THIS IS A NORTH CAROLINA STATE UNIVERSITY DOCUMENT PROVIDED TO ASRED DIRECTORS BY JON ORT. IT FOCUSES ON EXTENSION USE OF ANIMALS AS RELATED TO INSTITUTIONAL ANIMAL CAREAND USE COMMITTEES.
Note 1: This document was provided November 2005. It has been used in NC since 1996.
Note 2: In some cases, names and other information unique to the system at NCSU have been edited out. In these cases, it is noted as “edited.”
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SUBJECT: Statement on Review of Animal Related Extension Projects or Programs by the Institutional Animal Care and Use Committee (IACUC)
Over the past 12 months I have been working with the chairman of the IACUC and with Extension Administration to negotiate a reasonable policy to address the issue of IACUC consideration of plans of work for Extension programs involving use of animals. Early in the process, based on discussions over the past four or five years, I had drafted a statement and circulated it to a number of specialists and agents. With their input, I revised the document, presented it to the IACUC and Extension Administration for final approval.
You will find in the statement that not all animals nor programs are covered; rather, it is drafted generically with enough guidelines and examples that you can make an informed decision as to those activities or projects that should be reviewed versus those are do not need review.
Hopefully, this statement will provide you the guidance needed when you are developing proposals or planning activities and programs involving the use of animals.
In addition to the statement referred to in the subject line above, I have also included hard copies of three other documents. They are used if and when you need to develop an application to the IACUC. They include:
- IACUC General Information and Instructions (Rev. 1995)
- NCSU Application for Vertebrate Animal Use (Rev. 1995)
- Application for the Use of Vertebrate Animals Protocol Amendment Form (Rev. 1995)
Implementation of these guidelines and review of appropriate Extension projects and programs will provide assurance that our programs are covered by the same institutional review as research and academic programs activities.
“Edited” - Information about the NCSU process
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INSTITUTIONAL ANIMAL CAREAND USE COMMITTEE GENERAL INFORMATION AND INSTRUCTIONS
REVISED 1995
WHAT IS AN APPLICATION FOR VERTEBRATE ANIMAL USE (AVAU)?
North Carolina State University policy requires an approved application for all activities (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 which allows the investigator to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. 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 may be a violation of Federal law.
WHO MUST FILE AN AVAU?
All university faculty who plan to use animals in research, teaching or testing must file an AVAU. Persons submitting applications must be of faculty rank. Faculty are responsible for animal use by their students and staff. The Faculty Member (Principal Investigator) 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. Faculty members 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. Such information can be obtained from the Attending Veterinarian.
HOW LONG DOES IT TAKE THE IACUC TO PROCESS AN AVAU?
Most AVAU are processed in four to five 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 in time to meet various deadlines. It is the responsibility of the principal investigator to submit an AVAU with sufficient lead time t all University and agency deadlines.
MUST A DIFFERENT AVAU BE FILED FOR EACH RESEARCH PROJECT?
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 and a copy of each proposal. 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.
WHAT ABOUT FIELD PROJECTS, PROJECTS USING PRIVATELY OWNED ANIMALS, RESEARCH CONDUCTED IN ANOTHER STATE, COUNTRY OR RESEARCH CONDUCTED IN COLLABORATION WITH AN INVESTIGATOR AT ANOTHER INSTITUTION?
While the IACUC does not conduct inspections of field and overseas research sites, the use of vertebrate animals by NCSU faculty 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 has 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 may be 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.
WHEN SHOULD AN APPROVED PROTOCOL BE UPDATED OR AMENDED?
If significant changes are anticipated in an on-going project, a Protocol Amendment Form should 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 for information.
HOW ARE APPLICATIONS SUBMITTED?
Applications can be obtained from the appropriate College Research office. The application form must be typed. Applications are available on diskette. Each section must be answered in specific detail or noted "not applicable." It is not sufficient to answer a question by simply referring to a more detailed paper or reference or attached document.
All applications require an original and sixteen copies of the application form and two copies of the complete grant proposal, co-operative agreement, memorandum of agreement, NCARS project, etc. or syllabus (for teaching activities).Submit all applications through the IACUC office (NCSU IACUC Office, Campus Box 8401, Raleigh, NC 27695-8401) .After review and approval, the Chair of the Committee will send the approval information to the Principal Investigator for submission to the appropriate offices or federal agencies.
CATEGORIES OF ANIMAL USE ACTIVITIES BASED ON PAIN OR DISTRESS
Category A Experiments involving either no living materials or use of plants, bacteria, protozoa, unhatched eggs, cell culture or invertebrate animal species. NO REVIEW REQUIRED
Category B Animal use activities which involve only breeding, conditioning, or holding.
