Applying for ethics approval

Based on the type of protocol you intend to implement, you will be asked to attach documents to support your application and to help the ACU HREC understand the protocol you are proposing.

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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.

 
Name Type Format Link
HREC Guidelines on Research Proposals Guide .docx Download

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.

 
Name Purpose Format Link
Peer Review Guidelines Use these guidelines to inform the Peer Review. .docx Download
Peer Review Checklist Use this Checklist to guide you in providing feedback regarding research design and merit. .docx Download

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. 

 
Name Purpose Format Link
Participant Information Letter and Consent Form (Interviews, Focus Groups and Procedures) Use this standard PICF template for interviews, focus groups, surveys and procedures. .docx Download
Participant Information Letter and Consent Form (Indigenous) Use this PICF for interviews, focus groups, surveys and procedures with Indigenous participants. .docx Download
Participant Information Letter and Consent Form (Online surveys) Use this standard PICF template for online surveys only. .docx Download
Participant Information Letter and Consent Form (Parents and Guardians) Use this PICF for parents and guardians .docx Download
Participant Information Letter (Easy read) This is a simple language PIL that can be adapted to suit your audience e.g., for children, or people with an intellectual disability, English as a second language or CALD background. .docx Download
Oral Consent script and Consent log for verbal/phone Consent Use Verbal/Oral Consent with research conducted face-to-face or via video or telephone consultation and e-consent processes. Verbal consent may be used in situations where the research requires contact with participants who are illiterate, vulnerable, or in particular cultural settings where verbal consent is culturally appropriate. The PICF are to be provided in an accessible format to the participant group. .docx Download
Assent Form Use this form to gain consent from participants who are under 18 years of age. .docx Download
Debrief template Use this template to provide information to participants about limited disclosure or deception in the research study. .docx Download
 
Name Purpose Format Link
Interview guide Use this as a guide to read out to participants prior to an interview or focus group session. .docx Download
Recruitment Email Script Template Use this as a template for recruitment. Can be adapted for emails, letters or advertisements. .docx Download
Recruitment Email Script Template (ACU Students) Use this as a template for recruiting ACU students. Can be adapted for emails, letters or advertisements. .docx Download

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. 

 
Name Purpose Format Link
Risk Assessment and Management Plan Use this form 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. .docx Download
 
Name Purpose Format Link
Investigator Signatures This document is to be completed by all researchers to acknowledge their participation in the project. .docx Download

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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Name Purpose Format Link
Survey, interview and focus group application form Use this form to apply for approval to collect data from ACU students. .docx Download
 
Name Purpose Format Link
Research Data Management plan Use this template to provide detailed information on how you plan to manage, store and publish your data. .docx Download

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.

An individual's right to privacy is a fundamental human right.

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Name Purpose Format Link
Privacy Collection Notice Consent Statement   .docx Download

Research involving and engaging with First Nation Australians will be referred to the ACU Indigenous Research Ethics Advisory Panel (IREAP) for additional review and advice regarding the cultural aspects of the research.

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Name Purpose Format Link
IREAP Guidelines including Appendix B    .docx Download
IREAP PowerPoint template (PowerPoint)   .ppt Download
Sample IREAP letterhead   .docx Download

Managing your ethics approval

Researchers are responsible for ensuring that all conditions of approval are adhered to and that any modifications to the protocol, including changes to personnel, are approved prior to implementation.

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

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Name Purpose Format Link
Modification Form for Research Project Use this form before implementing any changes to your approved study. .docx Download

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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Name Purpose Format Link
Research Project Progress/Final Report/Request for Extension Use this form to request an extension. .docx Download

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

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Name Purpose Format Link
Research Project Progress/Final Report/Request for Extension Use this form to submit an Annual Progress Report or Final Report as required by approval conditions. .docx Download

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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Name Purpose Format Link
Guidelines and Form for Adverse Events Use this form to provide detailed information about an adverse event or incident resulting from the research. .docx Download

Other

 
Name Purpose Format Link
ACU Certificate of Currency Use this document if required, for example, in ACU clinical Trials. .docx Download
Transcription Confidentiality agreement Use this confidentiality agreement when utilising the services of external transcribers. .docx Download
Page last updated on 11/09/2024

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