Glossary. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

accountability

The measures by which researchers, review bodies and institutions can demonstrate that their responsibilities have been, or are being, fulfilled. Typical accountability measures involve reporting from one level of the hierarchy to a higher (or more general) level.

beneficence

Doing good to others: here also includes 'non-maleficence', avoiding doing harm.

benefit

That which positively affects the interests or welfare of an individual or group.

cell line

A term used by scientists to describe cells grown in the laboratory over an extended period. Cell lines can be created from many different types of tissues and include those that will only grow for a limited period of time as well as those that may become 'immortal ' through alteration of their genomes either through mutations arising naturally or induced artificially. Cell lines usually comprise a stable population of cells, although some heterogeneity is generally present and changes in the characteristics of the cells may occur over time.

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

A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure.

community

A collection of individuals, which may extend from the whole population to a smaller grouping associated by cultural, ethnic, geographical, social or political factors or some other commonality.

confidentiality

The obligation of people not to use private information – whether private because of its content or the context of its communication – for any purpose other than that for which it was given to them.

conflict of interest

In the research context: 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.

consent

A person's or group's agreement, based on adequate knowledge and understanding of relevant material, to participate in research.

co-researcher

One or more participants (or a particular sub-group of participants) who make/s a significant contribution to the planning, design, implementation or outputs of a research project, including the collection, analysis or interpretation of data. Examples of co-researcher contributions include where participants contribute expertise, such as their cultural knowledge of mores and local practices, or their personal insights into local conditions, special interests (e.g., gaming), or social identities or contexts (for example, young people living in out-of-home care, community activists or people who identify as LGBTIQ). (See Chapters 3.1 and 4.8.)

data

Data refers to bits of information in their raw form. Data can refer to raw data, cleaned data, transformed data, summary data and metadata (data about data). It can also refer to research outputs and outcomes. (See Chapter 3.1, Element 4). Note: Information generally refers to data that have been interpreted, analysed or contextualized.

databank

A systematic collection of data.

deception

Where relevant material is withheld from research participants and/or they are intentionally misled about procedures and/or purposes of research.

discomfort

A negative accompaniment or effect of research, less serious than harm.

ethical/ unethical

Right or morally acceptable / wrong or morally unacceptable.

ethics review

Review of research by an HREC or other body.

ethics review body

Body set up to carry out ethics review of human research.

genomic data

Raw data, processed data or information that has been subject to a process of critical analysis and/or interpretation to assign meaning in the context of genomic research.

genomic research

Research with the potential for hereditary implications which may range from single gene genetic research to whole genome sequencing and any other 'omic ' research (for example, exomic, proteomic, etc) with potential hereditary implications. Genomic research includes the full scope of 'genetic ' research.

harm

That which adversely affects the interests or welfare of an individual or a group. Harm includes physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social disadvantage.

HREC

Human Research Ethics Committee.

human tissue

The substance, structure, and texture of human organs or body parts when separated from human beings; includes blood, blood components and waste products. (See also the definition for 'human biospecimens' in Chapter 3.2)

identifier

Details attached to data, such as name and/or contact information, that identify an individual. It may remain possible to identify an individual even after all identifiers have been removed, if a code number has been assigned and there is access to the code, or if the data or tissue can be cross-linked to other data or tissue banks.

inconvenience

A minor negative accompaniment or effect of research, less serious than discomfort.

index case

The original patient or participant in genomic research who stimulates investigation of other members of the family. This person is also referred to as the 'proband'.

innovation

In the research context, the introduction of one or more novel elements of an intervention that represent/s a substantive departure from the spectrum of standard care or service delivery. An innovation may apply modalities or strategies used and tested in one domain to a novel application. An innovation may or may not be therapeutic in intent or effect and may or may not be considered to be experimental, however, a condition of research involving an innovation is that the safety, efficacy, or effectiveness of the innovation in the context in which it is used is not known at the onset of the research.

integrity

Honesty and probity as qualities of character and behaviour.

intervention

An intentional change in the circumstances of research participants. The aim of interventional research is to evaluate the impact of that change on one or more outcome measures. The intervention can be a health-related procedure or process or a behavioural, educational or social modification. It can involve a policy change, a therapeutic strategy, a change in service provision or an approach to provision of information that is introduced and manipulated, controlled or directed by the researcher.

