Low-risk Human Research Ethics Subcommittee
FMHS Low-risk ethics
Faculty Low-risk Human Research Ethics Subcommittee
In 2016, Macquarie University established its seventh ethics subcommittee within the Faculty of Medicine and Health Sciences (FMHS), to expedite the review of low-risk ethics applications for research involving human participants.
The FMHS subcommittee was established in accordance with the National Statement on Ethical Conduct in Human Research (2007),Updated 2018, (National Statement, chapter 5.1), and review ethics applications deemed no more than low-risk.
Dr Mark Butlin (Chair)
Dr Reidar Lystad
Dr Virginia Mumford (Deputy Chair)
Ms Kate Churruca
Dr Kathryn Mills
Dr Annie Lau
Dr Tejal Shah
Dr Joel Fuller
Tammy Harwood (Research and Ethics Administrator)
|Dr Mikaela Jorgensen|
About human research ethics
Ethics approval is required for all human research. The National Statement, defines human research as: "Human research is conducted with or about people, or their data or tissue".
You must apply for ethics approval before research can commence if your project involves collection of human data through:
- taking part in surveys, interviews or focus groups, observations;
- undergoing psychological, physiological or medical testing or treatment;
- accessing personal information or other materials;
- the collection and use of body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or even exhaled breath;
- accessing information from data sets (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database;
Obtaining ethics approval ensures that researchers are free to conduct legitimate investigator and that the rights and interests of all participants are protected and understood. It is the individual researcher’s responsibility to ensure that ethics approval has been obtained prior to commencing their project.
Retrospective ethics approval for a research project cannot be granted.
What is low-risk human research?
Low-risk research involves more risk than just inconvenience and is described as research in which the only foreseeable risk is not more serious than discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low-risk (National Statement, chapter 2.1.6). 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.
Examples of low-risk research could include but are not limited to research involving:
- analyses of records collected by an organisation where participant consent has been given and the individuals are not identifiable
- anonymous surveys containing questions regarding participants’ experiences, beliefs, thoughts and opinions
- non-sensitive interviews with participants where data is recorded so participants are not and cannot be identified
Training and information sessions
Presented by the Director of Research Ethics and Integrity at Macquarie University and/or the Secretary to HREC Medical Sciences, all University staff and students are welcome to attend, no RSVP required.
Any questions about these sessions should be directed to the Ethics Secretariat +61 2 9850 4459 or firstname.lastname@example.org.
For general enquiries regarding your ethics application, contact the FMHS Research and Ethics Administrator on +61 2 9850 4571 or email@example.com.
FAQS: FMHS Low-risk ethics
If we were unable to answer your question, please visit Human Research Ethics for further information.
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 Management System, and will be checked by ethics administrators. 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. If the application is deemed by the ethics administrators or subcommittee as being ‘more than low-risk’, it will be returned to the CI to change the risk pathway to more than low-risk, then resubmit for review by the HREC (Medical Sciences) at the next scheduled meeting date.
How does the FMHS Low-risk Human Ethics Subcommittee differ from the HREC?
The FMHS Low-risk Human Research Ethics Subcommittee
- Reviews research that is no more than low-risk (including negligible risk)
- No set meeting dates - reviews upon receipt of the application between February to late November
- Notification of the subcommittee's review within 20 working days from receipt of the ethics application confirmation email
HREC (Human Sciences): Human Research Ethics Committee
- Reviews research that is more than low-risk, all applications seeking a waiver of consent, regardless of risk level* and Externally Approved Application Forms (EAAF)
- Set meeting dates for application review - once a month via the between February to late November
- Notification about the HREC's decision within 10 working days following the meeting date
All applications, regardless of risk, are submitted for review via the Human Research Ethics Management System. During busy times (start and end of the year), it may take longer to process your application. The University HRECs and faculty subcommittees cease reviewing applications between approx. end of November/early December to early February.
HRECs and faculty subcommittees require that any issues communicated to investigators 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.
* For further information, refer to FAQ - Does your research project request a waiver of consent?
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:
Does your research require services from Macquarie Medical Imaging (MMI)?
