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Operating procedures

1. Introduction2. Definitions3. Frequency of meetings4. Attendance at meetings5. Conduct of meetings6. Preparation of agendas and minutes7. Timely distribution of papers to members before meetings8. Timely consideration of applications9. Methods of deliberation and decision-making10. Applications from unaffiliated or international applicants11. Disclosure of interests and management of conflicts of interest12. Confidentiality of the content of applications and the deliberations of our HREC13. Notification of decisions14. Communication with applicants15. Record keeping16. Monitoring of approved applications17. Reporting and handling of adverse events18. Receiving and handling of complaints19. Decisions to suspend or withdraw ethics approval of a project20. Attendance of people other than members at meetings21. Further questions

1. Introduction

This page provides information on the standard operating procedures that Iris Ethics' Human Research Ethics Committee uses to deliver services. Where relevant, these procedures also apply to other services provided by Iris Ethics, including but not limited to Lower Risk Reviews and Determinations. The standard operating procedures are guided by the contents of the National Statement, with particular reference to the responsibilities outlined in Chapter 5.2 of the National Statement.

2. Definitions

For the purposes of these standard operating procedures, the following definitions are applied:

  • National Statement: National Health and Medical Research Council, Australian Research Council and Universities Australia (2025). National Statement on Ethical Conduct in Human Research. Canberra: National Health and Medical Research Council.
  • HREC: The full pool of appointed members of the Human Research Ethics Committee as defined in Section 5.1.34 of the National Statement.
  • Panel: the subgroup of the committee as identified by the Chair and Managing Director as being relevant to the scope of an application and meeting the requirements of the National Statement in its composition, and conforming to conforming to the requirements of the National Statement (paragraphs 5.1.30 to 5.1.32, and 5.1.36). The Panel may also include other members of the HREC, subject matter experts engaged as part of the review process, and observers receiving professional development experience being able to attend at the discretion of the Chair where it is seen as necessary to enable fair and reasoned decision-making. Such attendees are required to conduct themselves in a manner consistent with being a member of the Committee, including respecting confidentiality requirements.
  • Secretariat: the Managing Director or Iris Ethics employees providing secretariat services as delegated by the Managing Director.
  • Applicant: the named researchers/evaluators and their organisations whose activities are the subject of an application. The lead applicant, who is listed as the primary contact on the application, may also be the Principal Investigator in respect of an application, though this is not compulsory.
  • Meeting: the virtual and/or in-person collaboration of the Panel on the review of a single application, which may include video, telephone, face-to-face or other mode of communication (synchronous and/or asynchronous) as determined by the Chair. 
  • Collaborative discussion: a session called by the Chair as part of a meeting to engage with applicants to discuss and resolve matters as agreed by committee members.
  • In camera session: a session called by the Chair as part of a meeting for the Panel, with other members of the HREC, subject matter experts engaged as part of the review process, and observers receiving professional development experience being able to attend at the discretion of the Chair where it is seen as necessary to enable fair and reasoned decision-making. These will be called by the Chair as required to make decisions and achieve consensus on recommendations to applications.

3. Frequency of meetings

Meetings will take place on an application-by-application basis. Meetings may or may not include collaborative discussions or in camera sessions as decided by the Chair.

4. Attendance at meetings

Attendance at meetings will at a minimum comprise the Panel and a Secretariat representative. The Panel shall comprise at a minimum:

  • 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.

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.

All attendees will be approached for participation and have the right of refusal at any point for reasons including but not limited to:

  • Perceived or real conflict of interest
  • Unavailability
  • Ethical, personal and/or moral discomfort with the subject matter of the application

In the event that a member withdraws consent to participate in a meeting, a suitable replacement member will be identified by the Chair and Managing Director and approached for participation.

5. Conduct of meetings

By default, meetings will be held online and asynchronous on a secure, Australia-hosted collaboration platform with document access restricted to the Panel and Secretariat. On this platform, Panel members can make comments and discuss matters relevant to decision-making.

