The National Statement on Ethical Conduct in Human Research 2025 (hereafter, National Statement) —developed jointly by the National Health and Medical Research Council (NHMRC), the Australian Research Council and Universities Australia—will take effect in 2026 1. While many of the changes made to the National Statement are considered minor, this updated version incorporates a fully revised section 4, including major thematic changes framing the need for greater ‘emphasis on inclusion of individuals and groups frequently excluded or under-represented in research’ 2. This addition aligns with the World Health Organization's Global Action Plan for Clinical Trial Ecosystem Strengthening 3, reinforcing and giving weight to widespread calls to embed equity in clinical trials and health research over recent years. The rationale for increasing representation in trials is clear: a lack of diversity undermines generalisability, external validity and the equitable distribution of research benefits 4. Inequitable research perpetuates disparities in treatment safety and efficacy, with profound health and economic consequences 4. Beyond improving evidence quality, inclusive research is a moral imperative. It reflects the ethical principles of justice and respect for persons, ensuring that all communities—not only the most easily reached—can benefit from and contribute to research. Existing frameworks and recommendations to address this challenge have largely focused on the responsibilities of researchers and trialists. However, individual efforts to increase diversity and inclusion in health and medical research must be matched by system-level reform of ethics and governance. Australia's system historically has not been designed to meet this goal. Although anchored in the National Statement, ethical review is devolved to local human research ethics committees (HRECs), each with its own policies, procedures and forms—many of which are not inclusive by design (e. g. , consent templates written above recommended readability levels) and vary across HRECs. These issues lead to exclusion of the very groups listed in the revised National Statement, including individuals with ‘limited communication skills or capacities; limited first or second language skills; illiteracy; educational or vocational skills deficits’ 1. There are signs of change. Earlier this year, the CT: IQ InFORMed PICF template, a simplified participant information and consent form template for health and medical research, received national endorsement from the NHMRC and all Australian health departments 5. The Therapeutic Goods Administration has also adopted the International Council for Harmonisation Guideline for Good Clinical Practice E6 (R3) 6, which requires that information for research participants be ‘as clear and concise as possible’, using simple language and avoiding unnecessary complexity, while supporting varied approaches such as text, images, video and interactive methods in the consent process. Building on these developments, Australia's National One Stop Shop for health and medical research 7—which received a 13. 6 million investment from the federal government in October 2025 8—offers a rare opportunity to ensure that Australia's ethics and governance infrastructure proactively supports equity, diversity and inclusion from the very start, as it moves towards a more streamlined, nationally consistent approvals and data system. This investment provides an opportunity to embed equity into the development of national standard operating procedures, the National Clinical Trials Governance Framework and the new HREC accreditation scheme. This could include supporting the consistent use of nationally endorsed participant information and consent templates, increasing transparency around approvals for alternative consent formats and language translation, providing guidance for researchers to implement equity-focused practices (e. g. , diversity and inclusion plans in trial protocols) and training HREC members in inclusive research to ensure that feedback and required changes uphold equity and diversity principles rather than unintentionally undermining them. Now is the moment for Australia to lead. With this investment, Australia must redefine research ethics and governance to make equity the standard, not the exception, in all of our health and medical research. Danielle Muscat: conceptualisation, writing – original draft. Kirsten J. McCaffery: conceptualisation, writing – review and editing. Heather Shepherd: conceptualisation, writing – review and editing. Marguerite Tracy: conceptualisation, writing – review and editing. The authors have nothing to report. Danielle Muscat and Kirsten McCaffery are co-directors of Health Literacy Solutions PTY Ltd. , which sub-licences the SHeLL Editor (a health literacy editing tool). They take no personal income from this role. The authors have nothing to report.
Muscat et al. (Wed,) studied this question.