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) (NS Chapter 5.1.7), and review ethics applications deemed no more than low-risk. For more information, visit the University’s Human ethics webpage.
Dr Mark Butlin (Chair)
Dr Ling Li
Dr Andrew Gauden
Dr Mikaela Jorgensen
Dr Annie Lau
Dr Virginia Mumford (Deputy Chair)
Dr Joel Fuller
Tammy Harwood (Research and Ethics Administrator)
Dr Kathryn Mills
About human research ethics
Ethics approval is required for all human research.
The National Statement on Ethical Conduct in Human Research (2007) (updated May 2015) defines human research as: "Human research is conducted with or about people, or their data or tissue".
If your project involves collection of human data through surveys, interviews, focus groups and observations, accessing personal information or materials, using information from data sets in identifiable, re-identifiable or non-identifiable form and physically invasive procedures such as the collection and/or use of human tissues or samples, etc, then you must apply for ethics approval before research can commence.
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 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
Learn more about the National Statement on Ethical Conduct in Human Research and the Macquarie University application process for human ethics and attend one of the regular information sessions. These 1-hour sessions will be presented by the Director of Research Ethics and Integrity at Macquarie University and/or Human Research Ethics Team Leader and 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 email@example.com.
For general enquiries regarding your ethics application, contact the FMHS Research and Ethics Administrator on +61 2 9850 4571 or firstname.lastname@example.org.
FAQS: FMHS Low-risk Ethics
If we were unable to answer your question, please visit the University's Human Ethics webpage 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".
Ethics applications are checked and assessed for risk by the Ethics Secretariat.
For further information and guidelines as to what constitutes risk in research, refer to the National Statement (Chapter 2.1 Risk and Benefit).
Who decides I need low-risk ethics approval?
The Ethics Secretariat has the authority to determine the level of risk for your application.
Macquarie University uses two review pathways; low-risk and greater than low-risk. Applications of negligible risk are processed and reviewed under the low-risk application pathway.
Applications assessed by the Ethics Secretariat as having no more risk than discomfort will be forwarded via email to the FMHS Subcommittee for low-risk review.
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 from the Secretariat between February to November
- Notification of the Subcommittee's review within 20 working days from receipt of the faculty’s ethics application confirmation email
HREC (Human Sciences): Human Research Ethics Committee
- Reviews research that is greater than low-risk
- Set meeting dates for application review - once a month between February to November
- Notification about the HREC's decision within 25 working days following the set meeting date
All applications are submitted via email through the Ethics Secretariat - email@example.com, who upon 'risk assessment and consideration', will forward low-risk applications to the FMHS Subcommittee for expedited review and greater than low-risk applications to be reviewed at the next scheduled HREC meeting. During busy times, it may take longer to process your application.
Both the University HRECs and faculty ethics subcommittees require that any issues communicated to investigators following the committee review be addressed within 6-weeks. This is to ensure that work is not undertaken without prior ethics review and approval and to ensure that issues remain relevant.
Who do I contact for research ethics advice?
The faculty research ethics advisor should be consulted prior to making an ethics submission if investigator's are at all unsure of any aspects, or have any questions. This will likely assist in providing a clear application that is easier for the FMHS Subcommittee to review.
Alternatively, for general enquiries regarding an ethics application, contact:
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.
Applications of low-risk can be lodged at any time throughout the year directly to the University's Ethics Secretariat
What ethics application form should I use?
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.
The HREA is a web-based application that enables researchers to complete research ethics proposals for submission to Human Research Ethics Committees (HRECs), and to assist HRECs to consistently and efficiently assess these proposals.
The HREA provides a range of support for researchers including FAQ's, online help details, reference guides and videos on getting started and navigating the system.
What is the low-risk ethics application process?
- Log on to the NHMRC website: Register for a Human Research Ethics Application (HREA) account.
- Create your HREA, upload the project description/protocol and all supporting documents. (eg. Participant Information and Consent Form (PICF), surveys, recruitment advertisements, etc).
