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 are required to be granted approval via the ANU Human Ethics processes prior to beginning data collection. The collection of data from human participants includes, but is not limited to:
- Collection of information about human participants and groups via the use of interviews, questionnaires, behavioural observation, tissue samples or provision of stimuli.
- The use of identifiable secondary data.
- The use of secondary medical data.
- Any research project 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 poses negligible risk to human participants will not be required to go through the ethics review process. However, it is advisable that you speak to someone within the ANU Research Ethics & Integrity team about the specifics of your research to get an in-depth answer as to whether you will require ANU Ethics approval. Examples of research that do not require ethics approval include:
- 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.
- Publically available media material (social media excluded).
- Unidentifiable secondary data (medical data excluded).
Note: 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.
What if I can't login to ARIES?
If you have completed the ARIES New User Form online, please allow up to 24 hours for your account to become active. Once you receive the email from the IT team about your ARIES account, you will be able to login using your ANU UID and network password.
If you are no longer affiliated with ANU, you will be unable to login to ARIES due to your internal credentials being removed from the system. If this is the case, any ongoing research ethics protocols you have at ANU will need to be closed, or transferred to a new primary investigator that is still affiliated with the ANU.
How do I begin preparing an ethics application at ANU?
Once you have created an ARIES account and been given access to the system you are able to being trained in how to use the system and the important issues related to research ethics at the ANU. The Research Ethics & Integrity run monthly face-to-face training sessions which allow researchers to ask specific questions whilst being walked through the process of creating an application. Alternatively, if researchers are unable to attend the face-to-face session, a training video is available online which was recorded at a previous face-to-face session.
In addition to the above training options, the ANU Research & Integrity team offer monthly Ethics Drop-In Sessions that present researchers with the opportunity to ask questions about their application at any point of the process and seek guidance on how to proceed. These sessions are held on the 2nd Wednesday of every month as per the ANU Human Ethics web pages. All options of Human Ethics training at ANU will provide complete guidance to researchers as to how to begin their application and complete it in full.
What is the risk level of my research?
The research ethics review requires research protocols to be classified in to one of three risk categories that are dependent on the methodology, target participant group, previously approved status, recruitment strategies and subject matter;
Low-Risk Expedited Level 1 Protocol (E1) - Data collection methodology that engages participants in activities they would encounter in everyday life.
Medium-Risk Expedited Level 2 Protocol (E2) - Data collection methodology that engages non-vulnerable participants in activities greater than a negligible level of risk.
High-Risk Full Review Protocol (Full) - Data collection methodology that engages participants who are in some way vulnerable, or research settings that are particularly unusual or uncomfortable.
During ANU Human Ethics training, the specifics of particular methodologies and target participant groups as they relate to risk level requirements are covered in detail.
ANU Human Ethics Risk Level Classification
Please Note: The HREC does not allow high-risk (FULL Review) research to be conducted by undergraduate or Honours level students.
How will ethical review occur?
The risk level of your research determines how and by whom your ethics protocol will be reviewed. At ANU there is three Delegated Ethics Review Committees (DERC) that sit beneath the ANU Human Research Ethics Committee (HREC) in terms of the review process, these delegated committees review E1 & E2 protocols from colleges in their jurisdiction.
Low-Risk Expedited Level 1 Protocol (E1) - Reviewed by the chairperson of the appropriate DERC out-of-session with no submission deadline.
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 that play a role in the process. However, the data we have on human ethics application at ANU suggests that on average the higher the risk of the protocol, the longer the approval time. The greatest contributor to this process is the quality of the protocol submitted by the researcher, as such it is recommended throughout the training process that researchers take care and allow adequate time in 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:
Low-Risk Expedited Level 1 Protocol (E1) - Allow up to 4 weeks from the time of submitting your signed documents.
Medium-Risk Expedited Level 2 Protocol (E2) - Allow up to 4 weeks from the next DERC submission deadline.
High-Risk Full Review Protocol (Full) - Allow 6-8 weeks from the next ANU HREC submission deadline.
What if I already have ethics approval from another institution?
Research that has a currently active approval from an NHMRC registered HREC will be reviewed at ANU as an Expedited Level 1 protocol, regardless of proposed methodology. This is on the provision that a copy of the previously approved application, and approval letter are provided as part of the submitted protocol on ARIES.
How long does ANU ethics approval remain valid?
All approved protocols at ANU are granted five years approval, on the condition that all monitoring and approval requirements are met during the life of the research. If a researcher wishes to continue a research study beyond the initial five years of the approval, they will need to apply for a new ethics approval via the standard ANU review process.
Are there additional considerations for research involving Aboriginal & Torres Strait Islander Peoples?
Research involving Aboriginal and Torres Strait Islander peoples is particularly sensitive and has its ethical aspects reviewed by the full HREC. Central to such research are principles of respectful engagement and consultation. The AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies states 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 evidence to be presented by researchers of such consultation and, wherever possible, letters of support from community leaders or organisations that attest to the willingness of the community to be engaged within the research. While it is understood that some documentation (e.g. permission to work within schools) may require ethics approval before it can be obtained, protocols will not generally be accepted for review by the HREC without evidence of consultation with relevant Indigenous communities and organisations, and researchers will generally be asked to provide relevant documentation as material evidence of such engagement and support.
