Nov 2017

Version 1.5

Human Research Ethics Committee

Terms of Reference

This document was developed by Macquarie University Human Research Ethics Committee

Historical Notes:
Table of Amendments

Amendment
Date
Short Description
Version

Draft current terms of
12/11/2012
Terms of Reference drafted  1.0
reference
Revision of full
13/11/2012
Reviewed by Director,
1.1
document
Research Ethics
Submitted to the
16/11/2012
Reviewed by DVCR
1.2
DVC(R)
Submitted to the Vice-
23/11/2012
Approved by Vice-Chancel or  1.2
Chancellor
Terms of Reference
09/04/2015
Reviewed by Director,
1.3
Revised
Research Ethics and Integrity
and HRECs
Submitted to the Vice-
12/06/2015
Approved by Vice-Chancel or  1.3
Chancellor
Terms of Reference
05/08/2015
Reviewed by the Director,
1.4
Revised
Research Ethics and Integrity
Submitted to the
12/08/2015
Approved by the Deputy
1.4
Deputy Vice-Chancel or
Vice-Chancellor
Terms of Reference
09/06/2017
To HREC’s for review
1.5
Revised

HREC
Terms of Reference v1.5
Page 1

Definitions and Acronyms
Acronyms:

FMHS
Faculty of Medicine and Health Sciences
HREC
Human Research Ethics Committee

MUH
Macquarie University Hospital

MQ
Macquarie University
DVC(R)  Deputy  Vice Chancel or: Research

TGA
Therapeutic Goods Administration

NHMRC  National Health and Medical Research Council  SAE
Serious Adverse Event
SUSAR  Suspected Unforseen Serious Adverse Reaction  RO
Research Office
HDR
Higher Degree Research

SOPs
Standard Operating Procedures

Definitions:

NHMRC  –  National Health and Medical Research Council. Australia’s peak body for supporting health and
medical research; for developing health advice for the Australian community, health professionals and
governments; and for providing advice on ethical behaviour in health care and in the conduct of health and
medical research.
The National Statement – The National Statement on Ethical Conduct in Human Research (2007). The National
Statement  consists of a series of Guidelines made in accordance with the National Health and Medical
Research Council Act 1992. It is intended for use by researchers conducting research with human participants,
HREC members reviewing that research,  those involved in research governance, and potential research
participants.
The  National Statement  is developed jointly by the National Health and Medical Research Council, the
Australian Research Council and Universities Australia.
The Code  –  The  Australian Code for the Responsible Conduct of Research  (2007)  guides institutions and
researchers in responsible research practices and promotes integrity in research for researchers. The Code
shows how to manage breaches of the Code and allegations of research misconduct, how to manage research
data and materials, how to publish and disseminate research findings, including proper attribution of
authorship, how to conduct effective peer review and how to manage conflicts of interest. It also explains the
responsibilities and rights of researchers if they witness research misconduct.
The Code is developed jointly by the National Health and Medical Research Council, the Australian Research
Council and Universities Australia and has broad relevance across al  research disciplines.

1.
Preamble
1.1
The  National Statement  sets out that institutions must ensure that all research involving
human participants is designed and conducted in accordance with The Code and ethically
HREC
Terms of Reference v1.5
Page 3

link to page 5 reviewed and monitored in accordance with the National Statement.1  Organisations that
regularly undertake research involving humans may establish a HREC to review this research.

1.2
To  provide timely review of research protocols that involve  human participants  from
Macquarie University and MUH as required,  Macquarie University has established two
HRECs, the Human Sciences and Humanities HREC and the Medical Sciences HREC.  As well,
there are a number of faculty-based HRECs that assess low and negligible risk research. All
HRECs operate in accordance with the  National Statement  (Sec. 5.1.33).

2.
Objectives
The objectives of the  Macquarie University  The HREC (Medical Sciences) and the HREC
(Human Sciences and Humanities) are :
2.1
To protect the rights and welfare of research participants by ensuring that research projects
are designed in accordance with the  following values:
a.
Respect for human beings
b.
Research merit and integrity
c.
Justice
d.
Beneficence
2.2
To facilitate ethically good research through efficient and thorough review processes
developed  in accordance with the  National Statement.
2.3
To  minimise the risk of harm arising from research studies involving humans.
2.4
Promote the development of an ‘ethical consciousness’ through education of the academic
and professional community.

