Margaret P. Martinetti, Chair
Institutional Animal Care and Use Committee P.O. Box 7718 Ewing, NJ08628-0718
Phone: (609) 771-2640
Email: _____
....MEMORANDUM......
______
TO:Principal Investigators
FROM:Institutional Animal Care and Use Committee
DATE:March 11, 2009
RE:Animal Care and Use Procedure (ACUP) form
______
The Institutional Animal Care and Use Committee (IACUC) is responsible for the regulation and monitoring of all University teaching and research that involves vertebrate animals. The IACUC must ensure that all federal and state regulatory requirements are met by The College. As part of the compliance requirements, the IACUC must review and approve each animal study. The completion, review and approval of the attached ACUP protocol review form is a legal requirement. To avoid unnecessary delays, the ACUP must be meticulously and accurately completed including all appropriate signatures.
Much of the IACUC membership consists of principal investigators who appreciate the frustration of College paperwork and committee approvals. Thus, the IACUC members, including the Consulting Veterinarian and the Chairperson of the IACUC, will provide support in completing the ACUP form. If you have questions or need assistance, please call the Chairperson of the IACUC who will direct you to an appropriate member of the committee.
The ACUP and instructions for completion are available on the IACUC website at
Thank you for your continued cooperation.
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INSTRUCTIONS FOR COMPLETING THE
ANIMAL CARE AND USE PROCEDURE (ACUP) FORM
GENERAL GUIDELINES
1.Please read and follow the instructions carefully.
2.Follow the steps listed below when submitting an ACUP form:
Investigators are reminded that, in addition to the literature searches performed for scientific perspective, a search into alternatives is necessary (including consideration of non-animal models and less distressful/painful procedures). Assistance with this type of search is available from the library.
Prepare a draft of the proposed protocol using an ACUP form. For routine (3 year) review and revised submissions, a brief progress report must be included summarizing research performed, findings and citations of any resulting publications since the last full review.
For Types II and III studies, it is required that you consult with the Consulting Veterinarian to plan the development of your protocol. For Type I studies, it is highly recommended that you discuss your protocol with the veterinarian.
Be sure all staff listed in the protocol are certified as having completed the Animal Care and Use Training Program. If additional training is needed, it should be discussed with the veterinarian.
If the project is externally funded, attach the Animal Care and Use section of the grant proposal.
Submit the final version of the protocol electronically () to the Chairperson of the IACUC for review and approval by the IACUC.
3.When the ACUP form is approved, you will receive an IACUC approval number. No animal may be ordered and no animal study can begin without an approved IACUC number. Approval by the IACUC in no way obligates the IACUC or the College to guarantee space, animals and/or equipment for the conduct of the research.
4.Consulting Veterinarian: Elizabeth Dodemaide,
5.Material for review as well as questions regarding format, policies and procedures of the IACUC should be directed to the Chairperson:
Margaret P. Martinetti, IACUC Chair
Department of Psychology
Phone: (609) 771-2640
Email:
ANIMALS COVERED
Any and all live vertebrate animals used by employees, faculty and students of The College of New Jersey.
ANIMAL USE CLASSIFICATION TYPES
Type I
(USDA-C)STUDIES CAUSING MOMENTARY OR SLIGHT PAIN OR DISTRESS
These include: animals being bred, conditioned or held for observation or examination; blood sampling; injection of non-toxic material. Studies involving normal tissue procurement using standard approved methods of euthanasia that induce rapid unconsciousness; short periods or overnight food and water deprivation; behavioral observations and behavioral studies on awake animals that involve short-term stressful restraint; and Freund's complete adjuvant following appropriate TCNJ guidelines and without adverse reactions or excessive necrosis, otherwise cite as Category III.
