The National Statement provides an ethical framework that governs research involving human participants (including clinical trials) in Australia. Set to take effect from 1 January 2024, the key changes to the National Statement are contained in Chapter 2.1 (Risk and benefit) and Section 5 (Research governance and ethics reviews), with the consequential changes outlined in a comparative summary on the NHMRC website.

Chapter 2.1 (Risk and benefit) has been fully revised and significant changes have been made to Section 5 (Research governance and ethics reviews).

Section 4 (Ethical considerations specific to participants) remains under review. There will also be consequential adjustments made to the Human Research Ethics Application (HREA) which will be available in time for the commencement of the new National Statement. We summarise the salient changes below.

Chapter 2.1 (Risk and benefit)

The National Statement User Guide states that "Chapter 2.1 will help researchers and reviewers to understand and describe the level of risk involved in the planned research, and how to minimise, justify and manage that risk, and (with reference to Chapter 5.1) what level of ethical review is suitable"

Assessment of risk

The National Statement will transition from the current three-tiered model of risk (greater than low risk, low risk and negligible risk) to a continuum-based model (high risk to minimal risk). A new colour-coded table (reproduced below) has been introduced to assist researchers and reviewers to understand and apply the continuum-based model.

This new continuum-based model differentiates between ‘harm’ (which can be experienced individually or collectively), 'discomfort', 'burden', and 'inconvenience'. It also provides the following additional guidance to assist the assessment of these risks:

• Types of harm: The National Statement will explicitly recognise the risk of death as a physical harm and the risk of anxiety-related psychological harm such as re-traumatisation; introduces the concept of cultural harm, which includes misunderstanding, misrepresenting or misappropriating cultural beliefs, customs or practices; and recognises the unauthorised disclosure of personal information as a social harm.
• Vulnerability to harm: It also recognises that some participants, by reason of the design study or their specific attributes, may be at higher risk of harm or discomfort from research. This risk of harm or discomfort can express itself in different ways, and at different times and degrees.
• Burden and inconvenience: Participation in research can also impose burdens or inconvenience on those involved in research. The National Statement makes clear that neither burden nor inconvenience should be considered a type of harm or discomfort (and therefore should not be viewed as a risk). It also makes clear that in designing, reviewing and conducting research, researchers and ethics review bodies should consider the impact of any burdens or inconvenience on participants and balance them against the potential benefits of the research.

This new framework and additional principles emphasises to researchers, institutions, and ethics review bodies that the assessment of risk informs the determination of the appropriate level of review for a research project by the institution. It also informs reviewers’ judgments about whether risks are justified by potential benefits. It specifically provides that research in which the only foreseeable risk is discomfort will be classified as lower risk. Higher risk will require review by a Human Research Ethics Committee (HREC).

Strengthening governance requirements

The new framework also enables researchers, reviewers and institutions to make relevant further distinctions in levels of risk in internal policies and practices.

The NHMRC has stated:

“The new text and the guidelines clarify that the processes for assessment of risk and review of research at various risk levels are distinct, that assessment of risk is a shared responsibility of institutions, review bodies and researchers and that developing and promoting clear policies for both processes are an institutional responsibility.”

Developing clear policies for the processes for assessment of risk and review of research is an institutional responsibility. Institutions may choose to develop review processes to accommodate these differentiations in level of risk (lower risk and higher risk), taking care to respect the principle of proportionate review when establishing any such review processes.

Section 5 (Research governance and ethics reviews)

Section 5 (Research governance and ethics review) describes the core responsibilities of research governance and sets out the processes by which institutions fulfil these responsibilities, including establishment and oversight of different levels of ethics review. It also covers the operations of HRECs, monitoring responsibilities, conflicts of interest, complaint management and accountability.

A number of consequential amendments to Section 5 have been made to align with the new risk profile in Chapter 2.1 (Risk and benefit). Additionally, the National Statement has introduced new criteria for HREC minimum membership, as well as guidance on additional membership of HRECs, membership pools, membership diversity and expertise, and delegation. It provides additional guidance on acceptance of external ethics review, including from overseas review bodies, and the power for the NHMRC to remove a HREC from its list of registered HRECs if the institution fails to comply the requirements of the National Statement.

The changes to Section 5 address ambiguities about HREC membership, provide more guidance on options available to institutions to meet their research governance responsibilities associated with ethics review of research, including international research, and aligns Australia more closely with international standards for eligibility criteria for research.

HREC minimum membership

HRECs have minimum composition requirements, which will be amended as bolded below:

• a chairperson with suitable experience, including previous membership of an HREC, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under the National Statement
• two people who bring a broader community or consumer perspective and who have no paid affiliation with the institution
• a person with knowledge of, and current experience in, the professional care or treatment of people; for example, a nurse, counsellor or allied health professional
• a person who performs a pastoral care role in a community including, but not limited to, an Aboriginal and/or Torres Strait Islander elder or community leader, a chaplain or a minister of religion or other religious leader
• a qualified lawyer, who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters
• two people with current research experience that is relevant to research proposals to be considered at the meetings they attend.

HREC membership pools, diversity and expertise, and delegation

In addition to minimum membership requirements, institutions that establish HRECs are encouraged to have a 'membership pool' of members, including additional members with relevant experience or expertise, to draw upon. Specifically:

• Expertise: The National Statement clarifies that institutions should ensure its ethics review bodies have access to expertise that enable it to properly review the research it considers, including individuals with specialised scientific or scholarly expertise (research methods), specialised technical expertise (e.g. statisticians or data security, storage and safety specialists), expertise related to participant groups (e.g. participant advocates) and expertise related to research contexts (e.g. clinical or community care).
• Aboriginal and Torres Strait Islander studies: HRECs that review research about Aboriginal and Torres Strait Islander people or communities should appoint one or more members who have knowledge of research with Aboriginal and Torres Strait Islander Peoples or are familiar with relevant cultural knowledge.
• Diversity: Institutions that establish HRECs should ensure, as far as possible, that each meeting has diversity including gender diversity and at least one third of HREC members participating in each meeting are from outside the institution.

Finally, the National Statement now allows a HREC to delegate some of its responsibilities to its chairperson, one or more of its members, a sub-committee, or its administrative officers. Actions taken by these delegates are not equivalent to decisions by the HREC and some of these actions should be ratified by an HREC.

Acceptance of external ethics review (including from overseas review bodies)

Institutions are permitted to establish their own processes for ethics review of research or use the review processes of another institution or external ethics review body, including an overseas review body, provided compliance with Chapter 5.5 (Minimising duplication of ethics review) is demonstrable.

An institution's decision to accept external ethics approval is to be made on a case-by-case basis, should be consistent with the institution's criteria for acceptance of approval and take into account evidence of approval and applicable standards provided by the researchers.

Power to remove a HREC

Failure to comply with the requirements of the National Statement may result in the HREC being removed from the list of HRECs registered with NHMRC.

Section 4 (Ethical considerations specific to participants)

A second revision of Section 4 of the National Statement will be released for public consultation in the second half of 2023. It is intended that a final version of Section 4 will be released in 2024. The closing date for submissions is 15 September 2023.

The new National Statement does not take effect until 1 January 2024. Applications submitted to an HREC prior to this date can be considered under the current version of the National Statement.

Researchers, HRECs, reviewers and other stakeholders should familiarise themselves with the new National Statement, and make any necessary adjustments to policy, processes or individualised application or project description templates in preparation for the effective date.