NHS Site Set Up, Research Passports and Modifications to Approved Studies
Once you have a sponsor confirmed, and you have applied for your NHS approvals via IRAS (HRA, MHRA or NHS REC approval), you will also need to go through a period of assessment and planning at the local NHS site you plan to open your study at.
The site set up process and assessment will involve procedures that are undertaken by the Research department at the trust in collaboration with the clinical teams and the researcher. You may be asked to provide information to the trust so they are able to assess their ability to set up as a site against the project details, you may also be asked to answer some more logistical queries and make arrangements for how the study will be conducted at the site. This can include providing all of your project and approval information, negotiating what you need the site to do to help you, and documenting this.
More information on site set up processes and documents you may require can be found under the below drop down options.
Once your study has received approval, you may then decide you need to change a document or an aspect of the study design. If you do need to make changes, these will need to be logged with the HRA and/or NHS REC and approved, before they can be implemented.
More information on making a modifications to your study can also be found in the drop down options below.
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When you submit your IRAS, once valid, the HRA will undertake an initial assessment, and issue a letter outlining the key details. The application will then be shared with your selected REC (if required), and the advisor will also undertake their HRA assessment (if required).
You may receive questions or queries from the HRA; you may also receive questions during your NHS REC meeting and afterwards. You will be given deadlines to respond within to keep your application on track.
Once both the HRA approvals advisor and the NHS REC (if required) have completed their assessments and are satisfied with any answers you provide, you will receive your letter of approval. The approval may come in a combined email with both HRA and NHS REC (if required) approval, or it may come separately.
Site Set Up
One process that most studies will need to go through at every research site is 'Site set up'. Site set up starts after you have submitted your IRAS application and will continue until the research site are satisfied everything is arranged in for you to begin recruitment.
When can you start setting up your site?
Once you have submitted a valid IRAS application, the HRA will undertake an 'initial assessment', and issue an initial assessment letter (link EG of letter). The initial assessment letter will prompt you to start site set up by sharing your documents as part of what is referred to as a 'local information pack'. Sites will then use this pack to assess their 'capacity and capability' (C&C) to support the study, and ensure that the project design is feasible within their current organisational structures and clinical pathways. They may also use this information to determine if they need to organise a 'research passport' or a 'letter of access' for example.
A local information pack is a pack used to 'invite' an NHS trust to consider acting as a research site. It is made up of a selection of your study documents that the site will use to assess if they have the capacity and capability to set up as a site. Contents of this pack include:
Covering email using standard template format
You should use the below email template when sharing the Local Information Pack with the chosen research sites in England and Wales. There are separate email templates for research sites in or .
Where the email asks for the sponsor contact who should be contacted for matters relating to capacity and capability, you should name one of your research team who is managing site set up. The sponsor delegates responsibility for site set up to the research team, and just asks that a completed version of the agreement used between the university and the site is sent to the sponsorship inbox for our records (this may be a model agreement, PIC model agreement or an organisational information document), but if you require an assistance when setting up your site, you can contact us for support.
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A copy of the template outline Organisation Information Document (OID) submitted with the IRAS application must be localised with site and study information for each site, where indicated; this should be completed by the researcher, in liaison with the participating organisation before sharing in the LIP. When localising, researchers should refer to the guidance provided with the templates.
If an OID was not submitted or an alternative agreement was used, for example a Model non-commercial PIC agreement (mNC-PICA) or other model agreement, then you should send a localised copy of this instead.
: The completed Schedule of Events (SOE) or Schedule of Events Cost Attribution Tool (SoECAT) should also form part of the local information pack, depending on which form you have used. For those who have PIC sites only, a SoE would not be required and may not be in the LIP.
: A delegation log is appropriate for studies that are clinical trials (defined as first four categories in IRAS Project Filter question 2) where the local study activities are managed by a Principal Investigator (PI). However some sites will require one for any type of study, so you should check with the R&D department at site. If you do require a delegation log, you can use the 糖心视频 template delegation log.
Relevant supporting documents: These will include some of the documents that have been submitted/approved with the IRAS Form submission and other documents to support study set up at the participating NHS/HSC organisation(s). The email template used to circulate the LIP should itemise the documents to include and include
Assess-> Arrange-> Confirm
Assessment
Capacity and capability (C&C) is the term that refers to an assessment of your study conducted by your potential research site, before determining if they have the capacity and capabilities to act as a site. It will include an assessment of all of your study documents to ensure they are correct and approvals have been granted, but also to ascertain what is required of them as part of the protocol. The site may also complete an assessment of the services capacity and capability to undertake those activities, or support you to undertake the activities at site. Some studies that require a large amount of input from the site may require a more lengthy process of capacity and capability and others may require a more light touch review. In some very limited cases, the site may not need to assess or confirm C and C (See guidance on this).
