Research and Ethics Office

Research Overview

According to the National Statement (page 8)
Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be 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 (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(in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.


Clinical Trials of Drugs and devices
A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure.
Clinical trials of new therapeutic substances are typically categorised into Phase I, II , III or IV trials.
Population Health and/or public health
Research involving populations and public health issues
Research involving children and young people
Aborigines and Torres Strait Islander
Research involving Aboriginal and Torres Strait Islander people's
Clinical Interventions research other than clinical trials
A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure that does not involve testing of a new therapeutic drug or device
Qualitative Health Research
Qualitative research involves disciplined inquiry that examines people’s lives, experiences and behaviours, and the stories and meanings individuals ascribe to them.4 It can also investigate organisational functioning, relationships between individuals and groups, and social environments.
Examples: Focus groups, interviews, surveys, observation,
Mental Health
The definition of “mental illness” used in the Mental Health Act 1990 is as follows:
Mental illness means a condition which seriously impairs, either temporarily or permanently, the mental functioning of a person and is characterised by the presence in the person of any one or more of the following symptoms:
(a) delusions,
(b) hallucinations,
(c) serious disorder of thought form,
(d) a severe disturbance of mood,
               (e) sustained or repeated irrational behaviour indicating the presence of any one or more of the symptoms referred to in paragraphs (a)–(d).
Human Gametes (eggs or sperms) or excess ART (assisted reproductive) embryos
ART- The application of laboratory or clinical techniques to gametes and/or embryos for the purposes of reproduction.
Gametes- A human sperm or egg (ovum or oocyte) and includes:
(a) any cell that has resulted from a process of meiosis or has a haploid chromosone complement; or
(b) tissue containing such cells (also referred to as gonadal tissue)
Women who are pregnant and the human foetus
Research involving women who are pregnant, the human foetus ex utero, and human foetal tissue after the separation of the foetus from the woman
People in dependent or unequal relationships
·   carers and people with chronic conditions or disabilities, including long-term hospital patients, involuntary patients, or people in residential care or supported accommodation;
• health care professionals and their patients or clients;
• teachers and their students;
• prison authorities and prisoners;
• governmental authorities and refugees;
• employers or supervisors and their employees (including members of the Police and Defence Forces);
• service-providers (government or private) and especially vulnerable communities to whom the service is provided.
People highly dependent on medical care who are unable to give consent
·      neonatal intensive care;
·      terminal care;
·      emergency care;
·      intensive care; and
·      the care of unconscious people.
Clinical Research
Clinical research increasingly involves a range of different health professionals studying a wide range of matters, including disease prevention and causation, diagnostic methods, treatments, and effects of and response to illness. Such research can occur in a number of settings, including public and private hospitals and clinics, other institutions or organisations, community settings, and general or specialist medical practices.

© 2016 South Western Sydney Local Health District
Last Updated: 28 June, 2013
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