Research Governance Dr. Sheila Francis

‘A process to ensure that research involving patients, data or human tissue is scientifically sound, properly financed and ethically approved’ ‘Registration of research with a sponsor’

Benefits Greater protection for researchers and participants Dignity, rights, safety and well being of people Research culture further strengthened Quality of research, eligibility of research applications Demonstrates the University’s commitment To accountable, high-quality and transparent research practices High quality reputation and credibility Protected and enhanced Reduction of risk Regulatory compliance, less potential for research misconduct

Does RG apply to your project? All UK ‘health care’ research. Studies in Volunteers - University-led projects not involving any NHS Trust – to follow the University’s research governance procedures Studies on patients - University projects involving the STH Trust – to follow the Trust’s research governance procedures

Understanding Research Governance SCIENCE Independent scientific scrutiny INFORMATION Partnership Agreements in place Information dissemination ETHICS Independent ethics scrutiny Scope of the Research Governance Standards FINANCE AND INTELLECTUAL PROPERTY SYSTEMS MONITORING Monitoring conditions and adverse events OTHER Role of research governance sponsors HEALTH, SAFETY, EMPLOYMENT

What to do if you think your project requires Research Governance approval Speak to your supervisor! Ask to see the protocol and approval letter If application is required, contact medschoolethics@shef.ac.uk University RIS/Medical School websites

Animal procedures

Ethical Review/Licensing of Animal Procedures All procedures with living animals are carefully regulated in the UK under an act of Parliament. Home Office Project Licence Home Office Licence (personal) Training courses - written and practical tests - certificate Certificate must be included in the licence application - it can take months to be granted a licence!. If you are unsure about the process then contact Mr Gerard Brower-Ince at the Veterinary Services Unit.