National Statement on Ethical Conduct in Human Research 2023 Update: Frequently Asked Questions

Chapter 2.1 has been fully revised and significant changes have been made to Section 5.

Chapter 2.1 of the National Statement addresses risk and benefit. It describes the types and levels of risk that are relevant to the conduct of human research, and the potential for harm, discomfort, burden or inconvenience that may be caused by participation in research.

Chapter 2.1 has been fully revised to provide new categories of risk and extends the guidance provided for assessing, minimising, mitigating and managing risk, as well as revised guidance on burden and benefit.

The core change is a transition from the current model with three levels of risk (greater than low risk, low risk and negligible risk) to a continuum-based model from high risk to minimal risk, falling under two broad categories: higher risk and lower risk. A new feature – a colour-coded table – has been introduced to assist in understanding and applying the new model. The new framework also enables researchers, reviewers and institutions to make relevant further distinctions in levels of risk in internal policy and practice.

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.

Previously, the National Statement defined three levels of risk: greater than low risk, low risk and negligible risk. These levels depended on a distinction between harm, discomfort and inconvenience. The terms ‘discomfort’ and ‘inconvenience’ are imprecise and raised issues of interpretation for researchers and reviewers. In addition, the National Statement did not prescribe review processes for low and negligible research that were distinct from one another. In the 2020 consultation, we proposed that the distinction between low and negligible levels of risk in research was unsupported and the two categories were merged into a single category (minimal research). However, concerns were expressed with this approach and the new framework (see response to Question 2, above) was developed.

Additionally, more clarity was required on the need for institutions to have a clear policy on both the assessment of risk and the proportionate review pathways that are available for research with differing levels of risk and that assessment of risk is a shared responsibility of researchers, institutions and reviewers. As well, we considered the absence of reference to burden in research in Chapter 2.1 (as distinct from risk of harm or discomfort) to be an issue that merited attention and the inclusion of appropriate guidance.

Section 5 of the National Statement on research governance and ethics review has been revised to include:

• a new Introduction
• changes to sections of Chapter 5.1 addressing (1) risk levels and corresponding review pathways to align with changes to risk levels adopted for Chapter 2.1 and (2) research that may be eligible for a grant of exemption from ethics review
• modification of criteria for HREC minimum membership categories (b), (d) and (e)
• new guidance on additional membership of HRECs, membership pools, membership diversity and expertise, and delegation
• a structural revision to separate out researcher responsibilities (Chapter 5.3) from the responsibilities of HRECs and other ethics review bodies (Chapter 5.2)
• additional guidance on acceptance (by institutions) of external ethics review, including, potentially, from overseas review bodies
• inclusion of advice that permits NHMRC to remove an HREC from its list of HRECs if the institution/HREC fails to comply the requirements of the National Statement.

The changes to Section 5 address ambiguities about HREC membership and provide more guidance on options available to institutions to meet their research governance responsibilities associated with ethics review of research, including international research. The expansion of the eligibility criteria for research that may be granted exemption from ethics review aligns Australia more closely with international standards in this area. In addition, changes were made to align guidance in Section 5 with the new framework for levels of risk adopted in Chapter 2.1.

As a consequence of the revision of Chapter 2.1 and Section 5, changes in language have been made to the following paragraphs to align them with the new approach to levels of risk and exemption of research from ethics review or to correct citations to relevant paragraphs:

• Purpose, Scope and Limits – under When is ethical review needed?
• 2.3.6(a)
• 2.3.10(a)
• 3.1.62
• 3.2.3
• 4.2.9(b) and 4.2.9(d)(i)

Similar changes have been made to the Introductions to Chapter 3.3, Section 4 and Chapters 4.1, 4.4, 4.5 and 4.6.

These revisions to the National Statement will take effect on 1 January 2024. Researchers, reviewers and other stakeholders should become familiar with the new guidance well before that date and to have any necessary adjustments to policy, processes or individualised application or project description templates in place in preparation for the effective date.

Applications for ethics review that were submitted to an HREC prior to the effective date (but not yet reviewed) or applications that are under review on the effective date can be considered under current National Statement guidance.

Yes. The effective date, 1 January 2024, is the date that NHMRC expects institutions, HRECs and researchers to be applying the revised National Statement. Governance changes to align with new requirements in Section 5 may be implemented progressively during the six-month period. However, institutions will need to communicate any early adoption of the 2023 National Statement to all relevant stakeholders at the time they are adopting it.

While NHMRC will not be providing a formal training program or online educational modules to introduce the updated National Statement, we will be exploring options for webinars or other ways to present information on the changes and opportunities for stakeholders to ask questions and provide feedback.

Yes. Although the changes to the HREA are minimal, we will be making the necessary adjustments, resulting in a revised HREA.

The release of the revised HREA will be coordinated with the effective date for the updated National Statement, 1 January 2024.

A second revision of Section 4 has been completed and will be made available for public consultation in mid-2023. After analysis of the feedback of this consultation in the second half of 2023, work will commence on a final version of Section 4 for release in 2024.

No. The review of Section 4 is underway. Once this review is completed in 2024, there are no further reviews of the National Statement planned at this stage.

The National Statement is only available online in PDF format, although stakeholders are welcome to print it if they wish.

Any questions or feedback on the National Statement should be addressed to ethics@nhmrc.gov.au.