We recommend you talk to our human research ethics committee (HREC) 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.

Step 1. Is the project a quality activity or research?

Quality assurance (QA) is any activity done to improve patient care through monitoring or improvement of a current service delivery.

QA and research have much in common. They share a rigorous approach to methodology for the design, procedure, analysis and interpretation of data. QA is the starting point for a range of ongoing improvements that may develop into research into new ways of doing things.

• Research leads to new knowledge
• Quality assurance evaluates what is currently being done

Step 2. 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 3. 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 Quality Assurance Checklist and CHQ Quality Assurance guidelines and flowchart document will help with the 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. Submission checklist
3. Quality assurance/exemption form completed in ERM
4. Research protocol
5. CV for each project team member
6. 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).
• Questionnaires and other instruments.
• Advertising materials, including transcripts for ads, emails, websites, letters or phone calls.

Participant information and consent forms

Use the following templates.

• Parent/Guardian Information Sheet
• Parent/Guardian Consent Form
• Child/Adolescent Information Sheet

Step 4. Submit your application

Submit your application online using the Ethics Review Manager (ERM).

Read the ERM how-to guides.