Pre approval - new applications

Pre approval - new applications

Preparing your ethics application

All staff and students who will be conducting research must apply to Macquarie University's Human Research Ethics Committee for ethics review.  Please consult a research ethics advisor (REA) prior to making a submission if you require ethics advice or guidance.

All applications must be submitted via the online system Forms for Research Applications (FoRA). For more information about this system, what application form to use and supporting resources relating to new submissions and the management of existing applications, please refer to the Human Research Ethics Management support page.

Questions about your application can be directed to the Ethics Secretariat on +61 (2) 9850 4459 or at ethics.secretariat@mq.edu.au.

Clinical Trial - If your submission is a clinical trial, visit the Clinical trials webpage.

MQ Health Clinical Research Governance - If your submission involves a clinical research project or clinical trial at MQ Health premises (Macquarie University Hospital, associated clinics and the Faculty of Medicine, Health and Human Sciences), involving patients or staff,  Institutional endorsement/authorisation must be obtained before its commencement. The Clinical Research Governance endorsement letter needs to be uploaded to the ethics application. For more information about the process and associated timelines, please visit the MQ Clinical Research Governance. Note: Clinical research governance authorisation is a separate process from an ethics review.

If you have any questions related to the MQ Health CRG process, please contact the Clinical Research Manager +61 (2) 9850 2834 or at clinical.research@mqhealth.org.au.

Low and Negligible Risk (LNR) in research

Low risk research is defined by the National Statement as "research in which the foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.” Negligible risk research is defined by the National Statement 2023 as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.

Deciding whether your project is low risk

Low risk research describes research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort. Accordingly, research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category is considered higher risk research and carries risk of harm. Higher risk research requires review by an HREC, (National Statement 2023, Chapter 2.1 Risk and benefit).

Discomforts can involve body and/or mind and could include minor side-effects of medication, the discomforts related to measuring blood pressure or the anxiety induced by an interview.

Useful Chapters in the National Statement when deciding risk level for your projects:

Chapter 2.1 - Risk and benefit: will help researchers  to understand and describe the level of risk involved in the planned research, and how to minimise, justify and manage that risk, and (with reference to Chapter 5.1) what level of ethical review is suitable

Chapter 2.3 - Waiver of consent: Only a HREC may grant waiver of consent for research using personal information in medical research, or personal health information.

What to include in your application

Applications are submitted via the Macquarie University online All applications must be submitted via the online system Forms for Research Applications (FoRA). For more information about this system, which form to use (HREA or EAEF), as well as supporting resources relating to new submissions and the management of existing applications, please refer to the Human Research Ethics Management support page.

All supporting documentation should be attached to the online application form in PDF format.  Supporting documentation may include:

  • Protocol/Project description
  • Participant information and consent forms (PICF)
  • Proposed questions, interview, questionnaires and surveys
  • Advertisements or recruitment leaflets, letters, social media posts and emails
  • Telephone scripts
  • Letters of approval from organisations or custodians of data assisting in the research in any way
  • Approval letters from other HRECs
  • MQ Clinical Research Governance endorsement, subject to conditions letter (if applicable to your research)

What online survey platform is acceptable for my data?

Researchers must choose appropriate data platforms for the sensitivity of their research data. This includes the survey platform to be used.

Refer to the information on Data Platforms and the additional considerations about Human Ethics and online survey platforms.

Application assessment

Human Research Ethics applications that are more than low risk are allocated to the next available HREC meeting.

You should expect to receive notification about the ethical review within 10 working days following the meeting. During busy periods (the start and end of the year), it may take longer to process your application.

Lower risk applications are reviewed upon receipt by the relevant subcommittee.

The low risk subcommittees review applications as they are submitted (there are no meeting dates).  Applications reviewed by the subcommittees should have a response within 20 working days of submission.

* During busy times (beginning and end of the year), it may take longer to process your application.

** The University HRECs and Subcommittees cease reviewing applications between approx. end of November/early December to mid February. Further information on closure can be found on our meeting dates page.

Notification of outcome

Notification of the outcome is sent to the Chief Investigator by email. Researchers may receive approval, or be asked by the HREC to make changes to the application, or the HREC may reject the application.  If you are asked to make changes to your application, these changes may need to be reviewed by the HREC at a meeting.  In planning your research, you should allow sufficient time for human research ethics review.

* HRECs and Subcommittees require that any issues communicated to researchers following the review, be addressed within six (6) weeks. This is to ensure that research is not undertaken without prior ethics approval and to ensure that issues remain relevant.

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