When do I need to obtain Human Research Ethics Committee (HREC) approval for my research?
The University requires researchers to conform to the NHMRC Australian Code for the Responsible Conduct of Research, the National Statement on Ethical Conduct in Human Research (2007) and to other relevant legislation and guidelines. These guidelines require that all research projects involving human participants require ethics approval prior to commencement. This includes both undergraduate and postgraduate research projects. Types of research activities that would require ethics approval include the following:
- Surveys (even on a small population of respondents)
- Questionnaires (even if they are handed to people known to the researcher)
- Participant observations
- Procedures (such as blood tests, x-rays, psychological tests and experiments, examinations, MRIs, ECGs etc)
- Focus groups or activities where research will be conducted (such as workshops or roundtables)
- Any research activity that involves recruiting human participants with the aim of obtaining their data and using this information in the formation of research findings and or publications
Some teaching units where students are encouraged to complete a research project may also require ethics approval. These units would be submitted on behalf of the students by the course convenor. For further information about ethics approval and teaching units, contact the Ethics Secretariat on 02 9850 4459 or by email email@example.com
Ethics approval ensures that researchers are free to conduct legitimate investigation and that the rights and interests of participants are protected and understood.
Institutional HREC approval also ensures that research can be published in journals. Many academic journals require a letter of approval from a HREC as a precondition for publication. Likewise, it is a requirement for all postgraduate research conducted with human participants that proof of HREC approval is submitted to the HDRO when a thesis is submitted for examination.
The Macquarie University HREC cannot grant retrospective approval for research conducted without ethics approval.
If you are not sure whether you need ethics approval for your research, then please do not hesitate to contact the Ethics Secretariat on 02 9850 4459 or by email firstname.lastname@example.org
For more information on the composition of the HREC, then please see the HREC Terms of Reference.
My research will not involve a lot of people. Do I still need to apply for ethics approval?
Any research that is to be conducted with human participants needs to obtain HREC approval. This is irrespective of the sample size, the complexity of the measures, or the aims of the research. Research activities include surveys, participant observation, undergoing psychological, physiological and
medical procedures, treatment or testing, having personal records accessed, or collecting bodily tissues, organs or fluids. Accessing personal information (in individually identifiable, re-identifiable or non-identifiable) form) as part of an existing published or unpublished source or database also
constitutes human research (see The National Statement "Purpose, Scope and Limits of this Document" p. 8).
Research can also be when a normally occurring event (such as a conference, meeting or web blog for instance) is utilised to collect data for analysis and publication.
I'm an international student and collecting data in Australia to go towards my degree. Do I need to obtain ethics approval?
Yes. Australian guidelines require all human research to be approved by a HREC prior to commencement. This is irrespective of the sample size, the complexity of the measures, or the aims of the research. If you are unsure about whether or not you need to apply to the HREC for approval, please contact the Ethics Secretariat on +61 2 9850 4459 or by email: email@example.com
What is the Autonomous Sanctions Act and how does it affect me?
In 2011 the Commonwealth Government enacted the Autonomous Sanctions Act 2011 (Cth). "Autonomous sanctions" are punitive measures not involving the use of armed force that the Australian Government chooses to take as a foreign policy response to situations of international concern. The Autonomous Sanctions Act 2011 (Cth) places restrictions on the University's interaction with persons and organisations who are associated with countries on the sanctions list.
Does single ethical review apply to institutions outside of the public health system?
Single ethical review is for the benefit of public health institutions. Even HRECs accredited under the Harmonisation of Multi-centre Ethical Review (HoMER) scheme - now known as the National Approach - do not necessarily extend the scope of their review to external institutions unless previously agreed upon. Hence ethical review is not automatically extended to a private organisation (such as Macquarie University).
NSW Health HRECs will conduct review for private sites if an external entity agreement has been signed. As Macquarie University has a fully-constituted HREC that operates in accordance with the guidelines set out by the NHMRC, an external entity agreement with various public health HRECs would not be required. As a risk management process of the institution, research that is undertaken on the at the University's sites must be reviewed in accordance with Macquarie University's ethics and governance processes.