Arrange
They may also use this process of assessing C and C to see if you require any additional input, including authorisation to access the site, such as a research passport in order to obtain a letter of access or honorary contract.
The process will involve them arranging anything further that is required to deliver your study at their research site. This may include reviewing research passports and issuing honorary contracts or letters or access, arranging access to facilities such as x-rays or scanners, blood services or lab services.
Confirm
Once the site has assessed everything and arranged any necessary support, they will liaise with you to fill in any remaining fields on your site agreement (OID, mNC-PICA etc.), sign the OID and return it to the sponsor and researcher. The sponsor signatory will need to add an signatures to the OID and ensure everything is correct before execution, this may have been added before IRAS submission, but some sites will ask that it is reauthorized given there may be some new additional information.
Once the site have completed C and C and both site and sponsor have signed the OID, they will email confirming they are able to and happy to deliver the study and issue 'C&C.
This will confirm that they will begin recruitment, or some letters may state they will allow you to begin recruitment when the sponsor give the 'green light' to do so.
The research passport initiative was developed by NHS R&D and UK Clinical Research Collaboration to streamline the engagement process for university researchers conducting research in the NHS.
The Research Passport must be signed by HR, and demonstrates to the NHS that the following checks have been made against the researcher:
Disclosure and Barring Service (DBS) - previously Criminal Records Bureau (CRB) clearance
Occupational Health clearance
Verification of Identity (passport/birth certificate)
Two references (from normal recruitment process)
Verification of permission to work in the UK
Evidence of professional registration (if appropriate)
Evidence of qualifications
University Researchers
Existing researchers who are regularly engaged in research in the NHS can be issued with a generic research passport to cover a period of three years (although this can be increased subject to discussion and agreement with all parties). At the end of the three year period the research passport can be replaced and checks will have to be re-validated.
Researchers employed for the purposes of research on a specific research grant, usually on externally funded fixed term contracts, would be issued with a project specific research passport. The duration of the Research Passport would be no greater than three years. If a project changed or a researcher's employment contract was extended the research passport would need to be replaced and checks re-validated.
Clinical Academics and Students Employed by the NHS
If a substantive and honorary contract is held by a clinical academic with the NHS Trust, there is no requirement to issue a research passport. Where there is no joint arrangement in place a research passport would be necessary.
If you are looking to undertake research at a different trust to that where your employment contract is held, you would need to contact your R&D department and complete an .
DClinPsy trainees who are employed by an NHS trust for their training contract (EG: Lancashire and South Cumbria) should be able to conduct research at that trust under their current contract of employment. Those who are wanting to conduct research at other trusts, must contact Lancashire and South Cumbria R&D and complete the check form to obtain a letter of access.
Portability
If a researcher moves from one university to another and continues working on an established project requiring a research passport, the new University should honour the checks already made by the previous HEI unless the research passport has expired or circumstances have changed (such as project scope or personal details).
What do I need to do to obtain a research passport?
Initial discussion should take place with the R&D departments of your research sites. If it is agreed that the project requires a research passport, letter of access or honorary contract, the following process should be followed:
If you are on an indefinite contract of employment (with or without an end date), you should complete a research passport form and follow the process in .
If you are on an engagement contract you should complete a research passport form and follow the process in .
Postgraduate Researchers are not employed by the university, and should therefore contact their supervisor or divisional officers about potentially entering into an engagement contract, in order for HR to undertake employment checks, and obtain a research passport. They would then be able to follow the process in .
If you know that you need a DBS for the activity you plan to undertake, then you should also complete a DBS initiation form and return this to HR as well. Not all projects require DBS checks, so please ensure you check if this is required with your NHS Lead R&D before initiating the check, as this is chargeable.
What do I do once HR have issued the signed research passport form?
Once HR have issued your signed research passport form you should follow the process in , and to send this to the NHS R&D department you plan to access for authorisation.
If you will be working in multiple NHS research sites, you only need to send your form to one site, which is usually the lead NHS R&D. The trust will authorise your form and issue either a letter of access or honorary contract for that site (whichever you require).
