FOR BEST VIEWING - USE VIEW-PRINT LAYOUT FLORIDA ATLANTIC UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE 5/10 Version RODENT BREEDING PROTOCOL FORM INSTRUCTIONS: 1. Please complete all sections of this form. Note: A. All personnel on the protocol must be trained by the University Veterinarian before the protocol will receive final approval. B. All personnel on the protocol must enroll in the Medical Monitoring Program for animal users. Please use the following link to enroll in the program. Completion of this form is required before the protocol will receive final approval. (http://www.fau.edu/research/rcs/files/Form7_Occupational_Health_Animal_Contact.doc C. There are at least 3 signatures that are required before submission – PI, University Veterinarian, and Department Chairperson. (Sections E & F ) 2. After a draft is completed, the PI must make an appointment to meet with the University Veterinarian. **THIS IS MANDATORY. 3. Submit the Protocol a. Email one copy to Dr. Kristen Ware (kcware@fau.edu), IACUC Coordinator, or Elisa Gaucher, Director, Research Integrity (egaucher@fau.edu). b. In addition, submit one complete paper copy with all signatures to: Research Integrity Division of Research SU-80, Rm. 106 Boca Campus Questions? Contact Dr. Sylvia Gografe, University Veterinarian, at (561) 297- 4233 or sgografe@fau.edu OR Dr. Kristen Ware, IACUC Coordinator, at (561) 297- 0961 or kcware@fau.edu. Finally: Please delete this page before submitting. Put your cursor on the frame and click. It should become a hash line. Then hit the delete key until the top line is deleted. Click once more to bring the protocol to the top of this page. **PLEASE NOTE THE REVISION DATE. YOU SHOULD USE THE LATEST VERSION FROM THE WEB. FAU Protocol Page 1 of 9 FLORIDA ATLANTIC UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE 5/10 Version RODENT BREEDING PROTOCOL FORM A. ANIMAL USE PROTOCOL SUMMARY IACUC DATE STAMP: Shaded areas for IACUC use only. PROTOCOL NUMBER: APPROVAL DATES: Original: MODIFICATION DATE: 1st Renewal: 2nd Renewal: A.1. PROTOCOL TITLE A.2. PRINCIPAL INVESTIGATOR (PI) NAME AND ADDRESS First Name Department Last Name Work Phone Email Address After Hours Phone A.3. PROJECT PERSONNEL (Include names of all individuals involved with the animals and this project) . ROLE IN PROJECT (please answer all that apply) Name Work Phone Email Address For additional names copy section and add at the end of a section.) Animal Contact: NONE (Not required to answer species and jobs below; General Training req’d) YES (Have to answer all below) TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users. Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Discuss previous training and background working with each species and each procedure marked including when trained and how trained. Name Work Phone Email Address Animal Contact: NONE (Not required to answer species and jobs below; General Training req’d) YES (Have to answer all below) TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occup. Health Program for Animal Users. Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Species FAU Protocol Page 2 of 9 Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Discuss previous training and background working with each species and each procedure marked including when trained and how trained. Animal Contact: NONE (Not required to answer species and jobs below; General Training req’d) Name Work Phone Email Address YES (Have to answer all below) TRAINING: Enter dates for FAU hands on or online training (If doing Anest. and Surg., it requires Surg. Training; Euthan. requires Euthan. Training), and mark an X to indicate if you are enrolled in the FAU Occupational Health Program (OHP) for Animal Users. Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Species Handling/monitoring Non-Surg Procedure General Anest/Surgery Euthanasia OHP Enroll Discuss previous training and background working with each species and each procedure marked including when trained and how trained. To add more people, place your pointer at the top, left corner of the above group (just outside of the “N”), right click, copy and then paste just below this line. Add as many as required. EMERGENCY CONTACT AND ANIMAL DISPOSITION A.4. Daily and weekend contact numbers for emergencies. (Please provide PI and an alternate’s emergency info.) Personnel listed in this section must also be listed as project personnel in the above section PI Alternate Person Emergency Phone Emergency Phone B. TYPE OF SUBMISSION B.1. TYPE OF SUBMISSION (CHECK ONE) New Protocol Related to IACUC Protocol(s) # Year 3 Renewal of IACUC Breeding Protocol # B.1.a. FUNDING SOURCE(S) B.2. PROJECT START DATE FAU Protocol Page 3 of 9 PROVIDE RELATED IACUC NUMBERS (Not applicable for new protocols) B.3. PROJECT END DATE C. PROJECTED ANIMAL USE C.1. Please provide estimates for each as best you can USDA Pain Level Add any comment or explanation List all strains intended for breeding Estimate Estimate Estimate (SPECIES Common Name and Strain) number at total total any one time number of number of breeders offspring 1 2 3 4 5 6 7 8 C.2. ANALGESIC/ANESTHETIC (Generic name) B B B B B B B B SPECIES DOSE MG/KG ROUTE FREQUENCY SPECIES DOSE MG/KG ROUTE SPECIES DOSE MG/KG ROUTE FREQUENCY 1 2 3 C.3. EUTHANASIA METHOD/DRUG (Generic name) 1 2 3 C.4. OTHER DRUGS (List all injected/given: i.e. antibiotics, fluids, Freund Complete Adj. etc.) 1 2 3 D. LOCATION OF BREEDING D.1. Facility and Room # Where Breeding Will Take Place Biomedical (Check as many as applicable.) Research Support Facility I Research Support Facility II (Modular Unit) Unknown or Veterinary Services selects FAU Protocol Page 4 of 9 E. INVESTIGATOR ASSURANCE READ CAREFULLY AND SIGN AND DATE BELOW PRINCIPAL INVESTIGATOR'S ASSURANCE I have provided an accurate description of the proposed breeding protocol and