Apply for ethics approval

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.

Some projects including quality assurance (QA) activities, may not need full ethics review by a HREC. The QA Activity Review Guide (PDF, 215 KB) should assist you to determine the correct review pathway for your project. If you’re unsure which pathway is right for your project, please contact the HREC Coordinator for advice on 07 4226 5513 or email FNQ_HREC@health.qld.gov.au.

Read more about quality activity applications.

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 Far North Queensland Human Research Ethics Committee (FNQ HREC) can consider ethics applications for research at:

• Cairns and Hinterland Hospital and Health Service
• Torres and Cape Hospital and Health Service.

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 FNQ HREC can't review multi-site research that involves Queensland Health sites that fall outside Cairns and Hinterland and Torres and Cape Hospital and Health Services.

The FNQ HREC can review multi-site research for non-Queensland health sites within the Cairns and Hinterland Hospital and Health Service area.

View a list of the NHMRC certified HRECs.

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

Research involving Aboriginal and Torres Strait Islander persons

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

This also applies if you plan to compare Aboriginal and Torres Strait Islander persons with non-indigenous persons.

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 the advice on:

• Research involving Aboriginal and Torres Strait Islander persons (PDF, 154 KB)
• NHMRC Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• NHMRC Keeping research on track II on the National Health and Medical Research Council website.

Application closing dates

The FNQ HREC meets every 5 weeks to review applications for ethics approval.

Please note that an application must be valid and complete by the submission closing date to be assigned to a meeting.

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 have 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 the Far North Queensland HREC Coordinator on 07 4226 5513 or email FNQ_HREC@health.qld.gov.au.

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 guide to writing a research protocol (PDF, 414KB) and research study protocol template (DOC, 51KB).

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 study checklist for Principal Investigators (PDF, 160KB) will help you keep track of the documents you need for your application.

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

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)
• Participant Information Sheet and Consent Form (DOC, 139 KB)
• 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

For more information on submission requirements read the HREA submission advice and process (PDF, 210KB).

Templates

• Research study protocol template (DOC, 44KB)
• Participant Information Sheet and Consent Form (DOC, 51KB)
• Abbreviated CV (DOCX, 261KB)

Step 3. Submit your application

1. Submit your application online using the ERM
2. Send one hard copy of your application to the HREC Coordinator
3. Email a copy of your application to FNQ_HREC@health.qld.gov.au

Postal address

FNQ HREC Coordinator
PO Box 902
Cairns QLD 4870

Office address

FNQ HREC Coordinator
Level 7, William McCormack Place 2
5b Sheridan Street
Cairns QLD 4870

Read the ERM how-to guides.

Standards and guidelines

• National Statement on Ethical Conduct in Human Research
• Australian Code for the Responsible Conduct of Research

Next steps

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

If your research has been given ethics approval, you’ll have reporting requirements.

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