Skip to Content

HREC Terms of Reference

1. Objectives2. Functions3. Accountability4. Responsibilities5. Status6. Membership7. Conduct of business8. Appeals and complaints9. Amendments10. Termination of HREC responsibility11. Fees12. Further questions

1. Objectives

The objectives of the Iris Ethics Human Research Ethics Committee (HREC) are to:

  • Protect the mental and physical welfare, rights, dignity and safety of participants of research;
  • Promote ethical principles in human research;
  • Review research in accordance with the National Statement on Ethical Conduct in Human Research 2025 (National Statement); and
  • Facilitate ethical research through efficient and effective review processes.

2. Functions

The HREC functions on behalf of Iris Ethics to:

  • Provide independent oversight of human research projects;
  • Provide competent, timely review and monitoring of human research projects in respect of their ethical and scientific acceptability for as long as projects are active;
  • Determine the compliance of a human research and/or evaluation project with the National Statement and grant, withhold or withdraw ethical approval; and
  • Provide advice to Iris Ethics on strategies and resources to promote awareness of the ethical conduct of human research.

3. Accountability

  • The HREC is accountable to the Managing Director of Iris Ethics in the conduct of its business.
  • The HREC shall provide regular reports, at least on an annual basis to the Managing Director, which will include information on membership, the number of proposals reviewed, status of proposals, a description of any complaints received and their outcome, and general issues raised.
  • The HREC may from time to time bring to the attention of the Managing Director issues of significant concern.
  • The HREC will provide reports to the National Health and Medical Research Council (NHMRC) in accordance with the requirements of the National Statement.
  • The HREC will undertake its review in a timely and efficient manner and have mechanisms to monitor and evaluate its performance.
  • The HREC Terms of Reference, Standard Operating Procedures and membership will be made publicly available by posting them on the Iris Ethics website.

4. Responsibilities

The responsibilities of the Iris Ethics HREC are to:

  • Review human research applications where the research involves entities working in the sectors of policy and program evaluation, social research, and market research.
  • Review human research applications where the research takes place at external institutions/organisations and researchers if the research project falls within the expertise of the HREC.

4.1 HREC Executive Committee

  • The HREC has an Executive Committee comprising at least the HREC Chairperson, one other HREC member and a member of Iris Ethics' Secretariat.
  • The HREC Executive Committee is delegated to undertake expedited review and approval of business that does not require Full HREC review, including some or all of the following:
    • amendments to current HREC approved research projects;
    • responses to HREC queries, as approved by the Full HREC for HREC Executive Committee review and approval;
    • annual progress reports and final reports; and
    • serious adverse events and suspected unexpected serious adverse reactions reports.

4.2 HREC Sub-committees

The HREC may appoint such sub-committees as it sees fit to carry out a scientific or technical review of a research proposal or ethical review of minimal risk research submitted to the HREC. The Chair of any such sub-committee will be appointed by the Managing Director. Members of the sub-committee need not be members of the HREC.

5. Status

The HREC is an advisory committee of Iris Ethics Pty Ltd with responsibility for:

  • granting ethical approval;
  • withholding ethical approval; and
  • withdrawing ethical approval

in accordance with the National Statement.

6. Membership

6.1 Composition

The composition of the HREC shall be in accordance with the National Statement and shall include at least:

  • a Chairperson ("Chair") with suitable experience, including previous membership of an HREC, whose other responsibilities will not impair the HREC's capacity to carry out its obligations under the National Statement;
  • two people who bring a broader community or consumer perspective and who have no paid affiliation with the institution;
  • a person with knowledge of, and current experience in, the professional care or treatment of people; for example, a nurse, counsellor or allied health professional;
  • a person who performs a pastoral care role in a community including, but not limited to, an Aboriginal and/or Torres Strait Islander elder or community leader, a chaplain or a minister of religion or other religious leader;
  • a qualified lawyer, who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters; and
  • two people with current research/evaluation experience that is relevant to research proposals to be considered at the meetings they attend.

No individual may represent more than one of the categories listed above at any individual meeting in respect of an application, but may fill a different category at a separate meeting, so long as all minimum membership categories are represented at each meeting. 

The HREC may include a Deputy Chairperson ("Deputy Chair"), whose responsibilities are to support the Chair in the carrying out of their duties alongside their role on the committee.

The HREC shall be free to consult any person(s) considered by the HREC to be qualified to provide expert advice and assistance in the review of any research proposal submitted to it, subject to that person(s) having no conflict of interest and providing an undertaking of confidentiality. Such person(s) shall not be entitled to vote on any matter.

6.2 Appointment

The Managing Director shall appoint members of the HREC, in consultation with the HREC and other senior Iris Ethics officials, as deemed appropriate.

