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Institutional Review Board

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 

1.    What kind of IRB application should I submit?  When you begin an application in Protis, the first step is a series of questions that will help you make this choice. To  to  view a flowchart that shows how this decision is made, click here.

2.     How do I submit an application to the IRB Office? Applications are submitted online using Protis.  We encourage users to visit the Protis Help site for instructions and tips on using Protis. The old paper and emailed forms are no longer accepted.

3.     Who can be a PI (Principal Investigator) on the application?  Only USU faculty can be a PI on an IRB application.  See the Personnel on Applications page or Chapter 4 of the USU Investigator Handbook for more information.

4.     Is IRB certification necessary before approval can be given to my application?  Yes.  IRB certification is also required before the protocol number can be assigned and the application advanced into the review phase.

5.     How do I obtain IRB certification?  IRB certification is obtained by completing the on-line training modules at https://www.citiprogram.org/default.asp or click here for a link to training procedures.

6.     What supporting documents do I need to email to the IRB office? Documents no longer need to be emailed to the IRB office. All supporting documents should be uploaded in your Protis application. See Uploading Files on the Protis Help site for instructions for uploading and managing files in Protis.

7.     What is the difference between Full Board, Expedite, and Exempt Reviews?

·        Full Board – requires the full committee to approve a protocol

·        Expedite – requires at least 2 committee members to approval a protocol

·        Exempt – requires at least 1 committee/or staff member to approve a protocol based on
       the 6 categories of exemptions as   listed in the Code of Federal Regulations, Title 45,
       Part 46.101(b) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101  

8.         What role does the IRB play in analyzing the scientific validity of human research studies?

9.         How will non-compliance with the Common Rule or the IRB’s determinations be evaluated?

10.          What are my responsibilities for recognizing and reporting to the IRB unanticipated problems as defined in the Common Rule?

11.       Under what conditions will the IRB suspend or terminate a human research study at USU?

12.       What are the IRB's responsibilities for quality improvement and assurance?

13.       Under what conditions does the IRB delegate the authority to review human research to a separate IRB?

14.      Which IRB determinations must be documented, and how will IRB votes be recorded?

15.      How does the IRB ensure that all required and appropriate elements of informed consent are included in the informed consent process and document?

16.    Must all non-exempt research be reviewed by the convened IRB?

17.    How are substantive changes made to protocols being reviewed by the IRB?