The role of the Secretariat is to observe discussion and mediate interaction between the Panel and applicants, for example if an issue is raised by a Panel member requiring clarification from the applicant the Secretariat can engage with the applicant directly through the Iris Ethics application portal or by other means of communication.

The Chair and Deputy Chair can convene the Panel in a collaborative discussion as required. Applicants will be invited by Chair to attend this collaborative discussion.

The Chair and Deputy Chair can convene an in camera session for further discussion relating to decisions and recommendations on an 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 representative 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.

The applicants may be approached to provide further information as part of the meeting and/or in response to a decision of the Panel. Applicants will be engaged by the Secretariat using the Iris Ethics application portal and may provide information through this portal, or if this is not feasible, by email to the Secretariat.

6. Preparation of agendas and minutes

Meetings for each application have a standing agenda available to all members of the Panel and the Secretariat.

The Chair and secretariat may develop agendas for collaborative discussions and in camera sessions as required – these are distributed to Panel members at a minimum of 24 hours prior to the discussion/session. 

Meetings will be minuted automatically by the collaboration platform as a record of the deliberation process.

Virtual discussions and in camera sessions will be minuted by a member of the Secretariat and placed on the meeting file.

7. Timely distribution of papers to members before meetings

Papers are provided to the Panel upon the consent of a panel member to participate in the Panel for an application.

Any further materials as provided by the applicant through the Secretariat shall be provided to Panel members as the earliest convenience of the Secretariat.

8. Timely consideration of applications

Meetings of a Panel are to commence within one business day of application confirmation by the Secretariat, except where an application comprises activities taking place outside Australia, in which case the meeting is to commence within three business days. 

The meeting is to close within 10 business days of application confirmation except where an extension has been requested in writing to the Secretariat by:

  • The Chair or an authorised delegate
  • The applicant

An extension may be requested for a range of reasons, including (but not limited to) delays in the collection and/or provision of additional information, unavailability of key personnel due to illness or other leave, or technical issues relating to platform access. Iris Ethics will endeavour as much as is practicable to avoid the need to request an extension.

While every effort will be made to confirm an application and commence review, Iris Ethics reserves the right to not confirm an application where the Secretariat and Chair agree that the above timeframes cannot be reasonably expected to be met (for example, where a Panel cannot reasonably be formed).

9. Methods of deliberation and decision-making

The primary mode of deliberation on an application will be through asynchronous discussion on the collaboration platform, moderated by the Chair and/or Deputy Chair. Collaborative discussions and in camera sessions may be called at the discretion of the Chair, in order to expedite decision-making and/or to clarify information in relation to the application where this is not possible using the collaboration platform. 

The goal of a meeting is to achieve a consensus decision regarding the ethical acceptability of an application. 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.

The Chair has final responsibility for the decision to end deliberation of the Panel and prepare a recommendation.

Decision types

The following decision types are available for an application:

  • Accept without amendment
  • Accept with amendments already received during the meeting
  • Provisional acceptance (acceptance subject to provision of further information and amendments in response to the recommendations of the Panel) 
  • Decline to accept with recommendations (with a requirement for a new application to be submitted taking into account these recommendations)
  • Decline to accept without recommendations

In all cases a rationale for the decision and any recommendations will be provided with reference to the relevant provisions of the National Statement as well as (where relevant) policies of Iris Ethics.

10. Applications from unaffiliated or international applicants

Iris Ethics reviews applications from unaffiliated institutions that work in or deliver services comprising:

  • Evaluation, audit and quality assurance of policies and programs
  • Market research
  • Social research

Institutions may include commercial entities, not-for-profit organisations, and government departments and agencies. 

Iris Ethics can receive applications directed to activities taking place outside of Australia, where such activities are within the scope of Section 4.6 of the National Statement. Prior to the commencement of the meeting, the Secretariat will review the application to ensure that the proposed activities meet the requirements of Section 4.6 of the National Statement.

