National Approach to Single Ethical Review of Multi-centre Research
The National Health and Medical Research Council (NHMRC) established the National Approach to Single Ethical Review of Multi-centre Research (National Approach), formally known as the Harmonisation of Multi-Centre Ethical Review (HoMER), in order to enable the recognition of a single ethical and scientific review of multi-centre human research within and/or across Australian jurisdictions
In Australian research institutions, HRECs review research proposals involving human participants and assess their conformity with the requirements of the National statement on ethical conduct in human research and other requirements before approving them.
There are over 200 Australian HRECs in public and private organisations, hospitals and universities, a number of which review clinical trial research. For researchers planning multisite and/or multicentre research projects, having to submit a number of applications for ethical review to multiple HRECs can result in considerable delays and additional costs.
The NHMRC has developed and published on the Human Research Ethics Portal (HREP) a variety of tools and guidance material to support the National Approach. These include the National Certification Scheme, standardised participant information and consent forms, HREC template letters, and information on the roles and responsibilities of key stakeholders in the process, including guidance on research governance and monitoring of human research.
The tools and guidance material apply to all human research and can be adopted and implemented by institutions in the publicly funded health sector, universities and private hospitals and research institutions.
Researchers seeking to conduct a multicentre human research project should first approach the relevant institution(s) to ascertain their willingness to accept the ethical review outcome of a HREC associated with a certified institution.
Ethics, regulations, and getting started.
- Getting started
- How to talk to potential participants
- Research principles and guidelines
- The regulatory environment
- Good Clinical Practice (GCP) in Australia
- National Approach to Single Ethical Review of Multi-centre Research
- National Ethics Application Form
- Ethical review process for each Australian state and territory
- Research governance
- Useful links