justice

Regard for the human sameness shared by all human beings, expressed in a concern for fairness or equity. Includes three aspects of justice: procedural justice, involving fair methods of making decisions and settling disputes; distributive justice, involving fair distribution of the benefits and burdens of society; and corrective justice, involving correcting wrongs and harms through compensation or retribution.

limited disclosure

Not disclosing to research participants all of the aims and/or methods of the research.

low risk (research)

Research in which the only foreseeable risk is one of discomfort.

monitoring (of research)

The process of verifying that the conduct of research conforms to the approved proposal.

mutations

Genetic changes that can be investigated or discovered in the form of:

• Germ line mutations, which involve inherited or de novo variations or mutations that occur in germ cells implicating one or more genes known to cause or predispose a person to disease (for example, BRCA1)
• Somatic mutations, which involve acquired variations or mutations in one or more genes within tissues (for example, tumours with BRAFV600E).

negligible risk

Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.

opt-out approach

A method used in the recruitment of participants into research where information is provided to the potential participant regarding the research and their involvement and where their participation is presumed unless they take action to decline to participate.

participant (in research)

Anyone who is the subject of research in any of the ways set out in Purpose, scope and limits of this document.

personal information

Information or an opinion about an identified individual, or an individual who is reasonably identifiable:

1. (a) whether the information or opinion is true or not
2. (b) whether the information or opinion is recorded in a material form or not.

placebo (in research)

A substance not containing an active agent under study, administered to some participants to compare the effects of the active agent administered to other participants.

privacy

A domain within which individuals and groups are entitled to be free from the scrutiny of others.

protocol

A document that 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

Research involving the studied use of empirical materials such as case studies, personal experience, life stories, interviews, observations, and cultural texts.

relatives

Persons related by blood to the index case, as distinguished from family members who are persons who may or may not be related by blood, but who may be affected by information with hereditary implications.

research

Includes at least investigation undertaken to gain knowledge and understanding or to train researchers.

research findings

Information that becomes known as a result of the research. Research findings may take the form of

• Findings related to primary aims of the research (including individual test results)
• Findings related to secondary aims of the research or that are unintended, unanticipated, inadvertent or incidental to the aims of the research.

research misconduct

Includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research, and failure to declare or manage a serious conflict of interest. Also includes failure to follow research proposals approved by a research ethics committee, particularly where this failure may result in unreasonable risk or harm to humans, other animals or the environment. Also includes the wilful concealment or facilitation of research misconduct by others. See also Australian code for the responsible conduct of research, 2018.

respect for human beings

Recognition that each human being has value in himself or herself.

risk

The function of the magnitude of a harm and the probability that it will occur.

sponsor

An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research.

validity

In the context of genomic research findings or individual test results, a judgement about the likely accuracy of the findings or results, as measured by National Association of Testing Authorities (NATA) accredited testing or its equivalent. Validity may refer to the pathology processes establishing the analytic validity and clinical validity of a testing method and/or the use of an accredited test to confirm the presence of a variant found in the research.

voluntary participation

Participation that is free of coercion and pressure.

young person

In the context of this National Statement, a minor who (subject to the law in the relevant jurisdiction) may have the maturity to make a decision whether or not to participate in research. See also child.

Footnotes

[1] Higher Education Funding Council for England, Scottish Higher Education Funding Council, Higher Education Funding Council for Wales, & Department for Employment and Learning Northern Ireland (2005) RAE 2008: Guidance to Panels, p.28. At http://www.rae.ac.uk/pubs/2005/01/rae0105.doc (Word document download), accessed 27th October 2006

[2] Adapted from National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, Bethesda, 2001 pp.71–72

[3] The National Statement does not use the terms 'identifiable ', 'potentially identifiable ', 'reidentifiable ', 'non-identifiable ' or 'de-identified ' as descriptive categories for data or information due to ambiguities in their meanings. Re-identification and de-identification are best understood as processes that change the character of information and are only used with this meaning.

[4] 'The six core principles in Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders have been updated as follows:

• spirit and integrity
• cultural continuity
• equity
• reciprocity
• respect
• responsibility.

[5] Where the context is the establishment and maintenance of an HREC, 'institutions' also includes any entity or agency that establishes an HREC but does not conduct human research.

 

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.