Australian evaluators and researchers are increasingly working internationally. A program evaluator might be assessing a development intervention in Indonesia. A social researcher might be exploring community cohesion in a Pacific Island nation. A market researcher might be running consumer sentiment studies across Southeast Asia. In each case, people in other communities with their own values, expectations, and regulatory environments are at the centre of the work.
Chapter 4.6 of the National Statement on Ethical Conduct in Human Research (2025) addresses research conducted in other countries. Like other chapters in Section 4, it doesn't replace the foundational principles elsewhere in the National Statement. Instead, it layers additional ethical considerations onto them, recognising that the international context creates specific challenges that need to be addressed explicitly.
The Non-Negotiable Baseline
The starting point is clear. Paragraph 4.6.1 states that when conducting research or evaluation overseas, Australian researchers and evaluators must adhere to the requirements of the National Statement. This closes an obvious loophole: you cannot argue that because a country has weaker protections (or no formal protections at all) you are free to operate below the standards the National Statement requires.
Paragraph 4.6.2 adds a complementary obligation: the design and conduct of the work should recognise local cultural values and expectations, particularly what evaluators/researchers and participants expect from one another. Critically, this recognition must demonstrate that participants will be accorded no less respect and protection than the National Statement requires.
Together, these two paragraphs establish a "floor, not a ceiling" principle. Australian ethical standards are the minimum. Local cultural values and practices can inform how those standards are met, but they cannot justify doing less. A researcher working in a context where community leaders traditionally provide consent on behalf of individuals cannot simply defer to that practice if it overrides individual autonomy. They need to think carefully about how both obligations can be honoured at the same time.
Respect and Beneficence
Paragraph 4.6.3 requires evaluators and researchers to demonstrate respect through the design, conduct, and monitoring of their work, drawing on paragraphs 1.10–1.13 of the National Statement. In practice, this means taking into account local beliefs and practices around recruitment, consent, and remuneration, and undertaking ongoing consultation and engagement with local participant populations and communities.
The emphasis on ongoing engagement matters. This is not a box to tick during planning. It is a commitment that should run through the life of the project.
Paragraph 4.6.4 adds that the distribution of benefits, risks, and burdens should be equitable and considered acceptable by local standards. This is a two-part test. A program evaluation that generates rich insights for an Australian client but leaves participants feeling used, burdened, or unclear about what they were involved in fails the second part — even if it looks compliant on paper. Beneficence has to be real and locally recognisable.
Know Your Communities and Demonstrate It
Paragraph 4.6.5 sets a specific and practical expectation: evaluators and researchers should be familiar with the communities in which they plan to work, demonstrate how they will engage with potential participants, and be able to assess the benefits of their work for those participants and communities as well as the risks and burdens placed upon them. They also need to take into account political, social, and cultural factors that may jeopardise the safety, wellbeing, or interests of participants.
This is an ethical requirement, not just good practice. An ethics application for work in, say, rural Vietnam or urban Nigeria should not read as though it was designed from a desk in Melbourne. Reviewers will look for evidence of genuine contextual familiarity.
Paragraph 4.6.6 reinforces this by requiring that the work take into account community expectations about how resource limitations might affect the way the work is conducted, participant wellbeing after the project ends, and how findings will be applied. For evaluators and researchers in development and policy contexts, this is particularly important: communities in low-resource settings have often seen many evaluation or research projects come and go with little tangible benefit. Demonstrating awareness of this history and planning accordingly is part of what the National Statement asks for.
What if you plan to diverge from local expectations? Paragraph 4.6.11 addresses this directly: any planned divergence must be disclosed and justified to reviewers, who will consider the rationale provided. This is a sensible mechanism, but the bar is real. Divergence is not a matter of preference, but not forbidden either. It requires a genuine and articulable reason.
Ethics Approval: What's Actually Required Where You're Working?
This is where things get complicated, and where evaluators and researchers operating outside of universities and government agencies are most likely to feel uncertain.
Paragraphs 4.6.7–4.6.10 require evaluators and researchers to:
- inform their Australian HREC whether relevant ethics approval or authorisation processes exist in each country where they will work;
- clarify whether such processes are mandatory or voluntary for the proposed work; and
- indicate whether Australian HREC approval needs to be reported to comply with local processes.
The honest answer is that requirements vary dramatically between jurisdictions, and for independent evaluators and social researchers not affiliated with a university or government body, the landscape is especially unclear. What follows is a broad summary of available literature on jurisdictional requirements. It is not comprehensive or authoritative, and evaluators and researchers should verify the current requirements in their specific jurisdiction as part of their research or evaluation planning (as anticipated by paragraph 4.6.7) especially as guidelines change over time.