Category CAnimal use activities which involve no pain, distress greater than an injection, or use of pain relieving drugs. Routine procedures (e.g. injections, blood sampling, physical examinations, food/water deprivations for a few hours) fall into this category.
Category DAnimal use activities which involve accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs are used. Procedures which would generally call for the use of anesthetics, analgesics or tranquilizers in human beings fall into this category.
Category EAnimal use activities which involve accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs are not used. An explanation of the procedures producing pain or distress in the animals and reasons such drugs were not used shall b4 included in Section A of the Application for Animal Use.
GENERAL REFERENCES ON ANIMAL CAREAND USE
Guide for the Care and Use of Laboratory Animals. NIH Publication NO. 86- 23. U.S.Dept. of Health and Human Services, Washington, DC, 1985.
Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. Consortium for Developing Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, Champaign, IL, 1988.
1993 Report of the AVMA Panel on Euthanasia 230-249. Jan 15, 1993. J Amer Vet Med Assoc, 202(2) 230-249. Jan 15, 1993
Animal Resource Handbook, NCSU College of Veterinary Medicine, Raleigh, NC, 1989
Special Reference Briefs -Alternatives to the Use of Animals in Research and Education NALSRB-11, National Agricultural Library, Beltsville, MD, 1988.
Weigler, B.J.; Justifying the Number of Animals in IACUC Proposals. Contemporary Topics in Laboratory Animal Science, 34(3) 47-50. 1995
Stokes, W.S. and Jensen, D.J.B.: Guidelines for Institutional Animal Care and Use Committees: Consideration of Alternatives. Contemporary Topics I: Laboratory Animal Science, 34(3) 51-60. 1995.
Hamm, T.E., Jr.; Proposed Institutional Animal Care and Use Committee Guidelines for Death as an End Point in Rodent Studies. Contemporary Topics in Laboratory Animal Science, 34(3) 61-71. 1995.
IACUC ATTENDING VETERINARIANS
“Edited” - (list of attending veterinarians)
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POLICY STATEMENT FOR REVIEW OF ANIMAL RELATED EXTENSION PROJECTS OR PROGRAMS BY THE INSTITUTIONAL ANIMAL CAREAND USE COMMITTEE
The following guidelines represent the basis upon which the IACUC and Extension program or project leaders determine that an animal care and use plan is required.
While the policy below suggests some differentiation based on animal ownership and type of Extension program, faculty should strongly consider submitting an application for approval anytime that animals are physically used in Extension programs. In many cases, a blanket application and approval for similar activities would be satisfactory and appropriate.
Only with an approved plan does the project or program leader have the support of the IACUC should questions arise regarding the use, care, treatment and disposition of animals involved in the program.
The following activities would require that the project or program be covered by an approved animal care and use plan. In some cases, ongoing activities could be covered by an existing Agricultural Research Service Station Project, for which an approved plan is in place, especially for faculty with joint appointments or by a blanket plan which could cover a group of similar activities in a program.
A. Programs or projects which involve subjecting animals to levels of stress above and beyond normal production practices. For example, teaching pregnancy diagnosis or artificial insemination during which cows would be palpated or inseminated multiple times would require approval. Other protocols requiring approval include those in which animals are used repetitively for electroejaculation, digesta collection, blood collection, etc.; extensive handling, movement or hauling of animals; intentional exposure to concentrated doses of pathogenic organisms; or other physical challenges (extreme heat, cold, noise, contaminated air, water deprivation, long-term fasting) that would not be done in routine production systems.
Rationale: These activities, which are often used in educational and research settings, subject animals to various stressors beyond those incurred in normal production activities. To ensure proper handling and application of these and similar stressful techniques and to document the planned use of these techniques, an application and approval would be required.
B. Programs or activities involving surgeries or other invasive procedures, including routine surgeries that would be performed on mature animals, e.g., dehorning or castration.
Rationale: Most of these activities can cause moderate to severe stress and pain to animals, and in many cases, should include the use of anesthesia. Appropriate application of these techniques needs to be monitored carefully to minimize the stress and pain that can result.
C. Programs, projects or activities that involve use or testing of materials or compounds that are not currently approved or in practical use in livestock production.
Rationale: Activities in this category may involve materials whose effects in animals are unknown. Concerns about food safety, animal and human health, pesticide impacts, and efficacy exist with many materials in the category. Therefore, to assure appropriate care in using these materials, to ensure appropriate sampling and monitoring of impacts on animal health and well- being, and to protect the food supply, these activities would require an approved plan.
