how to access the support available in your Trust.
When can you begin your project?
You cannot begin the project until you have received written management permission from your R&D department. You will need to submit an application to run the study to your R&D team and each Trust works slightly differently so ask your R&D team what they need. As part of the R&D review, a risk assessment will be conducted to look at risks such as insurance and indemnity, cost of conducting the study versus funding being supplied, any risks to the Trust’s reputation and the education and experience of the local team proposed to conduct the study, (Site Specific Assessment). Based upon this risk assessment, they will decide whether to approve the study locally. The timeline between submission and approval varies and you should regularly check progress with the R&D team. If your Trust has a contract with the Department of Health for NIHR funding, once your R&D Department accepts the study SSI as a ‘valid submission’ there is a 70-day benchmark for recruiting the first participant. It is therefore a good idea to have already ‘lined-up’ a few potentially willing patients in advance but you cannot officially recruit until you have received a letter detailing local approval.
What is required for submission?
Your R&D team will tell you what essential documentation is required for a valid submission and in many cases provide a guide to aid completion. Most documents such as a CV and GCP certificate you should already have but others such as a schedule of local costs may take longer to prepare. All necessary central study documents such as protocol and patient information sheets will be available electronically for the R&D team in the document repository of the Coordinated System for gaining NHS Permission (CSP) website.
Site Specific Information
Your SSI form is the most important document for submission. It contains all information relevant to your site for the study and is critical to the review conducted by your R&D team before permission is granted. The SSI form will be released to you by the Trial Manager via IRAS for you to accept electronically. Each section of the form is linked to guidance for correct completion and drafts can be downloaded as PDF documents for review. The SSI form is electronically authorised by you (as of April 2014, wet ink signatures are no longer accepted) and submitted through the e-submission tab in IRAS where it will be sent to your Local Clinical Research Network (LCRN). The LCRN will validate your form before uploading it to the document repository in CSP and starting the local governance clock. There is guidance throughout IRAS to help you submit your documents correctly. We have described the processes from an England perspective. NHS research administration processes are similar but separate in Scotland and Wales and Northern Ireland.
Finance
In order to determine if the proposed funding will cover the costs of conducting the study at the local site (assuming there is funding available), the local costs will need to be calculated. The AcoRD document 2 helps researchers to allocate costs and most Trusts have a standard template spreadsheet for investigators to use. Costs are based on the number of participants you expect to recruit and are broken down into 4 main categories.
Standard Treatment – the cost such as a tariff of standard care for this condition
Service Support – the cost of identifying and recruiting participants
Research - the cost of doing study-specific procedures such as blood tests and pharmacy costs
Excess Treatment – the additional treatment cost (or saving) in the study compared to standard
Contracts
To take part in the study your Trust may enter into a contract with the organisation leading the research (the research sponsor). This ensures each party knows their roles and responsibilities and what they are meant to provide in terms of resources and recruitment. Most studies will use one of the NIHR’s model clinical trial agreement (mCTA) templates and the contract is generally made available for review and signature through CSP. It is recommended that your R&D team have reviewed and agreed the terms of the mCTA before submission of your SSI form for approval as this is often the reason why local site permission is delayed.
Take home messages:
Conduct a feasibility assessment and be realistic with the number of participants that you can recruit; it is better for all concerned to over-recruit than under-recruit
Engage with your R&D team as early as possible to access available support and reduce any potential delays
Contracts are the number one delay for obtaining NHS Permission - make sure your R&D team have a copy of the proposed contract as soon as possible
Note that there are differences in NHS research processes between nations within the UK