Iris Ethics can receive applications from internationally-based applicants for research/evaluation activities conducted primarily in Australia.

11. Disclosure of interests and management of conflicts of interest

Disclosure of Conflicts of Interest by HREC members

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 Panel'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. If the matter is such that recusal of the member would lead to the Panel no longer meeting the requirements of the National Statement with respect to minimum membership (paragraphs 5.1.30 to 5.1.32), the member will be replaced by another member of the HREC who can perform the designated role of the original member.

Panel members will be selected consistent with Iris Ethics’ Conflict of Interest policy and register of interests to avoid perceived or real conflicts of interest where possible.

In the event of a Panel member, applicant or Secretariat becoming aware of a perceived or real interest, this is to be disclosed to the Chair and Managing Director who will agree on a strategy for management. These may include but are not limited to:

  • Recusal of the Panel member from discussions of matters in an application where the interest has been identified.
  • Replacement of the Panel member for that meeting.
  • Registering the interest and management action on the CoI register.
  • Discussion between the Managing Director and the Panel member and/or applicant on the nature of the interest and potential risks and impacts of said interest.

Disclosure of Conflicts of Interest by applicants

Applicants as part of the application process will be required to disclose any real or perceived interest, financial or otherwise that may constitute a conflict of interest in relation to their application. This includes involvement in projects that may comprise competing research or evaluation. Where such interests are identified this does not preclude consideration of the application, but the HREC as part of its decision may require the adoption of strategies to manage conflict of interest, including but not limited to:

  • Disclosure of the interest to research/evaluation participants
  • Disclosure of the interest as part of any presentation or publication of findings.
  • Requiring that the person(s) or persons recuse themselves from decisions about the project where the conflict exists.
  • Requiring that the person(s) modify their role in the project to avoid the conflict of interest, for example by not being involved in recruitment of participants or in collecting data from participants.
  • Requiring the inclusion of an oversight mechanism such as an independent peer review or advisory group.
  • Requiring the relinquishment of financial or other interests.
  • Requiring the person(s) withdraw from the research/evaluation.
  • Determining that the research/evaluation not be conducted.

Disclosure of Conflicts of Interest by staff of Iris Ethics

Any staff member of Iris Ethics 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. In the event of a perceived or real interest arising in the course of Iris Ethics' operations, this is to be disclosed to the Managing Director and/or Chair who will implement a strategy for management. These may include but are not limited to: 

  • Recusal from capacity as a member of the Secretariat.
  • Removal or restriction of access to all or part of platforms.
  • Delegation of decision-making capacity to another member of staff.
  • Relinquishment of financial or other interests.    

12. Confidentiality of the content of applications and the deliberations of our HREC

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

Applications are submitted through a secure applicant platform (Odoo). Applicants have access to a platform portal for the purposes of monitoring applications, uploading documentation, messaging Secretariat members (including receipt of Panel decisions and recommendations), and invoicing of payments. Access to the applicant platform by Iris Ethics is limited to the Secretariat and IT Administrator. The Secretariat is responsible for managing the transfer of information between the applicant platform and the collaboration platform.

Applicants cannot access the collaboration platform or the content of in camera sessions. Applicants may be invited to the collaboration discussion platform (Microsoft Teams) for the purposes of collaborative discussions. Access to this platform is granted by invitation of the Chair and managed by the Secretariat. 

To support the development of resources for the community, Iris Ethics may choose to publish generalised, de-identified and anonymised advice based on the content of an application (for example, considerations for applicants when using a given method of data collection). In such cases, Iris Ethics will seek explicit written permission from the applicant and provide access to a draft form of the advice prior to publication.

13. Notification of decisions

Applicants will be notified at earliest possible convenience of application confirmation, invitation to a collaboration discussion, and of a Panel decision through the applicant platform and by email. Iris Ethics will endeavour to ensure that notification of a decision takes place within one business day of the decision being made.

