If you are conducting research in these areas or with these participants, there are specific policies and guidelines about what you should consider, as well as certain procedures that must be followed. This information will be essential to completing your application as your ethics application must adequately address these considerations.
- Research with Indigenous Australian or Torres Strait Islander Communities
- Research with children and in schools
- Research with vulnerable of people
- Research with ACT Health and Clinical Trials
- Research in ANU Learning & Teaching
- Australian National Internship Program
- Policy & Guidelines for all ANU researchers
1. Research with Indigenous Australian or Torres Strait Islander Communities
Intentional Recruitment of Aboriginal and Torres Strait Islander Peoples
Research involving Aboriginal and Torres Strait Islander peoples is particularly sensitive and all research involving Aboriginal and Torres Strait Islander peoples is reviewed by the full HREC.
Evidence of Engagement, Consultation and Negotiation
Respectful engagement, consultation and negotiation are central to conducting research with Aboriginal and Torres Strait Islander peoples. AIATSIS Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) 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."
Consultation and negotiation are key elements of four out of 14 principles that are set out in GERAIS. Namely:
- Principle 6: Consultation, negotiation and free, prior and informed consent are the foundations for research with or about Indigenous peoples.
- Principle 7: Responsibility for consultation and negotiation is ongoing.
- Principle 8: Consultation and negotiation should achieve mutual understanding about the proposed research.
- Principle 9: Negotiation should result in a formal agreement for the conduct of a research project.
Accordingly, ethical review of protocols involving Indigenous peoples requires evidence of engagement and consultation. Wherever possible, letters of support from community leaders or organisations that attest to the willingness of the community to be engaged within the research should be included in the ethics protocol. 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 generally not be accepted for review by the HREC without evidence of consultation with relevant Indigenous communities and organisations. Such protocols will be returned to the researcher, and the researcher will be asked to provide relevant documentation as material evidence of engagement and support.
“Negotiation, consultation, agreement and mutual understanding” comprise only one of six categories of guidance provided by GERAIS. The GERAIS comprise of 14 principles grouped under the following six categories:
The NHMRC have also published Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities (2018) and Keeping research on track II (2018) to be read in conjunction with their general guidelines set out in the NHMRC National Statement on Ethical Conduct in Human Research. NHMRC summarises their guidance under six core values:
- survival and protection
- spirit and integrity.
Indigenous Cultural and Intellectual Property (ICIP)
2. Research with children and in schools
Ethical Concerns with Research Involving Children
Research involving children and young people raises particular ethical concerns about:
- their capacity to understand what the research entails, and therefore whether their consent to participate is sufficient for their participation;
- their possible coercion by parents, peers, researchers or others to participate in research; and
- conflicting values and interests of parents and children.
Guidance on how to apply the principles of Justice, Beneficence and Respect when conducting research with children are set out in National Statement Chapter 4.2: Children and young people.
Research in Schools
If research is to be conducted with students in government schools then permission must be sought first from both the relevant Department of Education and the individual schools through the principal. In the case of private schools the permission of the principal may suffice. Please consult the Research with school-aged children guidance page.
Working With Vulnerable People Accreditation
Working with Vulnerable People Accreditation (WWVP) is required in the ACT prior to beginning any work with vulnerable people, including children.
Research staff are not required to have a WWVP application completed during the review of their ethics application by the Human Research Ethics Committee (HREC). However, research staff must clearly state in their ethics application that their WWVP will be completed before any research with vulnerable people commences. Approvals to ethics applications are conditional on that basis. Copies of the WWVP must be forward to the human ethics team at firstname.lastname@example.org when completed, prior to beginning research with children. Where WWVP accreditation has already been completed at the time of ethics application, copies must be uploaded with the ethics application in ARIES.
Where research involves vulnerable people overseas, research staff must obtain an Australian WWVP Check. For other Australian states and territories, please see Information for community and volunteers: Working or volunteering with vulnerable people in another State or Territory.
3. Research with vulnerable people
4. Research with ACT Health and Clinical Trials
Researchers based at Canberra Hospital
A researcher based at the Canberra Hospital who is also affiliated to the Australian National University (ANU) will need to obtain ethics clearance both from the ACT Health Ethics Committee and from the ANU HREC. ACT Health HREC has agreements in place with the ANU HREC to facilitate streamlined ethical approval processes for research projects that are defined as “cross-institutional”.
If you are a researcher that requires ethics clearance from both HRECs, you should:
- Submit your protocol with ACT Health Ethics Committee
- Once the protocol has been cleared by ACT Health Ethics Committee, submit the application in ARIES as an expedited application for an expedited review.
If you are a researcher (from any college) conducting a clinical trial involving a drug or device, it will need to be assessed and supported by the ACT Health Clinical Trials Committee before being assessed by the ACT Health Ethics Committee and the ANU HREC. Please submit your application to the ANU HREC after obtaining clearance from the ACT Health Ethics Committee. You will also need to provide a copy of your protocol (with attachments) to the Insurance Office. Please contact the Insurance Office on extension 54257 or email email@example.com for further information.
