HREC Standard Operating Procedure - Complaint & Appeals

1.  AUTHORITY

1.1 This Standard Operating Procedure (SOP) is established by the [Vice Chancellor & Chief Executive Officer (VC & CEO), or the Deputy Vice-Chancellor Research (DVC-R) as their nominee] in accordance with the Ethics Standards, which requires that the University establish policies, rules and procedures for the effective governance and operation of ethical review and ongoing monitoring of Human Research at the University.

1.2 This SOP comes into effect upon approval by the University and is subject to review every 2 years from the date of approval.

2.  SCOPE

2.1 University has established complaints and appeals mechanisms for researchers, students, UNE Representatives and persons external to the University, including participants in research projects that involve Human Research.

2.2 These SOPs set out the process for:

a)  raising concerns or complaints about:

  • the conduct of a University researcher;
  • activities of a research project that has received the HREC approval;
  • research activities undertaken without appropriate ethics approval;
  • the review process and/or decisions of the HREC or the HREC Sub-Committee;
  • the conduct of a member or members (including the Chair) of the HREC or the HREC Sub-Committee or the HREC secretariat staff.

b)  appealing a decision of the HREC.

2.3 All complaints and appeals, including inquiries, allegations, reviews, assessments and investigations are conducted confidentially, with respect for the person making the complaint (complainant) or appeal (appellant) and the subject (respondent) of the complaint or appeal.

2.4  Complainants, appellants and respondents must be treated in accordance with legislative requirements, the principals of procedural fairness, natural justice, and with respect for cultural sensitivities.

2.5 Reprisal, threatening behaviour or other adverse action against any person involved in the complaint and appeals process will not be tolerated. Any such action will be dealt with as a separate action under the Student Behavioural Misconduct Rules, the UNE Code of Conduct, Staff Misconduct Policy or other provisions contained in the relevant collective agreement or university policy employment contract.

2.6  At all stages in considering and/or investigating complaints, where the respondent is a staff member, the requirements under the relevant collective agreement or equivalent employment contract must be met.

3. COMPLAINTS - RESEARCH AND RESEARCHER CONDUCT

3.1 Anyone involved in or affected by a human research project – including participants, researchers, supervisors, UNE staff or students, or members of the public, can lodge a complaint about the conduct of the research or concerns about ethical practices of the researcher.

3.2 Complaints should be reported as soon as possible if they relate to:

  • a participant’s welfare, rights, or consent
  • the behaviour of a researcher or research team
  • an alleged breach of the approved protocol or the Ethics Standards

3.3 Complaints should be in writing and directed to Research Integrity Office: researchintegrity@une.edu.au

3.4 The matter will be managed in accordance with the University’s Code of Conduct for Research Rule and Research Conduct - Managing Potential Breaches Procedures.

COMPLAINTS INVOLVING RECIPROCAL RESEARCH PROJECTS

3.5 Complaints about a research project that has received ethics approval from an external Ethics Committee must be referred to the original approving Ethics Committee. However, the Researcher(s) is/are required to notify the UNE HREC if a complaint has been received by the external Ethics Committee, including:

  1. details of the complaint;
  2. details of findings and recommendations from the external ethics committee; and/or
  3. any action taken with respect to the approved research project, such as variation, suspension or withdrawal of approval.

3.6 Where the complaint is being handled by the external Ethics Committee and not the UNE the researcher must immediately provide to the Chair and/or Human Research Ethics Officer (HREO) the contact details of the person responsible for managing the complaint on behalf of the external Ethics Committee. The Chair and HREO will liaise with the external Ethics Committee with respect to the management of the complaint and report the outcomes to the HREC and the University’s Research Integrity Office (if applicable).

4.   COMPLAINTS - HREC MEMBER OR THE CONDUCT OF THE COMMITTEE

4.1 The University, including the HREC, is committed to continuous service improvement based upon a culture in which people feel comfortable in submitting grievances and confident that their issues will be addressed fairly, as promptly as possible, accurately, sensitively and without recourse where a grievance has been submitted in good faith.

The Committee, as well as its individual members, are expected to adhere to the Ethics Standards when reviewing applications.

INFORMAL COMPLAINTS

4.2  In alignment with the University’s grievance policy, the HREC strongly encourages engaging in a direct approach to resolve any issues prior to lodging a formal written complaint.

4.3 Informal complaints regarding the conduct of HREC members (other than the Chair or the HREC Secretary) may be made to the HREC Chair via email at humanethics@une.edu.au. The Chair will investigate the complaint, and if required, propose recommendations with respect to resolution of the matter.

4.4 The Chair will communicate the outcome of the investigation, including recommendations, to the DVCR in the first instance. Following endorsement from the DVCR, the Chair will inform the complainant and the HREC of the outcome.

