Apply for ethics approval

Overview

An ethical review must be done by a Human Research Ethics Committee (HREC). The committee will assess your study against the National Health and Medical Research Council guidelines (NHMRC).

Research must ensure:

• it has scientific merit
• any benefits outweigh any associated risks
• the research team who work on your study are properly qualified
• participants are treated with respect, especially vulnerable groups
• you've considered the ethical issues associated with the methodology you'll use.

You'll also need to get governance authorisation for your study for each site. This may include more than one hospital and health service where you'll need to complete a site-specific assessment.

Quality improvement activities aren't accepted by researchers who don't already work for Torres and Cape Hospital and Health Service.

If you’re not sure which pathway is right for your project, please contact the Torres and Cape Research Governance Officer for advice by emailing torres-cape-research-governance@health.qld.gov.au.

How do I get ethics approval?

After you've completed planning your research, 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 Torres and Cape Hospital and Health Service.

If your research is Aboriginal and Torres Strait Islander persons focused, you must submit an ethics application to the FNQ HREC. This also applies if it's research being done at other sites external to Torres and Cape Hospital and Health Service.

Ethics approval for research that isn't focused on Aboriginal and Torres Strait Islander persons can be accepted under the National Mutual Acceptance Scheme (NMA). Contact the Research Governance Officer for more information.

Multi-site research

Multi-site research applications need to be approved by a HREC that has been certified and registered 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.

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.

All research studies must have an ethics approval.

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 must consult with the relevant Aboriginal and Torres Strait Islander organisations and communities. You’ll also need to provide letters of support and evidence of community consultation with your ethics 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 Far North Queensland Ethics Committee meets every 5 weeks to review applications for ethics approval.

The ethics review application process

Before you begin

We recommend you talk to FNQ HREC Coordinator before submitting your application. It’s better to do this after you’ve done the planning phase of your study and you have finalised your protocol.

They 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 study.

Contact the Torres and Cape Research Governance Officer for more information by emailing Torres-Cape-Research-Governance@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 your study
• evidence to support your activities from other research and your preliminary investigations
• timelines
• how you plan to deal with potential problems.

Use the 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 study checklist for Principal Investigators [PDF 143 KB] 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 very important to include logos, page numbers, document version numbers, document names and dates on your study documents. Your study 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 study.

• 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 51 KB], also known as PICFs.
• 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 communities and health organisation(s)
• 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 163 KB].

Templates

• Participant Information Sheet and Consent Form [DOC 51 KB]
• Abbreviated CV [DOC 261 KB]

Step 3. Submit your application

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

Postal address

Research and Governance Officer
PO Box 5607
Cairns Qld 4870

Standards and guidelines

• National Statement on Ethical Conduct in Human Research
• Australian Code for the Responsible Conduct of Research
• Doing research with Aboriginal and Torres Strait Islander peoples.

Next steps

After the committee has reviewed your application, you’ll get an email to let you know the outcome.

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

You also need to apply for Torres and Cape Hospital and Health Service research governance authorisation if your study sites involve Queensland Health resources such as staff, patients, facilities or data.