Low-risk Medical Sciences

What is risk assessment?

A risk assessment involves identifying any risks involved in the research, gauging their probability and severity, assessing whether they can be minimised and determining how they can be managed and justified by the potential benefits of the research. The National Statement outlines risk as "the likelihood that a harm (or discomfort or inconvenience) will occur" and "the severity of the harm, including its consequences".

For further information and guidelines as to what constitutes risk in research, refer to the National Statement (chapter 2.1 Risk and Benefit) prior to completing your ethics application.

Who decides I need low-risk ethics approval?

Applicants are required to determine the risk level of the research within the online application form in the Human Research Ethics System - FoRA, and will be checked by ethics officers. Applicants must consider their ethical requirements against the National Statement to determine the review pathway.

Macquarie University uses two review pathways; no more than low-risk and more than low-risk. Applications of negligible risk are processed and reviewed under the low-risk application pathway.

Applications assessed by the applicant as having no more risk than discomfort should be submitted via the low-risk pathway, selecting Medicine and Health Sciences. The application is automatically routed to the faculty subcommittee.

Applications deemed by the ethics officers or committee reviewers as being ‘more than low-risk’, will be returned to the CI to change the risk pathway to more than low-risk, and resubmit for review by the HREC (Medical Sciences).

Please note, submissions that are escalated for HREC review risk lengthy delays and may miss the submission deadline. Please refer to the  HREC important dates for application submission deadlines and HREC meeting dates.

Who do I contact for research ethics advice?

A Faculty Research Ethics Advisor (REA) should be consulted prior to making an ethics submission if investigator's are unsure of any aspects, or have further questions. This will likely assist in providing a clearly written application that enables a straightforward review.

Alternatively, for general enquiries regarding an ethics application, contact: the Ethics Secretariat: +61 2 9850 4459 or ethics.secretariat@mq.edu.au.

Does your research project require Clinical Research Governance authorisation?

If you are planning on conducting 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, you are required to have Clinical Research Governance (CRG) authorisation before your commence your project.

Note: Clinical research governance authorisation is a separate process from an ethics review.

For more information about the process and associated timelines, please visit the University's Clinical Research Governance webpage.

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

Amendments - post approval

How do I make changes to my application after the final approval?

Any changes to the study as outlined in the approved low-risk application, however minor, must be submitted as an amendment to the approved application for review as soon as possible. Common changes to protocols can include; a change in project title, the addition or removal of participants or staff including research assistants, students and investigators, new measures, changes to interview or survey questions, PICF's or research locations, recruitment changes, etc.

In the MQ Human Research Ethics System - FoRA, under the project file, use the correspondence tile and request for the project to be unlocked for an amendment. The application will be unlocked within 48 hours.

All changes must be done using tracked changes within the HREA application and the supporting document(s) (where required). This will keep the application current. Tracked changes allows the subcommittee to clearly see where and what changes have been made, which aids in reducing the amendment reviewing time and provides a quicker outcome response to investigators.

MQ HREA: If your application was created in the MQ Human Research Ethis System - FoRA using the built in HREA, go to section 0.3 "Application Purpose", select "Amendment". Amendment changes could be adding or removing personnel, project changes or both. Update the application and the system will automatically track these changes.

NHMRC HREA portal: Existing approved applications that were created using the NHMRC portal will need to continue to use the NHMRC Human Research Ethics Application (HREA) portal for the duration of the project. Modifications to your NHMRC created HREA must be done in the original approved form within the NHMRC HREA portal and uploaded into the MQ system as a PDF. The HREA has a tracking and version control built into the system for when you amend the application. For further information, visit HREA support, click Frequently Asked Questions and Answers PDF, referring to No.11: How do I edit and amend my HREA following feedback from an ethics committee?

Supporting documents for all applications: All changes made to supporting documents must have tracked changes and updated version numbers and dates in the footer, (eg. Participant Information and Consent Form (PICF), surveys, recruitment advertisements, etc before uploading to the amendment). For further information, download the general guide to tracked changes [327KB PDF] in Word documents.

Submit the amendment for review via MQ FoRA. There are no submission deadlines for amendments. Note: Changes cannot be made or implemented to your project prior to receiving an amendment approval email notification.

For more information about this system and the management of existing applications, please visit the Human Research Ethics Support WiKi page.

How long does it take to review an amendment request?

Between 7-10 working days. Notification of the outcome is sent by email to all listed Macquarie University research personnel via their Macquarie email address. This process may take some time, depending on the information that is supplied, the time taken to review the proposed amendment and if further information is required.

Occasionally some changes go beyond the remit of the original HREC approval and investigators will be advised to submit the proposed changes as a new application.

Annual reporting

The National Statement sets out that institutions are responsible for monitoring approved research and ensuring that research is conducted according to the approved protocol National Statement, (chapter 5.5).

As a condition of your ethics approval, investigators are advised in the final approval letter, that they are required to submit an ‘Annual or final report’ for the duration of the project.

The university Human Research Ethics System - FoRA will send automatic email reminders to all listed Macquarie University research personnel, to assist meeting the reporting obligations.

All reports must be submitted via FoRA. For more information about this system and the management of existing applications, please refer to the Human Research Ethics Support WiKi page.

Failure to comply with your reporting requirements by the due date may result in your ethics approval being suspended or cancelled. If ethics approval is withdrawn, investigators must immediately stop all research activities.

Reports must be digitally signed off by the chief investigator, or if you are a student, by the project supervisor. 

How do I know if I should submit an annual or a final report?

Annual report

Select annual report if data is still being collected from participants or if you are in contact with your participants (for instance, you are sending transcripts for verification). Once reviewed and accepted by the FMHHS Subcommittee, the report will be filed, and all Macquarie listed research personnel will be advised via email the annual report has been approved.

Final report

Select final report if you have finished conducting research data collection and do not intend to have any future contact with research participants to collect data or verify their contributions to the research, (even if you are still in the process of writing the results of your research). You may, however, send participants a summary of research findings after the final report has been submitted. Once reviewed and accepted by the FMHHS Subcommittee, the report will be filed, the project record will be archived and all Macquarie listed research personnel will be advised via email the report has been approved.

All reports must be submitted via FoRA. For more information about this system and the management of existing applications, please refer to the Human Research Ethics Support WiKi page.

Adverse events

An adverse event may be a harmful, unpleasant, or undesirable response, reaction, or outcome experienced by a research participant or even a researcher. All adverse events must be reported to the approving ethics committee within 72 hours of the event occurring.

Adverse events must be submitted via FoRA. For more information about this system and the management of existing applications, please refer to the Human Research Ethics Support WiKi page.

For further information on adverse events and how to report an incident, please visit Human Ethics post approvals.

Tracked changes in Word documents: What are they, how do I do it, why is it necessary?

When you submit an ethics application you may receive feedback from the subcommittee advising that changes must be made before it is approved, and to resubmit both tracked versions of your documents. When you turn on track changes [327KB PDF] before editing your document, Microsoft Word automatically marks up and shows any changes that are made to the document. This tracking allows the subcommittee members to clearly see where and what edits have been made, and aids to reduce the application reviewing time.

How do I become a member of the FMHHS Low-risk Subcommittee?

When the FMHHS Low-risk Ethics Subcommittee Chair, the Faculty Research Manager or the Research and Ethics Officer identify any gaps in expertise in the current membership, the Faculty Research Manager will contact the Head of Department for a particular discipline and asks for volunteers who are interested in serving on the committee.

If you are interested in becoming a member of the subcommittee, please contact your Head of Department or Clinical Head to express your interest.