This glossary has been adapted from the NHMRC
|ADR||Associate Dean of Research.|
|AIATSIS||Australian Institute of Aboriginal and Torres Strait Islander Studies.|
|Amendment Requests||A MQ process, applicable only to active applications that have previously received approval from MQ. Applicants submitting amendment requests are given the opportunity to update or change project details.|
|ANZCTR||Australian New Zealand Clinical Trials Registry.|
|ARC||Australian Research Council.|
|ARPANSA||Australian Radiation Protection and Nuclear Safety Agency.|
|ART||Assisted Reproductive Technology.|
|ASAM||Australian School of Advanced Medicine.|
|Benefits||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.|
|Capitation Payments||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.|
|CBMS||Chemistry and Biomolecular Sciences.|
|CEO||Chief Executive Officer.|
|Children and/or Young People||Persons who are under eighteen (18) years of age.|
|Clinical Research||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.|
|Clinical Trial||Research involving an unapproved or approved therapeutic goods, intervention or treatment.|
|COI||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 (Principal) Investigator||The person who - in a multi-site research project, where MQ 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.|
|CPI||Coordinating (Principal) Investigator.|
|CTN||Clinical Trial Notification.|
|CTP||Clinical Trial Protocol.|
|CTX||Clinical Trial Exemption.|
Discomforts (less serious than harm) can involve body and/or mind and include:|
- minor side-effects of medication,
- the discomforts related to measuring blood pressure, and
- anxiety induced by an interview.
Where a person's reactions exceed discomfort and become distress, they should be viewed as harms.
|Discontinue||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.|
|DSMB||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.|
|External Review||A MQ process, applicable only to internal applicants for externally-approved projects where all of the research will be conducted offsite (i.e. does not take place at MQ or MUH). Investigators must also be listed on the external application (either by an amendment or as a named Chief/Principal Investigator).|
|Genetic Research||The evaluation of somatic genetics/epigenetics of cells in which the primary purpose is not to identify germline disease-predisposing mutations.|
|Genetic Testing||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 assist: |
- physical harms (e.g. injury, illness, pain)
- psychological harms (e.g. feelings of worthlessness, distress, guilt, anger or fear)
- devaluation of personal worth (e.g. being humiliated, manipulated or treated disrespectfully or unjustly)
- social harms (e.g. damage to relationships with others, discrimination, etc.)
- economic harms (e.g. imposing costs onto participants), and
- legal harms (e.g. discovery and prosecution of criminal conduct).
|HDRO||Higher Degree Research Office.|
|HoD or HOD||Head of Department.|
|HREC||Human Research Ethics Committee.|
|HTML||HyperText Markup Language.|
|HUM||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 Samples||Includes blood, tissue, sputum, urine or autopsy with or without tissue retention.|
Examples of inconvenience (less serious than harm and discomfort) may include: |
- filling in a form,
- participating in a street survey, or
- giving up time to participate in research.
|Institution||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.|
|IPP||Information Privacy Principle.|
|IRIS||Integrated Research Information System.|
|LNR||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).|
|MGSM||Macquarie Graduate School of Management.|
|MUH||Macquarie University Hospital.|
|Multi-centre Research||A research project undertaken by a group of institutions (or individuals) at one or more sites (as defined by the NHMRC).|
|Multi-site Review||A MQ process, where MQ assumes oversight of one or more external institutions/sites. For external applicants, this would apply where MQ 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 MQ will be providing ethical review.|
|NEAF||National Ethics Application Form.|
|Negligible Risk Research||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).|
|NHMRC||National Health and Medical Research Council.|
|NPP||National Privacy Principle.|
|NS or National Statement||National Statement on Ethical Conduct in Human Research (2007).|
|NSW||New South Wales.|
|OGTR||Office of the Gene Technology Regulator.|
|PACE||Participation and Community Engagement.|
|Portable Document Format [i.e. Adobe Acrobat/Reader document].|
|PICF||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:|
- (if the project is for student research) to identify the Principal Supervisor of the student(s).
- to identify the lead researcher and, therefore, the primary contact.
- (if MQ is providing ethical review for more than one institution/site) to identify the lead researcher at each institution/site.
A MQ process, for instance where researchers (namely those in medical sciences) wish to obtain ethical review from MQ for an additional (single) site - i.e. one that was not covered by a previous application that received approval from one of the following types of external HRECs:|
- another Australian university.
- another Australian hospital.
- NSW Public Health (or other State equivalent).
- NSW Justice Health (or other State equivalent).
- Australian Department of Defence.
All Prior Review applications are reviewed by the HREC (Medical Sciences). External applicants may also apply.
|Protocol||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.|
|Research||Original investigation undertaken to gain knowledge, understanding and insight (see National Statement and the Code).|
|RIHE||Research Involving Human Embryos.|
A risk is a potential for harm, discomfort or inconvenience and involves:|
- the likelihood that a harm (or discomfort or inconvenience) will occur, and
- the severity of the harm, including its consequences.
|RPS||Radiation Protection Series.|
|SAE||Serious Adverse Event.|
|Scientific Review||A review of proposed research to consider the level of scientific validity of research methodology before the proposal is considered by a HREC.|
|SERAP||State Education Research Applications Process.|
|SIBT||Sydney Institute of Business and Technology.|
|Single-site Research||A research project undertaken at a single location.|
|Site||The location(s) at which the research is being conducted - namely in reference to universities, schools, hospitals and other health practices/clinics.|
|SUSAR||Serious Unexpected Suspected Adverse Reaction.|
|The Code||Australian Code for the Responsible Conduct of Research (2007).|
|TGA||Therapeutic Goods Administration.|
|URL||Uniform Resource Locator [i.e. a web address].|
|WHS||Work Health and Safety.|