Professional Development Workshop
Governance Approval for an Investigator-Initiated Clinical Trial: a Scenario-Based
Workshop.
A professional development workshop for research managers and administrators, across all sectors,
presented by the Australasian Research Management Society (ARMS) NSW Chapter. With the
generous support of the Kolling Institute of Medical Research, Northern Sydney Local Health
District, and with support from the ARMS Ethics and Research Integrity Special Interest Group and
its Australasian Ethics Network Stream.
Many Australian universities, medical research institutes and hospitals are involved in securing
approval for and conducting clinical trials. Commercially sponsored clinical trials have the
benefit of significant resources to ensure that the trial adheres to legal requirements, best
practice and good clinical practice; however, they are the smaller proportion of clinical trial
activity conducted within NSW Public Health Organisations. It is investigator-initiated,
institution-sponsored clinical trials that could significantly change healthcare delivery across the
state, and yet they often experience unnecessary delays in receiving approvals.
This professional development workshop will provide an introduction to the Australian and
NSW clinical trial landscape and then deliver a practical scenario-based workshop to provide
advice for those involved in non-commercially-sponsored clinical trials, including staff within
universities, medical research institutes and hospitals. The presenters and facilitators will be
practicing research governance and clinical trials staff, who will guide you in working through a
real-world scenario to give you hands-on insights into what it takes to get clinical trials
approved within a hospital environment.
Research managers and administrators have a critical part to play in successful approvals and
ongoing governance of clinical trials, so come along to learn more about how to do this in
practice.
Date:
Thursday 23 April 2015, 9am–2:15pm
Venue: TBC (either the Kolling or UNSW)
Cost:
Time
9:00
9:05
9:50
10:10
Members: $60
Non-members: $80
Program
Welcome
The changing landscape for clinical trials in Australia (Dr Gordon McGurk)
Introduction to clinical trials, and associated responsibilities and risks
Workshop – Part A
The research project will be introduced. Workshop participants will work with
facilitators to identify the initial risks and potential mitigation strategies.
11:10
11:30
13:15
Morning tea
Workshop – Part B
Further information related to the conduct of the study will be uncovered.
Participants will determine what other mitigation strategies will need to be
implemented before approval is given and patients can be recruited into the trial.
Networking lunch (concluding 2:15pm)
About the presenters and facilitators
Karyn Joyner, Chief Operating Officer of Research at the Kolling Institute of Medical Research
Karyn is Chief Operating Officer of Research at the Kolling. She was previously the Research &
Operations Manager at the Kids Research Institute, The Children’s Hospital at Westmead, where
she was responsible for managing laboratories and animal housing, clinical trials development,
ethics and governance approvals, IP & commercialisation, resource optimisation, and strategic
development. Karyn is an experienced senior executive with more than 18 years in research
leadership and management across commercial, university and health sectors, including working
in pharmaceutical regulatory affairs and research planning, entrepreneurial commercialisation
and business development, and health and medical research operations.
Gordon McGurk Ph.D., Director, Clinical Trials Section, National Health & Medical Research
Council
Gordon leads the Clinical Trials Section of the NHMRC which is focusing on implementation of
the Australian Government’s commitments to streamlining ethics and research governance
approvals for clinical trials. His previous roles at NHMRC have included a focus on issues around
research integrity and the Australian Code for Responsible Conduct of Research, and for
development and implementation of strategies for monitoring the use of public funding for
health and medical research. He currently chairs the Australian and New Zealand Standards subcommittee responsible for developing AS/NZS 2243.3 (2010): Microbiological Containment :
Safety in Laboratories, and is a board member of the association of biosafety for Australia and
New Zealand. Gordon has a Doctor of Philosophy from the University of Edinburgh, for research
in genetics and molecular biology.
Maria Mury, Research Governance and Compliance Manager, Northern Sydney Local Health
District
Maria is responsible for the governance of all research activities across the NSLHD to ensure
compliance with the relevant Hospital & NSLHD policies and procedures, NSW Health Directives
and other relevant State and Federal guidelines, regulations and legislations. Her role has a
strategic focus on developing and implementing the NSLHD’s Research Risk Management and
Mitigation program as well as providing advice to the Chief Operating Officer for Research with
regards to the development and implementation of governance structures that support research.
Maria has worked in medical research for over 15 years; she is a registered nurse and has held
previous positions such as executive officer for an NHMRC accredited HREC and project manager
for large randomised clinical trials in medical oncology.