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Investigator Handbook

 


On January 1, 2012, the IRB fully implemented Protis - Protocol Information System - for on line submission [and tracking] of applications. For an introduction to the system and user instructions click here: http://help.protis.usu.edu 

 
Email submission of the application forms found on this (IRB) website are no longer accepted.  The forms are made available as a reference only.

 

 Download the complete Investigator Handbook (pdf)  (updated 12/20/2011)

For the Executive Summary of the USU Investigator Handbook known as the Institutional Review Board (IRB) Basics click here

 

The Institutional Review Board (IRB) at Utah State University (USU) is a committee designated to review and approve research involving human participants prior to the initiation of such research, and to conduct periodic reviews of such research.  The IRB operates according to Title 45 Code of Federal Regulations (CFR) part 46, Federal and State guidelines, and the Belmont Report.  International studies involve the use and guidance of the International Code of Harmonization.

Research activities are overseen for DHHS by the Office for Human Research Protections (OHRP; www.hhs.gov/ohrp/).  Other agencies that the IRB reports to include: the Office of Research Integrity, funding agencies, and USU’s Institutional Official.  The Vice President for Research is the Institutional Official responsible for administering the program, ensuring compliance with the Public Health Service Act, Protection of Human Participants, and 45 CFR 46.  In order to remain consistent with a number of the specifications in the Public Health Service Act, all parts of this handbook that are not specific to USU are taken directly from the regulatory language

(http://www.hhs.gov/ohrp/archive/humansubjects/finreltn/finguid.htm). 

 

The IRB was established to protect the rights and welfare of human participants in research and has the authority to approve, disapprove, or require modifications of research activities that fall within its jurisdiction.  The IRB may work in conjunction with other universities or institutional committees; however, it independently reviews research projects independently based upon the principle that human participants must be adequately protected.  Any risk to participating in research should be outweighed by the potential benefits of the research.