See below answers to some of the frequently asked questions about Ethics approval and applications.
The Human Research Ethics Committees (HREC) work on a 60-day clock to approve research. This is from closing date until you are advised if your application has been approved.
On average, we approve:
- our standard risk applications within 27 days
- our low and negligible risk applications within seven days.
This does not include site specific assessment authorisation.
Yes, this ensures that you upload all your documents into the HREC database.
Supporting documents can be uploaded after you submit the ethics application. These can include:
- progress reports
- participant information and consent forms (PICF)
- annual reports
- study amendments.
- Choose an achievable start and finish date, allowing time for HREC and RGO processing. We recommend a minimum of one year for a project.
- Research data must comply with the Australian Code for the Responsible Conduct of Research (PDF, 246 kB), section 2.1.
- Include version numbers and dates on your supporting documents.
- Head of Department sign off and/or letters of support must be signed by the appropriate Head of Department, who cannot be on the research team.
- Include key references to support the study.
- Get someone to review your submission for errors you may have missed. Do a spelling and grammar check.
- Regardless of level of risk, you must have a protocol. The HREA or LNR Form is not your protocol or study plan.
- Cover letter outlining your application and which sites are seeking approval. Include a list of attachments for the submission.
- Research protocol is essential for all projects.
- Participant information and consent forms.
- Data collection tools.
- For low risk, Letter of Support from appropriate Heads of Department.
- All researchers must submit a signed and dated current curriculum vitae if they haven’t submitted one during the past two years.
- Investigator’s brochure.
- Questionnaires/surveys/anything given to the participant.
- Letters of invitation.
- Advertising materials including transcript for advertisement, brochure, webpage or poster.
- Peer review, expert independent review (highly recommended for all projects). Signature pages from the application form with “wet ink” signatures.
A research protocol is your complete study design. It includes:
- data analysis
- management of risks
- Data safety monitoring committee
- addendums (participant information, questionnaires, other tools)
- standard operating procedures
- day to day guidance for conducting a survey.
The ethics application, asks relevant ethical questions, but the format is not conducive to your research project. You probably won’t refer to this document again.
The protocol forms the basis for your final study publication. Amendments and changes to your study will be made in the study protocol, not in the full ethics or low risk application.
- Write for a reading age of 12, in simple language and for a non-expert.
- Include contact details for researchers and reviewing HREC.
- State if the consent will be for “future use of data and tissue in research”.
- Refer to National Statement sections 2.2, 3.2, and 3.4 for details on specific consent requirements.
- We suggest you use our Participant Information and Consent Form (PICF) template. While not needing to be a duplicate of the GCHHS form, it should contain all elements.
You will be required to submit a report for each research project on the annual anniversary of ethics approval, unless otherwise specified. Based on information in the progress report, the HREC or Research Governance Office may decide to undertake a monitoring visit.
Refer to the post-approval amendments, reports, and notifications page to find out how to make an amendment to your approved research protocols.