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, certified institutions (i.e. institutions and their HRECs whose ethics review processes have been evaluated and certified by NHMRC and external assessors against criteria outlined in the Certification Handbook and guidance in the National Statement 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 the National Certification 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.
After consultation with the sector, NHMRC has adopted a number of changes to the National Certification Scheme, including discontinuing the current renewal and extension processes and replacing them with a process of ‘continuous certification’ from 1 July 2020.
In light of the impacts of COVID-19, further revisions to the Certification Handbook are currently on hold.
How to apply for certification
Participation in the scheme is voluntary.
While the Certification scheme remains active, resource constraints and policy development since its conception mean that we are unable to operate the scheme as we did during its early years. For this reason, we will assess each institution’s interest for certification on a case-by-case basis.
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 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