Definitions Related to IRB
Persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. In Washington, a child is anyone under 18 years of age. See also Vulnerable Subjects.
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information; i.e., information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public.
Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of any actions. The individual needs to be in possession of all of her/his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Impairments include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.
Some acts cannot legally take place without informed consent. In other cases, consent of someone on behalf of a person not considered able to give informed consent is valid. Examples of this include the parents or legal guardians of a child or caregivers for the mentally ill.
Institutional Review Board
An independent administrative body established to protect the rights and welfare of human research subjects. It consists of at least five members from varied disciplinary backgrounds who are qualified to review research.
Abbreviation for Institutional Review Board.
The determination of the IRB that a research activity has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
The probability and magnitude of harm or discomfort anticipated in research activity that are no greater than those encountered in daily life or the performance of routine physical or psychological examinations or tests.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerable subjects must be afforded special safeguards in a study to protect their rights and welfare.
Sources: 45 CFR 46; Wikipedia; Sapp & Martin, 2005.