Forms and Applications
All research involving human subjects must be registered in one way or another with
the Institutional Review Board.
See Types of Review for more details.
Apply for Exempt Review via Topaz
Requests for Exemption are reviewed by the IRB Chair and/or IRB Administrator.
The title of the research and the decision will be reported to the IRB at its next meeting.
**PLAN AHEAD: PLEASE EXPECT AND ALLOW 1 WEEK MINIMUM FOR REVIEW RESPONSE TIME BEFORE CONTACTING THE IRB FOR A STATUS UPDATE.**
Apply for Expedited Review via Topaz
Expedited reviews are typically conducted by two members of the IRB Committee, the IRB Administrator, and the IRB Chair.
Reviewers can recommend that the application be reviewed by the Full Committee, in which case it will be considered at the next IRB meeting.
The title of the research and the decision will be reported to the IRB at its next meeting.
**PLAN AHEAD: PLEASE EXPECT AND ALLOW 2 WEEKS MINIMUM FOR REVIEW RESPONSE TIME BEFORE CONTACTING THE IRB FOR A STATUS UPDATE.**
Apply for Full Committee Review via Topaz
Full Committee Reviews ("FCR") are conducted by the entire IRB committee.
Applications are due 2 weeks prior to the next committee meeting date by 12:00pm noon. Investigators will receive a written response via TOPAZ (FCR feedback or approval) within 10 days of the meeting.
Submit an Amendment request via Topaz
Don't see your existing protocol in TOPAZ? Contact irb@montana.edu to request that your existing protocol be migrated. Most Expedited protocols are in our IRB queue for migration. Existing Exempt Word Document protocols that are more than 2 years old will not be migrated and should be submitted as new appliations in TOPAZ.
Changes cannot be implemented prior to IRB approval except when necessary to eliminate apparent immediate hazards to subjects. Minor changes may include change in PI, revision of survey questions, addition or removal of research team members and other minor changes. The Chair will determine approval of requested changes. The Chair may require additional information or documentation to make a determination of approval. If approved, an approval email will be sent to the investigator.
Full Committee-Reviewed (FCR) protocols must be reviewed once per year via the annual Interim Review. The MSU IRB Office will send out a reminder approximately one (1) month prior to the Interim Review date. FCR protocols may be reviewed in the 30-day window prior to expiration.
NOTE: “The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop..." Enrollment of new subjects cannot occur after the expiration of IRB approval.” It is ultimately the responsibility of the PI to maintain compliance with these regulations.
Per the Common Rule, Expedited and Exempt level protocols do not require annual continuing review.