The Institution
Institutions that conduct or sponsor human research are responsible for ensuring compliance with the National Statement on Ethical Conduct in Human Research (2025) and for promoting a culture of integrity and ethical practice.
- Establish and maintain Human Research Ethics Committees (HRECs) in accordance with the National Statement and ensure they are properly constituted, supported, and independent.(Clauses 5.1.24–5.1.29)
- Ensure researchers are trained and competent in ethical conduct and familiar with the National Statement, institutional policies, and relevant legislation. (Clause 5.1.4)
- Provide adequate resources and administrative support for HREC operations, ethical review, and ongoing monitoring of approved research. (Clauses 5.1.11–5.1.12)
- Ensure institutional policies and procedures promote responsible research conduct and reflect the values and principles of the National Statement. (Clauses 5.1.3, 5.1.9)
- Monitor research activities and compliance with approved protocols, ethical conditions, and reporting requirements.
(Clauses 5.1.18–5.1.19)
- Respond promptly and appropriately to complaints, concerns, or breaches of ethical conduct or HREC decisions.
(Clauses 5.6.1–5.6.3)
- Report to the NHMRC or other regulatory bodies when requested, including annual activity summaries where required. (Clause 5.1.22)
- Maintain independence and accountability of HREC operations, protecting committees from external or institutional influence in decision-making. (Clauses 5.1.9, 5.1.24)
- Ensure proportionate ethical review processes appropriate to the level of risk associated with the research. (Clauses 5.1.7–5.1.8)
- Keep accurate and secure records of ethical review processes, approvals, and monitoring outcomes. (Clause 5.1.13)
- Promote a culture of ethical awareness and research integrity through education, communication, and institutional leadership. (Clause 5.1.4)