  • Prospective members of the HREC may be recruited by direct approach, nomination or by advertisement.
  • For the addition of members to an existing committee, a selection committee, consisting of the Chair, the Managing Director and, where possible, one other HREC member shall interview prospective members, consult with the HREC members and make a recommendation on appointment.
  • Appointments will allow for continuity, the development of expertise within the HREC, and the regular input of fresh ideas and approaches.

6.3 Term of appointment

Members are appointed for an initial period of two years. Any member may serve a longer term with the approval of the Managing Director.

  • Re-appointment is on invitation from the Managing Director based on a recommendation from the Chair of the HREC.
  • Membership may lapse if a member fails without reasonable excuse or without notifying the Chair or Managing Director to participate in the review of three consecutive applications reviewed by the HREC, unless exceptional circumstances exist. The Chair or Managing Director will notify the member of such lapse of membership in writing. Steps shall be taken to fill the vacancy of the lapsed member. 
  • A member may resign from the HREC at any time upon giving notice in writing to the Chair. Steps shall be taken to fill the vacancy of the former member.
  • The Managing Director may terminate the appointment of any member of the HREC if they are of the opinion that:
    • it is necessary for the proper and effective functioning of the HREC;
    • the person is not a fit and proper person to serve on an HREC; and/or
    • the person has failed to carry out their duties as an HREC member.
  • Iris Ethics provides indemnity for members of the HREC for any liabilities that arise as a result of the member exercising their duties as a member in good faith. Such indemnity is provided through the Iris Ethics liability protections.

6.4 Conditions of appointment

Members must agree to their name and profession being made available to the NHMRC for reporting purposes. The Chair and Deputy Chair must further agree to their name and profession being published on the Iris Ethics website.

Payments made to HREC members are made in relation to the following items on the following basis:

  • All members will receive a flat rate payment for each application where they have agreed to be part of the subset of Members meeting to review said application. 
  • The Chair and Deputy Chair of each HREC will receive additional payment commensurate with the higher duties associated with this role.
  • Reimbursement of legitimate expenses incurred in attending HREC meetings or in otherwise carrying out the business of the HREC.

Members will be required to sign a statement undertaking that:

  • all matters of which they become aware during the course of their work on the HREC will be kept confidential;
  • any real or perceived conflicts of interest which exist or may arise during their tenure on the HREC will be declared; and
  • they have not been subject to any criminal conviction or disciplinary action which may prejudice their standing as a HREC member.

6.5 Education

  • Newly appointed members shall be provided with adequate induction and documentation.
  • Each member is expected to become familiar with the National Statement and consult other guidelines relevant to the review of specific research applications.
  • Throughout their tenure, members shall be given the opportunity to attend training conferences and workshops relevant to the work and responsibilities of the HREC, at the expense of Iris Ethics.

7. Conduct of business

7.1 Procedures

The HREC will perform its functions according to written standard operating procedures. These procedures shall be reviewed at least every three years and amended and updated as necessary. All HREC members shall have access to and/or be provided with copies of the procedures and shall be consulted with regard to changes thereto.

7.2 Meetings

For the purposes of these terms, a meeting is defined as the virtual collaboration between a subset of members of a HREC ("the Panel") on the review of a single application, which may include video, telephone, face-to-face or other mode of communication as determined by the Chair.

The selection of the Panel will be made by the Managing Director on the basis of the content of the application, agreement of the subset of members by invitation of the Chair (or their delegate), and ratified by the Chair. 

The selection of the Panel will also seek to ensure as far as is practicable that there is diversity of representation including gender diversity, and that at least one-third of those participating in each meeting are from outside the institution, per paragraph 5.1.36 of the National Statement.

For the purposes of holding a meeting of the HREC, a Panel shall exist when a minimum number of the representatives of each of the categories designated in the National Statement (the minimum number for each category being specified in paragraph 5.1.30) has consented to their participation in the review of the application. 

In circumstances where members can no longer participate in a meeting, they may provide written comments in lieu of continued attendance. However, in such circumstances, there must be at least five members participating, including one of each of the following categories: Chair/Deputy Chair, community member, researcher/evaluator familiar with the types of proposals that are normally reviewed by the HREC. Furthermore, prior to a decision being made, the Chair must be satisfied that the views of the members who are not present have been received and considered by all members of the Panel.

7.3 Declaration of interest

Any member of the HREC who has any real or perceived interest, financial or otherwise, in an application or other related matter(s) considered by the HREC, should as soon as practicable declare such interest. Iris Ethics will keep a register of interests for the recording and monitoring of such interests. If the member is present at a meeting at which the application or related matter is the subject of consideration, the member will withdraw from the meeting until the HREC's consideration of the relevant matter has been completed. The member will not participate in the discussions and will not be entitled to vote in the decision with respect to the matter. All declarations of interest and absence of the member concerned will be minuted.

