You are required to complete a brief Research Proposal outlining your proposed study. The research proposal should be a maximum of four pages and written in plain language in a way that non-specialists, particularly lay members of the HREC, can understand, without the use of technical or scientific language - feel free to include illustrations or tables. 

You should also familiarise yourself on the NHMRC National Statement on Ethical Conduct in Human Research in the areas that are pertinent to your research.

Your research project must be peer reviewed in accordance with the procedures set out by your affiliated School, Institute or Centre. The ACU Human Research Ethics Committee (HREC) has guidelines and a checklist to assist with peer review prior to ethics review. In most cases, ACU HREC require staff to attach evidence of peer review approval to your ethics application.

If peer review has already occurred as part of an award from a recognised granting body operating a competitive grants scheme, then researchers should provide this information within the ethics application form (and completion of the checklist will not normally be required). Postgraduate, Undergraduate and Honours student projects may be subject to an alternative but equally rigorous process through their faculty and need to provide evidence of this process.

A Participant Information Letter and Consent Form (PICF) is required for every research project and needs to be specific to each participant group. The PICF should explain in plain language the purpose of the study and provide a description of what the participants will be required to do to participate. 

PICFs can be provided to participants via paper, in an online format, emailed, or in some circumstances, verbally. The participant must be provided with a copy of the PICF for their records. If provided verbally, the reasoning will need to be justified to the HREC, and a mechanism in place to provide a copy of the PICF, and if provided online, an option to download.

Only the ACU Participant Information Letter templates will be accepted by the HREC and ethics review panels. These templates meet the requirements to comply with Section 2.2.6 of the National Statement. The PICFs can be converted into verbal scripts or translated into the local language to facilitate local cultural requirements or assist those who may experience reading or comprehension difficulties. Refer to the forms and templates section for the appropriate templates to use in these situations. 

The HREC's assessment of ethical acceptability of risks is based on the researcher identifying any possible risks, the likelihood and severity of the risks, who the risks may affect and how the identified risks may be minimised. Where there is a higher than low risk or a number of risks that may require management, this template provides a structure which enables researchers and HREC members to easily identify the risk and their proposed management. Completion and submission of this form is considered essential when completing a clinical trial ethics application form.

Researchers should refer to the ACU Risk Management Policy and Risk Management Procedure for guidance when completing this form and in the management of any risks at ACU. 

All research involving ACU students as participants needs to be approved by the Centre for Education and Innovation (CEI). Approval applies to ACU researchers and external researchers from other institutions. Approval from CEI to survey or conduct an interview or Focus Group on ACU students must be sought prior to ethical approval. A copy of the approval should be included in the Ethics application in Orion. The process can take up to 2 weeks.

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For Registration or Transfer applications, projects can only be registered when the ACU staff member and/or student are listed on the external approval and/or application form. Please ensure the following is provided in your application:

• Original approved application form – all ACU researchers need to be added to the original application. They can be added as an amendment.
• The approval document – the project must still be current.
• All relevant documents such as information letters, consents, and all amendments.
• The Project Proposal.

ACU’s Chair of the HREC will consider the Registration application and may also request that some amendments be made. These special conditions (if any) must be complied with before ACU will grant approval. For example, the Committee will look at whether ACU’s letterhead is used (or joint letterhead is required), the ACU HREC details should be in the information letter (or the main institution’s HREC details). Please refer to our standard information letters and consent forms for ACU’s requirements.

Before implementing any changes to your approved study, you are required to obtain HREC approval on the amended protocol.

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If your protocol is continuing and contact with participants or access to their data or records is still required, you can request an extension of ethics approval.

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Reporting is a requirement of the NHMRC and a condition of ACU HREC approval.

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The ACU HREC must be notified of any reportable matters including, but not limited to, incidents, complaints and unexpected issues. Any changes or incidents, complaints and unexpected issues must be reported to the HREC immediately.

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