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What is Research Governance?

Research Governance is a regulatory Framework issued by the Department of Health (http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/Researchgovernance/index.htm), covering research involving human subjects who have been recruited from health or social care settings. All research involving patients, human samples, patient data or NHS staff or facilities must meet the specific requirements set out in the framework.

Research Governance:

· Improves research quality and safeguards the public by:
- Enhancing ethical and scientific quality
- Promoting good practice
- Reducing adverse incidents and ensuring lessons are learned
- Preventing poor performance and misconduct

· Is for all those who:
- Participate in research
- Host research in their organisation
- Fund research proposals or infrastructure
- Manage research
- Undertake research

· Is for managers and staff, in all professional groups, no matter how senior

What are the responsibilities of the PCT in relation to research?

Primary Care Trusts are responsible for :

· Accountability:

Ensuring compliance with the Research Governance Framework

· Delegation of roles

Service level agreements to underpin definition and delegation of roles

· Organisational approval systems

Responsibility for ensuring that all research supported by the organisation has a sponsor, peer review, ethical approval and complies with Research Governance requirements.
Ensure written agreements are in place for research involving an external partner/ funder outlining responsibilities
Caldicott and data protection scrutiny/approval as appropriate
Arrangements for sponsorship of own account research

· Communication, information and monitoring

Awareness of all research taking place within the organisation
Information on skills and experience of local PCT researchers
Responsibility for ensuring staff and researcher awareness of Research Governance
Ensuring service users and staff are informed of research being undertaken that may affect care/services
Compliance with agreed project monitoring procedures
Commitment to consumer involvement in research

· Legal issues and Risk management

Ensuing that relevant employment contracts are in place
Systems to identify and learn from adverse events, complaints etc. associated with research
Systems to deal with research misconduct or fraud associated with internal research
Checking indemnity arrangements are in place
Ensuring financial probity for any research monies that come into the individual PCT
Monitoring of projects
Intellectual property

· Research utilisation and dissemination

Supporting local dissemination, publishing
Access to research findings
Identification of training needs
Use of websites, newsletters, intranet etc to disseminate research findings.

Ref: Department of Health ‘Research Governance Framework for Health and Social Care’ http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/Researchgovernance/index.htm

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