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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.

The Health Research Authority (HRA) decision tool can help you decide if your study is research.

See below for definitions:

Research

Generates new knowledge where there is no or limited research evidence available and which has the potential to be generalisable or transferable.

Service 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.

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.

For more information see: The Healthcare Quality Improvement Partnership (HQIP) 

To conduct service evaluation at the Trust, contact Sandra Parker to register.

Clinical Audit

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

To conduct a clinical audit at the Trust, contact Sandra Parker to register.

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’.

Clinical Trial

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. 

Is it a clinical trial?

The Medicines and Healthcare products Regulatory Agency (MHRA) have produced an algorithm to help you decide whether or not your study is a clinical trial – Is it a Clinical Trial of a Medicinal Product?

The National Institute for Health Research (NIHR) has produced this excellent resource: Clinical Trials Guide for Trainees.

If you want further clarification email: ClinTrialHelpline@mhra.gsi.gov.uk

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) have produced an algorithm to help you decide whether or not your study is a clinical trial. Please see Is it a Clinical Trial of a Medicinal Product?

If you want further clarification email: ClinTrialHelpline@mhra.gsi.gov.uk

Medical Device Trials

Medical Device Trials that involve the use of an investigational medical device, are subject to the Medical Devices Regulations.

Please see Medicines & Healthcare products Regulatory Agency for further information. 

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.

The R&D Department can provide a template for peer review.  Please email the Research and Development Governance team.

Research Database

A research database is a collection of data, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending.

Application for ethical review is voluntary.

There is no formal requirement for databases to apply for ethical review under NHS research governance systems, and ethical approval would only be required by legislation if processing identifiable data without consent. Applications for ethical review will therefore normally be made on a voluntary basis.

 

Last updated: 14 August, 2017

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