Research Governance

Research Governance Team (R&D) at OUH

The Research Governance team's role is to ensure that research which is using OUH NHS resources including NHS patients:

• is compliant with the relevant regulations (e.g. Data Protection Act)
  
• follows Clinical Research Principles (e.g. Good Clinical Practice (GCP) and The Department of Health UK Policy Framework for Health and Social Care)
  
• has relevant approvals in place (e.g. Research Ethics Committee, Health Research Authority, Medicines and Healthcare Products Regulatory Authority)
  
• is of a high scientific standard.

The Research Governance Team provides support throughout the research journey, from acting as sponsor for certain studies to providing local Trust Management Approval and GCP compliant training.

Ongoing oversight is maintained through collection of recruitment figures, progress reports and safety data, and through monitoring and audit responsibilities.

Who does it apply to and why do we need it?

Research Governance applies to everyone connected to Clinical Research, whether as a Chief Investigator, Care Professional, Researcher, their employer(s) or support staff.

By Clinical Research, we mean any health-related research that involves humans, their tissue and/or data.

Research Governance is needed to:

• safeguard participants in research
  
• protect researchers / investigators (by providing a clear framework within which to work)
  
• enhance ethical and scientific quality
  
• mitigate risk
  
• monitor practice and performance
  
• promote good practice and ensure that lessons are learned.

Is my study research?

There are times when the classification of a project is unclear; i.e. whether it is a research study, audit or service evaluation.

Clinical audit

Measures existing practice against evidence-based clinical standards. All clinical audits 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.

The above definitions are from the following document:

Healthcare Quality Improvement Partnership (HQIP) A Guide for Clinical Audit, Research and Service Review (pdf) - www.hqip.org.uk

Additional information can be found on the HRA website:

Is my study research? - www.hra-decisiontools.org.uk/research

Classification Group

In order to establish an authoritative and collective opinion on such projects, the Governance team and the Clinical Trials and Research Governance team in the University have an established group which meets to review project outlines and give a considered opinion.

The group meets at least monthly, or more often where there is high demand.

If you are unsure, please complete the classification form below and email it to us with your queries:

Governance form (Word, 774 KB)

Email: OUHTMA@ouh.nhs.uk