4.5 Informal complaints regarding the conduct of the HREC Chair or HREC Secretary should be made to the Director of Research Services at dires@une.edu.au

4.6 The Director of Research Services will investigate the complaint, and if required, propose recommendations with respect to resolution of the matter. The Director of Research Services will communicate the outcome of the investigation, including recommendations, to the DVCR in the first instance. Following endorsement from the DVCR, the Director of Research Services will inform the complainant and the HREC Chair and/or HREC Secretary (as applicable).

4.7 Where the complainant is not satisfied that the informal complaint has been satisfactorily resolved, they may lodge a formal complaint.

FORMAL COMPLAINTS

4.8 Where a matter is unable to be resolved informally, a formal complaint about the conduct of HREC Members, the HREC Chair or the HREC Secretary should be made in writing and addressed to Director of Research Services at dires@une.edu.au.

4.9 The Director of Research Services will conduct a preliminary assessment and recommend an appropriate course of action, which may include:

  1. Referral to DVCR for further action;
  2. Referral to Student Grievance Unit or
  3. Another appropriate course of action

4.10  Management of complaints will be confidential, with respect for the person making the complaint (complainant) and the subject (respondent) of the complaint and will follow relevant UNE guidelines and ensure a fair process. Where relevant and appropriate, the HREC will be informed of the outcome, in accordance with the UNE policy framework.

5. APPEALS AGAINST HREC DECISIONS

5.1  This appeals process applies to instances where the HREC or the HREC Sub-Committee has:

  1. rejected an application; or
  2. requested a re-submission of an application; or
  3. approved an application

and the appellant alleges there are inconsistencies or concerns in the way the HREC or the HREC Sub-Committee has applied the Ethics Standards and the HREC ToR and/or SOP (where applicable) in reaching its decision.

5.2  Where the appellant is the researcher, the researcher must have the endorsement of the Principal Supervisor/Principal Researcher to lodge the appeal. Anyone, including members of the general public, may file an appeal/complaint under 5.1.

5.3  All appeals must be lodged in writing to the HREC Chair within one month of the HREC decision.

5.4  The appeal must be in writing and clearly state the grounds for the appeal, including reference to the Ethics Standards, the HREC’s ToR and/or SOP and any supporting documents.

5.5  The HREC Chair will review the appeal and provide a written response outlining the outcome as soon as reasonably practicable.

5.6  In the event the appellant is not satisfied with the outcome of the first appeal, the appellant may lodge a second appeal to the DVCR (dvcr@une.edu.au) within one month of the decision of the first appeal. This appeal must be in writing and detail:

  • the grounds for appeal, including reference to the Ethics Standards, the HREC’s ToR and/or SOP and any supporting documents;
  • the outcome of the first appeal, including the response from the HREC Chair and any other correspondence between the HREC Chair and the appellant.

5.7  The DVCR will review the appeal and may liaise with the HREC Chair. The DVCR will then decide to:

  • fully endorse the decision of the first appeal by the Chair and dismiss the appeal; or
  • partially endorse the decision of the first appeal by the Chair, but make a recommendation to the HREC; or
  • appoint a suitable internal or external expert/s to review the appeal and make a recommendation to the HREC.

The HREC and the HREC Sub-Committee, in reviewing the application, will consider the recommendations made by the DVCR, including any recommendation provided by an internal or external expert, in its decision.

6.    COMMON TERMS

Ethics Standards means

  1. the National Statement;
  2. the Australian Code for the Responsible Conduct of Research (the Code);
  3. AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research; and
  4. other relevant legislation, regulation, standards or codes.

Human Research means research that is conducted with or about people, or their data or tissue, including the following:

  1. taking part in surveys, interviews or focus groups;
  2. undergoing psychological, physiological or medical testing or treatment;
  3. being observed by researchers;
  4. researchers having access to their personal documents or other materials;
  5. the collection and use of their biological material. ‘Human biospecimens’ is a broad term that, refers to any biological material obtained from a person including tissue, blood, urine and sputum; it also includes any derivative of these, such as cell lines access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

National Statement means the National Statement on Ethical Conduct in Human Research (2025) made in accordance with the National Health and Medical Research Council Act 1992.

The Code means Australian Code for the Responsible Conduct of Research

UNE Representative means a University employee (casual, fixed term and permanent), contractor, agent, appointee, UNE Council member, adjunct, visiting academic and any other person engaged by the University to undertake some activity for or on behalf of the University.  It includes corporations and other bodies falling into one or more of these categories.

Informal Complaint is an attempt to resolve an issue at a local level, typically through direct discussion or a casual conversation with the person or entity involved, without requiring complex procedures or formal investigations. This approach is often the first step in a complaint process and aims to achieve a quick and practical solution by encouraging dialogue and understanding between the parties.

Formal Complaint is a written or documented statement expressing dissatisfaction with a service, which expects a resolution or response and is lodged with a designated authority or person after informal attempts to resolve the issue have failed. It involves detailing the problem, providing key dates and evidence, stating the desired outcome, and often specifying a timeframe for a response.  A complainant is entitled to lodge a formal complaint without an informal complaint should they wish.