This is standard practice at public and private hospitals in Australia.
Further information on the system of single ethical review is available here: http://www0.health.nsw.gov.au/ethics/research/faq_nswhealthsystem_multicentreresearchgeneral.asp#para_2
The HRECs have an expedited review process for researchers who have already obtained approval from a NSW Health (or equivalent) HREC. Please contact the Ethics Secretariat on +61 2 9850 4459 or by email firstname.lastname@example.org for further information and submission requirements.
Do teaching projects require ethical review?
The role of the HREC is to review all research with human participants. When establishing whether or not a teaching exercise requires ethical review, unit conveners and students should address whether or not a given project is intended as a research (or quality assurance) activity, whether it is designed to teach research skills, or whether it is designed to teach a given skill set relevant for the completion of a unit or degree.
If the teaching project has a research component then this would require ethics approval, as there is a research question being designed and tested and the results are intended for dissemination. If the project is intended to teach research skills, then this should also be submitted to the HREC.
However, if the project is a class or teaching activity and is designed to teach a given skill set then this would not be considered a research project. In these cases unit conveners should consider whether any data collected will be kept for research purposes or shared with other researchers for the purpose of research and whether the class assignment may result in a research project.
In cases where unit conveners are unclear as to whether they need to apply for ethics approval, they should contact the Ethics Secretariat on +61 2 9850 4459 or by email email@example.com and seek advice.
Where do I find an application form?
The application form can be downloaded from application resources.
Only the latest version will be accepted. The HREC advises that you do not save a copy to your computer to use at a later time as the form is routinely revised and updated. The HREC advises that researchers download a new application from the website each time they apply for ethics clearance. This will ensure that the correct version of the form is submitted for review.
Who is the Chief Investigator?
For student research projects, the Chief Investigator must be a Macquarie University staff member. A student researcher may design their research project but the HREC recommends that students work on their ethics application in conjunction with their supervisor. As the student's supervisor is named
as Chief Investigator, students must be guided by their supervisors.
The HREC advises that as the Chief Investigator has responsibility for their student's research, the Chief Investigator must read the ethics application thoroughly before signing and submitting the application. All correspondence regarding the ethics application will be sent to the Chief Investigator.
For staff research where there may be two or more researchers working as chief investigators, the HREC requires that only one Chief Investigator is named, the others may be listed as co-investigators.
How do I obtain a working with children check?
If you are a member of staff and your research involves direct unsupervised contact with children then you need to obtain a working with children check (WWCC). WWCCs are not conducted by the HRECs and are instead managed by Human Resources (HR). Information about the WWCC is available on the HR website
If you have any additional questions regarding the working with children check then please contact your faculty/department administration or HR.
I have been told that my application is greater than low risk. What does this mean?
The University requires researchers to conform to the NH&MRC Australian Code for the Responsible Conduct of Research; the National Statement on Ethical Conduct in Human Research (2007); and to other relevant legislation and guidelines. As part of ensuring that Universities are able to meet these requirements, the National Statement sets out guidelines for what constitutes risk in research (See, the National Statement Chapter 2.1).
When an application is submitted to the HREC a 'risk assessment' will be made. According to the National Statement a risk is "the likelihood that a harm (or discomfort or inconvenience) will occur" and "the severity of the harm, including its consequences" (See, the National Statement, Chapter 2.1: Risk and Benefit). 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 (See, the National Statement, Chapter 2.1: Risk and Benefit).
The National Statement sets out that any application which may lead to harms for the participants is greater than low risk. Low risk research is described as research in which the only foreseeable risk is not more serious than discomfort. Ethics applications are assessed for risk on the basis of this form.
If you would like further information, please contact the Ethics Secretariat on 02 9850 6848 or by email firstname.lastname@example.org
You can also check the National Statement (Chapter 2.1) which is available at the following address: http://www.nhmrc.gov.au/publications/synopses/e72syn.htm
How long does the ethics process take and how will I be notified about the Committees decision?