7.4 Confidentiality

HREC meetings are held in private. The agenda and minutes of meetings, applications, supporting documentation and correspondences are all treated confidentially.

7.5 Decision making

The HREC will endeavour to reach a decision concerning the ethical acceptability of an application by unanimous agreement of the subgroup of the HREC assigned to the Panel. Where a unanimous decision is not reached, the decision will be considered to be carried by a majority of two-thirds of said subgroup, provided that the majority includes at least one member acting as the community representative. Any significant minority view (i.e. two or more members) shall be noted in the minutes.

7.6 Records

  • The Secretariat will prepare and maintain written records of the HREC's activities, including agendas and minutes of all meetings of the HREC.
  • Files shall be kept securely and confidentially in accordance with the requirements of the Privacy Act 1998 (Cth).
  • Records shall be held for sufficient time to allow for future reference. The minimum period for retention is at least seven years from the date of completion of a project.
  • The HREC will maintain a register of all the applications received and reviewed in accordance with the National Statement.

7.7 Monitoring approved projects

  • The HREC will monitor approved projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants. This includes review of annual progress reports and final reports, safety reports and reports of protocol violations.
  • The HREC will, as a condition of approval of each project, require that investigators immediately report anything which might warrant review of ethical approval of the project, including:
    • proposed changes in the research protocol or conduct;
    • unforeseen events that might affect continued ethical acceptability of the project;
    • serious or unexpected adverse events; and
    • if the project is abandoned for any reason.
  • The HREC has the discretion to adopt other appropriate mechanisms for monitoring depending on the complexity, design and risk perceived, including:
    • discussion of relevant aspects of the project with investigators, at any time;
    • random inspection of research/evaluation sites, data, or consent documentation;
    • interview with research/evaluation participants or other forms of feedback from them; and
    • request and review reports from independent agencies such as a Data and Safety Monitoring Board.
  • The HREC also has the discretion to recommend as part of approval that the site co-ordinates onsite monitoring at recommended intervals or randomly throughout the project.

8. Appeals and complaints

8.1 Appeals regarding HREC rejection

Where the HREC has rejected an application, the investigator has the discretion to:

  • submit a new application to the same HREC, taking due account of the HREC's concerns; or
  • lodge an appeal with the HREC Chair specifying the grounds of the appeal in writing. 

Complaints may also be made to the Managing Director per Iris Ethics' complaints policy.

8.2 Appeals regarding HREC approval

Where the HREC has given a favourable decision on an application and:

  • an ethical or scientific issue is subsequently identified by any party; or
  • it has become apparent that the decision was based on inconsistent application of policy and guidelines

a written appeal is lodged with the Chair in the first instance.

8.3 Appeals to the Managing Director

If the appellant considers that the HREC has failed to follow due process after making an appeal in line with the above terms and remains unsatisfied with the outcome, they have the discretion to lodge an appeal with the Managing Director or request the Chair to do so.

8.4 Complaints about the conduct of HREC members

Complaints about the conduct of an HREC member are managed by the Managing Director per Iris Ethics' complaints policy, who informs the Chair of the complaint.

8.5 Complaints about the conduct of an approved project

Any concern or complaint about the conduct of a project should be directed to the Managing Director per Iris Ethics' complaints policy. The Managing Director shall notify the Chair as soon as possible after a complaint is received. The Managing Director and Chair of the HREC will investigate the complaint and make a recommendation on the appropriate course of action. If the complainant is not satisfied with the outcome of the investigation, then they can refer the complaint to the Managing Director, or request the Chair to do so.  

9. Amendments

These Terms of Reference may be amended by following the procedure below:

For proposed amendments made by an HREC member:

  • The proposal must be in writing and circulated to all HREC members for their consideration.
  • The views of the members should be discussed at the next meeting of the HREC, and a vote taken at that meeting. Any member unable to attend such a meeting may register their views in writing.
  • The proposal shall be ratified if two thirds of the members agree to the amendment.
  • The Chair shall send the amendment to the Managing Director for review and approval if appropriate.

For those proposals made by the Managing Director, the Managing Director will send the proposal to the HREC and seek the views of any relevant person.

10. Termination of HREC responsibility

Where the HREC is to be merged, closed or has ceased to function, Iris Ethics will notify the NHMRC and determine the appropriate course of action, such as the status of its registration and/or status as a certified institution with the NHMRC and the monitoring of previously approved research.

11. Fees

A fee will be charged for applications submitted by researchers/evaluators who have no formal affiliation with Iris Ethics. They will be invoiced in accordance with the fee structure which is available on the Iris Ethics website. Prior to acceptance of the application they will be required to sign an agreement with Iris Ethics detailing the terms and conditions under which HREC review will take place.

12. Further questions

Further information and assistance can be received by contacting us at: info@irisethics.com.au  

Last updated: 13 June 2025