Greater than low: Risk of harm (+/- foreseeable burden)

High: Risk of significant harm (+/- foreseeable burden)

Data collection with participants who are vulnerable, or research settings that are particularly unusual or uncomfortable e.g., clinical trials, minors, Indigenous participants, illegal activity, or participants with a cognitive impairment.

Minimal: No risk of harm or discomfort; potential for minor burden or inconvenience Innocuous data collection with no foreseeable risk, such as a survey that may be perceived as inconvenience.

Low: No risk of harm; risk of discomfort (+/- foreseeable burden)

Data collection on non-vulnerable participants in activities including overseas research, or where there may be risk of discomfort e.g., a survey or interview where slight distress or embarrassment may occur.

If the project has approval from an external NHMRC registered Australian HREC and ALL components of the project have ethics approval, projects can be registered by an expedited process at ACU via Orion. Projects can only be registered when the ACU staff member and/or student are listed on the external approval and/or application form.

Attach all documentation that was approved by the External HREC, including a copy of the approved application, together with relevant information such as your approval letter, participant information documents and any subsequent modifications or progress reports. We require evidence that the ACU personnel are named on the original (external) approval documents, including students. We will accept a modification with these changes. In most cases, ACU HREC will accept the approval of the Primary (External) HREC up until the original end date.

You may be asked to make changes, such as the participant information material, to meet ACU requirements. We also require you to upload any amendments that may have already been approved by the external HREC. If you are an ACU staff member and registering as a student from another university, and plan on recruiting ACU’s staff or students, you will also need to detail your recruitment strategy and ensure any conflict of interest has been declared.

The approving institution will remain the responsible external HREC. Even though the approving HREC will remain responsible for the research, the researcher will need to register the details of the approval with ACU. The ACU HREC must also be informed if the approving HREC approves a modification, cancels, suspends or withdraws the approval and must be notified if unexpected adverse events, complaints or grievances are raised. You are also required to provide copies and acknowledgements of Annual Reviews and Final Reports from the external HREC.

Overseas Research

ACU HREC reserves the right not to accept an External HREC's approval, in which case we will ask you to submit a New ACU Project form for full review. If your project has been reviewed by an international ethics committee, your project will be considered for registration on a case-by-case basis. However, If you intend to recruit Australian participants, you will need to complete a new ACU application, and be reviewed by ACU’s NHMRC registered HREC, to ensure your project complies with Australian ethical standards.

Please reach out to res.ethics@acu.edu.au to seek specific information relevant to your project. Please ensure to include the Research Proposal, the original application form, the ethics approval form and Participant Information Letters and Consent forms.

The ACU staff member or student has active ethics approval for a project from an external NHMRC approved Australian HREC at another institution and is transferring ethical responsibility for the project to the ACU HREC (e.g. due to change of employment or enrolment).

A Waiver of Consent requires a researcher to seek approval from an ethical review body in order to use a person’s personal information or personal health information without obtaining consent directly from the individual in order to use that information in a research project.

The ACU HREC will only consider a Waiver of Consent where there are extenuating circumstances and researchers must provide justification for why it is not possible or impractical to seek consent from the original participants.

If you intend to establish a database for future research recruitment purposes and which would only store information on potential participants that is not considered to be personal, health or sensitive information. The database should only contain contact details and minor demographic details.

Exempt research, as defined by the National Statement, 5.1.22 (b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings.

Research can be exempted from ethics review where there is negligible risk (no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience). Generally exemptions are available for data that is in the public domain and is not identifiable and in some situations where data is in the public domain and it is identifiable eg: public webpages. Data that has the potential to identify participants does NOT qualify for an exemption from ethics review.

This is an expedited process for ACU Honours and Masters students in the Faculty of Health Sciences.

Minimal: No risk of harm or discomfort; potential for minor burden or inconvenience Innocuous data collection with no foreseeable risk, such as a survey that may be perceived as inconvenience.

Low: No risk of harm; risk of discomfort (+/- foreseeable burden) Data collection on non-vulnerable participants in activities including overseas research, or where there may be risk of discomfort e.g., a survey or interview where slight distress or embarrassment may occur.

If the research is deemed higher risk, then after SAP review, the application will also be reviewed by the HREC at their next meeting.

ACU does not have an Animal Ethics Committee and therefore cannot register such projects. However, ACU needs to record all projects that ACU staff are involved in.

Please email res.ethics@acu.edu.au to let ACU know that you are listed on a project involving the use of animals for research/scientific purposes.