Levels of Review
There are three levels of IRB Review (click header for additional information regarding each type of review!)
Exempt Status (Level I)
Research is reviewed for Exempt status (Level I review), by an IRB committee member if it involves very minimal or no risk. In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures, or involve deception will be exempt from full Committee review. Projects that involve more than very minimal risk and those that include any degree of deception do not qualify for Exempt status.
Please note that all of the rights and protection afforded to human subjects in research are required in Exempt status cases. Researchers engaged in human subjects research that qualifies for Exempt status 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. In short, research with Exempt status is exempt only from full committee review.
Expedited Review (Level II)
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.
Full Review (Level III)
All research not qualifying for Exempt status or Expedited review and most research involving protected classes of subjects requires Full (Level III) review. In general research requiring Full review places the subject at greater than minimal risk. Full review means that the research protocol is read, discussed and voted upon by the full IRB committee.
Special considerations apply to protecting the welfare of particularly vulnerable populations such as fetuses, children, prisoners, pregnant women, mentally disabled or cognitively impaired persons, terminally ill patients, the elderly, students and employees, survey research that involves AIDS information either with the general public or with vulnerable populations, or economically or educationally disadvantaged persons. Research involving a protected class may require a higher level of review.