Type II
(USDA-D)STUDIES THAT MAY CAUSE MORE THAN MOMENTARY OR SLIGHT PAIN OR DISTRESS FOR WHICH APPROPRIATE ANESTHETIC, ANALGESIC OR TRANQUILIZING DRUGS ARE USED
(Involvement of trained technicians, scientists, and veterinarians is critical to minimize this pain). These studies include: surgical procedures, under anesthesia, with or without recovery; procedures with recovery that adhere to acceptable veterinary practices, i.e. post-operative analgesia, fluid therapy and required veterinary post-operative care. Also included are studies where diseases or toxicities are induced, and when clinical symptoms begin to appear the animals are treated or euthanatized. Animals in Category II studies experience pain/discomfort, but the necessary treatments to alleviate the symptoms are available and provided, or the animals are euthanatized.
Comment: Animals used in Category II studies should not show signs of prolonged clinical distress, such as behavioral abnormalities, lack of grooming, dehydration, abnormal vocalization, prolonged anorexia, self-mutilation, increased signs of infectious processes (peritonitis, pneumonia, diarrhea, encephalitis, etc.). If these clinical abnormalities develop and cannot be alleviated, this will be considered a Category III procedure unless the animals are euthanatized with minimal delay.
Type III
(USDA-E)PROJECTS THAT INVOLVE PAIN OR DISTRESS FOR WHICH THE USE OF APPROPRIATE PAIN-RELIEVING DRUGS OR APPROPRIATE THERAPY WOULD ADVERSELY AFFECT THE PROCEDURE
(Active involvement of trained technicians, scientists, and veterinarians is required to minimize undue pain or distress). These studies include: prolonged periods (several hours or more) of physical restraint or deprivation of the animals' environmental necessities, such as maternal deprivation, aggression, predatory-prey interactions, procedures which alter perceptual or motor functions; application of noxious stimuli from which escape is impossible; exposure to noxious stimuli or agents whose effects are unknown; foot pad or intraperitoneal injections of Freund's complete adjuvant; the use of muscle relaxants or paralytics in surgery without concurrent use of anesthetics; post-operative discomfort that is not treated with analgesics; procedures that produce pain in which anesthetics are not used; induction of aggressive behavior leading to mutilation. Other examples to be included are toxicity testing where death is the end-point; induction of diseases where affected animals are permitted to succumb rather than be treated therapeutically; severe burn or trauma infliction on unanesthetized animals; using a euthanasia method not approved by the AVMA or the TCNJ IACUC. Also included are lethal or high doses of x-irradiation and using tumor implants/hybridomas.
Comment: Type III projects present an explicit responsibility on the principal investigator to explore alternative methods before proceeding with the study. Before the IACUC can review and approve these projects, the scientific justification must be clearly presented.
PREFERRED TERMINOLOGY
The IACUC encourages PIs to utilize the following list of preferred terminology when preparing an ACUP.
Abbreviations & Acronyms:The definition should be provided followed by the abbreviation or acronym when first used.
Animal facility:When referring to any of the College animal facilities, such as the 3rd Floor Animal Facility in the BiologyBuilding. Use in place of animal house or animal room.
Animal house:See animal facility.
Animal room:See animal facility.
Certification:See training.
Drugs:Generic names should be used (e.g. use sodium pentobarbital rather than nembutal).
Euthanize or Euthanatize:Use when referring to the killing of an animal. Use in place of kill and sacrifice.
Kill:See euthanize & euthanatize.
Sacrifice:See euthanize & euthanatize.
Training:It must be stated that each person that will handle live animals has completed the appropriate components of the TCNJ IACUC certification program.
INSTRUCTIONS BY SECTION
Please read all instructions. Complete all sections. Do not leave any questions unanswered. Incomplete or handwritten forms will delay the review of the protocol.
If any section does not pertain to your study, so state with “N/A”. Use terminology and phrasing that can be understood by a lay-audience. All abbreviations must be defined. Please avoid the use of scientific jargon wherever possible.
