Review of medical sciences ethics applications
Purpose:
This policy establishes the guidelines for the submission of ethics applications to conduct research
including sponsored trials, clinical trials and clinical research. This policy applies to research being
undertaken in Macquarie University Hospital (MUH), Australian School of Advanced Medicine
(ASAM), and the Departments of Chiropractic and Physiotherapy. It will apply to other research
projects at the discretion of the Director, Research Ethics.
Overview:
Macquarie University is committed to conducting its research in an ethical and accountable way. In
accordance with the MUH Clinical Research Policy and research policies and by-laws, Macquarie
University must ensure human research is compliant with the National Health and Medical Research
Council’s National Statement on Ethical Conduct in Human Research (2007), the Australian Code for
the Responsible Conduct of Research (2007), and other relevant guidelines and legislation.
This policy sets out the requirements for the submission of ethics applications to the Macquarie
University Human Research Ethics Committees (HRECs) for review.
Definitions and acronyms:
Human Research: Any research activity that is conducted with or about people, or involves the use
of their data and tissue.
Clinical Trial: Any research that prospectively assigns participants to one or more health-related
interventions to evaluate the effects on health outcomes is considered to be a clinical trial. A
medical intervention can include any intervention used to modify a health outcome and can include
drugs, surgical procedures, devices, behavioural treatments, etc. (Definition taken from the
Australian New Zealand Clinical Trials Registry (ANZCTR) FAQs http://www.anzctr.org.au/faq.aspx).
Sponsored Trial: Commercially-sponsored clinical trials including co-operative/collaborative trials
with commercial sponsorship.
Clinical Research: Research undertaken in combination with patient care with one or more of its
components designed to confer diagnostic, prophylactic or therapeutic benefits on the individuals
involved in addition to the development of new health knowledge.
Non-Clinical Research: Research undertaken on patients or other participants, or with their data,
with the sole intention of contributing to knowledge.
HREC (Medical Sciences)
Policy
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National Statement on Ethical Conduct in Human Research (2007): The National Statement clarifies
the responsibilities of institutions, researchers and review bodies for the ethical design, review,
conduct and dissemination of results of human research.
Australian Code for the Responsible Conduct of Research (2007): The Code provides guidance to
institutions and researchers about responsible research practices.
Greater than Low Risk: According to the National Statement a risk is “the likelihood that a harm (or
discomfort or inconvenience) will occur” and “the severity of the harm, including its consequences”.
Any application which may lead to harms for the participants is considered to be greater than low
risk.
ASAM: Australian School of Advanced Medicine
HREC: Human Research Ethics Committee
MQ: Macquarie University
MUH: Macquarie University Hospital
NEAF: National Ethics Application Form
NHMRC: National Health and Medical Research Council
Scope:
This policy applies to Macquarie University (MQ) and MUH researchers and their students, visiting
academics or medical personnel and other personnel involved in the conduct of health research
including sponsored trials, clinical trials and clinical research in the following areas:






MUH
ASAM
Physiotherapy
Chiropractic
Any research with human tissue
Other research, at the discretion of the Director, Research Ethics
Policy:
This policy applies to researchers conducting the following types of research:
1.
Single or multi-site research including clinical trials, sponsored trials and clinical research at a
public hospital, where MQ and/or MUH is not a site.
Multi-site
research
HREC (Medical Sciences)
MQ or MUH
NOT a site
Policy
External
application
noted
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Single or multi-site research must be approved by any of the following NHMRC-approved
HRECs:

NSW Health HRECs (or state-equivalent) or Lead HRECs
http://www.health.nsw.gov.au/ethics/research/contactshrec.asp

Cancer Institute NSW Clinical Research Ethics Committee
http://www.cancerinstitute.org.au/cancer_inst/research/ethics.html
Providing research will not be conducted at MUH, the MQ External HREC Application
Approval Form can be submitted with a copy of the external ethics application form, the
final approval letter from the external HREC and all correspondence between the
investigator and the external HREC. In this instance the external ethics approval will be
accepted by the Committee.
2. Research involving a public organisation where there is a fully-constituted HREC and public
organisation participants and where the research will not be conducted at MQ or MUH.
Public
organisation
and their
participants
Public
organisation's
HREC
approves the
research
MQ accepts
the approval
of the public
organisation's
HREC and
approves the
research
If the research has been approved by any of the following HRECs:

Justice Health

Australian Government (including Department of Veterans Affairs, Medicare etc.)

Another University
and includes non-MQ or non-MUH participants, providing the research will not be
undertaken at MQ, researchers can submit the external application form together with their
ethics approval form. This will be considered by the Committee Executive and the external
approval will be accepted.
HREC (Medical Sciences)
Policy
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3.
Multi-site research including sponsored trials, clinical trials and clinical research conducted
at public health and/or other institutions that include MQ personnel and where MUH or MQ
is listed as a site.
Multi-site
research
MQ or MUH
included as a
site
Submit to MQ
HREC for
review
If the research has been reviewed by a NSW, or state-equivalent, public health HREC or
another University, and MQ and/or MUH is to be included as a site, researchers must obtain
HREC approval from MQ in addition to approvals already obtained from other sites.
4.
Single-site or multi-site research including sponsored trials, clinical trials and clinical research
where MQ and MUH personnel are listed as investigators and where all the participating
sites are private (that is, not part of the public health system), which may or may not include
MUH.
Multi-site
research by
MQ
researchers
MQ
researchers
involved
and/or MQ
or MUH a
site
Submit to
MQ HREC for
review
If the research is conducted at multiple sites by MQ or MUH personnel then researchers
must obtain HREC approval from MQ in addition to approvals obtained from other
institutions.
All research being conducted at MUH and ASAM must be signed off prior to submission by
the Dean, Professor Simon Foote.
HREC (Medical Sciences)
Policy
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Appendix A: Table documenting approval requirements for MQ
Public institution/
site (examples)
Government
Department
MQ/MUH
as site
NSW Health and
Cancer Council
x

x

NSW Health and
Cancer Council

NSW Health and
Cancer Council
Staff/Students
x

(MQ supervisor not
included on external
research protocol)

NSW Health
Research at
MUH/MQ
HREC (Medical Sciences)




Application Type
Documents
Review Process
Decision
Request to access participants in
Government organisation, e.g.
Veterans
Notifying HREC of external
project of which MQ researchers
affiliated
Request for student to access
dataset as part of postgraduate
research
Government Department
application form & MQ external
review form
NSW Health NEAF & MQ external
review form
Executive review
HREC accepts
and approves
Executive review
NEAF & letter from NSW Health
granting approval for MQ
supervisor to access data in
supervisory role
Executive review
HREC accepts
External
Review
Accept and
approve
Request for researcher to access
dataset as part of research
HREC meeting review
Approve
Request to include MQ /MUH as
a site in multi-site research
project already approved by NSW
Health
Request to conduct research at
MQ/MUH or including MUH/MQ
NSW Health NEAF and MQ
Expedited Approval Form for
MUH/MQ.
MQ application (to
request access to
dataset)
HREC Expedited
Review
MQ HREC review
Approve
Policy
Submit full application to HREC
for review
Approve
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