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Institutional Review Board

Definitions

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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.

Institutional Review Board means an independent administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Minimal Risk means 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.

Generalizable knowledge means findings of the research will be made public (e.g. at a conference, published in a journal or book, etc.).

Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Research data include laboratory notebooks, as well as any other primary records that are necessary for the reconstruction and evaluation of reported results of research and the events and processes leading to those results, including subject informed consent forms, regardless of the form of the media on which they may be recorded.

Privacy means free from unsanctioned intrusion.

Confidentiality means holding secret all information relating to an individual, unless the individual gives consent permitting disclosure.

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