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Research and Development

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Is my project research?

Early in the study planning process, you need to first assess if the project being developed is research, service evaluation or audit.

Clinical audit

Measures existing practice against evidence-based clinical standards. All clinical audit must comply with the clinical audit governance requirements. If the project is audit it should be registered with the trust clinical audit team.

Research

Generates new knowledge where there is no or limited research evidence available and which has the potential to be generalisable or transferable. All research must comply with research governance requirements of the Oxford University Hospitals.

Service review

Incorporates both service/practice development and service/practice evaluation.

Service / practice development

Introduces a change in service delivery or practice for which there is evidence derived from research or from other health/social care settings that have already introduced and evaluated the change. New developments should always be evaluated.

Service / practice evaluation

Evaluates the effectiveness or efficiency of an existing or new service/practice that is evidence based, with the intention of generating information to inform local decision-making. This type of activity is sometimes referred to as a clinical effectiveness study, baseline audit, activity analysis, organisational audit and benchmarking. All service review activity should comply with clinical governance requirements.

Service/practice development which is concerned with introducing a new treatment or technique must follow the local policy on introduction of new treatments and techniques as summarised below.

Local clinical policy on introduction of new treatments and techniques

This policy could apply to the introduction of:

  • a treatment or technique which is understood to be safe and effective but new to your trust
  • a treatment or technique that is an interventional procedure (as defined by NICE) and has not been used in the NHS before
  • an existing treatment or technique that is to be adapted for new purposes
  • a medicine not on the trust formulary or a new indication for an existing formulary medicine.

The above definitions are from the following document from the Healthcare Quality Improvement Partnership (HQIP):

A Guide for Clinical Audit, Research and Service Review (pdf) - www.hqip.org.uk

If you are still unsure please contact us with your queries:

OUH R&D Department - Contact us

Additional information can be found on the HRA website:

HRA decision tool - www.hra-decisiontools.org.uk/research

If your project is Clinical Research, then it is important to consider whether it will be classified as a Clinical Trial of an Investigational Medicinal Product (CTIMP) or a Medical Device Trial.

This is important because, if so, it will have to be carried out under either the Clinical Trials Regulations or the Medical Devices Regulations, and different processes will need to be followed.

Clinical Trial of an Investigational Medicinal Product (CTIMP)

A CTIMP is defined as any investigation in human subjects intended to:

  • discover or verify the clinical, pharmacological and / or pharmacodynamic effects of one or more IMP(s)
  • ascertain the safety of one or more IMP(s)
  • study absorption, distribution, metabolism and excretion of one or more IMP(s)

The Medicines and Healthcare products Regulatory Agency (MHRA) has developed an algorithm to help you determine whether or not the proposed clinical research is within the scope of the Clinical Trials Regulations. If you remain unsure, please contact us.

OUH R&D Department - Contact us

For advice on designing and conducting clinical trials, please see Clinical trial planning.

Clinical trial planning

For further information see the Clinical Trials Toolkit and/or contact us.

OUH R&D Department - Contact us

It is a requirement of OUH approval that staff provide evidence of GCP training on their CV which should be refreshed every three years.

Please use the link below for information about the GCP training courses that the OUH R&D team runs in conjunction with colleagues in the University Clinical Trials and Research Governance Department.

GCP training courses

Peer review

All Clinical Trial Protocols need independent peer review. Major funding bodies often undertake this as part of their acceptance procedure. If your study is not funded by such a body, you will need to identify an independent peer to undertake the review.

Independent scientific review or 'peer review' is an essential process when setting up a research project. It mainly involves a researcher or clinician with expertise in the area to be researched reviewing and commenting on methodology, aims, statistics, primary end points, originality and the importance of your research project. It is important that the reviewer is in no way connected to the project itself as the review does have to be independent.

One of the main advantages of a peer review is that suggestions made by the reviewer may enable a stronger protocol, which in turn can aid ethics approval and R & D trust management approval.

It is now a requirement for NHS trusts to ensure that each protocol has been submitted to adequate peer review before R & D management approval can be given.

Oxford University Hospitals has a policy on accepted forms of peer review when making an application for trust management approval.

The R&D Department can provide a template for peer review.

OUH R&D Department - Contact us

Medical Device Trials

Medical Device Trials that involve the use of an investigational medical device (either a non-CE marked device, or a device that has been modified or is being used for a purpose not covered by the CE mark), are subject to the Medical Devices Regulations.

A medical device is an instrument, apparatus, implant, in-vitro reagent or similar, or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a medicinal product or drug).

Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.

Please contact OUH R&D Department for advice on Device Trials.

OUH R&D Department - Contact us

It is more than likely that the Ethics Committee will also ask to see a copy of your peer review during the process of ethical review.

Clinical Research Studies

All other Clinical Research that is not governed by the Clinical Trials or Medical Devices regulations will be referred to as 'Clinical Research Studies'.

Although REC review is not required for Clinical Research Studies limited to use of previously collected, non-identifiable information, even from NHS patients, where the OUH is sponsor we do need to be aware of the research and review the documents on behalf of the Trust.

Please note: if the research is being conducted within the NHS you will still need to gain NHS permission (Trust Management Approval).

The OUH R&D Department is able to assist with setting up your projects. You will need to follow the application procedure for:

  • Sponsorship
  • Research Ethics Committee approval
  • Medicine and Healthcare Product Regulatory Agency (for CTIMPs and Non CE marked Devices), and
  • NHS permission (Trust Management Approval).

Research Tissue Banks / Research Data Banks

Oxford University Hospitals requires that all Research Tissue Bank (Biobank) and Research Data Bank (Database) applications be submitted to an NHS REC for ethical review.

Research proposal documents must be sent to the R&D Team for review before submission to a REC and/or the Human Tissue Authority (HTA). For full details, please refer to our Research Tissue Banks / Research Data Banks page.

Research Tissue Banks / Research Data Banks

Procedures

The links below direct you to pages detailing study processes and considerations.

Steps 1, 2, 4 and 5 are applicable to all Clinical Research (CTIMPs, Device Trials and Clinical Research Studies).

For step 3, select the appropriate link for the study type.

  • Step 1 Clinical Research Process - from conception to study initiation
  • Step 2 Documents Required for all Clinical Research
  • Step 3
    • Clinical Trial (CTIMP) Preparation
    • Device Trial Preparation
    • Clinical Research Study Preparation
  • Step 4 Conduct of Clinical Research
  • Step 5 Research Completion

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