3.
Functions
3.1
Provide independent, sound and timely review of research projects  which involve human
research participants.
3.2
Ensure that researchers comply with the relevant guidelines on the conduct of human
research, including the National Statement and The Code, and other appropriate guidelines
and legislation as required.
3.3
Conduct regular monitoring processes to ensure that  ethical standards are maintained.
3.4
Provide ethics related advice to  researchers and their students,  visiting academics and other
personnel involved in the  conduct of health research.
3.5
To develop a policy and provide oversight of innovative surgery at MUH in order to provide
guidance to clinicians when assessing whether an innovative surgery constitutes research.
This is in accordance with the National Statement  Ch. 3.3.

1 Australian Government, National Health and Medical Research Council (NHMRC), The National Statement on Ethical
Conduct  in Human  Research (National Statement) s 5.1.1 <http://www.nhmrc.gov.au/book/chapter-5-1-institutional-
responsibilities>
HREC
Terms of Reference v1.5
Page 4

3.6
Receive complaints from research participants, researchers or others regarding the conduct
of human research projects and to deal with these in accordance with Macquarie University
policies and procedures.
3.7
Protect  the  privacy and confidentiality of research participants by ensuring that resea rchers
appropriately manage the  storage, security and disposal of confidential data collected during
the  conduct of research involving humans.
3.8
Promote an understanding of human research ethics within Macquarie University and the
broader community.
3.9
Provide advice to the other departments within the University including HDR, the DVC(R) on
matters relating to human research ethics.

4.
Scope of Responsibility
4.1
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) are
responsible for reviewing, approving and monitoring research protocols where humans are
involved in research and where  this research:
a.
Is undertaken by researchers and their students, visiting academics or medical
personnel and other  personnel formally recognised by the  University.
b.
Involves human participants recruited from Macquarie University, being staff or
students, or recruited externally.
c.
Is carried out using University or MUH equipment, facilities or premises owned by
the University or MUH or otherwise under control of the University or MUH.
d.
Is undertaken by individuals not affiliated by the University or MUH provided that
an agreement exists between the University/MUH and the external researchers that
defines the role of the HREC in providing ethical approval and ethical monitoring of
the research. The agreement will specify which party bears legal responsibility for
the  liabilities that arise from the  ethical review conducted by the  HREC.
4.2
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) can accept
another HREC ethical approval to allow both the release of funds and the commencement of
a research project, provided that such other  HREC  is properly constituted and registered with
the National Health and Medical Research Council.
4.3
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will provide
education and training to MACQUARIE UNIVERSITY  and MUH researchers and their students.

5.
Accountability and Reporting
5.1
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) are  an
advisory Committee of the DVC(R) mandated to:
a.
Approve  human research on ethical grounds
b.
Withhold human research approval on ethical grounds
c.
Suspend human research approval on ethical grounds
d.
Withdraw human research approval on ethical grounds
5.2
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) are
accountable to the VC through the DVC(R). They shall bring to the attention of the DVC(R)
HREC
Terms of Reference v1.5
Page 5

any issues relating to human research ethics that may constitute breaches of the
Macquarie  University Academic Honesty Policy, Macquarie University Code of Conduct,
National Statement  and The Code.
5.3
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will make the
Terms of Reference, Standard Operating Procedures and membership information publicly
available by posting them  on the  Research Office website.
5.4
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will provide
annual reports to:
a.
The NHMRC
b.
The NSW Privacy Commissioner in accordance with the requirements of the Health
Records and Information Privacy Act 2002 (NSW)
c.
The DVC(R)
5.5
The HREC (Medical Sciences)  and the HREC (Human Sciences and Humanities) will liaise
with the Dean, HDR  on matters of significant ethical concern regarding student research
projects.

6.
Membership
6.1
In accordance with the National Statement, Sec. 5.1.29 the HREC (Medical Sciences) and the
HREC  (Human  Sciences and Humanities)) will have a minimum membership of eight.  As  far as
possible, this will include:
a.
Equal numbers of men  and women
b.
A least one third of the members should be from outside of the institution
6.2
In accordance with the National Statement, Sec. 5.1.30 (a-f), the membership of the HREC
(Medical Sciences) and the HREC  (Human Sciences and Humanities) will constitute the
following:
a.
A Chairperson, with suitable experience and whose other responsibilities will not
impair the HREC’s capacity to carry out its obligations under the National
Statement.
b.
At least two lay people, one man and one woman, who have no affiliation with the
institution and do not currently engage in medical, scientific, legal or academic
work.
c.
At least one person with knowledge of, and current experience in, the professional
care, counselling or treatment  of people; for example, an allied health professional.
d.
At  least one  person who  performs a pastoral care role in the community.
e.
At  least one  lawyer, where  possible who is not engaged  to advise the  institution.
f.
At least two people with current research experience that is relevant to research
proposals to be considered at the  meetings  they  attend.
6.3
No member may be appointed in more than one of the above categories. The University may
establish a pool of inducted members in each category. These members may attend
meetings  as needed  to make  a quorum  and may also be available to provide expertise for the
research under review.
6.4
Wherever  possible one or more  of the  members  listed in 6.2 should be experienced  in ethical
decision-making.
HREC
Terms of Reference v1.5
Page 6

