Frequently Asked Questions
Before an investigator may submit an IACUC application for review by the IACUC, you are required to complete the Education and Certification Program. No application will be reviewed until this is completed. After completing the Education and Certification Program, make arrangements to discuss with the Animal Resource Facility (ARF) manager to be certain any special needs can be met. Very stringent requirements must be met if you plan to house your animals for more than 12 hours in any location other than the ARF. After these initial steps have been completed, you may submit a Protocol Application for Animal Use to the IACUC for review. There are many resources available on our web site to help facilitate the writing of your application. Please review the Related Regulations and Resources. Another excellent resource available is our Health Science Reference Librarian, firstname.lastname@example.org, to help conduct searches to optimize the choice of animal species, prevent duplication, and to minimize pain and distress.
I have prepared my new application and I'm ready to submit to the IACUC for review.
An electronic version of the completed Protocol Application is required to be submitted no later than 5:00 p.m. on the 1st Monday of each month. If the 1st Monday of the month falls on a university holiday the due date is 5:00 p.m. the 1st Tuesday. See Schedule of Meetings.
After I have submitted my Application for review at the monthly IACUC meeting, what should I expect?
Upon receipt of the Application by the IACUC Office, the Application is given an IACUC number and placed on the agenda for consideration at the next IACUC meeting. The Application is made available to all members of the IACUC. Before the meeting, the Chair and/or designee will assign a primary advocate to the Application. The committee will provide a courtesy pre-review of the Application. The primary advocate will then provide a list of the committee?s initial concerns or questions about the Application to the Principal Investigator prior to the scheduled monthly IACUC meeting. The Principal Investigator may then, if desired, make changes in the Application prior to the meeting to improve the likelihood of approval. The Principal Investigator may be asked to discuss the Application at the meeting at which the Application will be considered. Principal Investigators may also request to speak at the meeting.
During the meeting, the IACUC members decide the action to be taken on the Application and will assign one of the following five categories, based on a majority vote of the IACUC members present:
Approved: The Application is approved as presented with no revisions required.
Revision Required to Secure Approval: The Application is not approved because revisions are required to make the Application acceptable to the IACUC.
Tabled: The IACUC requires substantial additional information and/or has significant concerns about the Application.
Disapproved: The Application is not approved and the IACUC will not review a modified version of the Application.
Decline to Review: The Application has significant deficiencies in information, or the Principal Investigator has failed to follow the Instructions for completing the Application.
What is an Initial Application?
The first time a new project is submitted to the IACUC for review. Or the first time a renewal/resubmission application has been submitted to the IACUC for review.
What is an Annual Continuing Review application?
Federal Regulations require that all approved protocols be reviewed annually. To meet this requirement, the Principal Investigator completes the Annual Continuing Review Application. As a courtesy, the IACUC Office will send an electronic version of this application to you in time for your annual review. However, ultimately it is investigator's responsibility to keep track when Annual Continuing Review Applications are due. In the lifetime your protocol, you will normally complete two Annual Continuing Review Applications.
What is a Renewal/Resubmission Application?
All protocols are approved for no more than three years. If work on an approved protocol is to continue after three years, a new Application must be received and approved before the expiration date of the initial approved protocol. This date is usually one year from the date of your last Annual Continuing Review application. As a courtesy, the IACUC office will send an electronic notice approximately two months prior to your current protocol expiration date. This will allow you ample time to complete a new application before your current protocol expires. However, ultimately it is the investigator's responsibility to keep track when the renewal/resubmission application is due.
What is Revision Required to Secure Approval?
After Full Committee Review of an application, more information is required before the committee will grant approval of the application. It is one of the most common actions taken during the scheduled monthly IACUC meeting based on a majority vote of the IACUC members present. In this situation, the IACUC will most likely assign a Designated Reviewer(s) to review the revisions made by the investigator. In most cases, the Designated Reviewer is the primary advocate who helped facilitate your courtesy pre-review of the application. However, any committee member may request to be a Designated Reviewer in the Designated Review process, or he or she may also request that the full committee review the revisions at the next scheduled IACUC meeting.
Designated Reviewer(s) have the authority to approve, require revision to secure approval, or request Full Committee Review. If any Designated Reviewer does not agree to approve, the items will undergo Full Committee Review at the next scheduled IACUC meeting.
Confidential Research Hotline (402-280-3200)
Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to Kathy Taggart, Associate Vice President for Research and Compliance, at 402-280-2360.