Processing Applications

  • Applications received in the IRB office, are logged into a database. They are also listed on the agenda for the next scheduled meeting. If no applications requiring a full committee review are received that month, the meeting is canceled and the protocols are listed on the following month's agenda.
  • Depending on the type of review needed the investigator should submit 14 copies of the standard Application Form for full committee review, 3 copies for expedited review, and 1 copy for a request for exemption (see the types of reviews for details on how to decide which category best fits your proposal). Be sure to list the date(s) of your CITI training on the application form.
  • Applications for full committee review must be received in the IRB Office at least one week (by noon on the second Thursday of the month) prior to the meeting of the Institutional Review Board. The proposal will be considered at the monthly meeting which generally would be the third Thursday of the month (see meeting dates). Convened meetings are held in person with the possibility of videoconferencing if so deemed necessary. Depending on subject matter, investigators may be invited to attend a meeting if they wish to do so or if the Chair feels that the committee might require clarification on a number of items presented in an application.
  • Applications for consideration at meetings will be sent or hand delivered to members of the IRB at least 5 days prior to the meeting. Members will receive the entire application form, the informed consent document, and additional materials, as needed. Long questionnaires are not always sent to all members; however, a copy will be reviewed by the IRB Chair and will be made available at the meeting or in advance by special request. The IRB Chair is responsible for calling to the attention of the committee members any information from these sources that may be relevant. The Chair will assign a Primary Reviewer for each application; however, all members have the responsibility for reading and critiquing each application.
  • Decisions of the IRB will be sent to applicants within one week after the meeting at which the proposal was discussed. If the IRB has requested revisions or clarifications prior to approval, these must be sent back to the IRB Chair who will review and insure the revisions address all concerns presented at the IRB meeting. If revisions for certain applications are requested from the IRB these would also be sent to IRB members for review. The approved revisions must be incorporated into the application form and consent form, and the final revised application must be approved by the Chair before research can begin. Approvals are effective on the date the IRB Chair approves the revised protocol. Typically protocols are approved for one year; however, depending on the subject matter, the IRB can require a shorter time period (i.e. 3 months, 6 months, etc.). If the protocol is approved for less than a year, that will be documented in the minutes. Otherwise the assumption is that protocols are approved for one year with yearly renewals up to 5 years. The expiration date of the approval is included in the approval memorandum. The memorandum explains the terms of continuing review and the necessity of reporting adverse reactions and protocol changes to the committee.
  • Annual renewals for expedited protocols are reviewed by the IRB Chair. Annual renewals for protocols approved by full committee will be reviewed by full committee, either in person or by electronic review. Approval requires a quorum of the full committee.
  • Applicants have the right to appeal any decision of the committee. Appeals must be submitted in writing to the IRB Chair.
  • Applications and copies of letters pertaining to them are kept on file in the IRB Office for at least 5 years and are accessible to IRB members, the investigator to whom they apply, and the Office of Research Compliance at Montana State University. Applications are filed by the name of the principal investigator. In addition, a chronological log of applications and committee actions is maintained. Records maintained by the IRB Office contain all of the information stipulated by HHS regulations at 45CFR46, 115 .

 

01/24/2019