Common-law countries: funding-linked requirements
In the United Kingdom, the United States, and Canada, statutory requirements for ethics review are largely tied to research funding or institutional affiliation. In Canada, the Tri-Council Policy Statement (TCPS 2) explicitly states that research conducted by independent researchers not affiliated with an eligible institution is not legally required to undergo Research Ethics Board (REB) review, unless they collaborate with or are funded by an eligible institution. Program evaluations that do not constitute "research" fall outside the scope entirely. In the United States, IRB review is mandated for federally funded research or studies seeking FDA approval; privately funded social or market research has no legal requirement for IRB review, though publication and contractual obligations may create a practical expectation. In the UK, NHS Research Ethics Committees review health and social care research involving NHS patients; independent social or market research outside that system has no statutory review requirement, though data protection obligations remain significant.
Practical example: An Australian firm evaluating a UK government-funded employment program might find that local statutory ethics review requirements don't apply to them as independent contractors — but their Australian HREC approval, combined with GDPR compliance, is likely to be sufficient and expected by the client.
Countries with broader statutory scope
Several countries cast a much wider net. South Africa's National Health Act defines health research to include psychological and social processes, and requires all research involving human participants to be reviewed by a registered Research Ethics Committee before the work commences. Nigeria's National Health Act similarly mandates ethics review for all human research, with the NHREC providing national oversight. In Brazil, the CEP/CONEP system is among the most comprehensive: all projects involving human subjects including studies using interviews or questionnaires must be approved by a registered ethics committee, and data collection cannot begin without that approval. Senegal, South Sudan, and India also have broad mandatory ethics review requirements covering social and behavioural research.
Practical example: An evaluation team planning to conduct focus groups with community members in rural Nigeria as part of an international development evaluation would be required to obtain local ethics approval — either from a registered institutional committee or through the NHREC — before data collection begins, regardless of their Australian approval.
Aotearoa New Zealand: a close neighbour with its own framework
New Zealand is perhaps the jurisdiction Australian evaluators and researchers are most likely to work in, but its ethics landscape has some important differences worth understanding.
Health and disability research involving human participants is governed by the Health and Disability Ethics Committees (HDECs), administered by the Ministry of Health under the New Zealand Public Health and Disability Act 2000. HDEC review is mandatory for health and disability studies that recruit participants in their capacity as consumers of health or disability services, volunteers in clinical trials, or where health information is involved. For social research, market research, and program evaluation that falls outside the health and disability scope, HDEC review is not required, and the HDEC website includes a screening tool to confirm whether your study is in scope.
Research originating from a New Zealand university will typically be reviewed by the institution's own ethics committee. Independent evaluators and researchers (those not affiliated with a university or the health system) are in a similar position to their Australian counterparts: there is no single statutory body that covers all human research, and the appropriate pathway depends on the nature of the work.
For independent social, market, and evaluation research conducted in New Zealand, there is a specific and important consideration: the ethical standards applied must engage with Te Ara Tika, the framework for Māori research ethics developed by the Health Research Council of New Zealand. Te Ara Tika sets out values and principles, including whakapapa (relationships), tika (doing the right thing), manaaki (respect and care), and mana (authority and integrity), that are expected to inform research design and conduct when working with or for Māori communities. This is not optional guidance; it reflects the partnership obligations of Te Tiriti o Waitangi and is applied by New Zealand ethics committees as a standard framework alongside other ethical guidelines.
For Australian evaluators and researchers planning to work in Aotearoa New Zealand who are not affiliated with a New Zealand institution, we recommend engaging with the Independent Human Ethics Review Collective (IHREC). IHREC operates similarly to Iris Ethics, providing independent ethics review services for researchers who are not eligible to apply to an institutional or health and disability committee and applies the ethical standards expected in Aotearoa New Zealand, including Te Ara Tika. Working with a local independent committee like IHREC is the most direct way to ensure your application is assessed against the standards actually used by New Zealand reviewers, and to demonstrate to local communities, clients, and participants that you have engaged appropriately with the New Zealand context.
Practical example: An Australian policy research firm engaged to evaluate a community housing programme in Tāmaki Makaurau (Auckland), involving interviews with Māori and Pasifika participants, should seek review through IHREC rather than relying solely on Australian HREC approval. IHREC will assess the project against Te Ara Tika and local consent standards, and the approval will carry weight with New Zealand-based partner organisations and communities.
