Interstate Mutual Acceptance - for multi-centre clinical trials

Page contents: Application information | General information on Interstate Mutual Acceptance | Further information

The Victorian, Queensland, Departments of Health and the NSW Ministry of Health have signed a Memorandum of Understanding (MOU) to introduce mutual acceptance of ethical and scientific review in public hospitals regarding multicentre, clinical trials being conducted in more than one of these states.

Mutual acceptance of ethics review for multi-centre clinical trials for Queensland and Victoria commenced from Monday 24 October 2011. Commencement of mutual acceptance for NSW is from 1 February 2012.

Documents have been developed by New South Wales, Queensland and Victorian health departments to support users in the transition to interstate mutual acceptance of single ethics review for multi-centre clinical trials.

The scope of mutual acceptance can be found in the Mutual Acceptance Information Brochure. Note that studies that are exempt from single review include:

At this stage a standard Participant Information and Consent Form (PICF) is being developed, and when available it will be on this site.

If you are making a Human Research Ethics Committees (HREC) application in Victoria, until further notice use the current PICF which can be found on the How to Make an HREC Application page.

Application information

Contacts: Reviewing HRECs and Research Governance Officers (RGOs)

Reviewing HRECs are certified by the National Health and Medical Research Council (NHMRC). A full list of conttact details for reviewing HRECs, Research Governance Officers (RGOs) at participating sites, and participating health organisations in New South Wales, Queensland and Victoria is available below.

For more details regarding Victorian HRECs, see HREC Applications and for RGOs and health organisations see Site specific assessment research governance.

 HREC RGO and Organisations – January 2012

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Checklist for Coordinating Principal Investigators to submit with HREC applications

 CPI PI Ethics Checklist 2012

Cover letter for Coordinating Principal Investigators (CPIs) to submit with HREC applications

•  HREC Applications Cover Letter

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:

• Victorian Specific Module - Section 3 must be completed if Victorian sites participate

The NSW Privacy Form must be completed when NSW sites are participating:

•  NSW Privacy Addition to National Ethics Applicaton Form

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Reference documents for investigators

1. The National Ethics Application Form (NEAF) has questions which address Commonwealth Government legislation, however in some instances additional legislation exists in states and these requirements have been incorporated into the table below.

•  Jurisdictional Legislative Requirements

2. Monitoring and reporting of interstate mutual acceptance clinical trials is explained in the Monitoring Reporting Framework and the obligations of investigators, participating organisations and HRECs are set out in the Monitoring Reporting Tables.

•  Monitoring Reporting Framework
•  Monitoring Reporting Tables

General information on Interstate Mutual Acceptance

 Mutual Acceptance Information Brochure
 Mutual Acceptance Overview
 Terms of Reference - Interstate Mutual Acceptance

Further information

For more information about how to make an HREC application see Contacts.

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