Applications that are considered to be low risk are reviewed via an expedited review process, which allows applicants to receive feedback within 20 working days of submission. Notification of the Committee's feedback is sent to the Chief Investigator by email, and often researchers will be asked to provide clarifications or make changes to the application. Depending on the requested modifications, the responses received and the time taken to review responses, the review process from submission to final ethics approval may take longer than 20 working days. You are required to respond to the Committee within 6 weeks. If you fail to respond within the 6 week deadline your research will not be approved and you will have to resubmit your application. If you have trouble meeting the 6 week deadline then please contact the Ethics Secretariat on 9850 6848 or by email email@example.com
If your application is considered to be greater than low risk, it will be deferred to the Committee meetings for consideration. The Committee meets once a month. Meeting dates and cut-off dates for applications are available on the Important Dates
If your application was considered at a Committee meeting, then you can expect to receive notification about the Committee's decision within 7-10 working days following the meeting. Notification of the Committee's decision is not the same as final ethics approval and often researchers will be asked to make clarifications/amendments to the protocol. Researchers' replies will then be considered by the Committee Executive or deferred to the Committee for review. You are required to respond to the Committee within 6 weeks. If you fail to respond within the 6 week deadline your research will not be approved and you will have to resubmit your application. If you have trouble meeting the 6 week deadline then please contact the Ethics Secretariat on 9850 6848 or by email firstname.lastname@example.org
Please be aware that this response process takes some time.
If your application is suitable for consideration by a Faculty Ethics Committee you should expect to receive feedback regarding your application within 15 working days of submission. Faculty Ethics Committees may request further information so please remember that the process may take longer depending on the requested modifications and the responses received.
Please see the following link for further information about the ethics process:
What is the process for reviewing external applications and what documentation should I submit?
The National Statement sets out that where research is conducted at multiple sites or institutions, and wherever more than one institution has a responsibility to ensure that research is subject to ethical review , each institution has a responsibility to adopt a review process that eliminates any unnecessary duplication of ethical review (See, the National Statement Chapter 5.3). Therefore, an application that has been submitted for review by a fully constituted HREC at another institution (such as a hospital or university) the Macquarie University HREC will accept the ethical oversight of the original approving HREC.
In this instance, the researcher will need to submit a copy of the original application, any approval correspondence and a copy of the 'External Approval Application Form' available from: http://www.research.mq.edu.au/current_research_staff/human_research_ethics/application_resources
This approval will be noted by the HREC.
The Macquarie University HREC will accept applications submitted on the National Ethics Application Form (NEAF).
Applications submitted to the NSW public health system for review are usually submitted on the NEAF. Information on the NEAF can be found at: http://www.health.nsw.gov.au/ethics/research/faq_neaf.asp
Researchers completing the NEAF need to submit this and the 'External Approval Application Form' to the HREC for noting.
If you are not sure whether or not your application can be considered as externally approved, then please contact the Ethics Secretariat on 02 9850 6848 or by email email@example.com
Does Macquarie University HREC accept applications submitted on the NEAF?
I submitted my application in time for the main HREC meeting, it went to a sub-Committee, and now it's been deferred to the main HREC for further review. Which meeting will my application be considered at, and when can I expect to receive notice of the outcome of the HREC's review?
If your application was submitted to a sub-Committee for review, and that sub-Committee decided that the application needed to be deferred to the main HREC for review, then your application will be submitted to the next available meeting for consideration. This means that even if you submitted your application in time for a particular HREC meeting and the application deadline for that meeting has passed, then your application will be placed on the Agenda for the subsequent meeting (and not the previous meeting). This is because of the time requirements involved in preparing meeting agendas, ensuring that meeting papers are distributed to HREC members, and so on. Therefore, once your application has been forwarded to a sub-Committee for review, it cannot be guaranteed that your application will not be deferred back to the main HREC meeting and neither can it be guaranteed that your application will be sent to the closest available meeting date.
