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Human Research Ethics Committee

Ethics and Governance

New Ethics and Governance System – ERM

Effective Monday 16 July 2018, Queensland Health adopted a new ethics and governance system called ERM.

This replaces the online forms website for creating Human Research Ethics Committee (HREC) and Site-Specific Assessment (SSA) applications, and provides a platform for post-approval submissions, such as amendments and progress reports.

The following training guides have been provided by Queensland Health:

  • Interactive ERM training presentation for researchers
  • ERM ‘how to’ guide
  • Quick guide for researchers and applicants.

If you encounter any problems with the ERM system, please email helpdesk@infonetica.net

Darling Downs Health is committed to the highest standards of research integrity. Research governance, including the ethical review of research, refers to the processes to ensure that research in Darling Downs Health is conducted according to the appropriate regulatory, ethical and scientific standards. The framework for research governance is relevant to all stages of the research process.

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Research Approvals

In order to conduct research in Darling Downs Health, it is a requirement that all research first obtains the following:

  • Ethics approval from a Human Research Ethics Committee (HREC)
  • Site authorisation at each facility you are intending to do the research.

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Ethics Approval

Human Research Ethics Committee (HREC) approval is the first step in the research process, required for all human research conducted within Darling Downs Health.

Darling Downs Health is also a participant of the national approach to single ethical review of multi-centre research. Single ethical and scientific review of multi-centre clinical trials can occur via an appropriate NHMRC certified HREC in other jurisdictions and, for other study types, at another certified HREC in Queensland Health.

All ethics applications, apart from requests for ethics exemption (which follows the Not Requiring Ethical Review Work Instruction, should be made to a Darling Downs Health HREC using the Human Research Ethics Application (HREA) or Low or Negligible Risk (LNR) form available via Ethical Review Manager (ERM).

Ethics application process

The steps outlined below are a guideline for the ethics application process.

Protocol
A project protocol is an essential element of all applications, and should be developed early in the research process. The DDHS protocol template and guide (located in Research Resources) is provided to help you write your research protocol for HREC submission.

Participant information and consent forms
The NHMRC provides researchers with Participant information and consent form (PICF) templates. It is not compulsory to use these templates however they are useful tools.

Ethics application
There are three types of applications submitted to an HREC, based on the level of risk to the human participants of the research:

  • Human Research Ethics Application (HREA) for standard risk research - reviewed by the HREC
  • Low or negligible risk (LNR) research - reviewed by two members of the HREC (out of session)
  • Request for exemption from ethics review - reviewed by the HREC Chairperson (out of session). To complete this application process follow the Not Requiring Ethical Review Work Instruction (NRER) in place of the process below.

All ethics applications, apart from requests for ethics exemption (which follows the Not Requiring Ethical Review Work Instruction (NRER), should be made to Darling Downs Health HREC using the Human Research Ethics Application (HREA) or Low or Negligible Risk (LNR) form available via Ethical Review Manager (ERM).

HREC checklist
Complete the Darling Downs Human Research Ethics Committee site requirements HREC Checklist (PDF, 156KB). The checklist outlines the mandatory submission requirements, including supporting documentation. This should be completed by the Coordinating Principal Investigator (CPI). The CPI is the person who will submit the research project to the HREC on behalf of other sites and coordinate the ethical submission.

Submission applications
Submission applications must be submitted by 12.00pm on the closing date. View Darling Downs HREC meetings and submission closing dates (PDF, 156KB). Please note there are no exceptions. Incomplete applications will not be accepted.

Site-authorisation
After obtaining ethics approval from the Human Research Ethics Committee (HREC) applicable to your research, you must obtain site authorisation by submitting a site specific assessment (SSA) for research governance approval at all facilities you intend to conduct research.

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Research Governance

After obtaining ethics approval from the Human Research Ethics Committee (HREC) applicable to your research, you must obtain site authorisation by submitting a site specific assessment for approval at all facilities you intend to conduct research.

All site specific assessment (SSA) applications must be submitted as sub-forms of the projects Human Research Ethics Application (HREA) or Low or negligible risk (LNR) form on Ethical Review Manager (ERM). The owner of the HREA or LNR application can create SSA forms related to the site (or sites) that the research will be conducted at.

The completed application must be sent via ERM to the relevant Research Governance Officer, along with all of the documents approved by the HREC and as indicated on the SSA submission checklist found below.

An SSA is not valid until ALL paperwork has been submitted. Incomplete applications will not be assessed.

An SSA approval letter is required before a research study can commence at the site.

The Darling Downs Health Research Governance Officer is able to help researchers with:

  • SSA forms and the application processes for site authorisation, including relevant site contacts such as Director of Finance and Heads of Department
  • Negotiation of research contracts, including obtaining Darling Downs Health legal review where required
  • Guidance regarding legislation, policies and standards relating to the conduct of research, including access to confidential health information under the Public Health Act 2005
  • Education and training for new and experienced researchers to enhance the quality and conduct of research in accordance with good practice guidelines
  • Monitoring of research, including responding to concerns about research conduct.

Site Specific Assessment (SSA) application
List of documents required for the submission for a new site specific assessment to the Darling Downs Health Research Governance Officer.

Study budget
A budget of research costs associated, whether actual or in-kind, must be completed for all studies and signed-off by the relevant departmental Business Manager or hospital Director of Finance. The Darling Downs Health Research Governance Officer will assist with gaining this signature.

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Human Research Ethics Committee

The Darling Downs Hospital and Health Service Human Research Ethics Committee (HREC) (EC00182) are constituted and act in accordance with the:

Chair person: Ms Angela O’Shea
Coordinator: Deborah Wainwright

Meeting and submission closing dates
Researchers need to complete the application process and submit their application by 12pm on the closing date to be considered on the meeting date. LNR applications and exemption requests are reviewed out of session and can be submitted at any time.

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Toowoomba Hospital Foundation Research Grants

Please visit the Toowoomba Hospital Foundation website, or contact the Darling Downs HREC Coordinator for more information.

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Complaints Management of Research Projects

The Darling Downs Health Human Research Ethics Committee has a formal complaints management system. All complaints regarding the management of research within the Darling Downs will be managed according to the process outlined in the Complaints Management Protocol.

Please contact the HREC Coordinator - email DDHHS-RESEARCH@health.qld.gov.au or phone 4616 6696 in the first instance.

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Last updated: 21 October 2015