What is low or negligible risk
Low or negligible risk (LNR) research is where the only foreseeable risk is discomfort. If the risk for participants is more serious than discomfort, you’ll need to submit a standard risk application.
LNR research applications and exemption requests are reviewed out of session and can be submitted at any time.
We recommend you talk to our 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.
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 project.
Contact our ethics coordinator by emailing CHQEthics@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 LNR/QA Protocol Template .
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 Low Risk Submission Checklist 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
- Cover letter
- Submission checklist
- Human Research Ethics Application (HREA)/Exemption form generated in ERM
- Research protocol
- CV for each project team member
- Head of Department letter of support
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
- Invoicing and Fee Form.
Participant information and consent forms
Use the following templates.
Step 3. Submit your application
Submit your application online using the Ethics Review Manager (ERM).
Read the ERM how-to guides.
Ethics and Research Governance Review Fees
Fees apply to review industrial/commercially sponsored research made to Children’s Health Queensland. Fees are applicable to both Single and Multi-site industrial/commercially sponsored projects, and collaborative or cooperative research group (CRG) research.
Read our Schedule of fees .
Next steps
After the HREC has done their review, you will receive an email and formal letter to advise 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. Even if you have HREC approval, you can't start your research until you also have governance authorisation.
Reporting requirements
If your research has been given ethics approval and governance authorisation, you are required to report on your project's progress to ensure continuing approval.