Applications and approvals

If you are doing research involving humans you will need to apply for ethics review.

Human Research is conducted with or about people, or their data or tissue. See the list of what is classified as human involvement.

You should still apply for ethics review at Macquarie University even if:

• you have approval from an overseas ethics committee to conduct your research
• you have approval from another Australian ethics committee but you want to conduct research at Macquarie University or Macquarie University Hospital, and the ethics application submitted to the approving ethics committee does not contain information about this aspect of your research
• you are transferring to Macquarie from another university and would like Macquarie to have oversight of your project. The approving HREC should agree to Macquarie University assuming primary responsibility for the project and provide you with correspondence to this effect. Then you need to submit the approved application and the correspondence from the approving HREC online using the Forms for Research Applications (FoRA) system.

Projects which do not involve Macquarie

If your research does not involve Macquarie University or Macquarie University Hospital as a site, and you have approval from another Australian ethics committee to conduct research, you do not need to complete a Macquarie University ethics application.

Instead, you should submit a copy of all approved documents to the Ethics Secretariat online using the Forms for Research Applications (FoRA) system. The Ethics Secretariat will note your approval and provide a Macquarie University reference number.

Teaching projects

If a teaching project is designed to teach research skills or the unit/teaching program has a research component, you should obtain ethical approval.

Approval is also required if the unit convenor intends to conduct their own research project on the collected data or the data will be shared with another researcher in the future.

All supporting documentation should be attached to the online application form in PDF format.

Supporting documentation may include:

• MQ research protocol or the HREA project description
• participant information and consent forms (PICF). Download our guidelines for preparing PICFs
• proposed questions for interviews, questionnaires and surveys. You can send draft interview questions with your application, but the ethics committee will ask you to provide the final set for review before the interviews take place
• 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).

Researchers should visit the MQ Research Data Management (RDM) SharePoint site which provides information on research data policies, research data management (RDM), data management plan (DMP), research platforms, good practices, services and support available to Macquarie University research community.

Researchers must also 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.

The National Statement defines:

• low risk research as research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort
• negligible risk research as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.

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 a HREC.

Discomforts can involve body and/or mind and could include:

• minor side-effects of medication
• discomforts related to measuring blood pressure
• anxiety induced by an interview.

Refer to the following chapters in the National Statement when deciding risk level for your projects:

• Chapter 2.1 – Risk and benefit. This chapter will help researchers understand and describe:
  • the level of risk involved in the planned research
  • how to minimise, justify and manage that risk
  • what level of ethical review is suitable (with reference to Chapter 5.1).
• Chapter 2.3 – Waiver of consent. Only a HREC may grant waiver of consent for research using:
  • personal information in medical research
  • personal health information.

If your application raises ethical issues that the subcommittee determines would require HREC review, then your application will be returned back to you for resubmission via the greater than low risk pathway to be considered at the next available HREC meeting. Applicants will be notified via email when the application has been allocated to the next scheduled HREC meeting.

All applicants will receive the ethics committee decision / outcome via email.

Note: During busy periods, such as the start and end of the year, it may take longer to process your application. Additionally, the University HRECs and subcommittees cease reviewing applications between late November and mid February.

It is the responsibility of the Chief Investigator to ensure HREC approval is obtained for all amendments prior to implementation. Failure to conduct research according to an approved protocol risks researchers’ legal indemnity, right to publication and opportunity to seek future funding.

An amendment may include, but is not limited to, changes to:

• the protocol
• recruitment strategies
• information statements and consent forms
• letters, advertisements, questionnaires or any other documents
• the research team.

The Higher Degree Research Office requires students provide evidence of ethical approval to submit their theses for assessment.

Where modifications require changes to public document/s – such as participant information statements, consent forms, advertisements and questionnaires – you should include amended documentation with your modification request. Provide tracked and clean copies of any amended documentation.

You can amend your application at any time, even after it has received final approval, online using the FoRA system.

Notification of the outcome is sent to the Chief Investigator by email. Possible outcomes include:

• the researchers receiving approval
• HREC rejecting the application
• HREC asking the researchers to make changes to 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.

HRECs and subcommittees require that any issues be addressed within six weeks. This is to ensure that research is not undertaken without prior ethics approval.

In planning your research, you should allow sufficient time for human research ethics review.

You should submit a final report when you:

• have finished conducting research with participants
• do not intend to have any future contact with research participants to collect data or verify their contributions to the research.

You may, however, send participants a summary of research findings after the final report has been submitted.

1. Adverse Event (AE): any untoward medical occurrence in a patient or clinical trial participant administered a medical product and that does not necessarily have a causal relationship with this treatment. Not necessary to report to Human Research Ethics Committee (HREC).

2. Adverse Reaction: Any untoward and unintended response to an investigational medicinal product related to any dose administered. Not necessary to report to Human Research Ethics Committee (HREC).

3. Serious Adverse Event (SAE): Any adverse event/adverse reaction in response to an investigational medicinal product that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Not necessary to report to HREC. IMPORTANT: If the SAE includes an SSI, USM or an SUSAR, this must be reported to the HREC via FoRA system.

4. Significant Safety Issue (SSI): A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.  SSIs must be reported to the Human Research Ethics Committee (HREC) see table below.

5. Urgent Safety Measure (USM): A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety. USMs must be reported to the Human Research Ethics Committee (HREC) see table below.

6. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both serious and unexpected to an investigational medicinal product related. SUSARs must be reported to the Human Research Ethics Committee (HREC) see table below.

7. Unexpected Adverse Reaction (UAR): An adverse reaction, the nature or severity of which is not consistent with the Reference Safety Information (RSI). UARs must be reported to the Human Research Ethics Committee (HREC) in the annual and final report forms.

8. Reference Safety Information (RSI): The information contained in either an investigator’s brochure or an approved Australian Product Information (or another country’s equivalent) that contains the information used to determine what adverse reactions are to be considered expected adverse reactions and on the frequency and nature of those adverse reactions.

All information and definitions in the document are in accordance with:-

• NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods (2018)
• NHMRC Safety Monitoring and Reporting in Clinical Trials involving Therapeutic Goods (2016)