Release of Human Research Ethics Portal
The Human Research Ethics Portal contains information on the National Approach to Single Ethical Review (the National Approach) including links to relevant information for researchers, HREC members, and institutional staff and administrators.
Current information on the National Approach can be found at http://hrep.nhmrc.gov.au
The Harmonisation of Multi-centre Ethical Review (HoMER) Initiative
In Australian research institutions, it is the role of Human Research Ethics Committees (HRECs) to review research proposals involving human participants and approve their conformity with the requirements of the National Statement on Ethical Conduct in Human Research (the National Statement). This assures the public that all proposed research is ethically acceptable and complies with endorsed standards and guidelines.
Currently there are over 200 Australian HRECs in public and private organisations, hospitals and universities. For researchers planning multi-site and/or multi-centre research projects, having to submit a number of applications for ethical review to multiple institutional HRECs can result in considerable delays and additional costs.
In October 2006, the Australian Health Ministers’ Advisory Council (AHMAC), agreed to implement a national system facilitating the recognition of a single scientific and ethical review process within and across all Australian jurisdictions. This proposal was based on a working group paper submitted to AHMAC in September 2006, A streamlined national approach to scientific and ethics review of multi-centre health and medical research in Australia.
NHMRC established the Harmonisation of Multi-centre Ethical Review (HoMER) initiative as an outcome of AHMAC's decision. The first phase of the HoMER initiative was the development stage which led to the development of a range of tools to support the National Approach, including the National Certification Scheme, standardised participant information and consent forms, HREC template letters, and information on the roles and responsibilities of key stakeholders within single ethical review.
The second phase represents the progression from the development of the HoMER Initiative to the implementation and maintenance of a National Approach to single ethical review. This approach aims to facilitate the recognition by all jurisdictions of a review by any HREC in any jurisdiction.
Advisory Groups
A number of advisory groups were established to assist in the development of the National Approach. Currently active advisory groups include:
The Reference Group: established to “provide direction and guidance to the National Health and Medical Research Council on the implementation of the Streamlining of Ethical Review of Multi-Centre Research system”. This group consists of representatives from Therapeutic Goods Administration (TGA), Australian Health Ethics Committee (AHEC), Group of Eight, Department of Health and Ageing (DoHA), industry, consumers and State and Territory representatives;
The Jurisdiction Group: established “to assist the National Health and Medical Research Council in the development and implementation of the Harmonisation of Multi-centre Ethical Review (HoMER) project”. This group consists of representatives from State and Territory Health Departments; and
A number of specialised subgroups, with membership drawn from key stakeholders and individuals with experience in conducting or reviewing multi-centre research were also established, including:
- a Certification subgroup;
- an Education subgroup; and
- an Aboriginal and Torres Strait Islander Peoples Research working group.
Historical Documentation
Listed below are a number of historical documents that informed the development of the Harmonisation of Multi-centre Ethical Review:
- Towards timely, efficient and effective ethical review of multi-centre clinical trials (PDF, 210KB)
- A streamlined national approach to scientific and ethics review of multi-centre health and medical research in Australia: Issues and Options (PDF, 670KB)
- Streamlining scientific and ethics review of multi-centre health and medical research in Australia (PDF, 343KB)