Policy and Review
How do I obtain approval to recruit students from high schools?
As well as obtaining Macquarie University HREC approval you will also need to apply to relevant approving bodies in order to conduct research in schools.
In the case where research is being conducted in NSW State Schools then ethics approval will need to be sought from the Department of Education and Training (DET). This process is called the State Education Research Approvals Process (SERAP). More information about SERAP can be found at: https://www.det.nsw.edu.au/about-us/statistics-and-research/research-partnerships
The DET requires that all SERAP applications are logged online. For further information on SERAP, the DET's "Guidelines for Approving Applications from External Agencies to Conduct Research in NSW Government Schools" are available at:
In Australia, each state has its own approval process and you will need to check with your local DET what approvals are necessary.
Independent and private schools may have their own review bodies and separate approval will need to be sought from the relevant approving bodies depending on the schools being recruited.
Principal, teacher, parental and participant consent will also need to be obtained.
In all instances of research undertaken at schools, it is up to the discretion of the principal whether or not the school takes part in the study.
How do I obtain the consent of children?
As well as parental consent when required by law (less than 16 years), any teenager must be allowed to give their own consent/assent when taking part in research. Young children who are involved as research participants should be offered the option of assenting to the research.
In the case where a research project involves children, it is necessary to provide parental/guardian information and consent forms. A space may be included for the child to sign their consent/assent on the parental/guardian consent form. Depending on the age of the child involved, it may be appropriate to also provide separate information and consent forms for children and for adults.
The National Statement sets out that researchers should respect the capacity of young children to participate in decisions concerning their participation in research. Responsiveness to the various developmental levels of children means that researchers need to be aware that maturity will vary between children as will a child's understanding of the research tasks being imposed upon them. When applying to conduct research with children, researchers should consult the National Statement, Chapter 4.2: Children and Young People.
The following reference article discussing the ethical issues concerning consenting children may also be of use:
Merle Spriggs, Understanding Consent in Research Involving Children: The Ethical Issues Version 4, 2010. It is available at the following website:
What research is considered to be a clinical trial and what is the process for reviewing clinical trials?
Any research that prospectively assigns participants to one or more health related interventions to evaluate the effects on health outcomes is considered to be a clinical trial. A medical intervention can include any intervention used to modify a health outcome and can include drugs, surgical procedures, devices, behavioural treatments, etc (Definition taken from the Australian New Zealand Clinical Trials Registry (ANZCTR) FAQs http://www.anzctr.org.au/faq.aspx).
If your research is considered to be a clinical trial then in addition to completing your ethics application you will need to complete Appendix C, which is available at the following website: http://www.research.mq.edu.au/current_research_staff/human_research_ethics/application_resources
All clinical trials including Randomised Controlled Trials and physiological research will be submitted to the Macquarie University Scientific Committee for review. Review will be in accordance with the NSW Health "Standards for Scientific Review of Clinical Trials"New Insurance policy for Clinical Trials Effective 1 November 2012, the following clinical trials will need to be referred to the insurer via the Office of Financial Services:
- Trials involving pregnant women
- Trials involving children 5 years of age or less
- Trials involving Blood Plasma and whole blood products
- First in Human Phase 1 trials
- Any trial which is to be undertaken outside of Australia. Some countries require local insurances and the insurer may arrange cover if a specific request is made and a fee of approx $AUD 4,000 plus fronting fees will be charged. Please contact the Office of Financial Services for details.
For these clinical trials you should obtain ethics approval first and then contact the Tax and Insurance Manager, Ms Maggie Feng, with details of the clinical trial. Questions about insurance should be directed to Ms Feng: Phone: 9850-1683. Email:firstname.lastname@example.org
Can I use data collected or held by a third party in my research?