1.APPLICATION SUMMARY
a.Title of ACUP: Self-explanatory. Principal Investigator: Self-explanatory. Brief Summary: Please provide a few sentences containing an overview of the experiment in layperson’s terms. Research Category: Check all that apply, using the above descriptions as a guide. Surgery: Please indicate whether surgical procedures will be used in the protocol. ACUP Type: Self-explanatory. Submission Type: Self-explanatory.Permits: Self-explanatory. Funding Source: If funded externally, provide the sponsor name and the SPAF and Center numbers, and attach the Animal Care and Use section of the grant proposal.
b.(1) Rationale: Please address the following in detail: What is the rationale for the study; what new information will be derived from the study and what is its importance to the advancement of science? What possible benefits for the general public may accrue from the proposed research? Avoid excessive jargon so that reviewers unfamiliar with your area can gain an appreciation of the study. Define all technical terms in your description.
For Teaching ACUPs:Justify the use of animals by the students. How will students who do not wish to participate in the animal procedures satisfy the course requirements? Justify fully why alternate methods of instruction cannot be used, such as in the form of demonstrations or videotapes.
(2) Protocol: Provide details of the experimental procedure(s) as pertaining to the care and use of animals from the time an animal is entered into the study until the animal is euthanized or otherwise eliminated. The IACUC must determine that the study is “scientifically valid” and not a needless duplication of previous work; therefore, a detailed description of the scientific protocol is necessary
(3) Time in Study: Include a statement as to the length of time each animal will typically be in the study and housed in the College Laboratory Animal Facility. Different groups of animals may be in the study for different lengths of time.
2.PERSONNEL
a.Principal Investigator: The principal investigator (PI) is the person who assumes the final responsibility for the animals used in a study. Other Personnel:All other personnel involved in the protocol must be listed and be IACUC certified. If survival surgical procedures are to be performed, a Post-Operative Care Provider must be provided with an emergency contact phone number. Positions include: co-investigator, post-operative care provider, technician, assistant, study coordinator, and instructor (for teaching ACUPs).
b.(1) Additional Personnel: Use this section to list additional personnel if more personnel are involved in the study than will fit in section 2.a.
(2) Training: State the training and experience of each person who listed in 2.a. Each person must receive training through the IACUC. List who will be responsible for each procedure including post-operative care and medical record keeping.
If the personnel list changes (e.g., new students joining the research team) after approval of the protocol, please submit an amendment to the IACUC and provide the names of new personnel.
Teaching ACUPs:State the training and experience of each instructor participating in the animal procedures. Each instructor must have an appropriate training certificate from the IACUC—possession of this certificate must be noted. State clearly how students will be overseen and by whom. Give a brief synopsis or outline that will be presented to the students concerning the ethical use and care of the animals. Describe clearly how the student will be trained prior to starting the animal procedures.
3.SPECIES AND STUDY TYPE DATA
a.Name of Species/Strain/Breed/Gender: Common names (rat, rabbit, dog, etc) will suffice. Source: Please indicate vendor or source for each species used.Number of Animals: Provide the number of animals required per animal use classification type and provide the total number per species requested. Do not provide a range such as 10 to 15. The Animal Welfare Act Mandates Involvement of a Veterinarian in the Planning of Type II and III Studies: Provide the name of the veterinarian consulted and the date of the consultation for studies involving Type II and/or Type III animals.
b.(1) Additional Species: Use this section is you are requesting more species than would fit in section 3.a.
(2) Numbers Justification: Please justify the maximum number of animals required, indicating how that number was determined. The number should be based on experimental design, not on workload. If clarification is needed, please include a table or flow chart showing treatment groups and number per group. The total number of animals of each species must be identical to the number listed in item 2.
If the required number of animals changes after protocol approval, please submit an amendment to the IACUC with an explanation for the change.
