1. The purpose of our procedure
This procedure ensures that our human research is designed to respect research participants and is conducted in accordance with the Australian Code for the Responsible Conduct of Research 2018 (Cth) (the Code) and the National Statement on Ethical Conduct in Human Research (2025) (the National Statement).
Please read this procedure in conjunction with the Research Integrity Policy.
2. Who our procedure applies to
This procedure applies to:
- members of the Adelaide University community who are involved in, or who assist with, the conduct of human research associated with Adelaide University
- external researchers who want to conduct research with or at Adelaide University.
3. Our human research ethics procedure
3.1 How we conduct human research
Adelaide University is committed to the ethical design, review and conduct of human research. Human research must be approved through the processes Adelaide University has established for these purposes and must demonstrate the values of research merit and integrity, justice, beneficence, and respect as outlined in the National Statement and the Code.
Research involving Aboriginal and Torres Strait Islander Peoples must also be conducted in accordance with Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018) and the AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020).
3.2 Our human research ethics approval processes
We are committed to ensuring that all risks involved in human research are assessed and managed to ensure that the welfare and interests of participants, researchers and institutions are protected throughout the research process.
Adelaide University has established different pathways for the ethics review of human research according to the degree of risk involved in the research as outlined in the National Statement. Lower-risk research is defined as either “low risk” or “minimal risk” research.
In low-risk research, there:
- is no risk of harm,
- is a risk of discomfort
- may also be risk of a foreseeable burden or inconvenience.
In minimal-risk research, there is:
- no risk of harm or discomfort
- a potential for minor burden or inconvenience.
Higher-risk research is defined as research in which the risk for participants or others is greater than discomfort. Research that is considered higher risk requires review by a Human Research Ethics Committee (HREC). Additionally, the National Statement prescribes specific areas of research which cannot be reviewed via a lower-risk ethical review pathway. Adelaide University has established both lower and higher-risk ethics committees as part of our overall commitment to research.
3.3 Human research ethics committees
Adelaide University has established two HRECs to review higher-risk research and six lower-risk HRECs to review lower-risk research.
These committees report to and are accountable to the Deputy Vice Chancellor - Research and Innovation (DVCRI) and the [Adelaide University Research Committee]
HRECs will:
- work diligently to discharge the functions specified in their Terms of Reference in a timely and professional manner, and in accordance with the National Statement
- operate in accordance with the principles of procedural fairness.
All human research ethics reviewers will adhere to their relevant committee’s Terms of Reference, this procedure, and their specific terms of appointment in the discharge of their duties.
The HRECs will maintain standard operating procedures to promote good ethics review, in accordance with the [Adelaide University Governance Policy] and [Adelaide University Records Management Procedure].
3.3.1 HREC membership
Details of Adelaide University HREC membership, including membership categories, terms of office, and proxies, are outlined in the relevant Terms of Reference.
3.3.2 Cessation or termination of membership
HREC membership may be concluded prior to the end of the appointed term on the recommendation of the HREC Chair to the DVCRI. The decision to withdraw or conclude membership rests with the DVCRI. Where practicable, concerns will be addressed in a supportive and proportionate manner prior to any recommendation being made. The objective is to maintain a constructive and effective committee environment, recognising that personal or professional circumstances may change over time.
Membership lapses if a member fails to:
- attend three consecutive meetings without reasonable justification or in exceptional circumstances as approved by the Chair or the DVCRI in the absence of the Chair
- attend at least two thirds of all scheduled HREC meetings in each year, barring exceptional circumstances
- complete training or professional development related to their role as a HREC member, including the roles of Chair and Deputy Chair, as required by the HREC Chair or Adelaide University.
The appointment of any member of the HREC may be terminated by the DVCRI if they determine 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
- the person has failed to carry out their duties as an HREC member.
Members seeking to resign or take a planned leave of absence for an extended period from the HREC should provide at least four weeks’ written notice to the Chair and HREC Executive Officer so that steps can be taken to fill the vacancy.
The DVCRI will notify the member of a termination of membership in writing. The Director, Research Compliance, Ethics and Integrity (or delegate) will notify the member of a lapse or termination of membership in writing.
3.4 Human research ethics applications
Adelaide University human research must be subject to ethics review or qualify for an exemption from review.
Ethics approval or exemption must be granted before research commences.
Human research ethics applications must be submitted to the relevant HREC via the Adelaide Compliance and Ethics System (ACES). All information contained in human research applications must be factual, accurate and complete.
The level of ethical risk will be determined by the applicant's human research ethics application.
Researchers must demonstrate to reviewers that the potential benefits of the research justify the assessed risks and explain how they will minimise and/or manage potential and/or actual risks.
Where an exemption from human research ethics review has been granted, the activities subject to exemption must still be conducted in accordance with the principles of the National Statement and all relevant Adelaide University policies and procedures.
