Review Categories
All research, including that which the investigator believes falls into the exempt category, must be submitted to the departmental reviewer for confirmation of the relevant review category as defined by federal regulations. The criteria used to determine the categories of review are described below.
Expedited Review
For a research project to be eligible for expedited review, all items in Part A, AND at least one item in Part B MUST apply.
Part A (all items must apply)
- The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
- The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subject's financial standing, employability, insurability, or reputation.
- The research does not involve the collection of information regarding sensitive aspects of the subjects' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The procedures of this research present no more than minimal risk to the subject. ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)
Part B (at least one item must apply)
- Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected or will be collected solely for non-research purposes. [NOTE: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]
- Collection of data through use of