6.5
The HREC (Medical Sciences) will have access to scientific expertise, via the  Scientific Revi ew
sub-Committee in order to facilitate ethical issues arising from the protocol design. Where
necessary the HREC (Medical Sciences) may access the relevant expertise by going outside
the HREC membership.
6.6
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will maintain
an Executive  per HREC, consisting of the Chair, two  Deputy Chairs, the Director, Research
Ethics (if this is not the Chair) and one other (rotating) member of the HREC as required. This
Executive  will be responsible for issues that may arise outside of  session.

7.
Appointment  of Members
7.1
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) members may
recruited by direct approach from the Research Office. MUH and MACQUARIE UNIVERSITY
members will be formally nominated by the Faculty Dean. Members will be appointed by the
DVC(R) and the  VC  will formally approve all  memberships.
7.2
Prospective lay members will be recruited by word of mouth or direct approach. Lay
members  will be asked to  submit a curriculum vitae to the Research Office before formalising
membership.  Lay members  will be formally appointed by the  DVC(R).
7.3
Members are appointed for their expertise and not in a representative capacity.
7.4
All members including the Chairperson and Deputy Chairs will receive a letter of
appointment. The letter of appointment will include the date of appointment, length of
tenure, indemnity and termination. Members will also be provided with an orientation
package and will be asked to sign a confidentiality agreement  which indicates that all matters
of which the member becomes aware during the course of their work on the HREC (Medical
Sciences) will be kept  confidential and that any conflicts of interest will be declared.
7.5
Members will be provided with appropriate induction and support. Members will receive a
copy of the National Statement.
7.6
Members will be appointed for a period of three years with an opportunity to renew at the
end  of this period.
7.7
Members are expected to participate in education and training as required. Members are
expected to be familiar with the National Statement and other guidelines and legislation as
required.
7.8
The Chairperson of the HREC (Medical Sciences) and the Chairperson of the HREC (Human
Sciences and Humanities) will be available between meetings to undertake ethics business
and provide advice as required.
7.9
Membership will lapse if a member fails, without providing reason, to attend three
consecutive meeting or fails to attend at least five meetings in any one year. The Chair will
notify the member in writing prior to any lapse in membership. Termination of a member’s
appointment  will be in writing.
7.10
A member may resign at any time  upon giving notice in writing to the  Chair.
7.11
The DVC(R) may terminate the appointment of any member if the DVC(R) is of the opinion
that:
a.
It is necessary for the proper  and effective  functioning of the  HREC
HREC
Terms of Reference v1.5
Page 7

b.
The person is not a fit and proper person to serve on the HREC
c.
The  person has failed to carry out their duties as a HREC  member.

8.
Liability and Coverage
8.1
The University will provide indemnity for members of the HREC (Medical Sciences) and the
HREC (Human Sciences and Humanities) for any liabilities that may arise as a result of the
member  exercising their duties as a member  in good faith.

9.
Applications, Review and Approvals
9.1
Applications are to be submitted for review in accordance with the HREC (Medical Sciences)
and the HREC (Human Sciences and Humanities) Policy for the submission of ethics
applications.
9.2
All applications are to be submitted to the Ethics Secretariat, in hard or soft copy, by the
relevant closing date in a format  approved by the  Ethics Office.
9.3
Guidelines to assist applicants as well as document templates and policies and procedures
will be made available on the Research Office website.
9.4
The Ethics Secretariat will check applications for completeness and may request additional
information or corrections before submission to either the HREC (Medical Sciences) or the
HREC  (Human  Sciences and Humanities)
9.5
The HREC (Medical Sciences) or the HREC (Human Sciences and Humanities) may request the
applicant supply further information in relation to an application to clarify issues that may
arise during the course of review.
9.6
The HREC (Medical Sciences) or the HREC (Human Sciences and Humanities) may request an
applicant attend a meeting with a Committee Executive in order to facilitate review of a
research protocol. The HREC may also request an applicant attend a meeting of the HREC for
the  purpose of providing information to, and answering questions from, HREC  members.
9.7
The Ethics Secretariat will circulate the meeting agenda, previous meeting minutes and
associated documents and any new applications to all members of  the HREC (Medical
Sciences) or the HREC (Human Sciences and Humanities) at least 7 days prior to the meeting.
9.8
The HREC (Medical Sciences)  may delegate consideration of certain scientific/technical
matters to the Scientific Sub-Committee or a particular HREC member. The HREC (Medical
Sciences) may also obtain independent scientific or technical advice, subject to paragraph
6.5.
9.9
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) may take into
account the views and opinions of another properly constituted HREC in relation to a
research protocol.
9.10
The HREC (Medical Sciences) or the HREC (Human Sciences and Humanities) will notify the
applicant by email advising whether the  application which it has considered was approved i n
accordance with the  National Statement  within  10 working  days following a meeting.
9.11
The HREC (Medical Sciences) or the HREC (Human Sciences and Humanities)) will  notify the
applicant by email advising whether the application which it has considered needs
HREC
Terms of Reference v1.5
Page 8