Applications from researchers not employed by, enrolled at, or otherwise formally affiliated with Adelaide University may only be accepted for review where:
- the research involves collaboration with Adelaide University
- Adelaide University can assume appropriate oversight and accountability for the research in accordance with the National Statement.
Adelaide University does not charge a fee for ethical review as it is provided as part of our institutional responsibilities under the National Statement.
3.5 Exemptions from review
Research that may be eligible for exemption from ethics review includes research that carries a lower risk to participants or the community and satisfies one or more of the following conditions:
- the research involves the use of collections of information or data from which all personal identifiers have been removed prior to being received by the researchers, and where researchers explicitly agree:
- not to attempt to re-identify individuals associated with the information or data
- to take all reasonable steps to prevent re-identification for unauthorised purposes or access by individuals who are not authorised
- that any sharing of research data during or after the project will not create any additional risks of re-identification.
- the research is restricted to surveys and observation of public behaviour using information that was, or will be, collected and recorded without personal identifiers, and is highly unlikely to cause distress to anyone associated with the information or the outcomes of the research
- the research is conducted as part of an educational training program, in which the research activity is solely for training purposes and where any outcomes or documentation are for program use only
- the research uses only information that is publicly available through a mechanism set out by legislation or regulation and that is protected by law, such as mandatory reporting information, information obtained from registries of births and deaths, coronial investigations or reports of the Australian Bureau of Statistics.
3.6 External ethics review
To avoid duplication of ethics review, Adelaide University may accept ethics reviews conducted by an entity external to Adelaide University, including ethics review conducted overseas, if the external ethics approval meets our criteria.
These will be considered by the relevant HREC on a case-by-case basis.
3.7 Research participants
Some potential human research participants may be at increased risk of harm due to specific characteristics or circumstances, the nature of particular research projects, and/or how these factors interact. The inclusion or exclusion of individuals in research who may experience increased risk of harm raises ethical issues about self-determination and agency, consent, fairness, and the equitable distribution of benefits, risks and burdens.
Researchers and reviewers must consider potential sources of increased risk arising from the characteristics and circumstances of individual participants, when viewed in the context of a specific research project.
3.8 Research with Aboriginal and Torres Strait Islander people and communities
As outlined in the National Statement, research undertaken with Aboriginal and Torres Strait Islander people and communities must:
- respect the diverse values of Aboriginal and Torres Strait Islander people and communities
- reflect Aboriginal and Torres Strait Islander priorities, needs and aspirations
- contribute to the development of long-term, ethical relationships among researchers, institutions and sponsors
- be consistent with best practice ethical standards of research.
Researchers must consult and apply relevant guidelines and codes including:
- Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018)
- Keeping Research on Track II (2018)
- AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020).
HRECs and other ethics review bodies are also required to apply these guidelines as the basis for assessing proposals for research with Aboriginal and Torres Strait Islander participation.
3.9 Course approvals
Ethics approvals may be granted for courses in which a cohort of students undertakes short duration research projects. Course approval applications are subject to the same process (including risk assessment) as other applications and may be reviewed by the HRECs or lower-risk HRECs depending on the level of risk.
[Course Coordinators] are responsible for applying for course ethics approval and ensuring subsequent compliance with approval conditions. At the conclusion of the course, the coordinator must submit a completed course report form to the relevant HRECs or lower-risk HRECs.
3.10 Recognition of foundation university prior approvals
Adelaide University HRECs recognise ethics approvals granted by the HRECs of the foundation universities as prior ethics approvals. Research projects subject to a prior ethics approval will generally not require re-review by an Adelaide University HREC, provided there are no substantive changes to the approved protocols.
Prior ethics approvals will be deemed to be an ethics approval made by an Adelaide University HREC, and the responsibilities of the Adelaide University HREC Terms of Reference will apply.
3.11 Monitoring and reporting
Human research approved by Adelaide University is monitored in alignment with the National Statement.
Researchers must submit an annual report to the relevant approving body on every project that has human research ethics approval. Failure to submit an annual report may result in suspension or withdrawal of ethics approval.
The monitoring and reporting requirements for prior ethics approvals will transfer to the Adelaide University HRECs.
3.12 The Office of Research Compliance, Ethics, and Integrity, AU Research Services will prepare an annual report to Academic Board
This annual report will provide Academic Board with material information and data, overarching analysis of enterprise and committee activities, improvements to business, policy, procedure or process, and other matters relating to the integrity of research (as relevant or requested by Academic Board). Annual reports of the Adelaide University HREC, along with the annual reports of the other AU research ethics and compliance committees, will accompany the annual report to Academic Board. The annual report to Academic Board is intended to enable ongoing institutional oversight of research integrity, and will address the institutional obligations under Standard 5.2 of the Higher Education Threshold Standards Framework 2021.