agree to the following conditions: All personnel will be informed of the requirement to report all animal bites and animal related accidents. All personnel will be informed that any concerns for inhumane care and treatment of animals or unlawful acts involving animals should be reported to the IACUC or the Attending Veterinarian and that anyone reporting such concerns cannot be discriminated against or be subject to any reprisal for reporting their concerns. I agree to abide by governmental regulations and policies concerning the use of animals. I will ensure that veterinary care is provided to animals showing evidence of pain or illness. I agree to give consideration to tissue sharing and will do so whenever possible. If the procedures concerning animal use in this research activity are to be revised or changed, I will so notify the IACUC of these changes before the change is implemented. I understand that failure to request an amendment for changes in animal use may place the University and me in violation of Federal regulations and the Animal Welfare Act. As required by Federal regulations, I assure that the activities described do not unnecessarily produce animals and I assure the animal models proposed are the most appropriate for achieving the objectives of this project and have provided justification for each model used in the protocol. As required by Federal regulation (9CFR 2.31(e)(2), I assure that my proposal to conduct research or teaching utilizing animals "must contain... a rationale for involving animals." While this is not a proposal for research or teaching, it is in fact in support of those. To obtain the research animals required, “whole live animals” are required. The number of animals used will be kept to the minimum number to produce the required animals on a timely basis. Since this is a breeding colony, I do not plan to do any painful research procedures on the animals. I will follow all institutional policies and procedures in regard to animal use in a breeding colony. Principal Investigator Signature Date Requires a review of the protocol in a meeting with the veterinarian prior to submittal. Attending Veterinarian’s Initials Indicating that the meeting occurred. FAU Protocol Page 5 of 9 F. CONFIRMATION OF SCIENTIFIC/INSTRUCTIONAL MERIT REVIEW Before any project that utilizes animals can be initiated, it must be reviewed and approved based on scientific or instructional merit. The IACUC is responsible for ensuring a scientific or instructional review is conducted, not necessarily to conduct the review. The IACUC is responsible for the proper, legal, and humane use of animals. To assure the IACUC that this review is in place, the following information is needed regarding the review process which is applicable for this protocol. (Check one of the boxes below). This project will only be initiated after it has been peer-reviewed outside Florida Atlantic University (e.g. NIH, NSF, AHA, etc.) or within the University by a formal interdepartmental review group. If so, identify which group, agency or board has reviewed or will review this project for scientific or instructional merit. Name of Review Agency, Committee, or Board Date of Review OR This project is being reviewed within FAU by one of several methods. Departmental Committee for review of scientific or instructional merit Name of Committee Date of Review Name of Committee Chairperson or Official Designee of the committee indicating approval OR Other Review Process Describe the review process such as the IACUC, Department Chair person, etc. Note: While it does not necessarily require someone who is an “expert” in the field of study, it does require someone with sufficient scientific knowledge who can review a paper to ensure the project will have merit and not use animals unnecessarily. Until a review is completed and the protocol approved, the project cannot be started. Additional note: If the IACUC is asked to complete the scientific review, the project may be delayed until someone with the required expertise can be recruited. Name of person or persons who conducted the Scientific or Instructional Merit review. If this is to be reviewed by the IACUC, then nothing will be required in this block since the IACUC will have records of who reviewed the project. Signature of Person Date In addition to any review within FAU, an “administrative review” by the chair person to indicate his/her knowledge of the project and approval is required. Signature of Department Chairperson FAU Protocol Page 6 of 9 Date G. PROTOCOL SYNOPSIS NOTE: If this is a 3 year renewal, Include an estimate of the total number of animals transferred and to what protocol, and number euthanized. State about how much longer the breeding colony will be required (estimate or “unknown”) Breeding colonies require a justification. Check all that apply. □Our research requires the use of a special animal that has been genetically modified. The supply of these is limited or not available on the market therefore, we will need to obtain some breeders and produce our own stock. □Our research requires animal at a specific age, sex or number that cannot be readily supplied by an outside vendor. □Other, please explain. Quarantine. Check all that apply. □The stock animals we require are from an approved vendor (Charles River, Harlan, Jackson, and Taconic) and are free of all required diseases. □The stock animals we require are from an unapproved vendor and will require quarantine. □The stock animals we require are from an unapproved vendor and have known diseases. They will require rederivation. What breeding scheme do you plan to use? □Male:Female □Male:Female + Female □Other. Describe. _______________________________________________________________ What happens to the breeders? □They are transferred or euthanized. □Other. Describe. _______________________________________________________________ What happens to offspring that are not transferred to a research protocol? □They are transferred or euthanized □Other. Describe. _______________________________________________________________ Who will provide breeding? □I will provide the requirements for providing animals for my research/teaching protocol. Veterinary Services will manage the breeding. □I will manage the breeding. I understand no procedures may be performed on any animal in the breeding colony without coordinating the activity with Veterinary Services prior to performing the procedure. While I will do the match up and monitor the production of offspring, I will keep Veterinary Services completely informed of all activities. I understand this is required to be a breeding colony and not a research colony. Please add any other information that will help the IACUC understand why you plan to breed animals. FAU Protocol Page 7 of 9 H. NUMBER OF ANIMALS Discuss the NUMBER of animals that you have estimated in your breeding colony. While the numbers do not have to be exact, some basis should be used to calculate the number of breeders and the number of projected offspring necessary for your research protocol. I. INSTRUCTIONS FOR DISPOSITION OF SICK OR INJURED ANIMALS This section is used to indicate what is to be done with animals in case they become sick or injured and what is to be done with dead animals and tissue. (Weekend, holidays and nights are times that animals need care too, e.g., without being able to contact the investigator, the animal caretaker may not know whether or how to keep the carcass until it can be examined or utilized by the investigator). An alternate person should always be designated. The alternate person cannot include routine VS animal caretakers and that person should also be listed under the project personnel. YES NO I.1. Call investigator Immediately? (A “no” answer means the investigator will be called the next working day.)Normally, the investigator should be called. The investigator may wish to be notified the next working day). I.2. In case of emergency, should the Veterinarian treat the animals? In case of an emergency, the veterinarian needs to know whether the animal should be treated. If the animal should not be treated, why not? Should the animal just be euthanized? If the animal is to be treated, what restrictions, if any, should the veterinarian be aware of (i.e. no steroids; no drugs; etc?) If NO, include justification on why the animal will not be treated. If YES, explain any restrictions on treatment below. I.3. Comments J. INSTRUCTIONS FOR DISPOSITION OF DEAD ANIMALS J.1. J.2. J.3 YES NO YES NO Are deaths expected? If so, what age? Call investigator Immediately? (A “no” answer means the investigator will be called the next working day.) Do you specifically request the Veterinarian to do a necropsy? The veterinarian is required to be notified of any unexpected death and will either perform or be present at the necropsy. When deaths occur that are expected, the veterinarian does not need to be notified, but if the death occurs after normal hours, or if the investigator or his/her backup cannot be reached, the veterinarian may be asked to try to save certain tissues. In such circumstances, what instructions would you have for him/her? Discuss any special instructions for the Veterinarian. (i.e. look at lungs, save heart, save implant) K. BREEDING COLONY SPECIAL INFORMATION FAU Protocol Page 8 of 9 Complete only if applicable to your project. Rodent breeding colonies are best used to produce appropriate numbers of research animals in instances where the needed animals are transgenic, difficult to procure, or in short supply. Rodent breeding colonies are rarely cost effective in instances where the animals are easily procured from commercial vendors. If a breeding colony is deemed appropriate, it is the investigator’s responsibility to breed only enough animals necessary. Excess production of animals that are then destroyed is not in keeping with the University’s commitment to “Reduce”, “Refine” and “Replace” the use of animals in research. K.1. Describe your genetic monitoring program. How will you know you met your objective? K.2. What substrain designations do you use when reporting experimental results? K.3. At approximately what age will you transfer the animals? K.4. Indicate the criteria used for selecting animals for transfer to research protocol (more than 1 box may be checked). □Age Sex □Male Only □Female Only □Both □DNA results □Other, explain K.5. If you must select by DNA sampling, what screening technique do you use? K.5.a. Blood sample K.5.b. Saliva K.5.c. Tail snip K.5.d. Other (Describe) K.6. If you must select by DNA sampling, at what age do you sample? K.6.a. Note: Tail snips done beyond 3 weeks of age must be completed under anesthesia. Do you need to do tail snips beyond 3 weeks of age? K.6.b. What anesthetic will you use YES YES NO K.7. If you wish to wean animals beyond 3 weeks of age, at what age do you wish to wean them and why. K.8. Are there any special husbandry requirements that the Lab Animal Technicians need to be aware of? YES K.9. Will you use a physical method (ear punch, ear notch, ear tag, toe clip, tattoo, etc.) to identify weanlings? K.9.a. What method(s) are you planning to use? K.9.b. According to the GUIDE, “toe clipping should only be used when no other individual identification method is feasible and should be performed only on altricial1 neonates.” If you are using toe clipping, justify why an alternative method cannot be used. (1 Hair growth in mice generally begins at about 6 days of age) Once completed A minimum of 3 signatures are required: PI, University Veterinarian, and Dept. Chair. 1 original plus an electronic copy must be submitted to Research Integrity. FAU Protocol Page 9 of 9 NO