- 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).
- 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. 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. 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.
- 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 Sponsored Research 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,