FMHHS Low-Risk Ethics Subcommittees
About Human Research Ethics
All research conducted at Macquarie University or Macquarie University Hospital, or by staff, students or visitors to Macquarie University or Macquarie University Hospital, or which is carried out using University equipment, facilities or premises owned by the University or otherwise under control of the University must obtain ethics approval from a Macquarie University Human Research Ethics Committee (HREC) before it can commence.
According to the National Statement (National Statement on Ethical Conduct in Human Research (2007) updated 2018), human research is understood broadly 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 (e.g. 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information (in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database
Approval is required before there is any interaction with participants or their data. If your research includes any of the above, you must apply for ethics approval before you commence your research.
Macquarie has two Human Research Ethics Committees (HRECs) and several discipline-based low-risk ethics subcommittees that review the conduct of research involving humans.
Human Research Ethics Management System – Log in
- Human Research Ethics applications (HREA) are managed via the online Human Research Ethics System - FoRA.
- The HREA online form may also be accessed via WiKi. A Human Research Ethics Support WiKi page has been set up to provide detailed information to applicants, reviewers (ethics committees) and ethics administrators on how to submit and manage human ethics applications in the Human Research Ethics Management System.
When you log into WiKi, please select Team and choose Human Ethics (PDF)
Deciding whether your project is low risk
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.
Useful Chapters in the National Statement when deciding risk level for your projects:
Chapter 2.1
Low risk research - The expression ‘low risk research’ describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.
Negligible risk research - The expression ‘negligible risk research’ describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
Chapter 2.3.9
Waiver of consent: Only a HREC may grant waiver of consent for research using personal information in medical research, or personal health information.
Chapter 5.1.6
HRECs: research involving more than low risk
5.1.6 - The following types of research require review by a Human Research Ethics Committee (HREC):
(a) all research that involves more than low risk;
(b) research falling under the following chapters (except where research on collections of non-identifiable data under these chapters satisfies the conditions for exemption from review – see paragraphs 5.1.22 and 5.1.23):
- Chapter 4.1: Women who are pregnant and the human fetus
- Chapter 4.4: People highly dependent on medical care who may be unable to give consent
- Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness
- Chapter 4.7: Aboriginal and Torres Strait Islander Peoples and some categories of research falling under
- Chapter 4.6: People who may be involved in illegal activities (see first bolded paragraph for details).
National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 | NHMRC