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Getting involved in our research

Our Research and Innovation Directorate is the focal point for consultation by investigators about research activity. The expertise we provide is known as research management and governance, and outlined below. Further information can be found in our booklet titled ‘Research Governance – A Handbook for Researchers in Dorset’. Please contact us for a copy.

Sponsorship

The sponsor is an organisation (or group of organisations) that accepts responsibility for ensuring that there are proper arrangements to initiate, manage, monitor and finance a project. Any organisation that is a legal entity and which funds, initiates, hosts or employs staff involved in research may act as a sponsor. All clinical research projects need to identify a sponsor. It is important to note that the sponsor might not be the funder.

Tips for researchers

  • Contact us as soon as you have an idea for a research study, or are approached about a study. We can provide advice and liaison for existing and potential sponsors.
  • At RBCH, a request for the Trust to act as sponsor can be made by emailing a copy of the research proposal and all other available information to us.
  • Sponsorship needs to be confirmed before any approvals are sought from the Research Ethics Committee (REC) or NHS R&D Local Confirmation.

Health Research Authority (HRA)

If your study is led from England and involves the NHS in England, you should now use HRA Approval. Before you apply for REC review, please go to the applicant guidance section of their website for information about how to apply.

Individual Trusts are no longer required to issue local approval before a study can proceed at their site. Instead all applications are made to the central Health Research Authority who work in partnership with the Research Ethics Committees and will refer the project for ethical review (if necessary), and consider all elements of the study before issuing a central HRA Approval document which can then be used in all relevant organisations within England. The theory is then that local trusts will only need to perform their individual feasibility and capability exercises before a study can be adopted locally. Local R&D offices will require the HRA Approval document before they can issue local confirmation a study can proceed, with the exception of some low risk survey based studies that the HRA will issue without the need for any central approval. The HRA will continue to review and develop HRA Approval and feedback is encouraged to hra.approvalprogramme@nhs.net.

Research Ethics Committee favourable opinion

The role of the Research Ethics Committee is to safeguard the rights, safety, dignity and wellbeing of research participants by ensuring that research proposals have been designed and will be conducted in accordance with the Declaration of Helsinki. If the REC is satisfied that this is the case, they will offer a ‘favourable opinion’ for the research (often referred to as ‘REC approval’). In general, all research taking place within the NHS requires REC approval, with the exclusion of certain NHS projects including clinical audit, service evaluation, patient and staff surveys, case studies or case reports and consensus methods.

Tips for researchers

  • Application for REC approval is made through an online web portal known as the Integrated Research Application System, or ‘IRAS’ (see Useful links, below). We will provide guidance about gaining and using an IRAS account.
  • The minimum data set required to be submitted for review by a REC will include:
    • a protocol
    • completed IRAS form
    • a patient information leaflet
    • a consent form
    • a GP letter
  • In order to save time in the regulatory approvals application process, researchers are advised to apply for REC approval and NHS R&D Local Confirmation in tandem.

NHS R&D Local Confirmation

In order to remain a research active organisation, and protect the funding provided by the Department of Health to host research, all trusts must comply with national Research Governance standards set out by the Department of Health. Therefore we ensure all research that takes place in the Trust has managerial approval. The Research and Development Approval process assesses a research study application from a local perspective and is separate from issues addressed by the REC.

As a general rule, NHS R&D Local Confirmation will always be required if REC approval is required. However, there may be occasions where NHS R&D Local Confirmation is required when REC approval is not required, such as laboratory research on NHS premises and in studies interviewing NHS employees.

Tips for researchers

  • Application for NHS R&D Local Confirmation is made through the IRAS portal, as with the application for REC approval above. This will be accompanied by a Site Specific Information (SSI) form outlining the various activities to be carried out at the Trust.
  • Throughout the process and after approval, it is recommended that all versions of project documentation are saved, including track changes.
  • Providing a valid submission in the first instance will help us to process and review your application more efficiently.

Other approvals

Additional approvals might be required, and the staff at the Directorate can provide guidance where necessary.

A clinical trial involving a drug might be classed as a Clinical Trials of Investigations Medicinal Product or ‘CTIMP’. These trials are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA), and will require authorisation.

An Administration of Radioactive Substances Advisory Committee certificate is needed for any clinician who wishes to use ionising radiation or administer radioactive medicinal products (e.g. bone scans) to human subjects.

In certain circumstances the storage of human tissue (or ‘relevant material’) for research purposes will require a licence from the Human Tissue Authority.

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researchoffice@rbch.nhs.uk