D. Programs or projects in which euthanasia of the animal is an endpoint would require application to and approval by IACUC. One application, submitted by the state specialist covering the entire program would be required.
Rationale: Accepted means for disposing of animals resulting from projects include euthanasia. Appropriate procedures must be assured.
The following programs or projects would not require application to and approval by IACUC. If projects or programs involve activities that may raise issues regarding the care and well- being of subject animals, project leaders are encouraged to submit an application covering the program or project.
A. Programs or projects in which animals are used in 4-H and youth program delivery.
Rationale: The programs involve animals that are owned, supplied by and under the care of farmers or University Research or Teaching Units.
B. Programs in which animals are used in adult educational programs and demonstrations involving routine, accepted production management or marketing techniques, treatments, or handling, including working in handling facilities, implanting, ear tagging, injecting, castration art early ages, tattooing, insemination, pregnancy diagnosis, hoof trimming, collection of blood samples, etc.
Rationale: In most cases, animals used in these educational programs or projects are not under the ownership, care and management of Extension workers; rather, they are owned and overseen by farmers or University Research or Teaching Unit supervisors.
C.Programs or activities involving use of recognized and approved chemicals, drugs, feed additives and other products used in animal production. If a material is restricted in its use-- under the direction of a licensed veterinarian or a restricted use pesticide--appropriate involvement of a veterinarian or licensed pesticide applicator (private or commercial) is required.
NORTH CAROLINA STATE UNIVERSITY APPLICATION FOR VERTEBRATE ANIMAL USE (Revised 1995)
COMMITTEE USE ONLY I .D. # ______
APPLICANTS MUST ATTACH 16 COPIES OF TYPED APPLICATION AND 2 COPIES OF PROPOSAL (RESEARCH PROTOCOLS) OR SYLLABUS (TEACHING PROTOCOLS)
Title of project ______
Submitted to ______(Name of Funding Agency)
Agency Deadline ______
This is a New ______Renewal ______application. If this application is a Renew of a project previously approved by the Committee, please indicate the ID# (if known) of the previous application: ______
INFORMATION REQUESTED ON PAGE 2 OF THIS APPLICATION IS CONSIDERED PRIVATE ANDIS NOT SUBJECT TO RELEASE UNDER THE PUBLIC RECORDS ACT.
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Below, please check each of the areas this project involves and fill out appropriate sections on the succeeding pages.
Animal Care (Page 2 and Section A, pages 3, 4 & 5) REQUIRED FOR ALL APPLICATIONS
Antibody production --(FILE IACUC ANTIBODY PRODUCTION FORM)
Blood withdrawal --Section B, page 6
Restraint with mechanical devices --Section C, page 6
Appetitive or aversive conditioning or environmental stress-Section D, page 6
Surgery --Section E, page 6
Anesthesia or analgesia --Section F, page 7
Painful or distressful procedures without anesthesia or analgesia (not required for mild and transitory pain such as from injections)-- Page 7
Euthanasia --Section G, page 7 --REQUIRED FOR ALL APPLICATIONS
Administration of radioisotopes, viable organisms, toxic chemicals, carcinogens, transplantable tumors, biological tissues, or sera--Section H, page 8
DO NOT WRITE BELOW THIS LINE. APPLICATION CONTINUES ON NEXTPAGE
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A copy of this page only will be returned to you indicating the result of the review by the Committee. Please retain a copy and, AS APPROPRIATE, submit a copy with your application to various University offices through which applications must be routed, or send a copy directly to the review group or project officer in the Funding Agency for your project.
Date of review ______
______Approved______Approvedwith provisions (Attached) ______NotApproved
This institution has an Animal Welfare Assurance on file with OPRR (#A3331-01)
______Chairman, IACUC
______EXPIRATION DATE
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APPLICATION FOR VERTEBRATE ANIMAL USE
INFORMATION ON THIS PAGE IS CONSIDERED PRIVATE AND NOT SUBJECT TO RELEASE UNDE THE PUBLIC RECORDS ACT. PLEASE PROVIDE THE APPROPRIATE INFORMATION IN THE SPACES PROVIDED BELOW, BUT DO NOT INCLUDE THIS INFORMATION IN ANY OTHER PORTIC OF THE APPLICATION. THE REST OF THE APPLICATION IS CONSIDERED PUBLIC AND IS SUBJECT TO RELEASE.