Overview

An ethical review is done by a Human Research Ethics Committee (HREC). These committees are registered under the National Health and Medical Research Council (NHMRC).

All research must:

  • have scientific merit
  • be able to demonstrate that any benefits outweigh any risks
  • be done by qualified research staff
  • show respect for the participants, with guidelines for vulnerable groups
  • consider ethical issues associated with the methodology.

You'll also need to get governance authorisation for your project. This is sometimes called a site-specific assessment.

Low risk projects such as clinical audits or quality assurance activities, may not need full ethics review or be eligible for exemption. You can read the Eligibility for exemption from ethics review guide [PDF 158.94 KB] for more information. If you’re unsure which pathway is right for your project, please contact our ethics coordinator for advice.

How do I get ethics approval?

After your research planning phase, you’ll need to apply for ethics approval.

You’ll need to submit your ethics application online using the Ethical Review Manager (ERM).

The Darling Downs Health Human Research Ethics Committee reviews the ethical and scientific validity of proposed research within Darling Downs Health.

This also applies to studies done in other Queensland health services, New South Wales, Victoria, Australian Capital Territory, West Australia and South Australia.

The Darling Downs Health Human Research Ethics Committee (HREC) is constituted and acts in accordance with the:

Multi-site research

Multi-site research applications need to be approved by a HREC that has been certified by the National Health and Medical Research Council (NHMRC).

The Darling Downs Health HREC is registered with the National Health and Medical Research Council.

We’re certified to do multi-centre ethical reviews in the following research categories:

  • Clinical trials phase III, IV
  • Clinical trials devices
  • Clinical interventional research other than clinical trials
  • Qualitative research
  • Mental health
  • Other health and medical research
  • Rural and/or remote health research.

View a list of the NHMRC certified HRECs.

You’ll need to mark your application as a ‘multi-site’ application in the Ethical Review Manager (ERM) and share your application with the principal investigator at each site.

Research involving Aboriginal and Torres Strait Islander peoples

There are more steps you need to take if your research focuses on Aboriginal and Torres Strait Islander peoples.

This also applies if you plan to compare Aboriginal and Torres Strait Islander peoples with non-Indigenous people.

You’ll need to consult with the relevant Aboriginal and Torres Strait Islander bodies and communities. You’ll also need to provide letters of support and evidence of community consultation with your application.

Read more about Ethical guidelines for research involving Aboriginal and Torres Strait Islander peoples on the National Health and Medical Research Council website.

Application closing dates

The Darling Downs Ethics Committee meets on the 2nd Wednesday of each month to review applications for ethics approval. Your application must be submitted by 12 pm on the closing date. We won’t accept late or incomplete applications.

Low or negligible risk (LNR) research applications and exemption requests are reviewed out of session and can be submitted at any time.

Closing Dates 2024
Applications to be submitted by 12 pm		 Darling Downs Health HREC meeting dates 2024

31 January

14 February

28 February

13 March

27 March

10 April

24 April

8 May

29 May

12 June

26 June

10 July

31 July

14 August

28 August

11 September

25 September

9 October

30 October

13 November

27 November

11 December

The ethics review application process

Before you begin

We recommend you talk to the Human Research Ethics Committee Coordinator before submitting your application. It’s better to do this after you’ve done the planning phase of your project and you've finalised your project plan.

The coordinator can talk you through the submission requirements and answer any questions you may have. This will make it less likely that you miss something in your application and risk delaying the start of your project.

Contact our ethics coordinator by emailing DDHHS-Research@health.qld.gov.au.

Compulsory Research Integrity Training

Applications must include evidence of completed Research Integrity Training for all listed members of the research team.

Options to complete Research Integrity Training include:

Training remains current for three years from date of completion.

For more information:

Step 1. Design your research protocol

Design your research protocol first.

Your research protocol should include details on:

  • the activities you plan to include in the project
  • evidence to support your activities from other research and your preliminary investigations
  • timelines
  • how you plan to deal with potential problems.

Use our research study protocol template [DOC 44 KB].

Step 2. Prepare your supporting documents

You'll need to submit the following supporting documents with your application. It's a good idea to get started on these as soon as possible so you have plenty of time to submit your application.

The Research Application Checklist [PDF 143 KB] will help you keep track of the documents you need for your application.

The checklist should be completed by the Coordinating Principal Investigator (CPI). The CPI is the person who will submit your research project to the HREC on behalf of other sites and coordinate the ethical submission.

Required documents

  1. Cover letter
  2. Research study checklist
  3. Human Research Ethics Application (HREA) form generated in ERM
  4. Research protocol
  5. CV for each project team member
  6. Evidence of completed Research Integrity Training

It’s also important to include logos, page numbers, document version numbers, document names and dates on your study documents. Your project may evolve and change over time. Documenting the changes will ensure you’re using the most up to date version.

Supporting documents

Provide the following information if it's relevant to your project.

  • Data collection tool indicating all information to be collected for the project such as a survey, questionnaire, audit tool or Case Report Form (CRF)
  • Investigator brochure
  • Questionnaires and other instruments
  • Advertising materials, including transcripts for ads, emails, websites, letters or phone calls
  • Letter of invitation or letter to GP
  • Participant diaries or wallet cards
  • Letter of support from the relevant Aboriginal and Torres Strait Islander health group
  • Medicines Australia Form of Indemnity for a research site that isn’t a Queensland Health site
  • Independent assessment report or verification by a medical physicist or a district radiation safety officer detailing the total effective dose and organ doses for radiological procedures.

Participant information and consent forms

The National Health and Medical Research Council has Participant information and consent form (PICF) templates for researchers. It’s not compulsory to use them, but they’re useful tools.

Step 3. Submit your application

Submit your application online using the ERM.

Read the ERM how-to guides.

Ethics and Research Governance Review Fees

Each research application has a fee for a new project and a major amendment to a project.

Read our Schedule of Fees [PDF 156 KB].

Next steps

After the HREC has done their review, you’ll get an email to let you know the outcome of your application.

Site authorisation

You also need to apply for governance authorisation if your study sites involve Queensland Health resources such as staff, patients or facilities.

Reporting requirements

If your research has been given ethics approval and governance authorisation you’ll have reporting requirements.

  1. Fill in the Commencement form [PDF 864 KB] when you begin your research.
  2. Submit an Annual Report form [DOCX 819 KB] on 30 April each year.
  3. Complete Final Report form [DOCX 819 KB] – within 6 months of completing your study.

Standards and guidelines

Human Research Ethics Committee

Our Human Research Ethics Committee (HREC) review research proposals involving human participants. Their job is to decide if the research is ethically acceptable.

The research must meet recognised ethical standards and respect the dignity, rights, safety and wellbeing of the participants.

Darling Downs Health Human Research Ethics Committee Terms of Reference [PDF 333 KB]

Committee members

The committee is made up of health professionals, local researchers and academics, legal experts and members of the local community. You don't need specific experience to be a lay member of the committee.

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

The Darling Downs Health Human Research Ethics Committee (HREC) (EC00182) is constituted and acts in accordance with the:

Complaints management of research projects

We have a formal complaints management system. Complaints about the management of research projects are processed using our complaints management protocol.

You can give feedback or contact us by:

Last updated: October 2024