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IRB Definitions

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.

Informed consent means the knowing consent of an individual or his/her legally authorized representative so situated as to be able to exercise choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

Institution means any public or private entity or agency (including federal, state, and other agencies).

IRB means an institutional review board established in accord with and for the purposes expressed in this policy.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the requirements set forth by the IRB and by other institutional and federal requirements.

Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.