Glossary

Understand terms used in human research ethics

This glossary has been adapted from the National Health and Medical Research Council (NHMRC). It contains explanations for acronyms, institutions, roles and more.

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

A

ADR

Associate Dean of Research.

AIATSIS

Australian Institute of Aboriginal and Torres Strait Islander Studies.

Amendment requests

A change to an approved project.

B

Benefits

Benefits of research may include:

gains in knowledge, insight and understanding
improved social welfare and individual wellbeing
gains in skill or expertise for individual researchers, teams or institutions.

C

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.

Children and/or young people

Persons who are under 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
a therapeutic/preventative/diagnostic device, practice or service.

Clinical trial

Research involving an unapproved or approved therapeutic goods, intervention or treatment.

Conflict of Interest (COI)

Where a person’s individual interests or responsibilities have the potential to influence the carrying out of their 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 (CPI)

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.

CTN

Clinical Trial Notification.

CTP

Clinical Trial Protocol.

CTX

Clinical Trial Exemption.

D

Discomfort

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
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.

E

External review

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).

G

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.

H

Harm

No list of potential harms in research will be exhaustive; however, the following classifications may assist:

physical harms (eg injury, illness, pain)
psychological harms (eg feelings of worthlessness, distress, guilt, anger or fear)
devaluation of personal worth (eg being humiliated, manipulated or treated disrespectfully or unjustly)
social harms (eg damage to relationships with others, discrimination, etc)
economic harms (eg imposing costs onto participants)
legal harms (eg discovery and prosecution of criminal conduct).

HOD

Head of Department.

HREA

The Human Research Ethics Application Form.

HUM

Human Sciences and Humanities.

Human Research Ethics Committee (HREC)

An institutional body that:

has been established in accordance with the National Statement Chapter 5.1
conducts the ethical review of research.

Human tissue samples

Includes blood, tissue, sputum, urine or autopsy with or without tissue retention.

I

Inconvenience

Examples of inconvenience (less serious than harm and discomfort) may include:

completing a form
participating in a street survey
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 National Statement Chapter 5.1.

IPP

Information Privacy Principle.

IRIS

Integrated Research Information System.

L

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).

M

MDS

Medical Sciences.

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 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.

N

Negligible 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.

National Statement (NS)

National Statement on Ethical Conduct in Human Research 2007.

O

OGTR

Office of the Gene Technology Regulator.

P

PACE

Participation and Community Engagement.

PICF

Participant Information and Consent Form.

Principal Investigator (PI)

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 Macquarie University is providing ethical review for more than one institution/site) to identify the lead researcher at each institution/site.

Prior review

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:

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.

R

Research

Original investigation undertaken to gain knowledge, understanding and insight (see National Statement and the Code).

RIHE

Research Involving Human Embryos.

Risk

A risk is a potential for harm, discomfort or inconvenience and involves:

the likelihood that a harm (or discomfort or inconvenience) will occur
the severity of the harm, including its consequences.

RME

Research Master Enterprises.

RPS

Radiation Protection Series.

S

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.