REG 10.10.01 - Animal Care and Use Procedures
Authority: Vice Chancellor for Research and Innovation
History: First Issued: October 26, 1992. Last Revised: May 27, 2008.
NCSU POL10.00.02 - Research Policy
Contact Info: Associate Vice Chancellor and Director of Research Administration (919-515-2148), Regulatory Compliance Administrator: (919-515-7507) or (919-515-9532)
North Carolina State University policy requires an approved Application for Vertebrate Animal Use (AVAU) for all activities involving the use of animals (research, teaching, public service; intramurally or extramurally funded regardless of source or amount; and including animals being bred, conditioned, or held for future use). The AVAU is a form that allows the investigator to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. The IACUC is charged with overseeing all aspects of animal care and use at NCSU. The IACUC may approve, require modification of, or withhold approval from a project. Animal use in the absence of IACUC approval is a serious violation of University policy and a violation of federal law.
2. Persons submitting an AVAU must be of faculty rank or EPA staff with approval of the department chairperson (Principal Investigators). Principal Investigators (PIs) are responsible for animal use by their students and staff. The PI heading a research group or teaching a course must have an approved application on file for each project or course under his/her supervision. Collaborators, technicians, and students must care for and use animals according to the protocols described in the approved applications. Deviations should be reported to the IACUC. PIs must become familiar with laws, rules and regulations governing animal care and use as well as policies governing the review of animal care and use.
Most AVAU are processed in about four weeks. On occasion, an individual protocol may require a longer period of time because of the nature of the proposed use or other complicating factors. Therefore, it is prudent to submit the forms to the IACUC as soon as the need is anticipated. The IACUC cannot expedite the review of an application because the investigator failed to submit it in time to meet various deadlines. It is the responsibility of the principal investigator to submit an AVAU with sufficient lead-time to meet all University and agency deadlines.
3. Under certain circumstances, it may be possible to cover vertebrate animal use for more than one project under a single AVAU. For example, resubmission of a grant within one year of approval of an AVAU to the same or another funding agency which may involve changes in title, size of project, or contain other changes, but for which the scope of animal use (procedures, numbers, duration) does not significantly change. Co-submission of the same proposal to two or more granting agencies requires only one Application for Vertebrate Animal Use. Resubmission of an unfunded proposal will not require re-review as long as it is not significantly revised over the previous submission and as long as the previous submission was within the last 12 months. A renewal of a previously funded project does not require animal use re-review as long as it has not been significantly revised and has been reviewed by the Committee within the last three years.
4. While the IACUC does not conduct inspections of field and overseas research sites, the use of vertebrate animals by PIs is expected to be in accordance with University policy. That portion of vertebrate animal use conducted at NCSU in collaboration with outside researchers must be reviewed by the NCSU IACUC, even if it has already been reviewed by an IACUC or similar committee at the collaborating institution. NCSU investigators participating in vertebrate animal research conducted at other sites which have been reviewed and approved by IACUCs at other institutions may not be required to submit an application to the NCSU IACUC. However, the NCSU IACUC requires investigators to submit a copy of the IACUC approval from the other reviewing institution. The NCSU IACUC must be allowed to assess whether or not an application should be submitted to our office under these circumstances. With regard to collection of tissue samples (i.e. biopsies, blood, etc.), if samples are being collected expressly for the purposes of an NCSU investigator's research or teaching projects, that investigator must file an application for vertebrate animal use with the NCSU IACUC. For example, clinically necessary biopsies and blood samples may be split for research purposes without IACUC review, but no clinically unnecessary sample maybe taken without IACUC review and approval. This policy also applies to field studies in which samples are being collected expressly for the purposes of an investigator's research or teaching projects and to studies covered by government permits. The IACUC must review these projects.
5. The AVAU is approved for one year, renewable annually for up to three years. The PI is required to submit an annual report updating any changes that may have occurred during the year. The IACUC administrator distributes the form for updates at the appropriate time. After three years, the AVAU must be re-written and undergo the entire review process again.
If significant changes are anticipated in an on-going project, a Protocol Amendment Form must be submitted to the IACUC office prior to initiation of these changes. However, total approval time for a single Application for Vertebrate Animal Use may not exceed three years. Consult the IACUC office (phone 919/515-7507, 919/515-9532 e-mail email@example.com for information.)
6. Applications are available from the Animal Care and Use website.