Research Development Unit
Research Ethics and Governance changes under new NHRMC National Statement
In July 2023, the NHMRC released an updated National Statement on Ethical Conduct in Human Research (National Statement) incorporating changes to Chapter 2.1: Risk and Benefit, and Section 5: Research Governance and Ethics Review.
To learn more, join the A-CTEC March 2024 Webinar: Navigating the 2023 National Statement: what’s news and how to use?
- When: Thursday 7 March 2024 12:30pm - 1:30pm
- Delivered by: Gordon McGurk, General Manager, Research Governance and Funding, QIMR Berghofer Medical Research Institute
- Register: Log in or join A-CTEC to register here
Major Change to Chapter 2.1: Risk and Benefit
The core change is a transition from the current model of ethical risk stratification, which contained three levels of risk, to a continuum based model.
|Old National Statement
|Updated National Statement
3 levels of risk:
1. Negligible risk
2. Low risk
3. Greater than low risk
Continuum of risk from lower risk to higher risk, incorporating
1. Minimal risk
2. Low risk
3. Greater than low risk
4. High risk
See figure 1 below for schematic representation.
Source: National Health and Medical Research Council, National Statement 2023, Chapter 2.1, p 12.
Major Changes to Section 5: Research Governance and Ethics Review.
Section 5 of the National Statement on research governance and ethics review has been revised to 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.
Advice for researchers:
- The key change for researchers is the alteration to risk stratification. RDU recommends that researchers read and be familiar with the new risk framework (Section 2, Page 12).
- The RDU website will be undergoing updates to ensure compliance with the National Statement in early 2024.
- There is no need to change documentation for currently approved projects.
To provide expert guidance and support to Barwon Health staff and associates to undertake research activities that reflect high standards of ethical conduct and good governance.
The RDU team provides research oversight, advice, training and support to staff and students across all Barwon Health locations. Our role is to ensure the protection of research participants and that all research activities under the auspices of Barwon Health meet the highest standards of research ethics and governance. The RDU supports staff and students to design and implement high quality research that improves the health and wellbeing of the community.
The RDU team provides services in relation to:
- Support for the Barwon Health Human Research Ethics Committee
- Guidance on preparation of Human Research Ethics applications and supporting documents
- Oversight and monitoring of approved research activities
- Novice researcher training
- Research design support
- Developing quality control and service improvement activities
- Participant recruitment strategies, explanatory statements and consent
- Research dissemination and conference presentations
- Biostatistics advice and support
- Research integrity advice and support
- Complaints about research
Get in touch
RDU is here to help. If you are not sure where to start or have a question regarding your research project, email us at [email protected] and a member of the RDU team will get back to you within 24 hours. If you have a current application underway, please ensure you include your Barwon Health reference number in your enquiry.
Last Modified: Tuesday, 13 February 2024
Adrian Costa Clinical Trials Centre
Level 2, 73 Little Ryrie St
Geelong VIC 3220
Phone: (03) 4215 3374
Email: [email protected]