Glossary

The following descriptions of research, human subjects and NRC participation are intended to indicate the breadth of research involving human subjects.

Adverse event

Any untoward occurrence in a person participating in a research project, whether or not it can be determined to have been caused by participation in the project.

Research

Research includes, for example, fundamental and applied research, development of new products and technologies, or evaluation of processes and technologies, that are carried out with the intention to, for example, gain new knowledge, confirm existing knowledge, generate hypotheses, develop new products or technologies, or evaluate concepts, technologies or products.

Human subjects

Research involves human subjects when, for example, the actions or opinions or responses of human beings are studied in natural or staged environments, or when human biological materials (e.g., organs, tissues, cells, body fluids or excreta) obtained from e.g., living humans, cadavers, embryos or fetal tissues, are studied, or when personal or private documents or other materials that have not been placed in the public domain with the consent of the person directly affected, are studied.

NRC involvement

NRC is involved in research involving human subjects when NRC's employees undertake or collaborate in such research, when NRC allows the use of NRC equipment, laboratories or facilities, provides financial support, such as through IRAP, for such research, or when NRC provides products that it has developed for research.

Serious adverse event

Any adverse event that:

• Results in death
• Is life-threatening
• Requires hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability or incapacity.