NSW Health and the National Statement on Ethical Conduct of Research (2014) provide definitions to assist with the interpretation of the National Statement on Ethical Conduct of Research and the policies and Guidelines that support this policy;
Access Request Review
The mechanism used by NSW Public Health Organisations to ensure that a proposed research project complies with minimum governance requirements and to consider whether to support the provision of access to participants, their tissue or data through the Public Health Organisation.
A Human Research Ethics Committee (HREC) that is hosted by an institution that has been certified by the National Health and Medical Research Council to participate in the national approach to single ethical review.
A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure.
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.
The individual who takes overall responsibility for a research project and submits the project for ethical and scientific review. The Co-ordinating Investigator is responsible for ongoing communication with the HREC and passing on any outcomes from this to the Principal Investigators. For single centre research the Co-ordinating Investigator and Principal Investigator are synonymous.
A negative accompaniment or effect of research, less serious than harm.
The concepts of right and wrong, justice and injustice, virtue and vice, good and bad, and activities to which these concepts apply.
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.
Human Research Ethics Committee (HREC).
Research conducted with or about people, or their data or tissue as described in the National Statement on Ethical Conduct in Human Research (2014).
The substance, structure, and texture of human organs or body parts when separated from human beings; includes blood, blood components and waste products.
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).
Individually identifiable data
Data from which the identity of a specific individual can reasonably be ascertained.
A local HREC accredited by the Director-General of the NSW Ministry of Health to conduct ethical and scientific review of human research on behalf of the NSW public health system in the categories of: (a) clinical trials/interventional clinical research; and/or (b) general research.
An HREC established by a NSW Public Health Organisation to provide ethical and scientific review of human research to be conducted at sites under its control.
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.
Research that is conducted at more than one site within the NSW public health system, where those sites are within the jurisdiction of more than one NSW Health HREC.
Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.
Data that have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known they are about the same date subject, although the person’s identity remains unknown.
NSW Health HREC
A Human Research Ethics Committee (HREC) established by a NSW Public Health Organisation and registered with the National Health and Medical Research Council.
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 the National Statement on Ethical Conduct in Human Research (2014).
Information by which individuals can be identified.
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.
The individual who takes responsibility for the overall conduct, management, monitoring and reporting of research conducted at a site and submits the research project for site authorisation.
A domain within which individuals and groups are entitled to be free from the scrutiny of others.
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.
Public Health Organisation
Under the Health Services Act 1997 (NSW), a local health district, statutory health corporation or affiliated health organisation in respect of its recognised establishments and recognised services.
An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a quality activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably. There are a number of methods of monitoring and evaluating health care with the aim of improving its delivery. These quality improvement activities include incident monitoring, root cause analysis, sentinel event monitoring, peer review, morbidity and mortality review and other forms of audit.
Research involving the studied use of empirical materials such as case studies, personal experience, life stories, interviews, observations, and cultural texts.
Data from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets.
Research Governance Officer
The individual appointed within the NSW Public Health Organisation who is responsible for the management of applications for site authorisation and oversight of authorised research projects.
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.
Serious Adverse Event (SAE)
Any untoward medical occurrence that:
• results in death;
• is life-threatening (NOTE: The term “life-threatening” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe);
• requires inpatient hospitalisation or prolongation of existing hospitalisation;
• results in persistent or significant disability/incapacity;
• is a congenital anomaly/birth defect; or
• is a medically important event or reaction
Serious Unexpected Suspected Adverse Reaction (SUSAR)
A serious adverse event (see definition above) for which there is some degree of probability that the event is an adverse reaction to the administered drug, and the adverse reaction is unexpected.
Single centre research
Research that is conducted at one site only within the NSW public health system (i.e. single-site research) or at two or more sites under the jurisdiction of a single NSW Health HREC.
A facility, location or service where the research is being conducted.
Site Specific Assessment (SSA)
The mechanism used by NSW Public Health Organisations to ensure that the proposed research project complies with minimum governance requirements and to consider whether the research should be conducted and supported at the proposed site.
The Human Research Ethics Committee (HREC) will undertake an ethical and scientific review of the project and if approved will deem the project ethically and scientifically valid.
An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research.
Therapeutic Goods Administration
Unexpected adverse drug reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable scientific information (e.g. Investigator’s Brochure for an unapproved investigational product or Product Information (PI) document or similar for an approved, marketed product).
Participation that is free of coercion and pressure.