What is Expedited review?
Expedited review (Level II review), is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not "quicker" or conducted with less rigor, but fewer reviewers are required for approval. There are several types of research that may qualify for Expedited review.
|In general, research may be considered for Expedited review if it involves no more than minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures. Expedited review may also be used when minor changes have been made to a previously approved research project during the period (of one year or less) for which approval is authorized.|
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please keep in mind that research does not count as having "minimal risk" simply because it involves minimal physical risk or is non-invasive. There are many kinds of risk including financial risk, employment risk, criminal/civil liability, stigmatization, insurability and embarrassment. It is important to consider all of these when assessing risk.
Researchers engaged in human subjects research that qualifies for Expedited (Level II) review must still complete a full application form and prepare an informed consent statement. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.
For information on applying for Expedited (Level II) review, please visit "Procedures for Expedited review."
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