Research Governance ToolkitThe 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

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