HUMAN RESEARCH ETHICS POLICY
RELEVANT LEGISLATION
Regulation 17.1.R8 - Code of Conduct for Research
Australian Code for the Responsible Conduct of Research
National Statement on Ethical Conduct in Human Research
SCOPE
This policy applies to all research conducted with or about people, their data or tissue.
POLICY
1. Principles
1.1 The University is committed to the ethical conduct of human research.
1.2 The University considers that in order to be considered ethical, human research must
meet the following principles:
o
1.2.1 Respect for the rights, interests and welfare of the participants in human
research;
o
1.2.2 Beneficence through minimising risk of harm or burden to research
participants and enhancing potential benefits of research;
o
1.2.3
Justice in the distribution of benefits and burdens of research; and
o
1.2.4
Research merit and integrity.
2. Responsibilities
2.1 Before human research may be undertaken, researchers must obtain the approval of a
properly constituted Human Research Ethics Committee (HREC) for more than low-risk
research, or Human Ethics Advisory Group (HEAG) for low-risk research.
2.2 Approval for human research from an external organisation or institution other than the
University of Melbourne must be registered with the University.
2.3 Researchers will carry out human research only as approved.
2.4 Researchers must obtain approval for any amendments to the approved human research
activity prior to the implementation of any amendment or change.
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2.5 Researchers will act on and will promptly report adverse events in accordance with the
Human Research Adverse Event Procedure.
2.6 Researchers will report annually on the progress of the approved human research.
2.7 The University will maintain and resource the system required for the ethics review of
human research to ensure that regulatory requirements and ethical principles are met.
2.8 The University will provide training and education in the theory and practice of the ethical
conduct of human research.
2.9 The University will promulgate clear statements of policy, procedures and guidelines for
the ethical conduct of human research.
3. Framework for the ethics review of human research
3.1 The University will maintain a Human Research Ethics Committee that will have oversight
of all matters pertaining to the ethics review of human research at the University. This
committee is called the Central Human Research Ethics Committee (CHREC).
3.1.1
The CHREC will be properly constituted according to the National Statement on
Ethical Conduct in Human Research.
3.2 The CHREC will report via the Research Ethics and Integrity Strategy Committee to the
Committee of Associate Deans (Research) and the Deputy Vice-Chancellor (Research).
3.3 Human Ethics Sub-Committees (HESCs) will consider applications for ethics approval of
human research from researchers of the University.
3.3.1
HESCs will be properly constituted Human Research Ethics Committees
according to the National Statement on Ethical Conduct in Human Research.
3.3.2
HESCs will report to the CHREC.
3.4 Human Ethics Advisory Groups (HEAGs) will provide advice to HESCs about the
research merit of research submitted for ethics approval. They are empowered to
approve specified types of low risk research in accordance the provisions of the National
Statement on Ethical Conduct in Human Research.
3.4.1
HEAGs are not necessarily constituted as human research ethics committees in
the terms of the National Statement on Ethical Conduct in Human Research.
3.4.2
HEAGs will report to HESCs.
3.5 The CHREC will set the terms of reference for the HESCs and HEAGs.
3.6 Members of CHREC, HESCs and HEAGs will act in good faith and with integrity, and in
accordance with the terms of reference of their committees.
3.7 Members of CHREC, HESCs and HEAGs should disclose to their committee or advisory
group any actual or potential conflict of interest, including any financial or other interest or
affiliation that bears on any research coming before the review body.
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3.8 Complaints about HEAG and HESC processes or decisions, or with regard to human
research at the University will be handled in accordance with the Human Research Ethics
Complaints Procedure.
4. Melbourne Human Research Standards (MHRSs)
4.1 The CHREC will endorse a set of MHRSs, which will guide the ethical conduct of
research involving humans.
4.2 MHRSs will be made according to the Melbourne Human Research Standards
Procedure.
4.3 Researchers will refer to the MHRSs when making applications for human research
ethics approval.
4.4 HESCs and HEAGs will refer to the MHRSs when reviewing and making decisions about
applications for human research ethics approval.
RELATED DOCUMENTS
Human Research Adverse Event Procedure
Human Research Ethics Complaints Procedure
Melbourne Human Research Standards Procedure
Melbourne Human Research Standards
DEFINITIONS
Term
Low risk
Definition
As defined in the National Statement on Ethical Conduct in Human
Research
Researcher
Student, staff, honorary staff, visitor or anyone engaged in research at
the University of Melbourne.
Student engaged in research at the University of Melbourne as part of a
graduate or undergraduate course.
Research is broadly understood as scholarly activity intended to
produce new knowledge or new interpretation of existing knowledge. It
excludes routine data collection and analysis for University purposes
and the development of teaching materials.
Research involving humans includes any research conducted with or
about humans, their data or their tissue.
The National Statement on Ethical Conduct in Human Research defines
Student researcher
Research
Human research
Research merit
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research merit as research that is:
a. justifiable by its potential benefit, which may include its
contribution to knowledge and understanding, to improved
social welfare and individual wellbeing, and to the skill and
expertise of researchers. What constitutes potential benefit and
whether it justifies research may sometimes require consultation
with the relevant communities;
b. designed or developed using methods appropriate for achieving
the aims of the proposal;
c. based on a thorough study of the current literature, as well as
previous studies. This does not exclude the possibility of novel
research for which there is little or no literature available, or
research requiring a quick response to an unforeseen situation;
d. designed to ensure that respect for the participants is not
compromised by the aims of the research, by the way it is
carried out, or by the results;
e. conducted or supervised by persons or teams with experience,
qualifications and competence that are appropriate for the
research; and
f. conducted using facilities and resources appropriate for the
research.
RESPONSIBLE OFFICER
The Deputy Vice-Chancellor (Research) is responsible for the development, compliance monitoring
and review of this policy and any associated schedules, procedures and guidelines.
IMPLEMENTATION OFFICER
The Director, Office for Research Ethics and Integrity is responsible for the promulgation and
implementation of this policy in accordance with the scope outlined above. Enquiries about
interpretation of this policy should be directed to the Implementation Officer.
REVIEW
This policy is to be reviewed by XX/XX/XXXX.
VERSION HISTORY
Version
Approved By
Approval Date
1.0
Director, OREI
26 May 2014
Draft HRE Policy
Effective Date
Sections Modified
Consultation version
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Keywords
Draft HRE Policy
human, research, ethics
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