research governance toolkit the journey thus far bill karanatsios 20 may 2010
TRANSCRIPT
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.
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
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
RESEARCHRESEARCH GOVERNANCEGOVERNANCE
TOOLKITTOOLKITFOR VICTORIAN PUBLIC HOSPITALS
AND VMIA INSURED MEDICAL RESEARCH INSTITUTES
“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. ”
The RGT Elements
ETHICS INDUCTION RISKLEGALFINANCETISSUE &
DATAIP
•SOPs
•Guidelines/Templates
•Policy
•Proformas
•Training Module
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.
Bernice Davies Barwon Health
Jill Davis Austin Health
Lisa Nelson Nucleus Network
Suzanne HasthorpeDepartment of Human Services
Andrea Johanessen St Vincent's Hospital
LeeAnne Clavarino Peninsula Health
Peter DislerBendigo Health Care Group
Angela Watt Melbourne Health
Rowan Frew Alfred Health
Jeremy KennerPeter MacCallum Cancer Centre
Paul Komesaroff Alfred Health
Angela Henjak Alfred Health
Lai Wan Reid Eastern Health
Louise Sillar Western Health
Deb Dell Southern Health
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 Melbourne42
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
RESEARCH ETHICS
Key Performance Indicators (KPIs) for HRECs
and Research Administration Governance Units continued
1. Procedure
HREC Administrators’ Key Performance Indicators
Core business Goal Detail KPI Source (if required)
AHEC Annual Report
Annual Report submitted accurately and by the deadline as determined by AHEC
AHEC Report to government agencies on behalf of the institution
Reports submitted accurately and on time
Victorian Health Services Commissioner Annual Report
Annual Report submitted accurately and by the deadline as determined by the Office of the Victorian Health Services Commissioner
s. 4.8-4.10 of the Health Records Act 2001 (Victoria) Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1(e)(iii) and 2.2(g)(iii)
Report to institution
Reports submitted accurately and on time
Internal report, for example, Board or Research Committee
As required by organisation, for example monthly or annually
Institutional requirements
May be specified in HREC Terms of Reference
RESEARCH ETHICS
APPENDIX 9: Criteria for Allocation of Research to Different Levels of Review - Checklist
Allocation to Different Levels of Review – Checklist
Ticks in the High Risk column Full HREC Review is required.
Ticks in the low risk column but not in the high risk column >project requires “Low Risk Ethical Review” at a minimum.
Ticks in the negligible risk column only (which can only relate to “inconvenience”) >project may be exempt from Ethical Review.
1 Risk – a potential for harm, discomfort or inconvenience. It involves (a) the likelihood that a harm (or discomfort or inconvenience) will occur; and (b) the severity of the harm, including its consequences. 2 Negligible Risk – research where there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience. 3 Low Risk – research where the only foreseeable risk is one of discomfort. 4 High Risk – research where the risk is more serious than discomfort.
Type of Risk1 Level of Risk
Negligible2 Low risk3 High risk4
Physical harm
Psychological harm
Devaluation of personal worth
Social harm
Economic harm
Legal harm
Discomfort
Inconvenience
Level of Review Allocated:
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
Andy Giddy Nucleus Network
Denise Byrne St Vincent's Hospital
Angela Gray (MH) Melbourne Health
Marianne HundlingPeter MacCallum Cancer Centre
John McNeil Alfred Health
Jill Davis Austin Health
Robyn Lichter Nucleus Network
Rowan Frew Alfred Health
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
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
Induction,Training & Accreditation ( 2)
Training ModulesModule 1 – National Statement of Ethical Conduct in Human
ResearchModule 2 – Clinical Research Site SOPsModule 3 – VMIA CTN GuidelinesModule 4 – ACHS StandardsModule 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 programsTraining Module 7 – Radiation
INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mmm-yyyy
Research Governance Office New Starter Checklist
Section 1 – Employee (New Starter) Details Manager to complete all sections
Section 2 – Pre-Start Date Requirements The following actions should be completed prior to the new employee starting date
No. Description Required Completed
