Applications and approvals

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

The National Statement (NS) defines Human research as:

Human research is conducted with or about people, or their data or biospecimens. Human participation in research is therefore to be understood broadly to include the involvement of human beings through but not limited to:

• taking part in surveys, interviews or focus groups
• undergoing psychological, physiological or medical testing or treatment
• being observed by researchers
• researchers having access to their personal documents or other materials
• the collection and use of their biological material as defined in NS Chapter 3.2
• access to their individual information in identifiable or potentially re-identifiable form

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

Teaching projects

If a teaching project is designed to teach research skills or the unit/teaching program has a research component, you should obtain ethics 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 uploaded to the online application form and may include:

• Use the simplified HREA project description or the MQ research protocol
• MQ specific participant information and consent forms (PICF) refer to MQ PIS & CF template guidance, MQ Checklist for PIS & CF, or the CT:IQ templates: InFORMed Project template
• Proposed interview, questionnaire, and survey questions: Draft questions may be submitted with your application. Final versions must be provided to and approved by the ethics committee before any interviews, questionnaires, or surveys are conduct
• Advertisements, 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
• Distress protocol (if applicable to your research).
• MQ Clinical Research Governance endorsement, subject to conditions letter (if applicable to your research).

The integrated Human Research Ethics (HREA) form features a risk assessment section at the beginning to help guide applicants. The Risk Assessment Questions are only to be completed if you think your project could be exempt from ethics review or if you don’t know or are unsure of the risk level of your project. If you do know the risk level, you can skip the RA section and go straight to the Human Research Ethics (HREA) form and Data Management Plan (DMP) Questions.

Risk is defined in the National Statement (NS) as:

• Low risk research describes research, including some types of clinical trials, in which the only foreseeable risk is no greater than discomfort. Discomforts can involve body and/or mind and could include but not limited to:
  • minor side-effects of medication.
  • discomforts related to measuring blood pressure.
  • anxiety induced by an interview.
• Research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category carries risk of harm and is considered higher risk research that requires review by a Human Research Ethics Committee (HREC) (refer to NS 5.1.11).  Examples of higher risk research may include but not limited to:
• Clinical trials involving investigational medicinal products or devices.
• Research involving invasive procedures.
• Research involving participants who may experience psychological distress.
• Research involving the collection of human tissue or other biological samples.

Refer to the following chapters in the National Statement (NS) 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 ethics review is suitable (with reference to NS Chapter 5.1).
• Chapter 2.3.9 – 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 is seeking a waiver of consent for use of personal information or personnel health information in medical research, submit your application via the greater than low risk pathway for HREC review at a scheduled meeting.

It is the responsibility of the Chief Investigator to ensure human research ethics 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

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. Tracked and clean copies of any amended documentation must be uploaded to the application.

You can amend your application at any time, even after it has received final approval, use the correspondence function in project via the FoRA system, to request your project be unlocked for the amendment.

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 or the Executives 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. Applications that have not been resubmitted may be expired/archived without notification.

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

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. HREC reporting: Not required 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. HREC reporting: Not necessary to report to HREC.

3. Serious Adverse Event (SAE): Any adverse event or adverse reaction associated with 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 results in a congenital anomaly or birth defect. HREC reporting: SAEs are not required to be reported to the HREC unless they meet the criteria for a Significant Safety Issue (SSI), Unanticipated Serious Misconduct (USM), or Suspected Unexpected Serious Adverse Reaction (SUSAR). In these circumstances, the event must be reported to the HREC through the 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.  HREC reporting: SSIs must be reported to the Human Research Ethics Committee (HREC) through the FoRA system. Refer to the 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. HREC reporting: USMs must be reported to the Human Research Ethics Committee (HREC) through the FoRA system. Refer to the table below.

6. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse reaction that is both serious and unexpected to an investigational medicinal product related. HREC reporting: SUSARs must be reported to the Human Research Ethics Committee (HREC) through the FoRA system. Refer to the 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). HREC reporting: 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 are in accordance with documents such as the NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods and NHMRC Safety Monitoring and Reporting in Clinical Trials involving Therapeutic Goods located on NHMRC website Safety monitoring and reporting in clinical trials involving therapeutic goods.