Introduction to Research Governance, Ethics and Integrity Mrs April Lockyer Senior Research Policy Officer (Governance and Integrity)

Definition Research Governance • • • • Regulations Principles Standards Research quality

Definition Research Ethics • • • • • Morality Human subjects Animals Environment Potential future use

Definition Research Integrity • Responsible research practice

Statutory Obligations • • • • • • Human Tissue Act Medicines for Human Use Regulations Data Protection Act Mental Capacity Act Animals (Scientific Procedures) Act Health and Safety Regulations

Principles and Standards • • • • • • DoH Research Governance Framework Declaration of Helsinki Nuremburg Code UK Research Integrity Office Funding Bodies Organisational Codes of Good Research Conduct

Ethical Research • • • Dignity, rights, safety and well-being of participants.

Reduce, Refine and Replace Ethical review – NHS – UREC

Research Governance and Integrity Team • • • April Lockyer, Senior Research Policy Officer (Governance and Integrity) Andrea Evans, Research Policy Officer (HTA) Mohammed Zubair, Research Policy Officer (MHRA)

Research Governance and Integrity Team • • • • • Produce policies, procedures and training Provide support and advice to researchers Review and improve systems (central and local) Oversee regulated activities (human tissue and clinical trials) Governance and ethics breaches, participant complaints and research misconduct

Structure Research Conduct and Accountability Committee Professor Nalin Thakker Associate Vice President for Research Integrity Clinical Trials Management Group Professor Deborah Symmons Persons Designated Group Professor Giorgio Terenghi Designated Individual

Human Tissue Act • • • • • Human Tissue Authority Licence Consent Ethical review Traceability

Human Tissue Act • • • • • • Annual Survey Database Persons Designated Policies and SOPs Quality Manual Monitoring and Audit

Clinical Trials • • • • • • • • Medicines and Healthcare products Regulatory Agency Clinical Trials Authorisation Ethical review Sponsor Trial Master File Monitoring and audit Safety Reporting Archiving

Clinical Trials • • • • • Cradle to grave support Risk assessment Green light system Policy and SOPs Monitoring and Audit

Research Integrity • • Code of Good Research Conduct Code of Practice for Dealing with Complaints of Misconduct in Research

Current and Future Activities • • • • • Development of RMS Working Group – Information Governance Developments in ethical review Web site Launch Code of Good Research Conduct

Questions and Suggestions