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Research ethics process

Research ethics process

Introduction

All research involving humans must be ethically reviewed by a Human Research Ethics Committee (HREC) to ensure the research treats people ethically and adheres to the NHMRC National Statement of Ethical Conduct in Human Research (2007, updated 2018).

The Principal Investigator (PI), in a single site study, is responsible for the ethics application of the research project.

For multisite research, the Coordinating Principal Investigator (CPI) has responsibility for the ethics application and the conduct of the research. Each site involved in the research may have its own PI. The PI is responsible for the site’s research governance application and conduct of the project at that site. Where there is no site PI the CPI has responsibility.

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Multi-site Research

Before starting a multi-site research ethics application prepare a submission strategy for the sites involved in your research. For research in the public health domain you may only be required to submit to one HREC as public hospitals are part of a National Mutual Acceptance scheme.

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National Mutual Acceptance

The National Mutual Acceptance (NMA) scheme is a national system for mutual acceptance of human research projects conducted in public health services, and Mater research, across jurisdictions. Under the NMA agreement a multi-centre human research project needs only one ethical review by a certified HREC. Although there are some exceptions, for further information and an explanation see:

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HREC Application

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The NHMRC’s ethics application form is known as the Human Research Ethics Application (HREA), it guides applicants through the National Statement’s principles.

Each jurisdiction uses a different system to access an electronic copy of the HREA for completion and submission. These are:

All supporting documents must be uploaded with the HREA.

Certain states also require additional information with the submission of the HREA as follows:

  • Victoria – the Victorian Specific Module (VSM)
    • The VSM can be created in ERM. It is a separate document to the HREA on the project tree, but it is also required to be uploaded for review within the HREA. The VSM is to be reviewed by the lead HREC, for multi-site projects and be listed on the ethics approval letter.

Certain states also require additional information with the submission of the HREA as follows:

  • Victoria – the Victorian Specific Module (VSM)
    • The VSM can be created in ERM. It is a separate document to the HREA on the project tree, but it is also required to be uploaded for review within the HREA. The VSM is to be reviewed by the lead HREC, for multi-site projects and be listed on the ethics approval letter.
  • Western Australia – the Western Australian Specific Module (WASM)
    • The WASM is mandatory if the project has Western Australian (WA) sites. When submitting to a QLD HREC which includes a WA site, the Coordinating Principle Investigator (CPI) must complete the WASM in the WA Health's IT system (Research Governance Service (RGS)). The CPI must register with RGS. To activate the account the CPI must have details of a WA Health referee (e.g. the Site Principal Investigator). Once the form is complete the form is to be uploaded in ERM as an additional document. Following approval from the QLD HREC, the approval letter is to be uploaded in RGS and submitted.
  • Northern Territory

Non Public Health Organisations

For private health service research, university, government and research institutes, please refer to the organisations HREC website. Each will have its own review process.

For university, government organisations, or research institutes, which is a collaboration with a public or private health service, it is advised checking with the organisation to see if there is a ratification process for research which has been reviewed by a public or private health service. If this is the case it is suggested using either the public or private health service HREC as the lead reviewer and submitting the reviewed application for ratification.

The lead HREC will need to be accredited in the research area of the project. Where possible applications should be submitted to a site where the research is to be conducted.

Before commencing your HREC application consider your submission strategy.

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Ethics Decision Tool

The aim of this decision tool is to assist in navigating through the jurisdictional and organisational differing processes for the submission of a Human Research Ethics Application (HREA). It will assist in the understanding of National Mutual Acceptance (NMA) and forming a submission strategy. It does not inform on individual organisation's ethics review process and submission dates.

To provide feedback on this tool email research@healthtranslationqld.org.au

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Documentation

The following are documents to consider to be uploaded to your application. Some HRECs may ask for different information. It is always worth checking the application guidelines of the HREC you are submitting to.

Participant Facing Documents

  • Advertising material, e.g., transcript for phone call, email, flyer, website
  • Participant information and consent form
  • Participant documentation e.g., diary, wallet card

Data Collecting Documents

  • Case report forms
  • Questionnaires
  • Drug data sheet
  • Letter or invitation letter / information to GP etc.

Application

  • Protocol or project description (required)
  • Curriculum vitae (CV) or resume of investigator/researcher
  • Data management plan
  • Correspondence - Peer review, other HREC communication
  • Investigator brochure
  • Evidence of CTN or CTX (sponsors submit to the TGA)
  • Form of indemnity (Medicines Australia or TMAA HREC review only form) for each site

Jurisdictional Specific forms

  • NSW privacy form
  • Western Australia specific module
  • Victorian specific module

Project Specific forms

  • Radiation: Letter re standard care
  • Radiation: medical physicist's report
  • Licence for dealing with genetically modified organism

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Meeting Dates

HRECs meet on set dates throughout the year to consider research proposals. A list of Queensland Health HREC meting dates can be found here.

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