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INSTRUCTIONS FOR SUBMITTING
IRB APPLICATIONS
AT MONTANA STATE UNIVERSITY
(posted 9/23/13)

Montana Hall

FULL COMMITTEE REVIEW

Submit 14 copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. If you have questions, please call our office (Cheryl: 406-994-6783 or 406-994-4706 or Mark: 406-994-4707).

 

EXPEDITED REVIEW

Submit 3 copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. If you have questions, please call our office (Cheryl: 406-994-6783 or 406-994-4706 or Mark: 406-994-4707).

 

REQUEST FOR EXEMPTION

If a protocol falls under the "Exempt" category, that does NOT mean it is exempt from IRB review. You still need to submit the "Request for Exemption" application. The Exempt category means that it is exempt from full committee review and follow up reviews. As long as there are no changes to an approved protocol in the exempt category, the protocol is approved indefinitely. Any changes to an approved protocol need to be reviewed and approved by the IRB Chair. Submit one (1) copy of the "Request for Exemption" application, consent form, and other supporting documents such as surveys, questionnaires, etc. See "Required Wording" for surveys and questionnaires. Staple or clip the documents as a set in the following order: application, consent form, supporting documents. If you have questions, please call our office (Cheryl: 406-994-6783 or 406-994-4706 or Mark: 406-994-4707). IF YOU ARE AN MSSE STUDENT, DO NOT USE THIS FORM. USE THE FORM SPECIFICALLY DESIGNATED FOR MSSE STUDENTS.

 

EXEMPTION REQUESTS FOR MSSE STUDENTS ONLY

MSSE Students must use the Request for Exemption Form for MSSE Students. There are instructions and required wording specifically aimed toward their type of research projects. DO NOT USE THIS FORM IF YOU ARE NOT AN MSSE STUDENT.

 

REQUEST FOR MINOR MODIFICATION(S)

Requests for minor modifications can be made by sending an e-mail to: cherylj@montana.edu. Provide the title of the protocol and the approval number for the protocol you wish to modify. List all modifications you want to make. If the consent form is being modified, we need a copy of the revised consent form.

 

RENEWALS

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.”

The MSU IRB Office will send out renewal forms approximately one (1) month prior to the renewal date. The approval number assigned to the protocol is indicated in brackets after the title of the protocol. The approval number is usually two letters (PI's initials) followed by six numbers, which is the date the protocol was approved. So, if John Doe's protocol was approved on October 24, 2008, his assigned approval number would be JD102408. This way you know when your renewals are due. If you know that your protocol is nearing the expiration date and you have not received the renewals forms from our office, please contact our office as soon as possible so that your approval does not lapse. It is ultimately the responsibility of the PI to maintain compliance with these regulations. There is a 30-day window in which protocols can be renewed (not more than 30 days prior to renewal date and absolutely not after the renewal date).

The guidance document for renewals is found at: http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm#HOW_IS_THE_CONTINUING_REVIEW_DATE_DETERM


Questions and Comments: cherylj@montana.edu

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