- Once completed, generate the HREA document and submit.
- Download and save the zip folder and omni file to your computer for your reference.
- Submit the zip folder via email to the University's Ethics Secretariat.
- Applications assessed by the Ethics Secretariat as having no more risk than discomfort will be forwarded to the FMHS Subcommittee for low-risk review.
- FMHS Research and Ethics Administrator will send an email confirming application receipt.
- FMHS Subcommittee will review your application, and request clarification and/or changes if necessary, within 20 working days from of the application confirmation email, and will approve the application after they are satisfied with the clarification and/or changes made.
- Notification of approval will be sent via email from the FMHS Research and Ethics Administrator, with your approval letter attached.
For more detailed information, download the FMHS low-risk ethics application process guide.
How long does the low-risk ethics process take and how will I be notified about the outcome?
Applications considered to be low-risk by the Ethics Secretariat are forwarded to the FMHS Subcommittee for review via an expedited review process, which allows applicants to receive feedback within 20 working days from receipt of the faculty’s ethics application confirmation email.
Notification of the subcommittee's feedback is sent to the applications nominated contact person by email, and often researchers will be asked to provide clarifications or make changes to the application. 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.
You are required to respond to the subcommittee within 6-weeks, to ensure any issues remain relevant. If you fail to respond within the 6-week deadline the application will not be approved, and you will have to resubmit your application.
If you believe you will have trouble meeting the deadline, please contact the FMHS Research and Ethics Administrator on +61 2 9850 4571 or by email firstname.lastname@example.org
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 Research and Ethics Administrator, will send a final approval letter by email to the nominated contact person to be kept on file attached to the final proposal. Research on the project may commence.
Further clarification required:
If the FMHS Subcommittee requests clarification and/or modifications to the application, the nominated contact person will be notified by email outlining the issues to be addressed. 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 greater 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 referred to the HREC (Medical Sciences) for consideration. The Research and Ethics Administrator will notify the nominated contact person by email.
Not approved - resubmit:
If the FMHS Subcommittee has major ethical concerns and does not approve the research, the Research and Ethics Administrator will send a confirmation email to the nominated contact person 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.
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 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.
To make changes to the approved project, please complete the 'amendment request form'.
Where modifications require changes to public document(s) such as Participant Information Consent Forms, advertisements and questionnaires, etc, you should include the modified documentation with your amendment request form. Please provide tracked and clean copies of any amended documentation, including updated version numbers with dates in the footer of each document, eg [v2 10.07.18].
Email the amendment request form and the tracked and clean copies of the modified documents to email@example.com for FMHS Subcommittee review.
Changes cannot be made or implemented to your project prior to receiving an amendment approval letter from the FMHS Low-risk Ethics Subcommittee Chair.
How long does it take to review an amendment request?
Between 7-10 working days. Notification of the outcome is made via email to the nominated contact person. 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 you 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, you are advised in your final approval letter, that you are required to submit an ‘Annual or final report’ for the duration of your project.
One month prior to the due date, you will receive an email reminder from the FMHS Research and Ethics Administrator to assist you in meeting your reporting obligations. The ‘annual and final report’ can be downloaded from the Human Ethics resource page, and should be submitted by email to firstname.lastname@example.org for FMHS Subcommittee review.
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, a researcher must immediately stop all research activities.
Reports must be signed by the chief investigator, or if you are a student, by the project supervisor. An email from the supervisor or chief investigator (if this is not a student) will be accepted in lieu of a signature. Forms signed by students will not be accepted.
How do I know if I should submit an annual or a final report?
Select annual report if you are still collecting data from your participants or 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 you will be advised by email that your 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, and your record will be archived. No further correspondence will be issued.
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 the Human Ethics post approvals webpage.
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: 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 supply both tracked and clean versions of your documents. When you turn on ‘track changes’ before editing in 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.
A general guide to tracked changes in word documents can be found here.
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.