York Teaching Hospital NHS Foundation Trust provides a comprehensive range of acute hospital and specialist healthcare services for approximately 800,000 people living in and around York, North Yorkshire, North East Yorkshire and Ryedale - an area covering 3,400 square miles.
The Research & Development Office strive to increase the opportunities for patients and their families to be informed about, and involved in, our research and research processes.
The information on these pages will be relevant to York Hospital staff NHS Foundation Trust staff who are planning their own research study.
This section contains the Standard Operating Procedures (SOPs) and Guidance documents issued by the R&D Unit.
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For Researchers
If you are intending to undertake your own research study, please work through the sections below which will guide you through the process.
The R&I Department can help support the design, development, set-up, costing, management and delivery of research within the Trust and it's hospitals, and it is beneficial to researchers to involve them in the early phases of planning.
Please also refer to the interactive flowchart to guide you through the steps required.
The information on these pages relates only to RESEARCH studies.
It is important to be clear about the distinction between research and other types of investigative projects such as audit or service evaluation project. Please study the flowchart attached in the link below to help you make this distinction. The document will help you determine what kind of project you are hoping to undertake and the relevant route and contacts. 
What kind of project am I doing
For audit projects please contact the Trust's clinical effectiveness team: yhs-tr.ClinicalEffectivenessTeam@nhs.net
For service evaluation, development or improvement projects then you will need to register your intention at a Care Group level. Please contact the Care Group Governance mailboxes for the relevant Care Group.
You should liaise with the R&I Department, the relevant clinical teams in the hospital, any academic or external partners, and support departments at an early stage. Early discussion is encouraged and this should be at the protocol development stage to check that the study is feasible and to ensure that all financial costs are considered. This is beneficial to create the support and infrastructure required to deliver successful research projects.
Please be aware that Patient and Public Involvement is considered essential for most studies.
Establishing the right research team is key and advice on this can be sought from the R&D Unit.
Investigators should consider involvement of Pharmacy, Laboratories, Radiology and/or whether statistical input is required. Advice on how to make this contact will be given at the initial stage (4).
The initial stage of all research should be a literature review to determine what work has already been done in the proposed area and to ensure there is no duplication. The literature review will form the justification for the study and should explain how the proposed research will add to the existing knowledge.
At this early stage researchers are requested to contact the Trust's Research Advisor preferably by email.
yhs-tr.research.enquiries@nhs.net
It is important to include a short synopsis of your study so that the correct advice can be given.
Please note that advice on issues such as: study categorisation, sponsorship, research design, finances, governance approvals, training and required supporting documentation will only be offered following the receipt of a study synopsis.
All research in the NHS requires formal approval of some sort. The actual approvals required depend on the study to be undertaken. For this reason it is important to seek advice and to involve the R&I team at an early stage so that time is not spent on potentially unnecessary applications.
The Research Advisor or delegated other can offer guidance on this once a study synopsis has been received.
The HRA also provide a great deal of information on the approvals process. Please follow the link for further details.
What approvals and decisions do I need? - Health Research Authority (hra.nhs.uk)
All research has a cost and the R&I Department is able to help with calculating the cost of a study. Is it essential that all applications for funding are reviewed and signed off by the Head of Research and Innovation. It is important that investigators ensure that sufficient time is allocated to this, as obtaining some costs may not be routine and may take longer that envisaged.
The R&I Department can work with investigators to identify potential study funding and can offer assistance with making funding applications. Please contact the Grant Development Officers for advice.
Lisa Ballantine - l.ballantine@nhs.net
Cameron Stockwell - cameron.stockwell1@nhs.net
Marthe Ludtmann - marthe.ludtmann1@nhs.net
Investigators are not able to negotiate or sign contracts or agreements for research. All such requests should be sent to the Head of R&I. This includes Confidentiality Disclosure Agreements. The R&I Department will work directly with investigators planning their own research studies, to ensure such arrangements are in place with all parties.
Statistical support is available for all research studies registered with the R&I Department. Regrettably, we cannot offer any statistical support to studies not registered with or approved by the R&I Department.
All research studies require a study protocol. The content and detail will vary depending on the study to be undertaken. The requirement for other supporting documentation will also vary depending on the study. The R&I Department can offer advice about what will be required following the initial enquiry stage.
General advice can be found here: www.hra.nhs.uk/research-community/before-you-apply/protocol
HRA approved protocol templates should be followed where possible and can be found using the link above.
If your study is confirmed by the R&I Department to be a clinical trial of an investigational medicinal product (CTIMP) then researchers are expected to use the HRA approved template assessed via the link above.
Qualitative studies should use the HRA protocol template for qualitative studies.
Other interventional research studies are advised to adapt the HRA CTIMP protocol template.
General guidance on what is expected to be included in a protocol can be found here:
Writing your Research Protocol
The documents required will be dependent on the study to be undertaken. The Research Adviser or delegated other can provide information about what may be required for your specific study. Guidance and templates can be found on the HRA website using the links below.