Please note, if you require services from Macquarie Medical Imaging (MMI), it is likely that it will incur a fee. For example, if you are requesting imaging data for a retrospective study, MMI has recently introduced a fee for this service.
Please contact the Chief Research Facilitator for MMI via firstname.lastname@example.org to obtain a quote prior to commencing your application.
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 and Health 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 via email@example.com or +61 2 9850 2834.
Does your research project request a waiver of consent?
The National Statement on Ethical Conduct in Human Research (2007), section 2.3.9 states: Only a HREC may grant waiver of consent for research using personal information in medical research, or personal health information.
If your application is not obtaining participant consent and seeks a waiver of consent for research using personal information in medical research, or personal health information, it must be submitted and managed via the 'more than low-risk' pathway regardless of the level of risk of the project.
If you have any questions regarding a waiver of consent, please contact the Ethics Secretariat: +61 2 9850 4459 or via email: firstname.lastname@example.org.
Application preparation and process
An investigator is responsible for submitting their human ethics application in consultation with their supervisor and must consider their ethical requirements against the National Statement.
FMHS low-risk applications can be lodged at any time throughout the year via the Human Research Ethics Management System.
What ethics application form should I use?
All applicants from the Faculty of Medicine and Health Sciences must complete the Human Research Ethics Application (HREA). This is a requirement whether the application is reviewed via the main Medical Sciences Human Research Ethics Committee or by the faculty low-risk subcommittee.
The Human Research Ethics Application (HREA) is a streamlined and contemporary ethics application that uses dynamic content and guidance to assist researchers to consider and address the principles of the National Statement on Ethical Conduct in Human Research.
HREA help support provides a range of resources for researchers, including frequently asked questions, user guides, ‘how to’ videos and workshop slides.
What is the low-risk ethics application process?
STEP 1: Create an NHMRC Human Research Ethics Application (HREA)
- Log onto the NHMRC HREA and register an account. For more information about this system visit HREA help support.
- Create and complete your HREA - upload the project description/protocol and all supporting documents.
- Generate your HREA and click submit. (NOTE: This does not automatically submit your application for review).
- Download and save the zip folder, including the omni file to your computer.
STEP 2: Submit the HREA for review by the FMHS Low-risk Subcommittee within the Human Research Ethics Management System (HREMS)
- Log onto Macquarie University HREMS using your MQ OneID and MQ OneID password.
- Click "Create your project", add the project name to field "Project Title", for the Main Form field select "HREA and other application forms".
- Complete the tick box that you are fine to share your project with the University's Human Ethics Secretariat, this will enable the green "create" button for you to click.
- Complete all required fields in your project file.
- Follow the steps to append your HREA output form.pdf and supporting PDF documents to the 'HREA and other applications form'. For more information about this system visit HREMS support.
- Once submitted, all listed Macquarie University research personnel receive an email confirming the applications receipt and that it has been allocated for review.
- The subcommittee will review and may approve the application or request clarification and/or changes if necessary, within 20 working days of the confirmation email, and will approve the application after they are satisfied with the clarification and/or changes made. Note: Any changes that are made to the application, must be done within the relevant documents, eg. updated within the original HREA form on the NHMRC website, as well as the supporting documents.
- Notification of approval will be sent to all listed Macquarie University research personnel with an attached approval letter attached.
For more detailed information, download the FMHS low-risk ethics application process guide [167KB,PDF]
How long does the low-risk ethics process take and how will I be notified about the outcome?
In planning your research, you should allow sufficient time for human research ethics review. Low-risk applications submitted to the Medicines and Health Sciences Subcommittee for review will receive feedback within 20 working days from receipt of the ethics application confirmation email.
Email notification of the subcommittee's feedback is sent to all Macquarie University research personnel listed on the application via their Macquarie email address, and often researchers will be asked to provide clarifications or make changes to the application. Any changes that are made to your application, must be made within the relevant documents.
Depending on the requested clarification/modifications, the responses received, and the time taken to review the responses, the review process from submission to final ethics approval may take longer than 20 working days.
Investigators are required to respond to the subcommittee within six (6) weeks of the email notification to ensure any issues remain relevant. Failing to respond within this time frame will result in the application not being approved, and investigators will have to resubmit.
