Below are answers to some of the most frequent questions the Ethics Office answers. You can use the same-page links to go directly to a particular question.
Do I need ethics approval?
All Australian National University researchers (staff or students) who intend on conducting research involving the collection of data from human participants must get approval via the ANU Human Ethics processes before beginning data collection. Research that requires human ethics approval includes, but is not limited to:
- collection of information about human participants and groups via interviews, questionnaires, behavioural observation, tissue samples or provision of stimuli
- the use of identifiable secondary data
- the use of secondary medical data
- research involving issues related to Aboriginal or Torres Strait Islander peoples
- clinical trials
What are the types of projects that do not require human ethics approval?
Research that is not for academic use or publication is not required to go through the ethics review process. For example:
- Undergraduate training studies that are conducted with no view toward academic publication.
- Audits or quality assurance programs that do not require access to sensitive or personal information.
Please note that any survey or research targeting ANU students and/or staff will need to be approved by ANU Planning & Performance Measurement Division (E: firstname.lastname@example.org). See also Ethical considerations in quality assurance and evaluation activities for triggers for consideration for ethical review.
You may also be exempt from ethical review if you are using particular kinds of secondary data:
- Publically available media material (except social media).
- Unidentifiable secondary data (except medical data).
However, exceptions do apply to the above research types and all should be viewed in the appropriate context to accurately understand your requirement for ethics approval. Please speak to the Research Ethics Team (email@example.com) about the specifics of your research to confirm whether ethics approval is required.
Do students need ethics approval?
Research students also need ethics approval to conduct human research. You may be responsible for preparing the research ethics application for your own research projects, under the direction of your supervisor. Supervisors are responsible for advising the student if ethics approval is likely to be required, what ethical considerations may arise in the student’s research project, and how these may be addressed.
In particular, you and your supervisor must come to an agreement about the scope, research questions, design and methods of the research. Begin your application early so that your supervisor has time to read through and offer feedback about the application, and so that you have time to seek assistance if needed.
The student research ethics checklist provides guidance on the basic steps that need to be taken by the student and their supervisor prior to an ethics application being submitted.
For more information about student applications, see Student and supervisor responsibilities in research ethics.
What if I already have ethics approval from another institution?
If you have already written an ethics protocol for your research, and it has been approved by another HREC registered with NHMRC, the ANU will recognise that approval when considering your protocol here. If your research project is still being monitored by the original approving institution, then you may not need to apply for ANU ethics approval - just fill out the Notification of Prior Approval form. All other research that has approval from another ethics committee will be reviewed at ANU as an Expedited Level 1 protocol (regardless of proposed topic or method). Researchers will need to provide a copy of the previous application and approval as part of their submission.
How long does ANU ethics approval remain valid?
All approved protocols at ANU are granted five years' approval on the condition that researchers meet all monitoring and approval requirements during the life of the research. You can request extensions of up to a year on your original approval; requests will be considered by the HREC Chair. After that, you will need to submit a new ethics application for approval.
What is the risk level of my research?
The ANU ethics application process classifies applications into one of three review categories, depending on the research method, target participant group, previous approval status, recruitment strategies and subject matter:
- Expedited Level 1 Protocol (E1) - Data collection that engages non-vulnerable participants in activities they would encounter in everyday life.
- Expedited Level 2 Protocol (E2) - Data collection that engages non-vulnerable participants in activities with a greater than negligible level of risk.
- Full Review Protocol (Full) - Data collection that engages participants who are in some way vulnerable, research settings that are particularly unusual or uncomfortable, or research with Aboriginal and Torres Strait Islander peoples.
See the ANU Human Ethics Risk Level Classification flowchart for a more detailed breakdown. Human Ethics training also covers in detail the specifics of particular methods and target participant groups as they relate to risk level requirements. Please note the Committee will not accept Full Review applications led by undergraduate students.
Full Review applications are reviewed by the ANU Human Research Ethics Committee (HREC). Expedited applications go to one of the Delegated Ethical Review Committees (DERCs). See the Committees page for details.
When do the committees review applications?
The risk level of your research determines which Committee will review your ethics application. At ANU there are three Delegated Ethical Review Committees (DERC) that sit beneath the ANU Human Research Ethics Committee (HREC). These delegated committees review E1 & E2 protocols from colleges in their jurisdiction.
- Expedited Level 1 Protocol (E1) - Reviewed by the chairperson of the appropriate DERC out-of-session with no submission deadline.
- Expedited Level 2 Protocol (E2) - Reviewed by the appropriate DERC when they meet every fortnight. See DERC Submission Deadline dates.
- Full Review Protocol (Full) - Reviewed by the ANU HREC when they meet monthly. See ANU HREC Submission Deadline Dates.
How long does it take to get approval?
It is very difficult to quantify the approval time for any given protocol given the number of variables in the process. However, the data we have on human ethics applications at ANU suggests that, on average, the higher the risk of the protocol, the longer the approval time. The greatest determiner of this process is the quality of the protocol submitted by the researcher. As such, we recommend throughout the training process that researchers take care to allow adequate time when preparing their application for review.
The timelines below are to be used as a guide, noting that quality of the protocol, researcher response turnaround time, and ethics application backlog with the committee can create enormous variance in the process:
- Expedited Level 1 Protocol (E1) - Allow up to 4 weeks from the time of submitting your signed documents.
- Expedited Level 2 Protocol (E2) - Allow up to 4 weeks from the next DERC submission deadline.
