Research Governance and Ethics for Health and Social Care

1. Research Governanceand Ethics for Health and Social Care

2. What is it all about? Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, quality research in health and social care. The public has a right to expect scientific, ethical and financial standards, transparent decision-making processes, clear allocation of responsibilities and robust monitoring arrangements

3. 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

4. Who does it concern? • Those who undertake research in health and social care (students and staff) • Those who host research in their organisation (the Faculty and UWE) • Fund research (the Faculty and UWE) • Manage research (project managers, research leaders etc) • Those who participate in research

5. A contested concept? • Different disciplines and methodologies have different traditions with regard to ethics and governance issues • professional codes of conduct • role and function of ethics committees • ethical practice may be negotiated rather than objective

6. The Department of Health Research Governance Framework for Health and Social Care • Currently 2nd edition draft is out for consultation (July 2003) • Has specific requirements related to different groups and organisations undertaking or hosting research in the health and social care services

7. DOH Framework: Responsibilities and accountability All those involved in research with human participants, their organs, tissue or data must be aware and implement the law, and the basic principles relating to ethics, science, information, health and safety, and finance set out in the framework including EU requirements, DeFRA etc All those involved in research also have a duty to ensure that they and those they manage are appropriately qualified, both by education and experience, for the role they play in relation to any research.

8. Specific responsibilities in the Framework are identified for: • Sponsor (UWE is a sponsor and supervisors act as the student’s sponsor) • Researchers • Employing organisation including universities and other organisation • Research Ethics Committee • Patients • Care organisation/responsible care professionals

9. Sponsor responsibilities (including supervisors) • Assuring the scientific quality of proposed research • Ensuring research ethics committee approval obtained • Ensuring arrangements are in place for the management and monitoring of research

10. Researcher responsibilities (student and supervisor) • Developing proposals that are ethical and seeking research ethics committee approval • Conducting research to the agreed protocol and in accordance with legal requirements and guidance e.g. on consent • Ensuring patient/participation welfare while in the study • Feeding back results of research to participants

11. Employing organisation responsibilities • Promoting a quality research culture • Ensuring researchers understand and discharge their responsibilities • Taking responsibility for ensuring the research is properly managed and monitored

12. Ethics standards • Independent ethical review • Active involvement of service users and carers • Respective disposal of organs & tissues following post mortem • Highest standards of animal husbandry

13. Science standards • Independent peer review related to methodology • Collaboration to ensure quality & relevance, and avoid unnecessary duplication of functions • Commitment to support research careers • Training & updating • High standard of health & safety of laboratory work • Systems to monitor compliance with standards, investigate complaints, deal with poor conduct • Assessment of research outputs - impact & value for money

14. Quality research culture has: • Respect for participants’ dignity, rights, safety and well-being • Valuing of the diversity within society • Personal and scientific integrity • Leadership • Honesty • Accountability • Openness • Clear and supportive management

15. Monitoring, inspection and sanctions Organisations and individuals must be able to demonstrate adherence to the framework to reassure patients, service users and care professionals of the quality of their services and to assure their reputation in high quality research and care UWE has a Research Governance Task Force, and the Faculty has a Research Governance Implementation Group (students) to help us develop systems

16. Faculty Guidance A Research Governance and Ethics Guidance and Good Practice document has been produced covering: • the unacceptability of research misconduct • clarifying what records must be kept • identifying that the quality of research must be monitored • identifying the specific responsibilities related to research in the NHS that must be fulfilled e.g. registration, independent scientific review, ethics approval, honorary contracts, police checks etc.

17. Further information • DoH Website (www.doh.gov.uk) • NRES Website (www.nres.npsa.nhs.uk) • Faculty Research and Consultancy manager: Emma Spillane • Chair of Faculty Research Governance Implementation group: Selena Gray • Chair of Faculty Ethics Committee: Simon Evans