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.
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
RESEARCH
GOVERNANCE
TOOLKIT
FOR VICTORIAN PUBLIC HOSPITALS
AND VMIA INSURED MEDICAL RESEARCH INSTITUTES
“The Research Governance Toolkit has been
developed to assist Victorian Public entities
engaged in the conduct of clinical research with
the 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
•SOPs
•Guidelines/Templates
•Policy
•Proformas
•Training Module
IP
TISSUE &
DATA
FINANCE
LEGAL
RISK
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.
Angela Watt
Melbourne Health
Bernice Davies
Barwon Health
Rowan Frew
Alfred Health
Jill Davis
Austin Health
Jeremy Kenner
Peter MacCallum
Cancer Centre
Lisa Nelson
Nucleus Network
Paul Komesaroff
Alfred Health
Suzanne Hasthorpe
Department of Human
Services
Angela Henjak
Alfred Health
Andrea Johanessen
St Vincent's Hospital
Lai Wan Reid
Eastern Health
LeeAnne Clavarino
Peninsula Health
Louise Sillar
Western Health
Peter Disler
Bendigo Health Care
Group
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 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
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)
Report to
government
agencies on
behalf of the
institution
Reports submitted
accurately and on
time
AHEC Annual
Report
Annual Report submitted
accurately and by the
deadline as determined
by AHEC
AHEC
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)
Internal report, for
example, Board or
Research
Committee
As required by
organisation, for example
monthly or annually
Institutional
requirements
Report to
institution
Reports submitted
accurately and on
time
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.
Type of Risk
1
Level of Risk
Negligible
Physical harm
Psychological harm
Devaluation of personal worth
Social harm
Economic harm
Legal harm
Discomfort
Inconvenience
Level of Review Allocated:
2
Low risk
3
High risk
4
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 Hundling
Peter 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
Introduction
KPIs for induction, training and accreditation of Research
Governance Offices, Departments/Teams and Researchers
Research Governance Office New Starter Checklist
Research Governance Office Accreditation Checklist
Research Governance Office Checklist – ACHS Accreditation
Research Governance Office Audit Checklist – Researcher
p73
p74
p75
p77
p79
p83
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 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
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
Full Name :
Position / Title :
Type of Position :
 Existing
 New
Clasification :
 Permament Full Time Permanent Part-Time
 Casual
Generic Job Description :
 Yes
 To be created
Proposed Start Date:
 Requires Updating
Primary Site :
Manager’s Full Name :
Position / Title :
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

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
4.1
Ensure new employee has access to ‘National Statement on Ethical Conduct
in Human Research, 2007’
Yes / No / NA

Completed
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 Luci
Clinical Trials
Australia
Patricia Molloy
(Eastern)
Eastern Health
Research Finance Management
Introduction
Recommended clauses for Clinical Trial/Research Agreement
Research Grant Financial Management
Summary of Financial Position
Hospital Foundation Review of Research Funding
Application Checklist
p123
p125
p126
p129
p131
Legal & Insurance
Introduction
Version Control Coversheet
Contract creation, approval and execution SOP
Clinical Trial Preparation Agreement
Deed of Variation
Checklist for Participant Information & Informed Consent
Standard wording for research involving collection of drug use
Information
Register of Research Ethics Compliance
APPENDIX 1: Flow Chart
p109
p110
p111
p114
p117
p118
p119
p120
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 Penington
Bernard O'Brien
Institute
Data &Tissue Management
Introduction
Policy: Use of Human Tissue in Research
Establishment of Data/Biobank Checklist
Databank access request for research purposes
Use of cadaveric tissue for research
APPENDIX 1: Acknowledgement and Authorship
p135
p136
p140
p142
p144
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
Intellectual Property Policy
Review of Material Transfer Agreements
Material Transfer Deed
Non Disclosure Agreement
(NDA/ Creation, Review and Execution)
Guidelines for Determining Authorship
Evidencing Inventorship
Invention Disclosure
Guidelines for Determining Authorship
Evidencing Inventorship
Invention Disclosure
APPENDIX 1: Standard Terms and Conditions on Intellectual Property
APPENDIX 2: Flow Chart
APPENDIX 3: Standard NDA Template Non Disclosure Agreement
p151
p152
p165
p167
p175
p181
p183
p186
p181
p183
p186
p159
p178
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
Tools and Templates
Risk Management Glossary
Risk Management Process – AS 4360:2004
Risk Management Policy and Procedure
Risk Management Framework Checklist
Opportunities for identifying risks in Research Organisations
Risk reporting by category sample only
Sample research ‘risks’ and ‘risk categories’ 1
p189
p190
p191
p194
p195
p196
p198
p199
p200
Research Risk Management(2)
Risk Summary Heat Map samples only
Risk Assessment template sample only
Risk Register template sample only
An Introduction to ‘Risk Management’ Powerpoint
p204
p205
p206
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