amendments before it can be approved. Applicants will be advised that they have six weeks
in which to forward a response to the Committee. If a response is not received after six
weeks,  the  Ethics  Secretariat  will  send one reminder email advising that the file will be
closed, and a new application will need to be submitted for review, if a response is not
received within two weeks of the final reminder. If a file is closed due to no response having
been received the applicant must complete a new application to be submitted for review.
9.12
If the  application was rejected the HREC (Medical Sciences) or the HREC (Human Sciences and
Humanities) will inform the applicant in writing citing the relevant sections of the National
Statement.

10.
Meetings
10.1
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) meetings will
be conducted once a month between  February and November.
10.2
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) meeting dates,
and closing dates for the receipt of applications, will be advertised on the Research Office
website.
10.3
As set out in the National Statement Sec 5.1.29, the HREC (Medical Sciences) and the HREC
(Human Sciences and Humanities) meetings will require a minimum attendance of eight
members, with at least one third of these members from outside the institution, in order to
have a quorum.
10.4
Any member of the HREC (Medical Sciences) or the HREC (Human Sciences and Humanities)
who has a conflict of interest associated with a proposal or other related matter being
considered by their  HREC should declare such an interest at the earliest opportunity. The
member shall absent themselves from the meeting when the project is the subject of
consideration, and any related documentation regarding the project will be distributed to
other members of the  relevant  HREC separately. Once the HREC has considered the matter
and a decision has been reached, the member will be asked to return to the meeting. A
permanent item will be added to the meeting agenda whereby members can declare a
conflict of interest.  All declarations of interest and absences of members  will be minuted.
10.5
Where an institutional conflict of interest arises, this should be declared by a designated
officer at the request of the Chairperson. External expert reviewers will be recruited. These
reviewers will be required to declare an absence of conflict of interest and sign a
confidentiality agreement prior to undertaking review.
10.6
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will endeavour
to reach a unanimous decision concerning the ethical acceptability of a research protocol.
Where  a unanimous decision is not reached, the  decision will be considered to be carri ed by
a majority vote of two-thirds of members  who  examined the  proposal, providing the majority
includes at least one layperson. Minority views will be recorded in the  minutes.
10.7
Meetings will be conducted in such a way to encourage discussion, debate and the exchange
of ideas.

HREC
Terms of Reference v1.5
Page 9

11.
Fees
11.1
A fee will not be charged for applications submitted for assessment by the HREC (Medical
Sciences)  from researchers who are full-time, part-time or visiting appointees to the
University, unless engaged in sponsored research.
11.2
A fee will be charged for applications submitted for assessment by the  HREC (Medical
Sciences)  or the HREC (Human Sciences and Humanities)  from researchers who have no
formal affiliation with the University and  researchers who are appointees of MUH. These
researchers will be invoiced according the Macquarie University fee structure which i s  ma de
available on the Research Office website. These researchers will also be required to sign an
agreement with Macquarie University detailing the terms and conditions under which the
HREC (Medical Sciences) or the HREC (Human Sciences and Humanities) will review the
application and monitor the  protocol (once approved).

12.
Low and negligible risk research and research requiring expedited review
12.1
Research that is considered to be negligible or low risk will be submitted to the relevant
Faculty sub-Committee  for consideration.
12.2
Research that can requires expedited review, in accordance with the Macquarie University
policy regarding the submission ethics applications for health research, will be distributed  to
the relevant committee between meetings via a secure online review system.
12.3
Expedited review requests will be reviewed by the Chair, or the Chair’s delegate, and by a
nominated number of Committee  members.
12.4
Records will be kept of all expedited review applications. The Committee may decide to defer
an expedited review application to the HREC (Medical Sciences) or the HREC (Human
Sciences and Humanities) meeting  for further review if considerable ethical issues arise.
12.5
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) may defer an
expedited review application to the Scientific Sub-Committee for further review if
technical/scientific issues require further consideration.

