Sunday 25th February 2018

York Foundation Trust R&D Unit

NHS

Planning Your Own Research Project

If you are planning your own research study please work through the sections below which will guide you through the process.

The R&D Unit can support the design, development, set-up, costing, management and delivery of research within the Trust and it's hospitals.

Please also refer to the interactive flowchart to guide you through the steps required.

1.  Is my study Research?

It is important to be clear about the distinction between research and other types of investigative projects such as audit or service evaluation project.  R&D/G04 is useful in making this distinction.  Also refer to www.hra-decisiontools.org.uk/research

Refer also to website page: What Sort of Project Am I Doing?

The information on these pages relates only to RESEARCH studies.  For audit or evaluation projects please contact the Trust's clinical effectiveness team: effectivenessteam@york.nhs.uk

2.  Involve Others

You should liaise with the 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.  Click here

Patient and Public Involvement is considered essential for most studies.  Click here

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).

3.  Literature Review

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.

4.  Initial Enquiry

At this early stage all researchers are requested to complete and submit a short initial enquiry form to research.advice@york.nhs.uk

A  member of the R&D Unit will respond within 5 working days with advice and guidance that is specific to the proposed study.  It is therefore important that the questions on the form are answered as accurately as possible to enable the correct advice to be given.

Advice on issues such as: sponsorship, research design, finances, governance approvals, training and required supporting documentation will only be offered following the receipt of a completed form.

5.  What approvals do I require?

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&D team at an early stage so that time is not spent on potentially unnecessary applications.

A member of the R&D Unit will provide advice on this following review of the initial enquiry form.

6.  Costing studies

All research has a cost and the R&D Unit is able to help with costing of a study.  Is it essential that all applications for funding are reviewed and signed off by the Head of R&D.  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.

7.  Funding

The Trust has access to Idox grantfinder software available to help identify funding opportunities.  The R&D Unit will email weekly funding opportunities to investigators.  Please email the Unit Administrator to be added to this distribution list.  Additionally, we can work with investigators to set up more individualised searches.  Please contact the Unit Administrator.

8.  Contracts/ Agreements

Investigators are not able to negotiate or sign contracts or agreements for research.  All such requests should be sent to the Head of R&D.  This includes Confidentiality Disclosure Agreements.  The R&D Unit will work directly with investigators planning their own research studies to ensure such arrangements are in place, either via the Model Agreement or using the Statement of Activities and Schedule of Activities documents.

9.  Statistical Support

Statistical support is available for research studies registered with the R&D Unit via the initial Enquiry Form.  Regrettably, we cannot offer any statistical support to studies not registered with or approved by the R&D Unit.

10.  Prepare study documentation

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&D Unit will offer advice about what will be required following the initial enquiry stage.

  • Prepare a Protocol

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 here: www.hra.nhs.uk/hra-training/tools/

If your study is confirmed by the R&D Unit 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.  The following information may also be useful for qualitative projects www.england.nhs.uk/wp-content/uploads/2017/bitesize-guide-qualitative-research.pdf

Other interventional research studies are advised to adapt the HRA CTIMP protocol template required.

  • Other study supporting documentation

The documents required will be dependent on the study to be undertaken.  The Research Adviser will have provided information about what is required following the initial enquire stage.  Guidance and templates can be found on the HRA website using the links below.

11.  Risk Assessment

All sponsored studies require a risk assessment to be undertaken.  The risk assessment will inform a monitoring plan for the study. Click here for SOPs

12.  Sponsorship Application

The R&D Unit will have advised which of the following different sponsorship application processes will apply for your proposed study:

  1. CTIMP Sponsorship Application
  2. Full Sponsorship Application
  3. Proportionate Review

The Sponsorship Application is explained in more detail here.  Once Sponsorship has been confirmed then the Regulatory Application section below will apply.

13.  Regulatory Applications

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&D Unit can advise on making these applications however a dedicated full application service can also be provided if funding is available for this.

 14.  Applying for REC/MHRA/HRA through IRAS

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).  Where this is not the case the R&D Unit will advise of this following receipt of the initial enquiry form.

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.

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

15.  Additional considerations

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 (SoE) and Statement of Activities (SoA) templates should be used to capture all information around study activities being undertaken at a local level.

Note: where York Teaching Hospital 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/

16.  Support departments (Laboratory, Pharmacy, Radiology)

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.

17.  Training

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 Teaching Hospital 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.  Click here for training information.

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 Lead Research Nurse.

It is the responsibility of the Chief Investigator 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 n the proposed study.

18.  Capacity and Capability

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&D Department at that site.

Please be aware that no recruitment can commence until Capacity and Capability is confirmed by the Trust.