This designation, however, does not guarantee funding. No grant award will be made without IRB approval. . Human subjects research involves a living individual about whom an investigator obtains identifiable private information through intervention or interaction . Studies involving unidentifiable human tissue from a formal, legal autopsy is generally not considered human subjects research. Note, however, that the IRB at MCG has chosen to review all studies using autopsy tissues, because this can be a sensitive issue for the family of the deceased.
Exempt status is probably the most misunderstood classification in academia.
A study may be classified exempt from review if certain criteria are met, for example, the research involves information that is in the public domain, or the data or specimens are completely anonymous. Rather, it means that the study does not have to be presented to the full IRB for review. The investigator may request exempt status, but it is up to the IRB, or the chair of the IRB, to make the decision. Rather, the decision to approve can be made by the chair of the IRB or by someone appointed by the chair. Studies eligible for expedited review are those that involve no more than minimal risk to the subjects.