I. Introduction
 
In accordance with federal and institutional regulations, any undertaking in which a faculty, staff or student investigates and/or collects data on human subjects for research purposes MUST BE REVIEWED by the Institutional Review Board (IRB). It is the PRINCIPAL INVESTIGATOR”S RESPONSIBILITY to submit a proposed study involving subjects prior to initiation of the project.

The IRB is charged with the institutional responsibility for assurance of protection of human subjects involved in research or related activities. The IRB has the authority to review, approve, disapprove or require changes in research activities involving human subjects.

Under federal regulations, an investigator’s application to conduct a research project involving human subjects can be processed by the IRBs in four (4) ways:

BY EXEMPTION CERTIFICATION
BY EXPEDITED REVIEW
BY FULL REVIEW
BY EMERGENCY WAIVER
 

The preliminary determination that a research project is eligible for exemption certification, expedited or emergency review is made by the investigator. Below are the federally-mandated criteria which serve as a guide in making this determination.

The investigator should carefully review the information below. Questions of interpretation may be directed to the IRB. After the type of review required for the project has been determined, the appropriate review application packet may be selected.