Mutual acceptance for multi-centre clinical trials
Introduction of mutual acceptance of ethical and scientific review of multi-centre clinical trials in New South Wales, Queensland and Victorian Public Health Organisations
The New South Wales Ministry of Health and Queensland and Victorian Departments of Health have signed a Memorandum of Understanding to introduce mutual acceptance of ethical and scientific review of multi-centre clinical trials undertaken in Public Health Organisations across the three states. The aim of this initiative is to reduce duplication of ethical and scientific review and to inform the development of a national system of single ethical review.
Under the mutual acceptance initiative, each proposal for a multi-centre clinical trial conducted across the participating states will be ethically and scientifically reviewed once by a Public Health Organisation Human Research Ethics Committee (HREC) that has been certified by the National Health and Medical Research Council (NHMRC) to review clinical trials.
Public Health Organisations will continue to undertake a site-specific assessment (SSA) of all research projects that are to be conducted at institutions under their control, in compliance with the relevant jurisdictional standard operating procedures. A separate SSA application must be made for each site at which the research project is to be conducted.
The mutual acceptance initiative commenced in New South Wales on Wednesday 1st February 2012.
Further information and resources
- Frequently Asked Questions (FAQ)
Answers frequently asked questions about the Interstate Mutual Acceptance initiative.
Sets out the terms of understanding and co-operation that are the basis of implementation of the Interstate Mutual Acceptance initiative.
Provides an overview of the Interstate Mutual Acceptance initiative.
Provides information to investigators about the Interstate Mutual Acceptance initiative.
Checklist which must be completed by the Co-ordinating Principal Investigator and included with every new research project submitted to a certified HREC for review under the Interstate Mutual Acceptance initiative.
Provides details of NHMRC certified HRECs, Research Governance Offices and facilities participating in the Interstate Mutual Acceptance initiative.
- Monitoring and Reporting Tables [hosted by Department of Health, Victoria]
Sets out the monitoring and reporting responsibilities of Co-ordinating Principal Investigators, Principal Investigators, HRECs and Public Health Organisations under the Interstate Mutual Acceptance initiative.
Provides an overview of the various legislative and administrative frameworks that currently exist in New South Wales, Queensland and Victoria and that apply to the approval of human research under the Interstate Mutual Acceptance initiative.