Frequently Asked Questions

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

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

See also Ethical considerations in quality assurance and evaluation activities for triggers for consideration for ethical review

Please speak to the Human Ethics Team (human.ethics.officer@anu.edu.au) about the specifics of your research project to confirm whether ethics approval is required

Research students also need human research 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.

For more information about student applications, see Student and Supervisor Responsibilities in research ethics.

If you have already obtained human ethics approval for your research by another HREC registered with NHMRC, the ANU will recognise that approval when considering your protocol. Please review the information on the Projects with Prior Approval page for further information.

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 project. You can request extensions of up to a year on your original approval; requests will be considered by the HREC Chair.

The risk level of your research determines which ANU Ethics 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 low and medium risk protocols from Colleges in their jurisdiction.

• Low - Reviewed by the Chair of the appropriate ANU DERC

• Medium - Reviewed by the appropriate ANU DERC

• High - Reviewed by the ANU HREC

Please note the HREC Committee will not accept/review high risk applications led by undergraduate students.

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.

If you are collecting data from human participants, you must have a ANU 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 before giving consent to participant 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.

Most committee responses require researchers to answer questions about their research and/or provide amended supporting documents. The response from the researcher will be reviewed out-of-session by the relevant 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 and approval is given.

You are required to complete an annual report at least every 12 months while the research project is active. REMS will prompt you to complete a 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 via REMS in this report.

If you need to change something about your research from the initially approved protocol, you need to submit an amendment request via REMS 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 amendment, please get in touch with the Human Ethics Office. The amendment request will be reviewed out-of-session by the HREC chair.

The ANU HREC is not currently offering human research ethics reviews for external organisations.