If you are working with additional research sites, you should then forward your authorised research passport on to the R&D departments, and they will issue their own letter of access to their site or honorary contract.
If you are based in FHM, Margaret Sandars the FHM Research Project Manager is working with HR and our local NHS partners to streamline the process, and can also be contacted for more information.
Any additional information
A comprehensive should be completed by the Principal Investigator before submitting a Research Passport application form.
Should the grant award allow for a new research post the Principal Investigator should make clear to the HR Recruitment team that a Research Passport is required before the post is advertised.
If you are applying for multiple research passports on behalf of others, please ensure that you only apply for ONE passport per email to HR.
DBS checks are not always required, depending on the nature of the research you will be carrying out. You should check any guidance on what authorisations are required with the R&D department.
You should check if you may benefit from using the . The cost to do so is £13 per year, and in some cases can be added as a project expense (your line manager can confirm if expensing this is possible).
As part of the C and C process, the OID, or applicable site agreement (EG: UK Wide Model Non-Commercial Agreement or Model Non-Commercial Agreement-PICA) will need to be signed and executed by both parties. The researcher will need to fill in key details on a copy of the approved template, specific to the research site ahead of sending it over to the trust R&D as part of the local information pack. Once the site complete C and C checks, they will sign the agreement and return a copy of it to the researcher, along with an email confirming C and C and that the site is ready to begin recruitment.
Once the research site has confirmed C&C, they may state in the letter that they will begin when the sponsor issues the 'green light'. The green light is the sponsor confirming that they are satisfied that all process has been followed, all approvals have been obtained and the study can now begin recruitment.
The green light should come from the sponsor via the clinical research governance team. If your study site requires a formal green light approval to authorise recruitment, please prompt the clinical research governance team by emailing the sponsorship inbox, answering the following questions:
Have you completed a sponsor risk assessment or are your risks clearly documented in your IRAS? ?Y/N
Has the sponsor issued you with the indemnity certificates? Y/N
Have you had a favourable opinion from the correct Research Ethics Committee? Y/N
Please confirm which ethics committee this was:
Have you had HRA approval? Y/N/NA
Have you had any other required regulatory approvals (EG: MHRA, CAG, Ionising radiation etc.)? Y/N/NA
Have RSO confirmed all finances are in place, correct, and contracts between the funder and Lancaster are signed? Y/N/NA
Has the site and sponsor signed your OID, nMCA-PICA agreement or other site model agreement? Y/N/NA
Please specify and attached signed copy to your email.
Have all other required collaboration agreements or contracts being completed? (EG: Collaboration Agreements, Vendor agreements, data sharing agreements outside of the site data sharing where the nMCA PICA or OID arrangements cover data sharing)? Y/N/NA
If you wish to make any changes or additions to your approved documentation, study design, or the information submitted as part of your original IRAS application following HRA and/or NHS REC approval, you will need to submit a modification request.
You should not amend the original IRAS application itself to make any changes.
Please follow the steps below when requesting a modification:
Download the “” from the IRAS help pages, which is a document that is required in order to request authorisation for your proposed changes.
Unblock the file and complete all relevant sections, ensuring you clearly outline the purpose of the amendment. -If you are extending the study, please state the new end date-If you are adding a new site, please ensure this is done so on a tool in its own right, without any other changes present. -If you are making adjustments to or adding a new version controlled document/s, please list the new version number and date of the document in the details box on the tool.
Email the completed Modification Tool, along with tracked versions of any documents being modified, to the Clinical Research Governance Team inbox for sponsor review and authorisation.
Following review, the sponsor will complete the sponsor authorisation section and return the authorised document to you.
You must then submit the authorised version via the IRAS Identity Gateway (modification portal). Please ensure you follow the instructions outlined in the “Submission Guidance” tab within the Excel document when submitting your request.
The “Submission Guidance” tab also provides details on when sites should be notified of changes* and when amendments can be implemented.
*Please note that all participating sites must be informed of the proposed changes, and no amendments should be implemented without prior agreement from the sites. Some modifications are subject to a formal waiting period before implementation, allowing NHS sites time to raise any objections. Where applicable, this information will also be detailed in the “Submission Guidance” tab of the Modification Tool.
If you are unsure if you need to make a modification, or need any help when completing the above, then please contact the Clinical Research Governance Team for advice.
