Content
Harmonisation of Multi-centre Ethical Review (HoMER)
on this page
- » The conduct and approval of clinical trials in Australia
- » Initiating a streamlined system of multi-centre review
- » The Harmonisation of Multi-centre Ethical Review (HoMER) project
on other pages in this topic
- » HoMER milestones and history
- » HoMER Jurisdictional and Reference Group Membership
- » Other AHEC projects
- » Contact HoMER
The conduct and approval of clinical trials in Australia
In 1987, the Therapeutic Goods Administration (TGA) introduced the Clinical Trials Exemption (CTX) scheme. The scheme required the review of all clinical trials by Human Research Ethics Committees (HREC) and an application to the TGA for the use of an unapproved medication or medical device. Under CTX arrangements, the TGA evaluates the associated scientific data and approve usage guidelines of the particular medication or device used in the trial.
In 1991, the Clinical Trials Notification (CTN) scheme was introduced whereby the TGA need only be notified of the clinical trial being undertaken on the condition that a HREC, having reviewed the scientific data and the proposed management of ethical issues, is satisfied that the trial provides a low level of risk to trial participants.
A TGA commissioned report into the use of access to unapproved therapeutic goods, Report of the review of access to unapproved therapeutic goods (the Bansemer Report), was released in 2005. One of the key findings in the report was that the “necessity to obtain ethics committee endorsement from multiple committees for multi-site trials is seen as a considerable waste of scant resources and often results in slightly different conditions being imposed on the trial in question at different sites.” (Bansemer Report, 2005. pg 12).
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Initiating a streamlined system of multi-centre review
In 2006, an inter-jurisdictional working party was established to advise the Australian Health Ministers Advisory Council (AHMAC) on the issues and options for simplifying multi-centre research ethical review in Australia. The paper discussed the creation of a national system where a single scientific and ethical review applied to research carried out at more than one site and listed the issues associated with the current system of scientific and ethical review for single-site and multi-site research.
The paper, A Streamlined Approach to Scientific and Ethics Review of Multi-Centre Health and Medical Research in Australia, was submitted to AHMAC in September 2006 and prompted their decision in October 2006 to establish a nationally harmonised system of scientific and ethics review of multi-centre health and medical research based on mutual recognition by all jurisdictions of the single review undertaken by recognised human research ethics committee in any jurisdiction. AHMAC also agreed that a co-orientating body required to support the implementation of a nationally harmonised system should be situated within the National Health and Medical Research Council (NHMRC).
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The Harmonisation of Multi-centre Ethical Review (HoMER) project
In the 2007 Federal Budget, $5.6m was allocated to the Harmonisation of Multi-centre Ethical Review (HoMER) project over a period of three years. The allocation includes staff costs, information technology development and other associated costs of consultation, development and implementation.
The NHMRC engaged a consultant to assist the NHMRC in preparing an implementation plan for the HoMER initiative. This report was used by the NHMRC to inform its deliberations and consultations in this area. 2007 also saw the introduction of the revised NHMRC National Statement on Ethical Conduct in Human Research (National Statement) which provides that “…each institution has the further responsibility to adopt a review process that eliminates any unnecessary duplication of ethical review.” (NHMRC National Statement, 2007. pg 87)
To date, the NHMRC has established advisory groups to assist the NHMRC in the continued planning and implementation of the HoMER initiative. The groups consist of a Reference Group, established to provide expert advice and guidance to the NHMRC with membership drawn from the health, academic and government sectors and a Jurisdictional Group which will give consideration to practical issues of implementation of the system at a jurisdictional level. Membership is drawn from the government health agencies of all States and Territories.
In the next 6 to 12 months the NHMRC proposes:
- To consult extensively with stakeholder groups and jurisdictions on the essential elements and model for a harmonised system of multicentre ethical review
- To promote the harmonisation process with investigators and institutions
- To facilitate pilots of essential elements of HoMER supporting mutual recognition and single ethical review
- To develop an accreditation process for HRECs involved in multi-centre review
- To report to AHMAC on progress of model development and staged implementation of essential elements
Following that, the NHMRC will aim:
- To implement outstanding elements of HoMER
- To facilitate enabling and supporting elements for HoMER operation
- To launch HoMER
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