If you are conducting a clinical trial not involving a drug or device within the ACT Health system, it will need to be assessed by the ACT Health Ethics Committee. Once clearance is received by the ACT Health Ethics Committee for the clinical trial, please submit your application to the ANU HREC.
Drugs or devices not already approved by the Therapeutic Goods Administration will also need to be reported to the TGA under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes.
If you are conducting a clinical trial that does not involve a drug or device and is not conducted within the ACT Health system, please submit your application directly to the ANU HREC.
Researchers Seeking to Conduct Human Research in High-Risk Destinations
Researchers who are seeking ethics approval to conduct research in high-risk destinations (i.e. those declared by DFAT as "Do not travel" destinations within travel advisories at smarttraveller.gov.au) need to include details in their ethics protocols about risks to participants and themselves that may arise because of the high-risk environment within the countries that they wish to visit.
Formal travel approval from the Vice-Chancellor is a requirement for ANU staff wishing to conduct research in such countries, and this approval would normally require a formal risk assessment to be carried out for the researcher. Formal travel approval is a separate process from the research ethics approval process, however it would assist the Committee in understanding the risks to researchers if formal risk assessment details could be provided when the ethics application is submitted.
Critically, the Committee is concerned about any risk to participants in these destinations that might arise through their participation in the research, and detailing the risks to the researcher alone will be insufficient for the Committee to be able to approve the protocol. The Committee is interested in assessing both the level of risk and any risk management strategies that the researcher can put in place. Note that protocols that claim that there is no risk or negligible risk in such environments are likely to be carefully scrutinised and it is better for protocols to provide an honest assessment of the risk and for the researchers to develop strategies to deal with that risk, recognising that removing the risk entirely will almost certainly not be possible.
Researchers are encouraged to apply for the relevant travel approval as well as ethics approval well before they need to travel.
6. Terrorism Research
7. Research in ANU Learning & Teaching
Surveys on ANU Staff and/or Students: University Approvals
Surveys targeting ANU staff and/or students will need University approval before they can proceed. This process is distinct from the ethics approval process, and University approval may be required even if ethics approval is not. University approval for surveys involving students is from the Planning and Performance Measurement Division (PPM) while staff survey approval usually comes from HR (via PPM). For more information on the process involved, please refer to Planning and Performance Measurement Division’s website.
Human Research Ethics and Research in Teaching and Learning
Education-based research projects for which our students are research participants bring unique ethical challenges. This is especially since the students have a dual role both as learners in a class environment and as research participants in an environment in which they might represent a dependent or vulnerable population. In 2014 the Australian Government Office for Learning and Teaching (OLT) commissioned Australasian Human Research Ethics Consultancy Services (AHRECS) to undertake work to help researchers construct ethical protocols for conducting education research. The AHRECS Scholarship of Teaching and Learning Research Ethics Manual consists of six booklets that include academic references, recommended reading and prompts for ethical reflections. The booklets are practically focused and incorporate examples of problems and suggested strategies.
MOOC-based Research, edX and Human Research Ethics
The University recognises the increasing interest in conducting research using education data gathered from MOOCs. While the edX Terms of Service supports the carrying out of such research by explicitly making the availability of MOOC data a condition of course enrolment, the conduct of the research itself remains subject to the ANU Code of Research Conduct and the NHMRC's National Statement on Ethical Conduct in Human Research. The ANU Human Research Ethics Committee has considered research of this type and considers the main types of research to be of two broad types:
This includes research using data analytics that involves no "intervention" but rather involves analysis of de-identified learning analytics data. Such research can be carried out under the existing terms-of-service arrangements without formal ethics approval. However, assessments of risk to participants should be carried out on individual research projects and ethics clearance sought if specific risks to participants are identified.
Greater than negligible risk
This includes research that involves "interventions" (e.g. A/B testing where students are randomly assigned to different groups given different methods of instruction). Such research requires ethics approval prior to data collection.
In order to comply with the National Statement: (a) students must be informed that they are participants in an experiment; (b) alternative arrangements for voluntary participation (i.e. the right to NOT participate in the experiment without giving up the ability to remain in the course) must be made; (c) a record of consent and withdrawal must be kept; (d) use of data and feedback on results should be made available to participants.
8. Australian National Internship Program (ANIP)
Students enrolled in the Australian National Internship Program (ANIP) are required to register for the ANIP Training program on Wattle, delivered by the ANIP Director. This training session will outline the role of ethics in the ANIP project timeline, and important information regarding the submission process (e.g., ANIP students are unable to submit high risk ethics applications). Students should follow the ANIP Human Ethics Protocol Submission Guidelines, and ensure they are familiar with this document throughout the process. Upon submission of their ethics protocol, students should upload the completed ANIP Student Checklist as a supporting document.
9. Policy, Guidelines & Insurance for all ANU researchers
Policy & Guidelines for ANU Researchers
Insurance for ANU Researchers