2.1 Request Employee Contract by completing [institution’s hiring form]and ensure employment pack has been sent to employee
Yes / No / NA
2.2 Prepare Job Description, ready for sign off on day 1 Yes / No / NA
2.3 Create Training File Yes / No / NA
2.4 Determine training requirements for position and review requirements are correct for the position
Yes / No / NA
2.5 Complete new IT Account creation form Yes / No / NA
2.6 Organise/assign Desk and/or working space Yes / No / NA
2.7 Organise for new phone extension and update phone list (if required) Yes / No / NA
2.8 Assign Mentor/Buddy Yes / No / NA
2.9 Book employee into next scheduled [institute] Induction Yes / No / NA
Full Name : Position / Title :
Type of Position : Existing New Proposed Start Date:
Clasification : Permament Full Time Permanent Part-Time Casual
Generic Job Description : Yes Requires Updating To be created
Primary Site :
Manager’s Full Name : Position / Title :
INDUCTION, TRAINING & ACCREDITATION Document: [xxxxxxxxx] Implementation Date: dd-mmm-yyyy
Research Governance Office New Starter Checklist
3.11 Sign-off IT Policy prior to obtaining IT Network Access Yes / No / NA
3.12 Quick Tour of our Intranet Yes / No / NA
3.13 Complete Facility Orienation Checklist for Primary Site Yes / No / NA
3.14 If Employee is to work at multiple sites, organise a Facility Orientation for other sites
Yes / No / NA
Section 4 – Access to Key information
No. Description Required Completed
4.1 Ensure new employee has access to ‘National Statement on Ethical Conduct in Human Research, 2007’ Yes / No / NA
4.2 Ensure new employee has access to Research Governance Office & HREC SOPs
Yes / No / NA
4.3 Ensure new employee has access to [insititute] Policies & SOPs Yes / No / NA
4.4 Ensure new employee has access to ‘Australian Clinical Trial Handbook’, TGA, 2006
Yes / No / NA
4.5 Ensure new employee has access to ‘VMIA Guidelines for Clinical Trials for Victorian Public Hospitals, 2009’
Yes / No / NA
4.6 Ensure new employee has access to ‘Access to Unapproved Therapeutic Goods – Clinical trials in Australia, TGA, 2004’
Yes / No / NA
4.7 Ensure new employee has access to ‘Note for Guidance on Good Clinical practice (CPMP/ICH/135/95) annotated with TGA comments,, TGA, 2000’
Yes / No / NA
4.8 Ensure new employee has access to ‘Australian Code for the Responsible Conduct of Research, NHMRC, 2007’
Yes / No / NA
4.9 Ensure new employee has access to ‘Privacy Act, 1988’’ Yes / No / NA
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
David Rees (SVI) St Vincent's Institute
Katerina Canellopoulos (MH) Melbourne Health
Sianna Panagiotopoulos Austin Health
Marie LuciClinical Trials Australia
Patricia Molloy (Eastern) Eastern Health
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
Legal & Insurance
Introduction p109Version Control Coversheet p110Contract creation, approval and execution SOP p111Clinical Trial Preparation Agreement p114Deed of Variation p117Checklist for Participant Information & Informed Consent p118Standard wording for research involving collection of drug use Information p119Register of Research Ethics Compliance p120 APPENDIX 1: Flow Chart p122
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.
Lisa Devereux PeterMac
Bradley Crammond Monash
Kordula Dunscombe Alfred Health
Carmel Murone Ludwig Institute
Anthony PeningtonBernard O'Brien Institute
Data &Tissue Management
Introduction p135
Policy: Use of Human Tissue in Research p136
Establishment of Data/Biobank Checklist p140
Databank access request for research purposesp142
Use of cadaveric tissue for research p144
APPENDIX 1: Acknowledgement and Authorship p149
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.
Jacqueline Barry St Vincent's Hospital
Tony Mason St Vincent's Institute
Robert Merriel Melbourne Health
Shari Lofthouse Peter MacCallum
Heather Gallicio Alfred Health
Fiona Nelms Baker Institute
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
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.
Leanne Toby VMIA
Virginia Leopold St Vincent's Institute
Kathryn Frowen Southern Health
Rosemary French Burnet Institute
Janine Peterson (RWH)
Royal Women's Hospital
Eva Booth (Austin) Austin Health
John McNeil (Alfred) Alfred Health
Robin Luber (NN) Nucleus Network
Jack Beever Barwon Health
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
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
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.
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