FAQs

What counts as human research, and who is considered a participant?

Human research includes any research conducted with or about people, or using their data or tissue. Anyone whose behaviour, data, or biological material is involved — even through observation in public or classroom settings — is a participant and must be treated with full respect, including the opportunity to give consent or opt out. If consent is waived, researchers must justify this through the National Statement (Sections 2.3.9–2.3.12).

What are the key requirements for participant information and consent?

What must researchers justify when including specific participant groups?

Researchers must justify why particular groups are included and ensure the decision aligns with the National Statement’s ethical principles:

• Research Merit & Integrity: Participants should only be included when necessary to answer the research question, using appropriate methods and without compromising respect.
• Justice: Inclusion must be fair and not based on convenience or vulnerability. Benefits and burdens must be equitably distributed.
• Beneficence: Risks must be minimised and outweighed by the likely benefits to participants or communities.
• Respect: Inclusion must recognise cultural, personal, and community values and allow participants to make informed, voluntary decisions.

Can I exclude certain participants from my Study?

The exclusion of participants in research must be justifiable in terms of their contribution to answering the research question. Groups of people should not be excluded from participation merely because they are difficult to engage, have diminished capacity, or are vulnerable. Excluding participants during the design phase because it is inconvenient or too much work shows disrespect to entire cohorts from the outset. The inclusion or exclusion of specific groups can dramatically affect the ethical acceptability of a proposal. Researchers must think beyond convenience, availability, or captive audiences. Where additional resources are needed to engage methodologically relevant groups, these costs should be included in funding applications

How do I amend an approved application?

1. Open the application you wish to amend.

2. Click on "Correspond" in the "Actions" menu on the left and send a message to the Research and Integrity Team with a request unlock the form.  Email: humanethicscommittee@canberra.edu.au.

3. Research Ethics and Integrity will then unlock the form, and you will be able to Amend the form.

4. After amending the form, sign it electronically and confirm that you wish to submit it.

What does “data sovereignty” and “owning the narrative” mean in research involving identifiable communities, and what are researchers expected to consider?

“Data sovereignty” and “owning the narrative” refer to the rights of identifiable communities, including but not limited to Aboriginal and Torres Strait Islander peoples and to control how they are represented and how their data is used.

Human Research Ethics Committees (HRECs) increasingly expect researchers to demonstrate genuine understanding of self-determination, community empowerment, and respectful engagement. This includes:

• Consulting communities about how their stories, identities, and cultural materials are portrayed.
• Ensuring participants guide the narrative, especially when research outputs describe communities in positive or negative ways.
• Recognising community rights over data, particularly when it involves cultural knowledge, trauma-affected groups, or contested history.
• Addressing data ownership, access, and long-term use in data management plans.

The AIATSIS Code of Conduct and the UN Declaration on the Rights of Indigenous Peoples emphasise that Indigenous peoples have rights to maintain, protect, and control their cultural practices, histories, languages, sacred sites, and communal stories.

Researchers should therefore consider:

1. Who controls participant stories and cultural knowledge?
2. How participants wish to be identified in outputs.
3. Who owns the collected data.
4. Whether culturally or historically significant data requires ongoing community access or protections

Why must a research proposal be justified beyond identifying a gap in the literature?

Section 8.1 requires applicants to show research merit, as outlined in National Statement paragraph 1.1.
Identifying a knowledge gap is not enough as researchers must also explain:

• How this specific project will address the gap
• Why the chosen approach is appropriate
• What new knowledge, practice, or outcomes will result

HREC needs to see the direct link between the gap and the proposed study, not just a general need for research on the topic.

Why must sample size be explained, and what should this explanation include?

Sample size is an issue of both merit (1.1(b)) and justice (1.4):

• Too small → unreliable or invalid results
• Too large → unnecessary burden on participants

Applicants must:

• State the number of participants
• Explain the methodological basis for that number
• Link the sample size to the research question and study design

Simply referencing similar studies or naming a software tool (e.g., “SPSS will be used”) is not sufficient.

How should researchers present multi-phase studies or research using previously collected data?

For multi-phase or continuation studies, researchers should provide:

• A summary of findings from earlier phases
• Evidence of how those findings inform the current phase
• Documentation showing that participants consented to the data being reused as proposed

This ensures HREC can judge whether consent remains valid and whether the methodological progression is justified.