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Research Governance Toolkit The journey thus far

Research Governance Toolkit The journey thus far. Bill Karanatsios. 20 May 2010. VMIA. VMIA is the insurer and risk management advisor for the state of Victoria.

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Research Governance Toolkit The journey thus far

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  1. Research Governance ToolkitThe journey thus far Bill Karanatsios 20 May 2010

  2. VMIA • VMIA is the insurer and risk management advisor for the state of Victoria. • The VMIA aims to protect the interests of the State of Victoria through the TCOR concept and via the facilitation of a number of key projects.

  3. VMIA • Key projects within the clinical research arena: • National Clinical Trial Agreements • FTIH Guidelines • 13 SOPs for ICH-GCP Compliance • Research Governance Toolkit • VMIA CTN Guidelines

  4. Research Governance Toolkit • Commencement Date: 19 August 2008 • Proposed Launch Date: 2 June 2010 • Project Owner: Bill Karanatsios • Aim: to draw on the collective VMIA client base experience and IP to construct the elements of the RGT to be used by the collective

  5. RESEARCH GOVERNANCE TOOLKIT FOR VICTORIAN PUBLIC HOSPITALS AND VMIA INSURED MEDICAL RESEARCH INSTITUTES

  6. “The Research Governance Toolkit has beendeveloped to assist Victorian Public entitiesengaged in the conduct of clinical research withthe establishment of research governance.The RGT is intended to provide the appropriate guidance and provision of essential tools in the form of templates, proformas or SOPs that will facilitate good research governance practice. ”

  7. The RGT Elements ETHICS INDUCTION IP TISSUE & DATA FINANCE LEGAL RISK • SOPs • Guidelines/Templates • Policy • Proformas • Training Module

  8. Research Ethics • The National Statement on Ethical Conduct in Human Research (2007) sets out the establishment of HRECs, their reviewing practices, the monitoring of such decision making and the conduct of the approved research itself.

  9. Research Ethics Introduction 5 Recommended recruitment strategies for HREC members 6 Monitoring Human Research Policy 7 Key Performance Indicators for HRECs and Research Administration Governance Units 13 Allocation of research to different levels of review 18 Models of Ethics Review 21 Handling research-related complaints 24 Conflict of interest - research-related activities 28 Template for HREC Report to Institution 30 Template for reporting HREC review waiver of requirement for consent 31 APPENDIX 1: HREC Terms of Reference Template 32 APPENDIX 2: CTA HREC Mutual Acceptance Submissions 36 APPENDIX 3: Recognised Prior Review Guidelines - Peter MacCallum Cancer Institute 39 APPENDIX 4: Low Risk Research Review Procedures - Melbourne Health 41 APPENDIX 5: Human Ethics Advisory Groups (HEAGS) - University of Melbourne 42 APPENDIX 6: Low Risk Research Application Form - Alfred Health 44 APPENDIX 7: Melbourne Health QA Guidelines 52 APPENDIX 8: Approval of a Quality Assurance Project Application Form 54 APPENDIX 9: Criteria for Allocation of Research to Different Levels of Review - Checklist 63 APPENDIX A: HREC Spokesperson Project Review 64 APPENDIX B: Project Summary Report For Ethics Committee 67 APPENDIX C: Template for HREC Report to Institution 69 APPENDIX D: Waiver of the Requirement for Consent 72

  10. Induction, Training and Accreditation • In order to perform good quality research the individuals and teams engaged in research must have access to appropriate training and guidelines

  11. Induction, Training and Accreditation Clinical Research Stakeholders p73 Introduction p74 KPIs for induction, training and accreditation of Research Governance Offices, Departments/Teams and Researchers p75 Research Governance Office New Starter Checklist p77 Research Governance Office Accreditation Checklist p79 Research Governance Office Checklist – ACHS Accreditation p83 Research Governance Office Audit Checklist – Researcher p91

  12. Induction, Training and Accreditation(1) Research Team – New team Checklist p93 New Researcher Checklist p95 Researcher Self-Accreditation Checklist p97 Investigator Self-Accreditation Checklist for Clinical Trials p99 VMIA requirements for drug & device trials under CTN scheme p102 APPENDIX 1: Checklist for induction, training and accreditation - Research Governance Office p104 APPENDIX 2: Checklist for induction, training and accreditation - Department/Team p105 APPENDIX 3: Checklist for induction, training and accreditation - Researcher

