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Research Governance news - Health and Medical Research

2 February 2012

REGU e-bulletin - UPDATE: MOU for Single Ethical Review of Clinical Trials between NSW, Queensland & Victorian Departments of Health  

Download this REGU e-bulletin (PDF) MOU ebulletin

Memorandum of Understanding

The NSW, Queensland and Victorian Departments of Health have 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 site-specific assessment (SSA) of all research studies that are to be conducted at institutions under its control, in compliance with the relevant jurisdictional standard operating procedures. An SSA 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 Health and Victoria was Monday 24 October 2011. The NSW department of Health has commenced mutual acceptance for multi-centre clinical trials in PHOs from 1 February 2012.

The MOU will not apply to retrospective approvals.

Scope of Mutual Acceptance Research

Clinical trials excluded from the MOU

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

  • 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 statewide data collections
  • Clinical trials involving persons unable to provide consumer consent and
  • Clinical trials involving access to coronial material.

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

Checklist for Coordinating Principal Investigators to submit with HREC applications

CPI 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:


Read more from the REGU October e-bulletin. 


Model for single ethical review of clinical trials (NSW Health, Qld Health & Victorian Department of Health)

Terms of Reference

Victorian Specific Module

NSW Privacy Addition to National Ethics Application Form

 

REGU e-bulletim: Mutual acceptance of scientific and ethical review for multi-centre clinical trials between Queensland and Victoria
January 2012

 Download this REGU e-bulletin (PDF) MOU ebulletin

Memorandum of Understanding

Mutual Acceptance has progressed with commencement of single ethics review of multi-centre clinical trials between Queensland and Victoria on 24 October 2011.


There has been good uptake and interest from researchers and sponsors/CROs. Many enquiries have been received and in general users of the system are well informed. A total of twelve applications have been booked through the central allocation and coordinating services to date.


There are exceptions to the single review for some research types and these are outlined in this E-bulletin and the Mutual Acceptance Information Brochure. There are a suite of documents that have been developed for Mutual Acceptance and these are available on state ethics websites.


Remember to phone the respective booking offices in Victoria and Queensland to have a reviewing HREC assigned to review your ethics application.


Queensland
Melissa Hagan
Manager, Health and Medical Research
Queensland Health


Victoria
Suzanne Hasthorpe
Manager, Coordinating Office for Human Research Ethics
Department of Health Victoria
The NSW, Queensland and Victorian Departments of Health have signed a Memorandum of Understanding (MOU) to introduce mutual acceptance of ethical and scientific review of multicentre, interstate clinical trials undertaken in Public Health Organisations.

 

Scope of Mutual Acceptance Research

Clinical trial

Interventional research involving a drug/device trial, radiation therapy, surgery, treatment or diagnostic procedure.

Exclusions from Mutual Acceptance

Certain research projects are excluded from Mutual Acceptance because fo State specific requirements. The following clinical trials are excluded:

  • 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 statewide data collections
  • Clinical trials involving persons unble to provide consent and
  • Clinical trials involving access to coronial material.


The above studies will continue to be reviewed under the current State arrangements. Researchers should contact their local jursdiction for further detail. 


The Mutual Acceptance initiative will give the participating jurisdictions an opportunity to identify any issues that may inform the NHMRC Homer Project. Your feedback would be welcomed.

 

Information and Supporting Documents

Supporting documents can also be accessed from the websites below and contain all the information investigators and industry need to submit for single ethics review.  See the following websites for information:
www.health.qld.gov.au/ohmr/html/regu/multicentre_research.asp and
http://www.health.vic.gov.au/cchre 
 
We look forward to receiving your trials this year.

REGU e-bulletin: Streamlining ethical review for multi-centre clinical trials - going live

20 October 2011

MOU ebulletinDownload this REGU e-bulletin (PDF)

Memorandum of Understanding

The NSW, Queensland and Victorian Departments of Health have signed a Memorandum of Understanding (MOU) to introduce mutual acceptance of ethical and scientific review of multicentre, interstate clinical trials undertaken in Public Health Organisations.

Aim

The aim of the MOU is to reduce duplication of review and to inform the development of a national system of single ethical review which will be implemented by the National Health and Medical Research Council (NHMRC) in early 2012.

What does this mean?

Under the MOU arrangements, each proposal for a multicentre, clinical trial conducted across the participating states will be ethically and scientifically reviewed only once by a Public Health Organisation HREC that has been certified by the NHMRC in clinical trials.  Only Public Health Institutions can participate in this new process.

Commencement date

The commencement date for the introduction of the MOU is 24 October 2011.

Initially only Victoria and Queensland will be implementing the MOU. NSW will implement the MOU in the not too distant future. Stakeholders will be kept informed of the progress of NSW’s participation in the MOU.  

Read more (PDF)

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 REGU e-newsletter Edition 3 Sep 2011

28 Septmeber 2011

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The third edition of the Research Ethics and Governance Unit (REGU) e-newsletter has been released and contains information on:

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Last updated: 18 February 2013