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.
What makes a project standard risk?
When research causes more than just discomfort or inconvenience for study participants, it's standard risk. This includes emotional, physical, spiritual, and psychological wellbeing of participants.
If any of the following activities are involved, then your study may also require standard risk submission.
An intervention
When a study involves an intervention to routine care. This may include a clinical trial of a device or drug, an educational intervention or an alternate treatment option.
The study involves genetic research
Any studies involving genetic research.
Personally intrusive, confronting or involves potentially embarrassing questions
The study has topics that participants may be uncomfortable talking about or find distressing such as anxiety, depression or sexuality.
Staff are participants
Studies involving staff generally need a standard, full HREA application to protect their rights at work, whether they decide to take part or not.
The following groups are specifically targeted
- Pregnant women and the human foetus
- Children and young people
- People in dependent or unequal relationships
- People highly dependent on medical care and unable to consent
- People with a cognitive impairment, an intellectual disability or a mental illness
- People who may be involved in illegal activities or residents of custodial institutions
- Aboriginal and Torres Strait Islander peoples
- People who are unable to give informed consent because of literacy or language barriers
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.
Multi-site research
Multi-site research applications need to be approved by a HREC that’s been certified by the National Health and Medical Research Council (NHMRC).
Our HREC is registered with the National Health and Medical Research Council (NHMRC) and is certified to review multi-site research in the following categories:
- paediatric clinical trials Phase I, II, III and IV
- paediatric clinical trials drugs and devices
- paediatric clinical interventional research other than clinical trials
- other health and medical research – Paediatric research with adult component
- paediatric qualitative research
- paediatric mental health
- paediatric justice health
- paediatric population health and/or public health.
View a list of certified HRECs on the NHMRC website.
Your application
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 Standard Risk 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 Standard 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
- Two hard, collated copies of all documentation submitted to HREC office
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 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.
- 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). Please note that for standard risk submissions, two hard copies are also required (see Standard Risk Submission Checklist)
Read the ERM how-to guides.
Ethics and research governance review fees
If your research is industry or commercially sponsored, you will need to pay review fees. This applies to single and multi-site projects, as well as 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, your research cannot commence 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.
Standards and guidelines
Information about human research projects, including policies and guidelines for researchers and HRECs.