Emerging and sector-specific frameworks
In Indonesia, Thailand, and Vietnam, statutory requirements are clearest for health and biomedical research, and there are well-established systems in place for ethical review in these domains. The obligations for independent social research or program evaluation are less explicit in law, though guidelines may still apply and cultural expectations around consent and process remain important.
The grey zone: market research and program evaluation
Many jurisdictions treat market research as a commercial activity, and formal ethics review may not be mandated unless the study is framed as research intended to contribute to generalisable knowledge, or involves sensitive personal data. Canada's TCPS explicitly excludes quality assurance and program evaluation from its scope. The EU has no single research ethics law; for purely social or market research, GDPR compliance may be the primary legal obligation, though EU-funded projects face additional ethics appraisal requirements.
This grey zone is familiar territory for evaluators and social and market researchers in Australia too. If you're unsure whether your international project constitutes "research" for the purposes of the local jurisdiction, the safest position is to treat it as research and seek review.
When No Local Process Exists
Paragraph 4.6.8 addresses this directly. Where there are no relevant ethics approval processes in the country where the work will be conducted, the Australian HREC or other ethics review body should apply the principles and relevant guidelines of the National Statement, with additional regard for the outcomes of consultation and engagement with the local participant population and communities.
This means that approval by an Australian HREC, including Iris Ethics, can stand as sufficient oversight where no local process exists or applies to your work. In those circumstances, paragraphs 4.6.16 and 4.6.17 set out what reviewers will look for.
Paragraph 4.6.16 (Reviewer considerations): Reviewers will assess whether evaluators and researchers have sufficient experience or access to expertise to engage with participants in ways that accord them the respect they are entitled to, and whether the engagement plan and assessment of benefits, risks, and burdens adequately reflects both the values of the National Statement and local standards and expectations.
Paragraph 4.6.17 (Complaint mechanisms): Evaluators and researchers must ensure arrangements are in place for a local and readily accessible contact who can receive questions and complaints from participants; clear communication between that contact and the research or evaluation team; a process for participants to contact the team and/or the reviewing HREC if no viable local contact is available; and an independent process for handling complaints.
This last point is practical and important. An evaluator working in a remote community in the Pacific needs to have thought through what happens if a participant has a concern after data collection ends. A contact number in Sydney is not likely to be an adequate answer.
What a Good Application Looks Like
For evaluators and researchers bringing an international project to an HREC, Chapter 4.6 translates into a set of concrete expectations.
Contextual knowledge
Genuine evidence of familiarity with the communities, political context, and cultural norms in the country or countries where the work will be conducted. Prior experience in the region, consultation with local partners, or input from community members in the design phase.
Regulatory clarity
A clear account of what, if any, ethics approval or authorisation processes exist in each country, whether they are mandatory or voluntary for the type of work proposed, and how they relate to Australian HREC approval.
Cultural responsiveness
A demonstration of how local beliefs and practices, particularly around recruitment, consent, and remuneration, have been incorporated into the design. Where you plan to diverge from local expectations, a clear and well-reasoned justification (Paragraph 4.6.11).
Equitable benefit distribution
A genuine account of the benefits the work will bring to participants and communities, assessed against local standards. For program evaluations, this typically means thinking about how findings will be shared with, and useful to, the communities involved, not just the commissioning client.
Local complaint mechanisms
Practical arrangements for a local contact who can receive questions and complaints, with clear communication channels back to the team and the reviewing HREC (Paragraph 4.6.17).
Summary
Chapter 4.6 places a real responsibility on evaluators and researchers. Reviewers can only assess what they are given, and institutions can only set frameworks. The person navigating the ethical complexity on the ground is the evaluator or researcher themselves.
The National Statement's approach is to equip that person with clear principles and practical guidance, rather than pretend a checklist will cover every situation. Working internationally means accepting that uncertainty is inherent, that local knowledge matters, and that the obligation to participants does not diminish just because they are geographically remote from the bodies that oversee Australian research and evaluation practice.
If you have questions about how Chapter 4.6 applies to your project, whether you need local ethics approval, how to document cultural engagement, or how to structure complaint mechanisms for an international context, get in touch. We'd rather help you get it right at the design stage than review an application that needs to be reworked.
This post is intended as a practical guide to Chapter 4.6 of the National Statement on Ethical Conduct in Human Research (2025). It does not constitute legal advice. The jurisdictional information provided is a summary of available literature to assist with planning; evaluators and researchers should verify current requirements in their specific jurisdiction before commencing work.
AI Disclosure: Initial drafts of the content for this article were prepared using Large Language Models with input from Iris Ethics staff who guided the scope and design. Subsequent revisions and final versions were developed and approved by Iris Ethics staff.