Frequently Asked Questions
Getting Started
I haven't worked with animals before at Creighton University. What will I need to do to start a protocol?
First, you will need to receive IACUC Investigator Certification. Additional information regarding certification may be found a in Creighton University's IACUC Education and Certification Program. Next, you should discuss your animal housing requirements with the Animal Resource Facility manager to be certain any special needs can be met. When possible, research space may also be provided with the Animal Resource Facility to reduce re-entry of animals into the facility. Finally, you will need to submit a Protocol Application for Animal Use to the IACUC. Final approval must be given before animals can be ordered or used.
What are the requirements to have a protocol approved by the IACUC?
All personnel listed on the protocol must have IACUC Basic Certification or have In-Training Status. All Principal Investigators must have IACUC Investigator Certification. If the protocol involves surgery, all trained personnel listed must also have IACUC Surgical Procedure Certification.
The completed Protocol Application (signed original, four copies, and electronic version) must be submitted to the IACUC Office before noon on the 1st Monday of each month in order for the protocol to be reviewed at the current month's IACUC meeting. See schedule of meetings for application due dates.
What are the requirements for IACUC Certification?
Additional information regarding certification may be found a in Creighton University's IACUC Education and Certification Program.
How can I get help with the application process?
The Instructions for the Protocol Application for Animal Use address many of the common questions associated with the Applications, but additional help is also available. Contact the IACUC Office with general questions. The Attending Veterinarian and the committee biostatistician can provide advice in their areas of expertise. It may also be helpful to ask one of the IACUC members to informally review your completed application prior to submission.
How does the protocol review process work?
Protocol Applications are reviewed at each month's IACUC meeting by the the full committee. Principal Investigator's are encouraged to attend the meeting to address any questions or concerns about the protocol. Investigators will be contacted by the IACUC Office prior to the meeting to inquire about attendance. Committee members read each application prior to the meeting. At the meeting, the Principal Investigator, if available, meets with committee members, and then the committee discusses the protocol in closed session. The disposition of the protocol is determined by majority vote, and applicants are notified by letter of the IACUC's decision. Possible outcomes are:
- Approval of the protocol as written. Work covered by the protocol may begin immediately.
- Approval pending receipt of a revised protocol with clarifications or changes requested by the committee. The notification letter will indicate the changes necessary for approval. On receipt of an acceptably revised protocol, the IACUC Chair will send notification of final approval, and work can begin.
- The protocol is tabled, meaning that a revised protocol must be reviewed by the entire committee again due to significant concerns. The notification letter will indicate the nature of these concerns. Tabled protocols cannot receive approval until the following IACUC meeting.
More rarely, a protocol may be:
- Returned without review; for example, when the application is not complete.
- Disapproved additional information is available in the IACUC Policies and Procedures.
How long is a protocol valid and when do I submit a continuing review?
A protocol is valid for up to three years from the date in which it was approved. All approved protocols are reviewed annually; Principal Investigators must complete the Continuing Review Form as part of this process. This form is normally mailed to the Principal Investigator in time for renewal; however, it is the investigator's responsibility to keep track of when continuing review of a protocol is due. Failure to provide the requested information on time will result in administrative hold of the protocol. The IACUC Office will inform you when Continuing Review forms are due and when protocols are due to expire.
What if I want to continue work on my protocol after three years?
If work on a protocol is to continue after the closing date of the original protocol, a new Protocol Application must be received and the application approved before that date. Renewal applications are reviewed using the same process as with new applications. A renewed protocol is valid for up to three more years. A Continuing Review form should be submitted annually upon approval.
I have a new person to add to the protocol; what is required?
A Personnel Change form should be submitted to the IACUC. In addition, all personnel must have IACUC Basic Certification or have In-Training Status.
What if I need to make changes in my protocol?
A modification request form should be submitted to the IACUC.
Minor changes in a protocol will be reviewed by the IACUC Chair, who can generally grant approval without a committee review. Minor changes could include addition of personnel, a change in methodology that does not affect pain or distress levels, or use of a new strain or experimental group.
Significant changes in a protocol require that the proposed changes be reviewed by the full IACUC using the same process as with new protocols. Significant changes could include a major new component to the protocol, changes in key personnel, procedural changes that will increase the category of pain or distress, or the use of a different species or large numbers of additional animals. It is recommended that you contact the IACUC Chair to determine into which category proposed changes would fall.