Participation that is free of coercion and pressure.
Learn more...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 […]
Learn more...Therapeutic (intervention)
Intervention directed towards the wellbeing of the individual concerned.
Learn more...Sponsor
An individual, company, institution or organisation that takes responsibility for the initiation, management, and/or financing of research.
Learn more...Single Ethical Review
Single ethics review is a process whereby one Human Research Ethics Committee (HREC) provides the ethics review for a research […]
Learn more...Serious unexpected suspected adverse reaction
A serious adverse event (see definition above) for which there is some degree of probability that the event is an […]
Learn more...Serious adverse event
Any untoward medical occurrence that: results in death; is life-threatening (NOTE: The term “life-threatening” refers to an event/reaction in which […]
Learn more...Risk
The function of the magnitude of a harm and the probability that it will occur.
Learn more...Respect for human beings
Recognition that each human being has value in himself or herself.
Learn more...Research misconduct
Includes fabrication, falsification, plagiarism or deception in proposing, carrying out or reporting the results of research, and failure to declare […]
Learn more...Research
Includes at least investigation undertaken to gain knowledge and understanding or to train researchers.
Learn more...Re-identifiable data
Data from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific […]
Learn more...Qualitative research
Research involving the studied use of empirical materials such as case studies, personal experience, life stories, interview, observations and cultural […]
Learn more...Protocol
A document that provides the background, rationale and objectives of the research and describes its design, methodology, organisation and the […]
Learn more...Privacy
A domain within which individuals and groups are entitled to be free from the scrutiny of others.
Learn more...Placebo (in research)
A substance not containing an active agent under study, administered to some participants to compare the effects of the active […]
Learn more...Personal information
Information by which individuals can be identified.
Learn more...Participant (in research)
Anyone who is the subject of research.
Learn more...Non-identifiable data
Data that have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means […]
Learn more...Negligible risk
Research in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is of inconvenience only.
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