Do I need a participant information sheet & consent form?
Participant Information Sheet
A Participant Information Sheet is required for every research project. The purpose of this Information Sheet is to explain the research, what will be asked of participants, and the safeguards in place for them. The Information Sheet 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.
The Information Sheet template linked here should be used for all ethics applications, as it contains all of the elements typically required. Information Sheets submitted using another format will be returned for revision to the required format before approval. Not all items on the template will be needed for all applications, so items that are not relevant for a particular application may be deleted. Ideally, Information Sheets should be one to two pages in length, so please keep this in mind as you prepare your Information Sheet using the above template.
The Information Sheet must include contact details for the Human Research Ethics Committee in case of any ethical concerns (see the National Statement). The Privacy Notice must be included. Any special provisions should also be included, e.g. agreement to the use of audio and/or videotapes, with details about how these will be stored and handled.
An example of an adequate ANU Participant Information Sheet is available here.
An expression of consent in a Written Consent Form or Oral Consent Form is required for every research project, with the exception of some online surveys/questionnaires. (In an online survey, the click of the "submit" button online is deemed consent).
Generally speaking the HREC prefers that written consent be obtained. Tear-off slips at the bottom of an information sheet are not adequate as consent forms. The consent form should provide the same details as the Information Sheet and should be on a separate page. A Written Consent Form template is available here.
In some cases (e.g. with illiterate participants or in particular cultural settings), it may not be possible to seek written consent. Instead, oral consent may be more appropriate. If researchers choose to seek oral consent, they need to explain to the HREC in their submission why oral consent will be sufficient and how they propose to obtain it. This should include a list of the points that will be made in order to obtain informed consent. In some situations, it may be appropriate to have a witness present during the oral consent process. In situations where consent is obtained from people in positions of authority (e.g. village elders, community groups etc.) individual consent from each participant should still be sought in principle. An Oral Consent Form template is available here.
In the case of low-risk, anonymous questionnaires, where return of the questionnaire can be deemed to constitute consent, a consent form may not be required. However if the questionnaire is actually or potentially identifiable, the HREC prefers a written consent form separated from the questionnaire immediately upon its return so that no link can be made between the consent form and the questionnaire responses. Participants should be told in the Information Sheet and Consent Form that this separation will take place.
What can I expect following the review of my protocol?
The vast majority of ethics protocols reviewed at ANU will receive a response from the reviewing committee requiring some clarification on certain areas of the research methodology or changes to ensure that the research is fully compliant with the NHMRC National Statement on Ethical Conduct in Human Research. Commonly, these changes will be related to the participant information sheet and/or consent form as it is imperative that these documents be clear and accurate as per the section above.
Along with this feedback from the committee, you will receive instructions as to how to respond via email. Most forms of feedback from the committee won't require editing your protocol in ARIES, instead - the researcher will be responding to questions about their research and/or providing edited supporting documentation that aligns with the committee's requirements. The response from the researcher will be reviewed out-of-session by the chair of the committee that reviewed the protocol initially, 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?
As per the conditions of the ANU Research Ethics approval, researchers are required to complete an ARIES monitoring report on ARIES every 12 months while the research is still active. Researchers are prompted to complete this report via a system generated email that provides all the instructions of how to do so. Completion of this report should take no longer than 5-10 minutes, and it provides the ethics office an update to ensure that nothing unexpected has occurred, and also an updated anticipated end date to the research.
How do I make changes my approved protocol?
Should the researcher be required to change something about their research that is different to the initially approved protocol, they are required to submit a variation on ARIES. This includes changes to; methodology, recruitment, investigators, location & 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. All variations are reviewed out-of-session by the ANU HREC chair.
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 for the service.
How can I report an incident involving ANU research?
The Australian National University takes every complaint seriously. Once a complaint has been submitted, the HREC will investigate the allegations. Investigations may take up to 6 weeks, if you wish to make a complaint please contact the ethics office (details available below).
Complaints from research participants
- Complaints by research participants will be made normally to the Office of Research Integrity. Researchers who receive a complaint from a research participant must notify the Ethics Office as soon as possible. The Ethics Office will advise the Director of the Office of Research Integrity and Chairperson of the relevant Ethics Committee of the complaint at the earliest opportunity.
- The Chairperson will consider the complaint and will take what action he/she deems appropriate, as soon as possible. This action may include nominating the Director of the Office of Research Integrity to have a direct discussion with the relevant research participant and/or direct contact with the Primary Investigator. The process will usually involve verification that the protocol approved by the Committee has been followed and subsequent action may include temporary withholding of 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 had 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 Office of Research Integrity, 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.
How can I talk to someone from the ethics office?
Human Ethics Office
Monthly Drop-In Sessions
Second Wednesday of each Month, see here for details.