- Full Review Protocol (Full) - Allow 6-8 weeks from the next HREC submission deadline.
What if I can't log into ARIES?
New ANU academic staff are automatically registered for ARIES.
If you are a research student, complete the ARIES New User Form to gain access to ARIES. Please allow up to 48 hours for IT to activate your account. You will get an email when your account is activated. After this, you will be able to log in using your ANU UID and network password.
If you are no longer affiliated with ANU, your credentials will be removed from the system and you will be unable to log into ARIES. Any research ethics protocols you have at ANU will need to be closed or transferred to a new primary investigator who is still affiliated with the ANU.
If you need assistance with ARIES, contact: firstname.lastname@example.org
Are there additional considerations for research involving Aboriginal & Torres Strait Islander Peoples?
Research involving Aboriginal and Torres Strait Islander peoples must be reviewed by the HREC, as per the National Statement Chapter 4.7. Central to such research are principles of respectful engagement and consultation. The AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies state that:
"…it is essential that Indigenous people are full participants in research projects that concern them, share an understanding of the aims and methods of the research, and share the results of this work. At every stage, research with and about Indigenous peoples must be founded on a process of meaningful engagement and reciprocity between the researcher and Indigenous people."
Accordingly, ethical review of protocols involving Indigenous peoples requires researchers to provide evidence of such consultation and, wherever possible, letters of support from community leaders or organisations that attest to the willingness of the community to engage with the research. The HREC does not accept applications without any evidence of consultation with relevant Indigenous communities and organisations.
Do I need a participant information sheet & consent form?
If you are collecting data from human participants, you must have a Participant Information Sheet. It should be brief, written in plain language, and provide sufficient detail to allow an informed decision by the participant on whether to take part in the research project or not. It is imperative that the information participants receive is clear and accurate.
An expression of consent is also required for every research project. In most cases this means a written consent form or some record of oral consent (e.g. audio recording, witness signature). In online surveys, clicking the 'submit' button can constitute consent.
For more information about informed consent requirements, see the Information Sheets and Consent Forms page.
What can I expect following the review of my protocol?
The Committee will review your protocol and usually send back a response: they may require clarifications in some areas, or request changes to ensure that the research is fully compliant with the National Statement. The changes requested are often related to the participant information sheet and/or consent form. It is crucial that the information participants receive is clear and accurate.
Researchers should provide responses to the Committee by emailing email@example.com. Most responses require researchers to answer questions about their research and/or provide edited supporting documents. The response from the researcher will be reviewed out-of-session by the Chair of the committee that initially reviewed the protocol. Any further questions will be sent back to the researcher, and then this process will go back and forth until both the researcher and the chair are happy with the final protocol and documentation.
What are the ongoing requirements of my ethics approval?
You are required to complete a monitoring report in ARIES at least every 12 months while the research is still active. The system will prompt you to complete this report when it is due, via a system-generated email which provides instructions on finding and submitting the form. Completing this report should take no longer than 5-10 minutes.
Any unexpected incidents should also be reported to the Ethics Office either by email or via the monitoring report form.
For more information, please see the Variations, monitoring and expiries page.
How do I make changes to my approved protocol?
If you need to change something about your research from the initially approved protocol, you need to submit a variation request in ARIES before the change takes place. This includes changes to research method, recruitment, investigators, location and others. If you are unsure whether the changes you are making require the submission of a variation, please get in touch with the Ethics Office and discuss it with our staff. The request will be reviewed out-of-session by the HREC chair.
For more information, please see the Variations, monitoring and expiries page.
Does the ANU HREC review ethics applications from external organisations?
The ANU HREC has the capacity to review applications from external organisations. However, unlike ANU research projects, these applications are accompanied by an administrative fee. Please email firstname.lastname@example.org for advice.
How do I make a complaint about ANU research?
The Australian National University takes every complaint seriously. Once a complaint has been submitted, the HREC and/or the Director of the Research Services Division will investigate the allegations. Investigations may take up to 6 weeks.
Complaints from research participants
Researchers who receive a complaint from a research participant must notify the Ethics Office as soon as possible (contact details below). The Ethics Office will advise the Director of the Research Services Division, the Chair of the relevant committee, and (if applicable) the primary investigator of the complaint. The Chair will consider the complaint and will take what action they deem appropriate as soon as possible. Actions may include:
- verifying that the researcher has conducted themselves according to the approved protocol
- nominating the Director to meet with the participant and/or the researcher
- requesting the researcher take steps to rectify the issue by, for example, deleting participant data or issuing an apology
- temporarily suspending ethics approval
All discussions will be conducted in a confidential manner.
Complaints from researchers
- Consistently with the National Statement, the ANU provides for complaints about the process of ethical review, but does not provide for an appeal against a final decision to reject a proposal.
- If an application is being considered for rejection, it must be reviewed by the HREC, and the Researcher/s must have an opportunity to address the HREC's concerns at an interview. The decision by the HREC to reject an application is final and may not be appealed.
- Complaints about the process of ethical review must be made in writing to the Director of the Research Services Division, who will inform the Chairperson of the HREC of the complaint, and investigate and attempt to resolve the matter. Researchers have the right to attend one meeting of the HREC to present their complaint in person.
Human Ethics Office
Monthly Drop-In Sessions
The Ethics Office also hosts drop-in sessions on the second Wednesday of each month where you can meet the team in person. See our Drop-In Sessions page for details.