It is really important to involve the NHS when designing your research, and gain a clinical perspective, as well as input in your recruitment and data collection methods to ensure they will work in practice and feasible in the clinical setting. However, you will also need to identify sites where the research will take place and R&D departments to support this set up. It is important you are clear on who you need to contact at trusts, for what purpose, and when to contact them.
Contacting for Clinical Input
If you are contacting trusts for clinical input during your design phase, clinical collaboration, or input around if the clinical department could support your study, you can do this early on in the development and throughout. You will most likely already have contacts in place for this, or have supervisors or colleagues who work in the department. This does not replace the need to contact R&D departments to support the site management and legal set up as a site, which also needs to take place as well and will be outlined below.
Contacting to act as Lead NHS R&D
Often researchers will have a preferred NHS trust that they are working with as outlined above, or that they are affiliated with. As well as discussing clinical input and collaboration with the clinical department, you will also require a lead NHS R&D identified on your IRAS application (Question A68-1) you will need to identify a trust R&D department that can act as a lead R&D for your IRAS application. They often help with guidance and information on the NHS process if needed, and may manage things like verifying research passports etc.
The Lead NHS R&D role does not necessarily need to be undertaken by a site that will act as a research site, although they often do act as both lead NHS R&D and a research site.
The lead NHS R&D contact could be the R&D contact for the Chief Investigator's employing NHS organisation; a partner NHS organisation of the university employing the Chief Investigator; or a main NHS collaborator.
The lead R&D office should be contacted at the earliest possible stage to advise and support the research through the review process. You should be clear you are approaching them to act as a lead NHS R&D on the IRAS and not yet asking them to set up the site, as this will happen later on and a full process of capacity and capability needs to be undertaken.
Contacting to act as NHS Research Site
The other reason you will need to contact the NHS, is to act as a research site. You may discuss this with a clinical collaborator, clinical department or site R&D or R&I department initially or early on in the process of designing the study. However, to formally request the site host your research or for you to collect data at that NHS trust site, you will need to approach them in a specific manner. This approach will be via the NHS site R&D or R&I department, as they will need to ensure the project follows the standard procedure for site set up. You can find R&D contacts for most trusts on the Rhttps://rdforum.nhs.uk/rd-contacts-directory/&D forum contact list or contact the trust directly.
When you contact sites to request they act as a site, you will need to include a local information pack (information on the contents and what this is can be found on the drop down below) in the email correspondence.
Once you submit your IRAS application for review, it will be validated by the HRA and they will send out an email to confirm that it will be reviewed in due course. This validation email will also let you know that you can then contact your potential NHS site R&D with your local information packs. If you are contacting the site early on in the development phase for support, please be aware that they may not be able to confirm they can act as such, and they will not begin the assessment to see if they can act as a site until prompted by the local information pack being sent to them. This assessment is called Capacity and Capability (C and C). You can find more about C and C assessments in the Capacity and Capability drop down option below.
Site research activities must not begin until you have obtained the correct approvals in place and the research site has confirmed their Capacity and Capability to conduct your study.
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 NHS-NHS pre-engagement check form.
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 NHS-NHS pre-engagement 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 honarary 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 Research Passport Flow 1.
If you are on an engagement contract you should complete a research passport form and follow the process in Research Passport Flow 2.
Post-graduate 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 Research Passport Flow 2.
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.
Application Forms:
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 Research Passport Flow 3, 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 honarary 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 honarary contract.
You can contact the Research Governance Team or HR for more information or support.
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 Risk Assessment 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 DBS update service. 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).
