When do I need to submit an application for ethical review?
If you are doing research involving humans in Australia and overseas you will need to apply for ethics review. Human Research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood to include the involvement of human beings through:
- 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 body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
- Access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.
When do teaching projects require ethics approval?
If the teaching project is designed to teach research skills or the unit/teaching program has a research component, you should obtain ethical 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.
Do I need to complete a Macquarie University ethics application form if I have approval from another Australian ethics committee to conduct research that does not involve Macquarie University or Macquarie University Hospital as a site.
No. You should submit a copy of all approved documents to the Ethics Secretariat, along with an Externally Approved Application Form. The Ethics Secretariat will note your approval and provide a Macquarie University reference number.
I have approval from another Australian ethics committee, and I want to conduct research at Macquarie University/Macquarie University Hospital. Do I need to complete a full Macquarie University ethics application?
You should apply for ethics review at Macquarie University if the ethics application submitted to the approving ethics committee does not contain information about the research that will be conducted at Macquarie University/Macquarie University Hospital.
Do I need ethics approval from Macquarie University if I have approval from an overseas ethics committee to conduct my research?
I am transferring to Macquarie University from another university and I would like Macquarie University to have oversight of my project. What do I do?
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 to one of Macquarie University’s HRECs for ethical review via email@example.com.
The documents you should submit include:
- Correspondence from the approving HREC indicating their willingness for Macquarie University to provide ethical oversight for the research
- A copy of the approved application and other documents that were reviewed and approved
- All formal correspondence between you and the HREC
- Copies of approved amendments.
Can I complete the National Human Research Ethics Application (NHEA) instead of the Macquarie University ethics application?
Can I submit my application without my supervisor’s signature?
No. Your application will not be processed without evidence that your supervisor has read your application and supports its submission for ethical review. This evidence can be in the form of your supervisor’s signature on the application or an email of support from your supervisor to the Ethics Secretariat.
Who is the Chief Investigator on the ethics application?
The Chief Investigator must be a Macquarie University staff member. For student projects, the Chief Investigator must be the primary supervisor. Students should be listed as Co-Investigators.
I can’t provide my finalised interview questions with my application until I have conducted the first part of my research. Can I send a set of draft questions with my application?
Yes. The ethics committee will ask you to provide the final set of interview questions for review before the interviews take place.
Which ethics committee will review my ethics application?
The Ethics Secretariat conducts a risk assessment that involves assessing participant sample, procedures, location and topic of research. If the risk to participants is no more than discomfort, the application will be reviewed by a faculty subcommittee. Applications that include risks greater than discomfort will be reviewed by a central HREC.
When and how will I receive the ethic committee’s decision about my application?
All applicants will receive the ethics committee decision via email. Low risk applications should receive a decision within 20 working days of submission. Applications requiring HREC review should receive a decision within 10–15 working days from the date of the meeting.
Can an ethics subcommittee defer my low risk application to the HREC for review?
Yes. If your application raises ethical issues that the subcommittee determines would require HREC review, then your application will be considered at the next available HREC meeting. The subcommittee administrator will advise you when the HREC will review your application.
My project is being conducted overseas in a country with a Department of Foreign Affairs Trade (DFAT) travel advisory of ‘Reconsider your need to travel/Do not travel’. How do I get approval from the Vice-Chancellor (VC) to travel?
Visit our travel information. When Risk and Assurance has approved the travel, please attach the email correspondence to your ethics application.
I’ve been given approval from the VC's office to travel to a high-risk country. Does this mean I am insured?
No. Insurance cover is assessed separately to the travel risk assessment. Contact Risk and Assurance for information
As my research involves Aboriginal and Torres Strait Islander peoples, what guidelines are available?
- The Australian Institute of Aboriginal and Torres Strait Islander Studies (AIATSIS) Guidelines for Ethical Research in Australian Indigenous Studies
- Values and Ethics – Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research
- Aboriginal Health and Medical Research Council
How do I obtain approval to recruit participants from schools?
- Research in New South Wales state schools requires approval from the NSW Department of Education and Communities via the State Education Research Application Process (SERAP)
- Research in other states’ public schools requires approval from the relevant state government Department of Education
- Research in catholic schools requires approval from the relevant Catholic Education Office Diocese
- Research in independent/private schools requires approval from the principal.
How do I obtain the consent of children?
Depending on the age of the child and their capacity to understand the research, consent from children can be obtained in the following ways:
- Verbally, and recorded in writing, audio recording or video recording.
- Using simple words or pictures to convey the information. This could be delivered in paper format or electronically, eg via an iPad, computer, etc.
- Using a child-friendly version of a parent information and consent form, written in age-appropriate language.
The following reference article discussing the ethical issues concerning consenting children may also be useful: Merle Spriggs, Understanding Consent in Research Involving Children: The Ethical Issues Version 4, 2010.
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, what consent was obtained from participants at the time of initial data collection, and how it is to be used. Sharing data can be complex and is subject to the relevant national and state legislation. You should contact the Ethics Secretariat for tailored assistance, after consulting the following guidelines, policies and legislation:
- Chapter 2.3: Qualifying and Waiving Consent, from the National Statement on Ethical Conduct in Human Research (2007)
- Office of the Australian Information Commissioner (OAIC)
- Health Records and Information Privacy Act 2002
- Section 27B of the NSW Privacy and Personal Information Protection Act (NSW)
- Australian National Data Service (ANDS)
- Macquarie University’s Release of Student Information Policy and Guidelines
Can I amend my application once it has received final approval?
Yes. Complete and submit an Amendment Form
How long should it take to review my amendment request?
Small amendments, such as a change of personnel and minor protocol changes, may be approved by the Ethics Secretariat. These are usually approved within 5 working days. Larger amendments may need to be reviewed by the Executive or the HREC, with approval taking about 20 days.
When should I submit a final report?
When you have finished conducting research with participants and do not intend to have any future contact with research participants to collect data or verify their contributions to the research. You may, however, send participants a summary of research findings after the final report has been submitted.
What do I do if a participant has an adverse event?
All adverse events must be reported to the approving ethics committee within 72 hours of the event via an Adverse Event Form (available under resources).