If you believe you will have trouble responding to the subcommittee within this time frame, please contact the FMHS Research and Ethics Administrator on +61 2 9850 4571 or via email email@example.com.
What are the possible outcomes of my low-risk ethics application?
Investigators may receive approval, be asked to make changes to the application or further clarification, or the application may be rejected or referred back to the HREC (Medical Sciences) for further consideration.
Upon approval by the FMHS Subcommittee, the final approval letter is sent via email to all listed Macquarie University research personnel via their Macquarie email address and must be kept on file attached to the final approved application. Research on the project may commence.
Further clarification required:
If the FMHS Subcommittee requests clarification and/or modifications to the application, all listed Macquarie University research personnel will be notified via their Macquarie email address. Feedback on the application is provided in the panel comments. Any changes made to the application, must be done within the original documents using tracked changes. For information on modifying the application, refer to FAQ: How do I edit and amend my application following feedback from the faculty subcommittee?
Investigators have a maximum of 6-weeks to respond to the issues raised by the subcommittee. Research cannot commence on your project until final approval has been given.
Referral to the HREC (Medical Sciences):
Occasionally 'more' than low-risk aspects are discovered either upon detailed review, in clarifications sought from investigators, or ethical issues beyond the scope of the FMHS Subcommittee are identified. In these cases, the application will be returned to investigators to change the review pathway to 'more than low-risk', then resubmit to the HREC (Medical Sciences) for consideration at their next scheduled meeting.
Not approved - resubmit:
If the FMHS Subcommittee has major ethical concerns and does not approve the research, an email is sent to all listed Macquarie University research personnel within 20 working days. Investigators are invited to resubmit the application addressing the subcommittee's concerns and feedback.
Can I trial my survey or interview questions before getting ethics approval?
Without ethics approval you can test or trial your survey or interview questions in order to refine and ensure they are clear and appropriate, so long as you are not collecting any research data. Research data can't be collected without ethics approval.
How do I edit and amend my application following feedback from the subcommittee?
All responses to the FMHS Subcommittee comments 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 application reviewing time and provides a quicker outcome response to investigators.
HREA: The NHMRC HREA features tracked changes and version control within the system. For further information, visit HREA help support, referring to the HREA How to Guide section 2.3.2. to makes edits and amendments to your application.
Supporting documents: For modifications in supporting document(s) such as the Participant Information Consent Forms, questionnaires, etc, use the tracked changes [327KB PDF] feature in Microsoft Word . It is important to maintain document control through updating the version numbers and dates in the footer of each document, eg. [v2 19.01.19].
If further clarification is required and can't be updated as stated, investigators should complete their response on a word document and upload this in HREMS under section 6.1.5 Other Project Material.
Resubmit the updated application for review via Macquarie Unversity (HREMS).
For more information about this system and the management of existing applications, please visit HREMS support.
Post-approval: amendments, reporting and adverse events
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.
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.
HREA: Modifications to your HREA must be done in the original approved form on the NHMRC website. 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: All changes made to supporting documents (WORD) must have tracked changes and updated version numbers and dates in the footer, (eg. Participant Information and Consent Form (PICF), surveys, recruitment advertisements, etc). For further information, download the general guide to tracked changes [327KB PDF] in Word documents.
Submit the amendment for review via HREMS. 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 HREMS support.
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.
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 Management System (HREMS) will send automatic email reminders to all listed Macquarie University research personnel, to assist meeting the reporting obligations.
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?
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 FMHS Subcommittee, the report will be filed, and all Macquarie listed research personnel will be advised via email the annual report has been approved.
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 FMHS 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.
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.
For further information on adverse events and how to report an incident, please visit Human Ethics post approvals.
Resources for human ethics
Resources for human ethics in research, such as forms and templates eg PICF's, reports and appendices, policies, legislation, guidelines and training sessions can be found on the University's Human ethics webpage.
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 FMHS Low-risk Subcommittee?
When the FMHS Low-risk Ethics Subcommittee Chair, the Faculty Research Manager or the Research and Ethics Administrator 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 to express your interest.