This depends on the type of data being collected, the purpose for which it was collected and is to be used. Sharing data can be complex and is subject to the relevant National and State legislation. In addition, the National Statement sets out that participants should be able to consent to participate in research in a voluntary manner and their consent should be based on sufficient information and adequate understanding of the research (see, The National Statement, Chapter 2.3: Qualifying or Waiving Conditions for Consent).
The following information is relevant when accessing data collected from a third party:
This act covers the collection and handling of health information.
The University's own policy regarding the use of student data is relevant and is available here:
My research involves Aboriginal and Torres Strait Islander People, what guidelines are available?
Researchers conducting studies involving Aboriginal and Torres Strait Islander Communities must ensure that their research is compliant with the NHMRC Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research.
Researchers conducting health research involving Aboriginal and Torres Strait Islander Communities must submit an application to the Aboriginal Health and Medical Research Council . This will need to be approved prior to being submitted to the University HREC.
Research involving Aboriginal and Torres Strait Islander People will need to demonstrate evidence of community consultation and approval before it can be approved by the HREC.
Researchers will also need to complete Appendix A of the ethics application form. In addition, the following guidelines should be consulted:
Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Indigenous Studies.
I want to use a Market Research company to collect my data. Will this be approved by the HREC?
The HREC's policy on the use of Market Research companies to collect data can be viewed here.
What is a conflict of interest and will it stop me from doing my research if I have one?
The Australian Code for the Responsible Conduct of Research (The Code) defines a conflict of interest as "a divergence between the individual interests of a person and their professional responsibilities such that an independent observer might reasonably conclude that the professional actions of that person are unduly influenced by their own interests" (See, The Code, Section 7).
The National Statement advises that measures are adopted by researchers to manage conflicts of interest. These measures include disclosing the conflict of interest to research participants, having a person other than the researcher recruit participants, disclosing the conflict of interest in any publications or reports or if at all possible, not conducting the research (See, The National Statement 5.4.3). Further information about conflicts of interest can be found in The National Statement Chapter 5.4.
Contact the Ethics Secretariat on 9850 6848 or by email email@example.com for further information.
How do I amend my application once it has received final approval?
Changes to approved applications need to be submitted on the HREC's 'Request for Amendment' form available at:
Changes to protocols that need to be submitted for review include the addition or removal of personnel including research assistants and investigators, new measures or questionnaires, changes to interview questions or research locations, recruitment changes, the addition of participants etc. Any changes to the HREC approved processes will need to be submitted as an Amendment Request. Please note that any changes should not be made prior to receiving formal correspondence from the HREC approving your amendment request.
For further information, please contact the Ethics Secretariat on 02 9850 6848 or by email firstname.lastname@example.org
How long should it take to review my amendment request?
It usually takes between 7-10 working days to review amendment requests. If further information is required, then you will be contacted. Please be advised that this process may take some time, depending on the information that is supplied and the time taken to review the proposed amendment.
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.
I've received a reminder to submit a progress report. What should I do?
The National Statement sets out that institutions are responsible for monitoring approved research and ensuring that research is conducted according to the approved protocol (See the National Statement, Chapter 5.5).
As a condition of HREC approval researchers are advised in the letter of Final Approval from the Committee that they are required to submit an annual report informing the Committee on the progress of the research.
This report is a 'Progress Report' and is available at: http://www.research.mq.edu.au/current_research_staff/human_research_ethics/application_resources
Reminders are sent by the Ethics Secretariat to assist researchers in meeting their reporting obligations. It is a condition of ethics approval that a report is submitted.
Progress reports should be completed and submitted to the Ethics Secretariat annually.
Should I submit a Progress or a Final 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) then a progress report must be submitted.
You will be advised by email when your progress report has been approved.
If you have finished conducting research with participants and do not intend to have any future contact with research participants, then a final report can be submitted (even if you are still in the process of writing the results of your research).
The Final Report is available at: http://www.research.mq.edu.au/current_research_staff/human_research_ethics/application_resources
Once your final report has been received by the Ethics Secretariat and has been checked, it will be filed and your record will be archived. No further correspondence will be issued.
Progress and Final reports must be signed by either 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.