13.
Records
13.1
The Ethics Secretariat will prepare and retain written records of the HREC (Medical Sciences)
and the  HREC  (Human Sciences and Humanities)  activities, including agendas and minutes of
all meetings  of  all meetings. Meeting minutes will be retained  in a  Minutes file in accordance
with the State Records Act.
13.2
The  Ethics Secretariat will prepare and maintain an official University file for each application
received. This will include a copy of the application, any relevant correspondence including
that between  the  applicant and the HREC  in accordance with the  State  Records Act.
13.3
Files will be kept  securely and confidentially in accordance with the  state and federal priva cy
legislation and the State Records Act. Files will remain open until a final report has been
received and the project closed off. A file may also be closed after two unsuccessful attempts
to contact the research personnel by email or by phone. An applicant may request in writing
HREC
Terms of Reference v1.5
Page 10

that an application is withdrawn. The Ethics Secretariat will close and archive the file in
accordance with the State Records Act.
13.4
Records will be held for sufficient time to allow for future reference. The minimum period of
retention  will be in accordance with The  Code  and the  State  Records Act.
13.5
The Ethics Secretariat will maintain a database of all applications received and reviewed.
13.6
The  Ethics Secretariat will maintain a record of all complaints received regarding the  activities
of the Committee. This record will include the complaint, the outcome of the complaint, and
any related investigations. A record of complaints received regarding HREC (Medical
Sciences)-approved research will also be maintained. This will include the complaint, the
outcome of the complaint and any related investigations.

14.
Monitoring and Reporting Requirements
14.1
The HREC (Medical Sciences) and the HREC (Human Sciences and Humanities) will monitor
approved projects in accordance with the National Statement  Ch. 5.5 to verify that the
conduct of the research conforms to the approved proposal.
14.2
Mechanisms for reporting include:
a.
Annual progress reports from researchers. If a project is deemed to be of
considerable risk to participants researchers may be requested to provide more
frequent  progress reports.
b.
Reports from  safety or other  monitoring boards
c.
Review of adverse event forms
d.
Other forms in accordance with the National Statement and at the discretion of the
HREC (Medical Sciences) or the  HREC  (Human Sciences and Humanities)
14.3
Researchers will be advised in the letter of final approval that they are required to submit
reports as a condition of approval.
14.4
The  Ethics Secretariat will send reminders to  the  Chief Investigator when  a report  is due.
14.5
The HREC (Medical Sciences) and the  HREC  (Human  Sciences and Humanities) will require, a s
a condition of final approval, that investigators immediately report any  of  the  following:
a.
Proposed changes to the protocol  or project  in the form of a request for
amendment
b.
Other unforeseen events that may affect the continued ethical acceptability of the
project
c.
If the  project is discontinued for any reason

15.
Complaints regarding approved research
15.1
Complaints about the conduct of an approved research project, whether from the research
participants, the general public or university staff or students, should be directed in writing in
the first instance to the Director, Research Ethics.
15.2
If a complainant provides their consent, the  complainant’s contact details will be recorded  i n
the Complaints file maintained by the Ethics Secretariat so that the outcome of the
investigation can be reported  to the  complainant.
HREC
Terms of Reference v1.5
Page 11

15.3
The complaints procedure will be made clear to research participants on the participant
information and consent form.
15.4
The Ethics Officer will notify the HREC (Medical Sciences) or the HREC (Human Sciences and
Humanities) members of the  complaint immediately after it has been received.
15.5
Complaints considered to raise the possibility of research misconduct, as outlined in the
Code, will be  referred immediately to the DVC(R).
15.6
Where a complaint alleges serious misconduct that falls outside of the range of research
misconduct as described in The Code, the matter will be dealt with in accordance with the
Macquarie University Grievance Management Policy  and other relevant policies and
procedures.

16.
Complaints regarding the HREC review processes
16.1
Complaints regarding the process of review should be directed in writing in the  first insta nce
to the Director, Research Ethics. If this is not successfully resolved, the complaint should be
managed in accordance with the  Macquarie University grievance procedure.
16.2
The complaint may be referred to the DVC(R) in accordance with these  procedures.

HREC
Terms of Reference v1.5
Page 12

Notes:
__________________________________________________________________________________
HREC
Terms of Reference v1.5
Page 13

_+______

HUMAN RESEARCH ETHICS

Research Office | Level 3, C5C  Building
Macquarie  University, NSW 2109, Australia

E: xxxxxx.xxxxxxxxxxx@xx.xxx.xx
http://www.mq.edu.au/research/about-research-at-macquarie/research-integrity-and-ethics

HREC
Terms of Reference v1.5
Page 14

Document Outline