14. Communication with applicants

The primary mode of communication with an applicant will be through the applicant platform's messaging system and email account. The applicant may also be contacted by the Secretariat via email or telephone if needed. 

Per Section 5, if an issue is raised by a Panel member requiring clarification from the applicant the Secretariat can engage with the applicant directly to resolve the issue. Furthermore, should the Chair or Deputy Chair choose to convene the Panel in a collaborative discussion, applicants will be invited by Chair (through the Secretariat) to attend this collaborative discussion.

Should applicants be asked to provide further information in respect of an application (such as documentation), this will be requested by the Panel through the Secretariat. Applicants may provide the information through the applicant portal, or where this is not feasible via email to the Secretariat.

15. Record keeping

The Secretariat will prepare and maintain written records of the HREC's activities, including agendas and minutes of all meetings of the HREC. The HREC will maintain a register of all the applications received and reviewed in accordance with the National Statement. The HREC will maintain a complete record of all applications received and reviewed, said record including but not limited to administrative and decision information as detailed at paragraph 5.2.19 of the National Statement, and copies of all applications, approved documentation and any relevant correspondence. The record will be maintained in accordance with the requirements of relevant Commonwealth and state/territory legislation and guidelines.

Documents and minutes relating to applications will be retained by Iris Ethics for monitoring, audit and regulatory reporting purposes for a minimum of 7 years after the completion of the project, and in accordance with the requirements of the Privacy Act 1998 (Cth).

Documents on the collaboration platform are stored on a secure, Australia-hosted cloud platform (Microsoft Azure) with backups, with data encrypted both in transit and at rest. Two-factor authentication is required for access to the collaboration platform.

Documents on the applicant platform are stored on a secure Australia-hosted cloud platform (Odoo) with backups. While in most cases backups are stored in Australia, in some circumstances backups may be retained on an EU-hosted cloud platform. In all cases data are encrypted both in transit and at rest.

16. Monitoring of approved applications

The HREC, in conjunction with the Secretariat 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.

The HREC also has the discretion to recommend as part of approval that the applicant co-ordinates onsite monitoring at recommended intervals or randomly throughout the project.

17. Reporting and handling of adverse events

Applicants should have documented processes to monitor and manage the ongoing safety of projects, to avoid adverse events. These processes should include information on notifying the HREC of significant safety issues and serious adverse events. 

Applicants must ensure that the nature and extent of safety monitoring is determined through a risk assessment so that safety monitoring plans developed are proportionate to risk, and include a mechanism for recording all reported adverse events. The application materials should include information to demonstrate that this risk assessment and monitoring plan is in place.

Applicants must notify the HREC of all significant safety issues that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of activities forming part of an application approved by the HREC. For urgent safety issues, this notification should be provided within 72 hours; for all other significant safety issues, this should be provided within 15 calendar days of the applicant being made aware of the issue. Any amendments to the application (including changes in the timing) arising from a safety issue should be submitted to the HREC as soon as is reasonably possible.

The HREC will as part of the application review process and ongoing monitoring:

  • assess the safety of proposed activities, including whether the evaluation of the anticipated benefits and risks is satisfactory and ensure that the sponsor has proportionate systems in place to mitigate and manage any identified risks;
  • satisfy itself that the applicant’s ongoing safety monitoring arrangements are adequate, including criteria for withdrawing individual participants from the research/evaluation;
  • keep under review the adequacy and completeness of the informed consent process and documentation in the light of new information about risks and benefits;
  • assess whether changes to the risk-benefit ratio that are reported by the applicant are compatible with continued ethical approval; and
  • advise applicants and their institutions of any decision to withdraw approval.

