Do I Need to Get IACUC Approval?
| Q. When am I required to submit an application to use animals? |
| All proposed research projects, laboratory projects, classroom activities or extension programs involving the use of vertebrate animals and being conducted under the auspices of the University of Nebraska-Lincoln are to be submitted for IACUC review. This involves submitting an Application to Use Animals Form (AUAF) via NUgrant. |
| Q. I’m requesting a change in protocol for a procedure that I’ve done previously on a prior protocol. Can I just reference that protocol in my request? |
| Requests for changes in protocol procedures, staff, number or type of animals, etc. are described and submitted on the Modification Form, which is accessed via NUgrant. Changes must be approved before they are implemented. Each new protocol (AUAF) must contain details of each procedure performed and references to other protocols are not accepted. Descriptions of procedures currently used (approved) can be electronically transferred to a Modification Form to accommodate the request for change(s). Please also note that regulations continue to evolve, so procedures approved in the past may require additional information before committee approval on a new AUAF. |
| Q. I will be collaborating with a researcher at another institution; do I need to file for IACUC approval at both UNL and the other institution? |
| Investigators should contact an IACP staff person whenever collaborative research is planned. Separate applications to use animals are not necessary in most cases. A protocol approval from another institution must be documented and the UNL IACUC must also review the approved protocol and approve it as well. Release of funds by the UNL Office of Sponsored Programs for work conducted at another institution requires both actions to be completed. Animal work conducted at UNL, if funded by a collaborator, must also be approved by the UNL IACUC. |
| Q. Should I wait until my research proposal has been funded to submit a protocol for IACUC approval? |
| No. If you submit your Application to Use Animals Form at the time your research proposal is submitted to the sponsor or before, the protocol can be reviewed and approved. Then, when your proposal is funded, you will be ready to conduct the work and the sponsored funding can be released. |
Before/During the Review Process…
| Q. How do I submit my application for IACUC approval? |
| Beginning January 1, 2009, all IACUC protocols must be submitted via NUgrant on the Application to Use Animals Form (AUAF). The previous electronic AUAF is no longer accepted. The principal investigator must submit the application using their login and password to achieve the required electronic signature on the form. Approval by the department head/chair (and in some cases, the dean or director) is achieved in similar manner, and is required before the application is sent forward for IACP pre-review. |
| Q. How long does it take to review an application for IACUC approval? |
| It varies. The length of time for review depends both on the IACUC and on the investigator. The IACUC reviewed 67 AUAFs in 2008 and 58 in 2007. The mean length of time from submission to approval for simpler protocols was 10-15 days; for more complex protocols, 30-45 days. At certain times of the year, a large volume of protocols appear in the reviewing queue and this may extend review time. Sometimes, the investigator needs to make modifications to the research description or make other revisions to the AUAF as a result of review. The faster these changes are made, the less time it will take for approval. NUgrant time-stamps each step in the AUAF submission and review process, and those data will be posted at the end of 2009. |
| Q. Who is required to complete the general regulations training? |
| All faculty, students, and staff proposing to use or care for animals used in research, teaching and extension education under the auspices of UNL are required to complete the general regulation training (GRT) offered on-line through AALAS or conducted by IACP staff on the UNL campus. Approvals for use of animals in proposed research projects will be not be granted until this training has been completed and verified. |
After Approval is Granted…
| Q. When should I submit a request to modify an approved protocol? |
| All changes to an approved protocol are to be submitted for review and approval before you incorporate the change into the research project, including but not limited to, changing methodologies, adding more animals, a title change, change in principal investigator or other personnel, change of funding source, or early termination of a project. All requests for changes must be submitted via NUgrant. |
| Q. Does approval of a modification for an approved protocol extend the original approval date? |
| No. By law, extensions of approved protocols are not allowed. The expiration date of the original approval is not changed by the review and approval of a modification. |
| In the case of an adverse event involving animals, when and to whom am I expected to report this occurrence? |
| You should report a significant adverse event immediately by phone or in person, and a formal report should be submitted within 5 – 10 working business days, using the unexpected adverse event report form in NUgrant. A phone call to the IACP office or to the Attending Veterinarian and to the responsible faculty member is expected as part of the “first response” reporting of an adverse event. |
| Q. Can the IACUC temporarily or permanently discontinue a research project as result of an adverse event? |
| Yes. The IACUC may temporarily discontinue a research project until a thorough investigation has been conducted. Depending on the results of the investigation, the IACUC may request changes to a research project or permanently discontinue the research project. Likewise, the IACUC Chair, the Attending Veterinarian, the IACP director and the IO may temporarily stop work on an approved project, and the IACUC must quickly initiate an investigation. |
