Question: How do I submit an application for vertebrate animal use for IACUC review?
Answer: Use the most recent version of the application for vertebrate animal use. Please make sure that you are using the most recent version of the form before you begin. Prepare your form using that download (MSWord). Submit your form as an MSWord document attachment to the IACUC Administrator via email (email@example.com).
To document your assurances to the IACUC regarding conduct of the study, print out the “investigator assures” page, sign and date it. Then save it as a PDF document to be forwarded by email to firstname.lastname@example.org, or print it out and fax it to the IACUC office (attention: IACUC Administrator or Coordinator) at 919.515.7721, or send it by campus mail to: IACUC Office, Campus Box 7514. This signed assurance page will be retained until the IACUC has completed its review of your submission, and will then be added to the final document for the Chair’s approval. There is no need to send in a hard copy of the entire protocol, nor is there a need to send in revised signature pages each time your protocol is revised during the review process.
Question: How long does it take for the IACUC to review and approve a submission?
Answer: The average turnaround time for IACUC review and approval is 4-6 weeks. Some reviews may require more or less time. Please review our Standard Operating Procedure for Protocol and Amendment Review.
Question: I already have one IACUC-approved protocol to work with one species of live vertebrates. Do I need a separate protocol to do another experiment with live vertebrates of a different strain of the same species?
Answer: If your currently approved protocol is limited to certain species of live vertebrate, and you want to use another species under the same experimental design, you are required to submit an amendment to your approved protocol and obtain IACUC review and approval prior to initiating the experiments with a different species. In some instances, new experiments may also be added to an approved protocol via the amendment process, if those experiments fall within the objectives of the currently approved protocol. However, if the new experiment includes objectives, species and procedures well outside those described in your currently approved protocol, you should submit a new, full application.
- An investigator approved to work with a specific strain of mice decides to try the same protocol (i.e. receives funding from another agency for the same study) using a different strain of mice. The IACUC must review and approve a protocol amendment requesting use of the new strain before those experiments are initiated. However, if the investigator has a protocol which covers the use of mice without specifying a strain, IACUC review and approval of an amendment would not be required, as long as there are no issues with including a particular strain (phenotype) that might require special veterinary care or husbandry. Note: The investigator should submit an amendment to document the change in or addition of a funding source.
- An investigator is approved to work with flathead catfish. She wants to try the study with channel catfish, using the same experimental design and methods, under the original objectives. She must submit an amendment to request IACUC review and approval prior to initiating the experiments with channel catfish, because her protocol approval is limited to the use of flathead catfish. She is advised by IACUC reviewers that if there is any possibility that she might want to work with still other species of catfish during the duration of her IACUC approval, it might be best to change the species requested to the study from “Flathead Catfish” to “Catfish (all species/strains).” She might have to request additional numbers of fish if her experiments are expanded, but it would not be necessary to request IACUC review and approval each time she decides to try the study on a different species of catfish, unless the new species requires different husbandry or care than what is described in the approved protocol, or the objectives and goals of the additional use are outside those approved in the original protocol.
For further guidance, see: Review Procedures for Significant Changes in an Approved AVAU, or contact the IACUC Office (email@example.com, 919.515.7507 or 919.515.9532). Protocol amendments that include significant changes require the same degree of review as full applications: Standard Operating Procedure for Protocol and Amendment Review.
Question: The animals I will be using in my study/course/extension are not covered by the federal Animal Welfare Act. Do I need to have IACUC review and approval?
Answer: North Carolina State University’s Animal Care and Use Policy states: “All research projects and educational or extension activities using vertebrate animals under the jurisdiction or control of NCSU shall be reviewed and approved by the Institutional Animal Care and Use Committee.” Therefore, while a faculty member’s research, teaching or extension activities may not include animals covered by the federal Animal Welfare Act, all such activities are covered by NCSU Policy. As such, NCSU IACUC review and approval is required prior to initiation of those activities.
Question: Why do the regulations and policies keep changing?
Answer: The truth is that the federal regulations and policies have not changed in decades. However, generally accepted guidelines such as The Guide for the Care and Use of Laboratory Animals and The Guide for the Use of Agricultural Animals in Agricultural Research and Teaching [also known as the Federation of Animal Science Societies (FASS) Guide are periodically revised and updated. Additionally, institutional awareness of federal policies and regulations has increased over the years. Furthermore, interpretation by representatives of the Public Health Service Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture (USDA) of regulations and their guidance regarding them change over time as officials at those levels come and go. At the institutional (i.e. university) level, IACUCs struggle to keep up with the most current information available from federal regulatory bodies. We’re here to help investigators and instructors understand the regulations and policies. Please contact the IACUC office (firstname.lastname@example.org, 919.515.7507, 919.515.9532) whenever you have questions.
Question: If I see animals being mistreated at NCSU, or if I think an investigator or instructor is doing something that is not covered by his/her IACUC approval, to whom should I report it?
Answer: Please follow our guidance on how to report animal mistreatment or protocol noncompliance.
Question: Doesn’t IACUC approval for the use of a particular species cover any use of that species that I might engage in?
Answer: There are a few scenarios under which this question arises. In general, the answer is “no.”
- Investigator A has IACUC approval to use a particular species of fish (fathead minnows) for toxicity studies. Another faculty member has a graduate student who wants to run a similar type of toxicity study using flathead catfish. As a favor to the other faculty member and in the spirit of academic collegiality, Investigator A allows the graduate student to use his lab to house the fish and run the toxicity experiments, without submitting an amendment request to his currently approved IACUC protocol. Though Investigator A’s intentions are good, this action results in noncompliance with the University’s policy on animal use. Investigator A mistakenly assumes that his IACUC approval covers the use of any species of fish for any similar type of experiment, and fails to request IACUC review and approval prior to allowing the graduate student to initiate the study with a species of fish that is not included under the approved protocol. Furthermore, the goals and objectives of the graduate student’s study may differ significantly from those described in the approved protocol, and the student’s study may actually require submission of a full application.
- Investigators X and Y have IACUC approval to use chickens for a study that is specific to a funded USDA proposal (Protocol Z). Investigator X’s IACUC approval for another study (Protocol R) is expiring, but he has waited until two weeks prior to expiration of Protocol R to submit his renewal application. The IACUC Administrator informs him that the committee will probably not be able to complete its review of the renewal application prior to the expiration of Protocol R, and he should make plans to move any animals housed under that protocol to a facility holding protocol while he awaits IACUC approval of the renewal application. He may maintain and house the animals while he waits for IACUC review and approval of the renewal application, but he may not continue the research on the animals. Investigator X responds that it will not be a problem for him, since he already has IACUC approval under Protocol Z (with Investigator Y) to use chickens. The IACUC Administrator then informs Investigator X that if he must continue the study (i.e. he cannot stop the experiments while he waits a few weeks for IACUC approval), the appropriate thing to do would be to submit a protocol amendment to Protocol Z to include the studies under Protocol R, because even though the species used and the procedures may be the same, Protocol Z is specific to a funded project and the objectives/goals of that funded project. IACUC protocol approvals are not interchangeable. Investigators may cover more than one funded project under one IACUC approved protocol. However, if a protocol is specific to a particular funded project, it does not automatically cover other (non-project) use of the same species unless there is IACUC review and approval of the additional use.