  13. Induction,Training & Accreditation ( 2) Training Modules Module 1 – National Statement of Ethical Conduct in Human Research Module 2 – Clinical Research Site SOPs Module 3 – VMIA CTN Guidelines Module 4 – ACHS Standards Module 5 – To describe the process to access TGA unapproved therapeutic goods (drugs and devices) Module 6 – Privacy – Overview of Privacy Law requirements for governance of research programs Training Module 7 – Radiation

  14. Research Finance Management • Having in place the appropriate tools to administer financial transactions intended for research purposes should facilitate better financial administration, better provision of accountability and assist with the institute’s annual reporting requirements

  15. Research Finance Management Introduction p123 Recommended clauses for Clinical Trial/Research Agreement p125 Research Grant Financial Management p126 Summary of Financial Position p129 Hospital Foundation Review of Research Funding Application Checklist p131

  16. Legal & Insurance Introduction p109 Version Control Coversheet p110 Contract creation, approval and execution SOP p111 Clinical Trial Preparation Agreement p114 Deed of Variation p117 Checklist for Participant Information & Informed Consent p118 Standard wording for research involving collection of drug use Information p119 Register of Research Ethics Compliance p120 APPENDIX 1: Flow Chart p122

  17. Data &Tissue Management • Research involving human tissue must observe the fundamental ethical principle of respect for tissue donor, including the provision of full information, consent, professional removal of samples and secure storage of the tissue to maintain confidentiality and privacy.

  18. Data &Tissue Management Introduction p135 Policy: Use of Human Tissue in Research p136 Establishment of Data/Biobank Checklist p140 Databank access request for research purposes p142 Use of cadaveric tissue for research p144 APPENDIX 1: Acknowledgement and Authorship p149

  19. Intellectual Property & Publication • Effective administration, protection and utilisation of an organisation’s Intellectual Property can provide important financial benefits to that organisation and thus can offset the substantial costs of an organisation’s investment in its research activity and contribute enormously towards its financial viability, reputation and ongoing success.

  20. Intellectual Property & Publication Introduction p151 Intellectual Property Policy p152 Review of Material Transfer Agreements p165 Material Transfer Deed p167 Non Disclosure Agreement (NDA/ Creation, Review and Execution) p175 Guidelines for Determining Authorship p181 Evidencing Inventorship p183 Invention Disclosure p186 Guidelines for Determining Authorship p181 Evidencing Inventorship p183 Invention Disclosure p186 APPENDIX 1: Standard Terms and Conditions on Intellectual Property p159 APPENDIX 2: Flow Chart p178 APPENDIX 3: Standard NDA Template Non Disclosure Agreement p179

  21. Research Risk Management • By definition “risk management’ describes the activities an organisation undertakes to manage the “effect of uncertainty on its objectives’. Equally as important however, it should be about seizing opportunities as well.

  22. Research Risk Management How to use the Research Risk Management Guide p189 Tools and Templates p190 Risk Management Glossary p191 Risk Management Process – AS 4360:2004 p194 Risk Management Policy and Procedure p195 Risk Management Framework Checklist p196 Opportunities for identifying risks in Research Organisations p198 Risk reporting by category sample only p199 Sample research ‘risks’ and ‘risk categories’ 1 p200

  23. Research Risk Management(2) Risk Summary Heat Map samples only p204 Risk Assessment template sample only p205 Risk Register template sample only p206 An Introduction to ‘Risk Management’ Powerpoint p207

  24. RGT • The challenges • The scope of works for the project were considerable given the allocated timeframe • Not mandating strongly a specific template for submitting work packages • The natural evolution of legislation or standards over the allocated project period • The ever evolving clinical trial landscape • Proof reading & final sign off.

  25. The Launch • RGT to be made officially available 2nd of June • Each VMIA insured healthcare & medical research entity involved in research will receive: • a hardcopy of the RGT • a CD with: • a complete PDF and word version • Each institute must protect the version control of their own RGT

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