4.HAZARDS
a.Indicate hazards to humans and/or animals by checking all appropriate boxes (if no hazards are involved, so indicate by checking “none”).
b.If hazards are indicated in 4.a., describe in detail environmental health and safety concerns and procedures to protect animals and/or humans.
5.CHECKLIST
a.Read each item carefully and check “yes” to all that apply. If “yes” is checked for any item, please describe in space provided.
6.DOSING
a.Complete this section if drugs will be administered to any animals.
7.BLEEDING
a.If blood is to be drawn from any animal, please complete this section.
8.ANESTHESIA, ANALGESIA, TRANQUILIZERS AND PARALYTICS
a.Species: Self-explanatory. Agent: Provide the generic name. Induction Dose: Provide in mg/kg or percent gas. Maintenance Dose: Provide in mg/kg or percent gas. Route: Self-explanatory. Administered: Indicate whether the agent will be administered pre-, peri- and/or post-operatively.
b.Use this section if you will be using more agents than will fit in 8.a.
9.SURGERY
a.If surgery will be performed, please check “yes” and then indicate all that apply. Provide a description of each procedure in the space provided. The entire surgical procedure should be described in detail (e.g., preparation of animal, instruments used, personnel involved).
10.EUTHANASIA
a.Please check all euthanasia methods that will be used. If methods other than those listed will be used, please check “Other” and indicate these other methods.
If any agent OTHER THAN carbon dioxide gas will be used, please complete the table: Species: Self-explanatory. Agent: Provide the generic name. Induction Dose: Provide in mg/kg or percent gas. Route: Self-explanatory. Method: Examples include cardiectomy, exsanguination, and decapitation.
If cervical dislocation or decapitation will be used, please provide a justification in the space provided.
Euthanasia for sick animals: Please describe how animals will be euthanized in case of illness.
11.UNNECESSARY DUPLICATION AND ALTERNATIVES
a.Indicate which databases and other sources have been searched to assure that the proposed experiments do not unnecessarily duplicate previous experiments, do not cause undue stress or pain, and that less painful or distressful alternatives have been considered and are not available. USDA Policy #12 recommends that “the databases searched, the date of the search, and the years covered by the search” be included. If this is a Type II or III ACUP, provide the parameters (keywords, title words, etc.) used for the search. The PI is reminded that assistance with an alternatives search is available from the library. Indicate whether the PI attends scientific meetings, is a journal reviewer, and/or has consulted with an expert not affiliated with TCNJ.
b.The PI must provide written assurance that the activities do not unnecessarily duplicate previous experiments, and that the investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals. Fed. Register, Vol. 54, No. 168.
Describe any alternatives that were incorporated into the protocol. The concepts of alternatives concerning the use of animals is built on the three R’s originated by Russell and Burch: replacement, reduction, and refinement. This includes the replacement of animals used in teaching or research with alternatives when possible, the reduction in the number of animals used, and the refinement of animal use to include new approaches that are less invasive, painful and/or distressful to the research animal.
12.LABORATORY AND PROCEDURE ROOM LOCATIONS
a.List all laboratory and procedure room locations. Check all boxes that apply: survival surgery (SS) procedures, non-survival surgery (NSS) procedures, in vivo research for more than 12 hours (>12hrs), and/or other (Other) research procedures (e.g. tissue harvesting or injections). All SS, NSS and >12hrs labs will be inspected by the IACUC prior to study initiation with follow-up semi-annual inspections.
Briefly identify which procedures will be conducted in an investigator's research laboratory and justify why these studies cannot be conducted in the College’s Animal Facility.
13.REFERENCES
a.Provide citations for any publications referenced in the ACUP.
INVESTIGATOR CERTIFICATION AND ENDORSEMENT OF DEPARTMENT CHAIR
The original copy of the ACUP form must be signed by the PI and endorsed by the departmental chairperson. Endorsement by section head, laboratory director, etc. is not sufficient. If the PI is not a faculty member, the faculty advisor must countersign as the PI’s sponsor.
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