National Statement on Ethical
Conduct in Research Involving Humans
Appendix 3 - Glossary of Definitions[from the Privacy Act, 1988 (Commonwealth)]
The definitions provided within this Glossary apply as they are used in the Statement. These are based on the definitions used in the Canadian Code of Ethical Conduct for Research Involving Humans (1996).
anonymous samples or data
See De-identified samples or data
benefit
That which positively affects the interests or welfare of an individual or
group.
child
Subject to law in the relevant jurisdiction, a minor who lacks the
maturity to make a decision whether or not to participate in research.
See also
Young Person
clinical trial
Preplanned, usually controlled, clinical study of the safety, efficacy, or
optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic,
or prophylactic drugs, devices or interventions in humans
selected according to predetermined criteria of eligibility and observed
for predefined evidence of favourable and unfavourable effects.
collectivities
Distinct human groups with their own social structures that link members with a
common identity, with common customs and with designated leaders or other
persons who represent collective interests in dealing with researchers.
Collectivities may include cultural or ethnic groups, and indigenous
communities.
competence
The ability of a person or a group to make choices in accord with their own
fundamental values.
confidentiality
The obligation of persons to whom private information has been given is not
to use the information for any purpose other than that for which it was given.
consent
The voluntary agreement of a person or group, based on adequate knowledge
and understanding of relevant material, to participate in research. Informed
consent is one possible result of the informed choice process, the other
possible result is refusal.
deception
This occurs when research participants have essential information withheld
and/or are intentionally misled about procedures and purposes, including studies
where participants are deliberately given misleading information about the
purpose of a research study.
de-identified (not re-identifiable, anonymous) samples or data
The process of de-identification can be irreversible if the identifiers have
been removed permanently or the data have never been identified. These data are
referred to as "de-identified". It should be recognised that the term
"de-identified" is used frequently, in documents other than this
Statement, to refer to sets of data from which only names have been removed.
Such data may remain "potentially identifiable."
See also
Identified samples or data
Potentially identifiable samples or data
ethics
The study of morals and values; that is, the study of right and wrong,
justice
and injustice, virtue and vice, good and bad, and related concepts and
principles.
ethical / unethical
Right or morally acceptable/wrong or morally unacceptable.
families
Individuals forming part of the social construct of the family; families may or
may not include biological relatives.
genetic material
Any source of DNA or RNA which can be tested to obtain genetic information.
It thus includes cells, whether as single cells or as part of tissues, and
extracted DNA and RNA.
harm
That which adversely affects the interests or welfare of an individual or a
group;
The amount of harm, conservatively estimated which is, from the research participant's perspective, an ethically acceptable addition to harm that they would experience were they not part of the research study;
Harm extends to physical harm, discomfort, anxiety, pain, psychological disturbance and includes social disadvantage (eg. ostracism).
human tissue
Includes the substance, structure, and texture of which the human body or
any part or organ of it is composed that is removed or separated from living
human beings; includes blood, blood components and waste products.
identified samples or data
Data that allow the identification of a specific individual are referred to as "identified data". Examples of identifiers may include the individual's name, date of birth or address. In particularly small sets of data even information such as a postcode may be an identifier.
See also
De-identified samples or data
Potentially identifiable samples or data
justice
That which concerns fairness or equity, often divided into three parts:
procedural justice, concerned with fair methods of making decisions and settling
disputes; distributive justice, concerned with the fair distribution of the
benefits and burdens of society; and corrective justice, concerned with
correcting wrongs and harms through compensation or retribution.
minimal risk
The probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered
in daily life.
monitoring
The review by an HREC of on-going research. Such monitoring can take a
variety of forms including review of annual reports, formal review of the
informed consent process, establishment of a safety monitoring committee, a
periodic review by a third party of the documents generated by the study, a
review of the impact of the research on a collectivity, a review of reports of
adverse events, or a random audit of the particular processes.
multi-centre research
The conduct of a research project in or by researchers in several autonomous
institutions or organisations. This includes multi-centre clinical trials.
non-therapeutic
Interventions not directed towards the benefit of the individual but rather
towards improving scientific knowledge or technical application.
personal information
Information by which individuals or collectivities can be identified. This
is defined in the Privacy Act 1988 (Cth) as information or an opinion
(including information or an opinion forming part of a database), whether true
or not, and whether recorded in a material form or not, about an individual
whose identity is apparent, or can reasonably be ascertained, from the
information or opinion.
placebo
A product or substance which excludes the active agent under study to
differentiate the effect of the other product influences from the effect of the
active agent.
potentially identifiable (coded, re-identifiable) samples or data
Data may have identifiers removed and replaced by a code. In such cases it is
possible to use the code to re-identify the person to whom the data relate, that
is the process of de-identification is reversible. In these cases the data are
referred to as "potentially identifiable".
See also
Identified samples or data
De-identified samples or data
privacy
Control over the extent, timing, and circumstances of sharing oneself
(physically, behaviourally, or intellectually) with others. Privacy implies a
zone of exclusivity where individuals and collectivities are free from the
scrutiny of others.
protocol
A document which provides the background, rationale and objectives of the
research and describes its design, methodology, organisation and the conditions
under which it is to be performed and managed.
qualitative research
Any kind of research that produces findings not arrived at by means of
statistical procedures or other means of quantification.
research
This involves systematic investigation to establish facts, principles, and
knowledge.
research participant
Living individual (or groups of living individuals) about whom a researcher
conducting research obtains data through intervention or interaction with the
person or identifiable private information.
respect for persons
This has two fundamental aspects: 1) respect for the autonomy of those
individuals who are capable of making informed choices and respect for their
capacity for self-determination; and 2) protection of persons with impaired or
diminished autonomy, that is, those individuals who are incompetent or whose
voluntariness is compromised.
risk
The function of the magnitude of a harm and the probability of its
occurrence.
See also
Minimal risk
serious adverse effect (event or reaction)
Any untoward medical occurrence that at any dose:
- results in death;
- is life-threatening;
- requires in-patient hospitalisation or prolongation of existing
hospitalisation;
- results in persistent or significant disability/incapacity; or
- is a congenital anomaly/birth defect.
sponsor
An individual, company or institution or organisation that takes
responsibility for the initiation, management, and/or financing of a clinical
trial.
Statement
National Statement on Ethical Conduct in Research Involving Humans.
therapeutic
Interventions directed towards the well-being of the individual involved.
unexpected adverse effect (event or reaction)
An adverse reaction, the nature or severity of which is not consistent with
the applicable product information.
voluntary
Free of coercion, duress or undue inducement.
young person
Subject to the law in the relevant jurisdiction, a minor who may have
the maturity to make a decision whether or not to participate in research.
See also
Child
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]