This is a link to the NHS England guide as a resource for people doing research which may include a patient questionnaire: https://www.england.nhs.uk/wp-content/uploads/2018/01/bitesize-guide-writing-an-effective-questionnaire.pdf
Data Protection
Your Protocol and Participant Information Sheet should both contain information regarding data protection. Potential participants must be properly informed of what personal data you are planning to collect and how this will be utilised and stored. The HRA website offers guidance on what you must consider and the correct wording required. More information can be found here: Data protection and information governance - Health Research Authority (hra.nhs.uk)
All sponsored studies require a risk assessment to be undertaken. The risk assessment will inform a monitoring plan for the study.
If your project is eligible the R&I Department will have already advised which of the following different sponsorship application processes will apply for your proposed study:
The Sponsorship Application is explained in more detail here. Once Sponsorship has been confirmed then the Regulatory Application section below will apply.
Once sponsorship has been agreed it is the responsibility of the Chief Investigator (or delegate) to prepare and arrange for the necessary regulatory applications to be submitted. The applications required to be made will have been advised following the initial enquiry stage. Applications should be made through the Integrated Research Application System (IRAS).
The R&I Department can advise on making these applications however a dedicated full application service can also be provided if funding is available for this.
Use the Integrated Research Application System (IRAS) to make the necessary regulatory applications www.myresearchproject.org.uk
The dataset that is entered into this system can be used for most of the necessary regulatory applications (e.g. REC/HRA/MHRA).
It is important to ensure that when you create your new project that you consider and answer the filter questions carefully as the responses to these will generate the specific form(s) required to be completed. An incorrect response here will mean that the applications created are not accepted as valid and will result in delay for the applicant. For guidance please contact the Research Adviser yhs-tr.research.enquiries@nhs.net
The Health Research Authority (HRA) works on behalf of NHS Trusts in England and in conjunction with the NHS Research Ethics Committee (REC). Their duty is to ensure that clinical research conducted within the health service adheres to strict ethical, legal and governance guidelines in order to ensure the safety and dignity of our patients and the integrity of the Trust.
The Health Research Authority (HRA) website contains all the necessary guidance and information required to make these applications www.hra.nhs.uk/research-community/applying-for-approvals/
For further information on the HRA please visit www.hra.nhs.uk/ or download our HRA Approvals training slides
It is important that there is clarity on the resource implications for participating NHS organisations and others delivering research within an NHS care setting. This information should enable participating NHS organisations in England to assess and confirm their capacity and capability to deliver the research. For non-commercially sponsored multi-centred studies the Schedule of Events/Schedule of Events Cost Attribution Template (SoECAT) and Organisation Information Document templates should be used to capture all information around study activities being undertaken at a local level.
Note: where York & Scarborough Teaching Hospitals NHS Foundation Trust is the Sponsor and the study is only taking place within this Trust then it is not necessary to complete the SoE or SoA.
Templates and further information is available here www.hra.nhs.uk/resources/hra-approval-applicant-guidance/statement-activities-hra-approval/
The involvement of support departments should be sought at an early stage to ensure that the study being planned is feasible and deliverable within the Trust. The costs of the support departments will need to be considered.
All staff working on CTIMP studies will be required to undergo GCP training where their role within the study is not limited to their normal clinical practice. York & Scarborough Teaching Hospitals NHS Foundation Trust currently requires staff to undergo refresher training at least every three years. Changes to GCP or the legislation may require further retraining although the Trust will take a risk based approach to this depending on the nature of the update. All updates will be communicated to the research staff.
Additionally, staff obtaining Informed Consent for research will be required to complete the Trust's own course in circumstances where obtaining patient consent has not otherwise been taught e.g. non clinical staff. All research nurses involved in the informed consent process are required to have this competency signed off by the Senior Research Nurse Team.
It is the responsibility of the Chief Investigator, or delegated other, for the study to train the rest of the research team and the support departments where required. For CTIMP studies it is essential that this training is undertaken prior to the study being given approval to begin recruiting. The R&D Unit will liaise with the CI to ensure that the appropriate training is undertaken before the study can commence. The extent and content of this training will vary depending on the proposed study.
Once the Regulatory Approvals have been obtained contact the Research Delivery Facilitator (RDF) to inform them that you are ready to submit your application for Capacity and Capability. The RDF will confirm that the local information pack can be submitted. At this stage it is expected that all local issues will have been resolved and that necessary discussions will have taken place between the research team and any involved support departments, clinic staff and directorate management.
For multi-centre studies, investigators should always open the study in York Trust before other Sites. Applications should be made to all sites via the R&I Department at that site.
Please be aware that no recruitment can commence until Capacity and Capability is confirmed by the Trust.
1st April 2023 – 31st March 2024
York & Scarborough
50 research studies open to recruitment
3246 patients recruited into clinical trials