3.13 Complaints and appeals
Complaints relating to research projects approved by Adelaide University’s HREC’s will be managed through publicly available pathways and may involve review by the relevant HREC and/or referral to Adelaide University’s [Office of Research Compliance, Ethics and Integrity].
Complaints about Adelaide University’s HRECs or decisions made by Adelaide University’s HRECs should be directed in the first instance to the [Human Ethics Officer] of the relevant HREC. The Human Ethics Officer will forward the complaint to the appropriate Chair, Deputy Chair or the Director, Research Compliance, Ethics and Integrity, as appropriate in the circumstances.
Where a complaint raises the possibility of a breach of the standards governing the conduct of research, it will generally be managed in accordance with the [Adelaide University Investigation and Management of Research Conduct Procedure] and the Code.
Depending on the nature and severity of the complaint, the Chair or Deputy Chair of the relevant HREC will either investigate the matter in consultation with the appropriate parties or forward the complaint to the DVCRI for further investigation.
4. Who holds a responsibility within this procedure
Refer to the Delegation Policy for all delegations at Adelaide University.
4.1 Adelaide University staff undertaking human research are responsible for:
- seeking appropriate ethics approvals (or exemptions) as outlined in this procedure and obtaining all relevant approvals (or exemptions) prior to commencing the research
- complying with the terms of any ethics approval or exemption
- complying with this procedure, the National Statement, relevant legislation, regulations, statutory guidelines, codes, and other applicable Adelaide University policies and processes
- supporting appropriate monitoring of human research, including through the preparation and submission of annual and incident reports in accordance with this procedure
- ensuring that human research is within acceptable risk parameters in accordance with this procedure
- ensuring that human research is authorised under local area governance processes, considering applicable laws, regulations, policies and processes
4.2 DVCRI is responsible for:
- establishing, maintaining and removing our Human Research Ethics Committees as required
- monitoring and auditing our ethical review processes to ensure they comply with the requirements specified in the National Statement and the Code
- providing training or support, resources, processes and infrastructure to support researchers, reviewers, and staff to understand their ethical responsibilities and obligations and to engage with the human research ethics submission and monitoring processes in an informed manner.
4.3 Human Research Ethics Committee reviewers are responsible for:
- reviewing applications
- monitoring ongoing research
- ensuring research is consistent with the National Statement.
5. Definitions used in our procedure
Please refer to our Adelaide University glossary for a full list of our definitions.
Adelaide University community refers to a broad range of stakeholders who engage with Adelaide University and includes (but is not limited to) all students, staff, and nonstaff members of Adelaide University including alumni, honorary title holders, adjuncts, visiting academics, guest lecturers, volunteers, suppliers and partners who are engaging with and contributing to the work of Adelaide University.
Foundation universities means the University of South Australia and The University of Adelaide.
Human research means research conducted with or about people, or their data or biospecimens.
6. How our procedure is governed
This procedure is categorised, approved and owned in line with the governance structure of Adelaide University and the offices and officers listed below.
| Parent policy | Research Integrity Policy |
|---|---|
| Policy category | Academic |
| Policy owner | Deputy Vice Chancellor – Research and Innovation |
| Approving authority | co-Vice Chancellors/Vice Chancellor and President |
| Procedure owner | Pro Vice Chancellor, Research Services and Infrastructure |
| Responsible officer | Director, Research Compliance, Ethics and Integrity |
| Effective from | [Take-effect date] |
| Review date | [1 year after date this version is approved] |
| Enquiries | Interim Central Policy Unit |
| Replaced documents | None |
7. Legislation and other documents related to our procedure
Refer to the Delegation Policy for all delegations at Adelaide University.
| Category | Documents |
|---|---|
| Related policy documents |
[First Nations Policy] [Research and Primary Materials Procedure] |
| Referenced legislation |
National Statement on Ethical Conduct in Human Research 2025 (Cth) Australian Code for the Responsible Conduct of Research 2018 (Cth) Higher Education Standards Framework (Threshold Standards) 2021 Standards: 4.1 Research, 5.2 Academic and Research Integrity |
| Related legislation | Therapeutic Goods Act 1989 (Cth) Privacy Act 1988 (Cth) |
| External references | Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders (2018) AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (2020) Keeping Research on Track II (2018) Guidelines approved under Section 95A of the Privacy Act 1988 |
8. History of changes
| Date approved | To section/clauses | Description of change |
|---|---|---|
| DD Month Year | N/A | New procedure |
At the time of writing, Adelaide University’s organisational structure, position titles, and committee names have not been confirmed. Square brackets [ ] indicate placeholders for these details. Brackets are also used to identify policy elements that are subject to further decision-making or confirmation. These will be updated once final decisions are made.