In multi-centre research, it is important that the policies and processes of an institution and its Human Research Ethics Committee (HREC) comply with Australian guidelines, but that this requirement does not take time and resources away from researchers.
We developed the National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme) to enable the single ethics and scientific review of human research that is occurring at multiple institutions in Australia.
Under this scheme, NHMRC and external assessors evaluate and certify the ethics review processes of institutions and their HRECs against criteria outlined in the Certification Handbook and guidance in the National Statement.
Certified institutions can have their ethics review accepted by other institutions participating in the research project. This means that researchers only need to submit an ethics application to one HREC instead of multiple HRECs. The list of certified institutions is available below.
As the acceptance of an HREC’s ethics review is not mandatory under our scheme, it is up to individual institutions participating in the research project to decide whether they will accept the review outcome from a certified institution’s HREC, or conduct their own review.
Certification respects institutional decisions about research governance matters, including whether research should be conducted at a given site.
As part of this scheme, certified institutions and their HRECs are required to self-report to us on their multi-centre research activities.
Review of the scheme
In 2016, NHMRC engaged ThinkDifferent Consulting to review the scheme. This was to ensure that it remained contemporary, used best practice approaches for ethics review and continued to meet community needs and expectations.
The full report from the review, available below, identifies a number of potential improvements to strengthen the scheme.
We have already adopted a number of the improvements identified in the review and we are currently revising the Certification Handbook. We will consult with relevant stakeholders and certified institutions as we revise the handbook and implement other improvements to the scheme.
How to apply for certification
Participation in the scheme is voluntary.
The certification application process, as outlined in the Certification Handbook, is currently under review. Before commencing steps to apply for certification, please contact us at HREC.email@example.com for further advice.
You may wish to view the below documents that were used to inform the development of the scheme.
- Framework for Monitoring: Guidance for the National Approach to Single Ethical Review of Multi-centre Research (PDF 368 KB)
- Research Governance Handbook: Guidance for the National Approach to Single Ethical Review (PDF 349 KB)
- Indemnity and insurance arrangements for multi-centre research (PDF 83 KB)
- Indemnity and Insurance Arrangements for Clinical Trials in the Public and Private Sectors in Australia
- Ethical issues and resources
National Mutual Acceptance Scheme
All states and territories, with the exception of the Northern Territory and Tasmania, are a part of a National Mutual Acceptance (NMA) scheme. This scheme supports the acceptance of a single scientific and ethical review for multi-centre research conducted in publicly-funded health services.
As the NMA scheme is a state/territory-based system, policy decisions are made at the jurisdictional level and do not involve NHMRC.
Email address: HREC.firstname.lastname@example.org