The objective of the National Approach to Single Ethical Review of Multi-centre Research (National Approach), formally known as the Harmonisation of Multi-Centre Ethical Review (HoMER), is to enable the recognition of a single ethics and scientific review of multi-centre human research within and/or across Australian jurisdictions.
Benefits of adopting a national approach to single ethics review of multi-centre research include:
- The amount of time from ethics review application to research start-up is shortened, with a resultant savings in human and monetary resources
- Australia’s attractiveness as a place for international investment in commercially sponsored clinical trials is enhanced
- Public confidence in the rigour of Australia’s system of ethics review of human research is increased due to the standardisation of ethics review processes and
- The roles and responsibilities of the researcher, the institution, the Human Research Ethics Committee (HREC) and other key stakeholders in the conduct of multi-centre research are transparent and consistent.
A central component of the National Approach is the National Certification Scheme of Institutional Processes related to the Ethical Review of Multi-centre research (National Certification Scheme), which provides a level of assurance that an institution’s ethics review processes conform to nationally consistent standards.
National Certification Scheme
Certification provides assurance that the policies, processes and procedures of an institution1 and its HREC comply with an agreed set of national criteria2 for the conduct of an ethics review of multi-centre human research.
Institutions and their HRECs that have had their ethics review processes certified through the National Certification Scheme, and which undertake ethics review of multi-centre research proposals, can have that review accepted by any institution within any jurisdiction, without the need for a separate, additional, ethics review.
Participation in the National Certification Scheme is voluntary. In order for an institution to be certified, its ethics review processes undergo an independent assessment conducted by the NHMRC.
Certification begins with the institution carrying out a self-assessment of its ethics review processes and supporting structures against agreed national criteria. This is followed by a desktop assessment by NHMRC and a panel of independent assessors, before an on-site visit to verify institutional claims and practices.
Certification is dependent upon a satisfactory demonstration of institutional conformance to specified criteria which, in part, are based on the National Statement on Ethical Conduct in Human Research (2007) (National Statement) or any document that complements, supplements or succeeds it.
Certification also respects institutional decisions regarding whether research should be conducted at a given site. Advice received from a HREC undertaking the single ethics review will not replace the need for local institutional decision making on matters of research governance.
1 For the purposes of the National Certification Scheme, the ‘institution’ is the entity responsible for the conduct of research as described in the National Statement and the Australian Code for the Responsible Conduct of Research (2007), and that has nominated itself for assessment under the National Certification Scheme.
2 The ‘agreed set of criteria’ includes those included in the National Certification Handbook, 2012, as well as demonstration of compliance with the National Statement.
- List of institutions with certified ethics review processes
- National Certification Scheme Handbook (2012)
- How to apply for certification
- Certified institution annual reporting
The below forms and templates serve as a starting point for researchers, institutions and HRECs in the conduct of multi-centre ethics review.
- Standardised participant information and consent forms
- HREC template letters for certified institutions
In 2006, the Australian Health Ministers' Advisory Council (AHMAC) requested NHMRC to facilitate the development and implementation of a system where the single ethics review of a HREC would be recognised by all institutions participating in a multi-centre research project.
NHMRC established the Harmonisation of Multi-centre Ethical Review (HoMER) project as an outcome of AHMAC's decision. HoMER included the development of a range of tools to support a national approach, including the National Certification Scheme, standardised participant information and consent forms, HREC template letters, information on the roles and responsibilities of key stakeholders within single ethics review and guidance on research governance and monitoring of research.
Listed below are a number of documents that informed the development of HoMER, the National Approach and the National Certification Scheme.
- What is meant by ‘Single Ethics Review’?
- Roles and Responsibilities in Single Ethics Review of Multi-Centre Research (PDF, 39KB)
- Best Practice Guidance on Information Sharing Activities for Single Ethics Review of Multi-centre Research (PDF, 55KB)
- Framework for Monitoring: Guidance for the National Approach to Single Ethical Review of Multi-centre Research (PDF, 368KB)
- Research Governance Handbook: Guidance for the National Approach to Single Ethical Review (PDF, 349KB)
- Indemnity and insurance QandAs
- 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)
Email address: HREC.email@example.com