USE OF CELL LINES OBTAINED FROM COMMERCIAL SOURCES

 Federal regulations (45 CFR 46.102(f) defines a human subject as a living individual about whom an investigator (professional or student) conducting research obtains:

1. data through intervention or interaction with the individual;
OR
2.identifiable private information.

 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) to meet the criterion of human subject.

 The Office of Human Research Protections has further clarified that ìnon-identifiableî material must be submitted to a repository (e.g., ATCC) without any identifiable private data or information. That is, no codes or linkers of any sort may be maintained, either by the submitter or by the repository, that would permit access to identifiable private data or information about the living individual from whom the material was obtained.

 If either of the above criteria (1 or 2) is met, then an application for Exempt Status MUST be submitted and approved by the IRB prior to use of the cell line.

 If neither of the above criteria are met, then an application to the IRB is NOT required.

 FAQ

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