Great Western Hospitals NHS Foundation Trust

Guidance for setting up a research study

Step 1: Establish that it is research

When setting up a study it is important to establish that it is research, rather than a clinical audit or service evaluation.

The National Research Ethics Service (now part of the Health Research Authority) and the NHS Research and Innovation Forum have issued guidance on the categorisation of research, clinical audit and service evaluation.

All three types of study require the approval of host Trusts, however, systems for approval for each type of study vary and only research requires REC (Research Ethics Committee) review.

• Research is designed and conducted to generate new knowledge and should follow the systems for approval of NHS Research.
• Audit is designed to answer the question "Does this service reach a predetermined standard?"
• Service evaluation is designed to answer the question "What standard does this service achieve?"  

Step 2: Develop the research idea

You now need to turn your research idea into a protocol.

The protocol is a document that describes how a clinical trial will be conducted: the objective(s), design, methodology, statistical considerations and organisation.

It also ensures the safety of the trial subjects and integrity of the trial data.

Protocol guidance and template can be found on the HRA website (www.hra.nhs.uk/about-the-hra/consultations-calls/closed-consultations/protocol-guidance-template-use-clinical-trial-investigational-medicinal-product-ctimp-consultation-use/).

Step 3: Obtain a sponsor

A sponsor is an organisation that accepts responsibility for ensuring that there are proper arrangements to manage and finance a research study.

The NHS Research Governance Framework requires that all research taking place in the NHS or social care must have sponsor.

This will normally be an NHS Trust, a University or a commercial company.

The Research and Innovation team need proof of a sponsor for all research taking place within the Trust.

Step 4: Establish how your research will be funded

Researchers should establish how their study will be funded before they make a formal application to proceed.

If grant funding is necessary to fund research work, the grant application should be completed and submitted as early as possible, as a negative outcome may prevent the project from being taken further.

For further information on the funding opportunities available, please visit the Research Design Service website (www.rds.nihr.ac.uk).

Step 5: Obtain approvals

Before starting your research or recruiting patients into an existing NIHR or commercial study, all potential researchers need to apply for the necessary approvals.

They key approvals currently required are outlined below; however, this process is currently being reviewed nationally.

For more information, please see the NIHR website (www.hra.nhs.uk/research-community/applying-for-approvals) or contact us.

Ethical Approval

All trials will need approval by the Health Research Authority (HRA) which incorporates a review by a Research Ethics Committee (REC).

Medicines and Healthcare products Regulatory Authority (MHRA)

The MHRA reviews and offers approvals for clinical trials of investigational medicinal products (CTIMPs).

It is essential that the sponsor has received this approval for any CTIMP to begin recruiting patients.

Departmental Approvals

Many research studies will involve multiple departments throughout the hospital.

For example, the study may require additional outpatient appointments, CT scans, blood tests or ECG's.

It is essential when setting up a research project that these additional interventions are discussed with and approved by the department providing the service.

Research and Innovation Approval

The final stage of the approval process is to seek Trust approval via the Research and Innovation department.

This ensures that the research has received all the other appropriate referrals and that the trial is appropriate for the Great Western Hospital. 

This process has recently changed at a national level, and Trust approval will now be granted through a mechanism to confirm local capacity and capability to deliver a research study.

The process will need to be completed by a member of the Research & Innovation department before the study commences.

Applying for approvals - Integrated Research Application System (IRAS)

Most applications to regulatory review bodies can be made via the IRAS.

IRAS was developed to bring all the research regulatory application forms together in one place.

By completing a checklist of questions, the system will generate the forms you need to complete based upon your responses.

These include:

• Portfolio Adoption Form
• Research Ethics Committee Form
• Research & Innovation Form
• Site Specific Information Form
• MHRA Form

For information on how to use IRAS and set up an account, please see the IRAS website (www.myresearchproject.org.uk/help/hlpusingiras.aspx).

Contact

If you have a research idea or proposal that you wish the Trust to support, please contact us at the earliest opportunity to discuss it.

Process flow diagrams

Please click on an image below to view the flow diagram full size.

Step 6: Complete the Site Specific Information (SSI) form

The SSI form is a tool that enables an NHS Trust to evaluate the probable impact of a proposed research study and reach an informed judgment on whether or not to grant NHS permission/R and I approval.

The SSI Form should only be completed after Parts A-D have been completed by the Chief Investigator and validated by the main REC.

The CI will then forward Parts A-D of the R and D application to the PI to assist in completion of the SSI Form.

This is a period of transition and in future completion of the SSI form will be replaced by the Capacity and Capability statement process.

It is envisaged that the SSI form and Capacity and Capability statement processes will run concurrently for a period of time, before the SSI form is finally phased out.  

Step 7: Commence your research

The study can commence (including recruitment of patients) once all the required approvals are obtained and the site initiation visit by the Sponsor has taken place.