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Single Ethical Review of Multi-Centre Clinical Trials

National Approach to Single Ethical Review of Multi-Centre Clinical Research

After much negotiation, the National Approach to single ethical and scientific review of multi-centre research is finally here. As of 1 November 2013, National Mutual Acceptance of single ethical review of multi-centre research conducted in public health organisations will commence.

All Australian States and Territories support the concept of single scientific and ethical review of multi-centre clinical trials in publicly funded health organisations. However, State and Territory participation will be phased, with Queensland, New South Wales, Victoria and South Australia leading the way. Other jurisdictions will join when their systems are in place.

For further updates please click here.

MOU for Single Ethical Review of Clinical Trials between NSW, Queensland & Victorian Deptartments of Health.

The NSW, Queensland and Victorian Departments of Health signed a Memorandum of Understanding to introduce mutual acceptance of ethical and scientific review of multi-centre interstate clinical trials undertaken by Public Health Organisations (PHO). The aim is to reduce duplication of ethical review and to inform the development of a national system of single ethical review.

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 (PHO) HREC that has been certified by the National Health and Medical Research Council (NHMRC) in clinical trials.

PHOs will continue to undertake a governance review of all research studies that are to be conducted at institutions under its control, in compliance with the relevant jurisdictional standard operating procedures. A governance application must be completed for all research projects to be conducted at sites under the control of NSW, Queensland and Victorian Public Health Organisations.

The commencement date for the introduction of the MOU between Queensland and Victoria was Monday 24 October 2011. The NSW department of Health commenced mutual acceptance for mulit-centre clinical trials in public health organisation on 1 February 2012

The MOU will not apply to retrospective approvals.

Clinical trials Excluded from the MOU

Some studies are excluded from the MOU because of State specific requirements. The following clinical trials are excluded from the MOU:

  • Clinical trials involving persons in custody or staff of the jurisdictional Justice Health departments;
  • Clinical trials specifically affecting the health and wellbeing of Aboriginal people and communities;
  • Clinical trials requiring access to state-wide data collections; and
  • Clinical trials involving access to coronial material.

The above studies will continue to be reviewed under the current local jurisdictional arrangements. Researchers should contact their local jurisdiction if unsure of the process or require further detail.

Application information

Checklist for Coordinating Principal Investigators to submit with HREC applications

CPI PI Ethics Checklist 2012

Privacy forms

If consent is not being sought from participants and there is a request for the reviewing HREC to waive the need for informed consent for a research project in Victoria and New South Wales then the following must be completed:

In Queensland, the Public Health Act 2005 (PHA) application is made after HREC approval. Click here to access the application form.

For Further information see: Terms of Reference

Last updated: 31 October 2013