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HoMER tools - HoMER initiative national policies
The policies appearing in the table below provide the framework for the national approach to the single ethical review of multi-centre research carried out across and/or within jurisdictions. These policies may be equally applicable to the ethical review of human research that is not multi-centre.
The HoMER policies are ‘in-common’ and underpin, in part, the implementation of existing and planned State and Territory systems for streamlined ethical review. The list of policies appearing below is not intended to be exhaustive. Some policies may apply only to certain categories of research (e.g. clinical trials).
Policy Title |
Source |
Descriptor |
Implementation of a national system of single ethical review | Australian Health Ministers’ Advisory Council (AMHAC) | A nationally harmonised system of scientific and ethics review of multi-centre health and medical research, based on the mutual recognition of the single ethical review undertaken by a recognised human research ethics committee in any jurisdiction [is to] be established. AHMAC 2006 There should be a single national certification scheme where an institution and its Human Research Ethics Committee are recognised in all jurisdictions as competent to carry out a single ethical review for all multi-centre health and medical research. AHMAC 2009 The delivery of the nationally harmonised system [will] be by implementing in-common policies and in-common processes through existing and planned jurisdictional systems of streamlined ethical review (covering both scientific and ethical aspects). AHMAC 2009 A national coordinating body [will] support and co-ordinate the nationally harmonised system, including the establishment of a system of review and recognition of human research ethics committees and the development of policies regarding the separation of research governance from research ethics. AHMAC 2006 The NHMRC [will] have an ongoing coordinating role in the maintenance and development of the in-common policies and processes and the development of standard forms and national guidance. AHMAC 2009 The nationally harmonised system enabling the single ethical review of multi-centre health and medical research should be accessible to all institutions, including universities, medical research institutes, private sector hospitals and other private sector institutions. AHMAC 2009 |
National Statement on Ethical Conduct in Human Research (2007) | NHMRC/ARC/AVCC | Chapter 5.3 Minimising the Duplication of ethical review Section 5.1.9 Legal protection for HRECs |
Australian Code for the Responsible Conduct of Research (2007) | NHMRC/ARC/ Universities Australia | Section 1.2 Good governance and management practices |
Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) Annotated with TGA Comments | Therapeutic Goods Administration (TGA) | |
Human Research Ethics Committee and the Therapeutic Goods Administration Legislation | TGA |
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