18. Receiving and handling of complaints

Complaints about the conduct of the HREC

Complaints about the conduct of the HREC are lodged with the Managing Director per Iris Ethics' complaints policy. The Managing Director will receive the complaint and acknowledge this to you as soon as possible. Your complaint will then be forwarded to the Iris Ethics Human Research Ethics Committee Chair for review and action, except where the Chair is the subject of the complaint, in which case, the Managing Director will be directly responsible for the handling of the complaint. The complaint will be investigated, which may include assessment of existing records, as well as the collection of further information from stakeholders.

Iris Ethics will keep a record of the outcome of the complaint including actions taken, and notify you at the earliest possible time of this outcome.

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 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 directly refer the complaint to the Managing Director, or request the Chair to do so. The complaint will be investigated, which may include assessment of existing records relating to the project, as well as the collection of further information from stakeholders.

Iris Ethics will keep a record of the outcome of the complaint including actions taken, and notify you at the earliest possible time of this outcome.

19. Decisions to suspend or withdraw ethics approval of a project

Where the HREC has reason to believe that:

  • the ongoing delivery of activities as part of an approved project will compromise participants’ welfare; or 
  • that activities as part of an approved application is not being or cannot be conducted in accordance with the conditions of its approval;

the HREC should immediately establish whether approval for the project should be suspended or withdrawn. 

In such circumstances, the Chair must convene as soon as practicable a meeting of a Panel of the HREC to decide whether the ethical approval of the application should be suspended or withdrawn. Ideally the Panel will be of the same composition as the original Panel for the application; if this is not possible, the Panel should seek to have the same representation of expertise relevant for the subject matter of the activities. 

In urgent cases, the Chair may suspend approval immediately. In such circumstances, the suspension shall be until a meeting of the Panel can be convened where the suspension may be extended, ceased or the project’s ethical approval permanently withdrawn.

Whenever a project is suspended, the HREC will immediately notify the applicant (and if different to the applicant, the Principal Investigator (PI)) and their affiliated institution(s) of the suspension of the ethical approval including details of reasons for suspension. Where possible and feasible, participants will also be notified.

An applicant cannot continue with the research if ethical approval has been suspended and must comply with any special conditions imposed by the HREC. The research may not be resumed unless:

  • The applicant and PI subsequently establish to the HREC that continuance will not compromise participants’ welfare and/or is to be conducted in accordance with its ethical approval;
  • The research is modified to provide sufficient protection for participants, the modification is the subject of a review by a Panel of the HREC, and the modified research is approved by the Panel; and
  • The affiliated institution(s) of the applicants authorise the continuation of the research.

The Panel, after consideration at a meeting, makes the final decision with regards to reinstatement or withdrawal of ethical approval. The applicant (and, if different, the PI) and affiliated institution(s) will be notified in writing of the decision within three business days of the meeting.

The Secretariat will update the status of the project on the application platform.

In the case of withdrawal of ethical approval, the HREC will immediately notify the applicant (and if different to the applicant, the Principal Investigator (PI)) and their affiliated institution(s) of the withdrawal of the ethical approval including details of reasons for withdrawal. The applicant, affiliated institution(s) and the Secretariat will cooperate to inform participants involved in the activities where necessary (and if required, provide support), and to ensure that activities are halted and that the HREC and affiliated institution(s) are notified that these steps have been taken.

In such a case, continuation of the project can only occur subject to re-application and re-approval by the HREC.

20. Attendance of people other than members at meetings

As noted, the Panel may also include other members of the HREC, subject matter experts engaged as part of the review process, and observers receiving professional development experience being able to attend at the discretion of the Chair where it is seen as necessary to enable fair and reasoned decision-making (noting that observers are not involved in deliberations or decision making). Such attendees are required to conduct themselves in a manner consistent with being a member of the Committee, including respecting confidentiality and conflict of interest requirements. 

Applicants may at the Chair’s discretion be invited to attend collaborative discussions with the Panel for the purposes of resolving matters related to the application. Applicants are otherwise engaged by the Secretariat on behalf of the Panel through the applicant platform.

21. Further questions

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

Last updated: 13 June 2025