This glossary has been adapted from the NHMRCNational Health and Medical Research Council.
|Australian Institute of Aboriginal and Torres Strait Islander Studies|
A change to an approved project
Australian School of Advanced Medicine
Benefits of research may include, for example, gains in knowledge, insight and understanding, improved social welfare and individual wellbeing, and gains in skill or expertise for individual researchers, teams or institutions.
A fee or grant paid to a doctor, school, etc., the amount of which is determined by the number of patients, pupils or customers that are recruited to the research project.
Chemistry and Biomolecular Sciences
Chief Executive Officer
Children and/or young people
Persons who are under eighteen (18) years of age
Clinical research involving humans seeks to find out whether an intervention – including treatments or diagnostic procedures – may improve a person's health. An intervention may involve testing a drug, a surgical or other therapeutic/preventative procedure, or a therapeutic/preventative/diagnostic device, practice or service
Research involving an unapproved or approved therapeutic goods, intervention or treatment
|Conflict of Interest|
Conflict of Interest
Where a person's individual interests or responsibilities have the potential to influence the carrying out of his or her institutional role or professional obligations in research; or where an institution's interests or responsibilities have the potential to influence the carrying out of its research obligations
Coordinating (Principalprincipal) investigator
The person who – in a multi-site research project, where Macquarie University is providing ethical review for more than one institution/site – is the primary point of contact between the groups of collaborating investigators/researchers and the HREC
Coordinating (Principal) Investigator
Clinical Trial Notification
Clinical Trial Protocol
Clinical Trial Exemption
Discomforts (less serious
than harm) can involve body and/or mind and include:
The process by which a principal or coordinating investigator notifies the Human Research Ethics Committee responsible for providing ethics approval that a project will not be completed.
Data and Safety Monitoring Board
Duality of interest
Where two or more interests co-exist. These interests may or may not conflict, depending on the specific circumstances.
A Macquarie University process, applicable only to internal applicants for externally-approved projects where all of the research will be conducted offsite (ie does not take place at Macquarie University or at Macquarie University Hospital). Investigators must also be listed on the external application (either by an amendment or as a named Principal Investigator).
The evaluation of somatic genetics/epigenetics of cells in which the primary purpose is not to identify germline disease-predisposing mutations.
The analysis of genetic material in which the primary purpose is to identify high or low penetrance germline disease-predisposing mutations.
No list of potential harms
in research will be exhaustive; however, the following classifications may
HoD or HOD
Head of Department
Hypertext Markup Language
Human Sciences and Humanities
Human Research Ethics Committee
An institutional body that has been established in accordance with Chapter 5.1 of the National Statement and conducts the ethical review of research.
Human Tissue tissue samples
Includes blood, tissue, sputum, urine or autopsy with or without tissue retention.
Examples of inconvenience
(less serious than harm and discomfort) may include:
The entity responsible for the conduct of research as described in the National Statement and the Code. Alternatively, the entity that has established a HREC as per Chapter 5.1 of the National Statement.
Information Privacy Principle
Integrated Research Information System
Low and/or negligible risk (research)
Low risk research
Where the only foreseeable risk is one of discomfort to the research participant (see National Statement Chapter 2.1).
A research project undertaken by a group of institutions (or individuals) at one or more sites (as defined by the NHMRC).
A Macquarie University process, where Macquarie University assumes oversight of one or more external institutions/sites. For external applicants, this would apply where Macquarie University oversight involves two or more external institutions/sites. This type of application needs to report on all research personnel and project details that apply to the sites for which the Macquarie University will be providing ethical review.
|The Human Research Ethics Application Form|
|Where there is no foreseeable risk of harm or discomfort, and any foreseeable risk is no more than one of inconvenience to the research participant (see National Statement Chapter 2.1).|
|National Health and Medical Research Council|
National Privacy Principle
NS or National Statement
|New South Wales|
|Office of the Gene Technology Regulator|
|Participation and Community Engagement|
|Portable Document Format (ie Adobe Acrobat/Reader document)|
|Participant Information and Consent Form|
The person who is the
principal point of contact with the HREC for all the research personnel
listed in the research proposal. Principal Investigator (or PI) should be used
in the following circumstances:
A Macquarie University
process, for instance where researchers (namely those in medical sciences)
wish to obtain ethical review from Macquarie University for an additional
(single) site – ie one that was not covered by a previous application
that received approval from one of the following types of external HRECs:
A document that provides the background, rationale and objectives of the proposed research and describes its design, methodology, organisation and the conditions under which it is to be performed and managed.
Original investigation undertaken to gain knowledge, understanding and insight (see National Statement and the Code).
|Research Involving Human Embryos|
A risk is a potential for
harm, discomfort or inconvenience and involves:
Research Master Enterprises
|Radiation Protection Series|
Serious Adverse Event
A review of proposed research to consider the level of scientific validity of research methodology before the proposal is considered by a HREC.
State Education Research Applications Process
|Sydney Institute of Business and Technology|
A research project undertaken at a single location
The location(s) at which the research is being conducted – namely in reference to universities, schools, hospitals and other health practices/clinics
Serious Unexpected Suspected Adverse Reaction
|Australian Code for the Responsible Conduct of Research (2007)|
Therapeutic Goods Administration
Uniform Resource Locator (ie a web address)
Work Health and Safety