ANIMAL USE PROTOCOL UNIVERSITY OF MASSACHUSETTS BOSTON INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE This form must be completed for New, 3-Year Rewrite or Approved Protocols having significant revisions/modifications including changing the species of animals, changing procedures involving pain or stress, using hazardous substances, or other types of significant changes as may be determined by the Institutional Animal Care and Use Committee (IACUC). For IACUC Use Only Date Submitted: ____________ Protocol Number: __________ Date Approved: ____________ The IACUC at the University of Massachusetts Boston (UMB), in compliance with Federal Regulations and Guidelines, requires this application to be completed and approved, in writing, prior to initiating any animal activities involving the teaching, testing or research use of animals. Changes in personnel or nonsignificant changes in procedures, such as equivalent methods, can be submitted directly to the Chairman of the IACUC, who is authorized to approve such changes upon verification of training for personnel and equivalency of methods. This application must be completed for activities performed on UMB premises, at off-site facilities, or under field conditions. The responsibility for completing this form and securing approval rests entirely with the Principal Investigator (PI) named in this document. Type of Application: [ ] New Submission [ PHS Policy) [ ] Revision/Modification ] Three Year Rewrite (Required by General Information Title Proposal: _____________________________________________________________________ Name of Principal Investigator (PI):_________________________________________ (Note: If graduate student, a PI of standing with the IACUC must also be listed) Qualifications & Training (Degree, years of experience in working with animals, etc.): ______________________________________________________________________ Department: ________________________ Telephone: ____________________ Emergency Telephone: ___________________________________________________ Source of Funding: ____________________ A.U.P. 6/1/2014 RH Funding Period: ___________________ UMB Training Record: CITIprogram.org date: _______________ LATAnet.com date: ________________ IACUC training date: ________________ Other Training (describe):___________ Animal Information Species: _____________________________________________________________ Breed/Strain: __________________________________________________________ Vendor/Source: ________________________________________________________ (Note: Laboratory rodents are to be acquired from disease-free vendors/sources) Weight Range: __________ Age Range: _________ Sex: Male [ ] Female [ ] Maximum Daily Census: __________ Maximum Monthly Census: ___________ Total Annual Use: __________ To be completed by Animal Facility Manager: Is adequate caging available? [ ] Yes [ ] No Is special caging required? Describe: ___________________________________________________ Animal Room Assignment: __________________________________________________________ Are there any animals to be used off site? [ ] Yes [ ] No If “Yes”, describe facility, room or field circumstances: ______________________________________________________________________ ______________________________________________________________________ Justification for Animal Activities Justification for Species: _________________________________________________ Justification for Breed/Strain: ______________________________________________ Justification for Numbers of Animals: ________________________________________ A.U.P. 6/1/2014 RH Rationale for procedures that may cause more than momentary pain or distress (Category D) and why alternatives are not available: ____________________________ _____________________________________________________________________ Assurance that activities do not unnecessarily duplicate previous research use of animals: _________________________________________________________ Literature searches: computer searches, references, conferences or consultations that justify species, breed/strain, numbers of animals and rationale for Category D activities should be performed. Computer searches should list by keywords, date and citation for each justification. Justification is mandatory for Category D procedures. Face page printouts of computer searches may be attached to this application: Brief Abstract Description of Animal Activities and Objectives (500 words) Detailed Description of Teaching, Testing or Research Design In separate sections, below, describe groups of animals, acclimation of animals, sequence of procedures from acquisition of animals to euthanasia (illustrated by timeline), administration of drugs or test substances, surgery procedures, special methods, endpoints, technical problems, adverse effects and euthanasia of animals. Experimental Groups of Animals (how animals will be assigned for use): Acclimation of Animals (methods to screen animals prior to use): Sequence of Procedures and Timeline (describe all procedures from acquisition of animals to euthanasia and provide a simple timeline to illustrate the description): A.U.P. 6/1/2014 RH Administration of Drugs, Chemicals or Test Substances: Describe the drug, chemical, or test substance including - any method of preparation for a non-drug, route of administration, dose, frequency of administration and duration of repeat administration (days, weeks, etc.) for groups of animals: The use of anesthetic agents for non-surgical procedures that might have associated pain or stress must also be described. Information should include anesthetic agent(s), route, dosage, signs of surgical plane and repeat dosage: Surgery Procedures: Survival [ ] Multiple-Survival [ ] Non-Survival [ ] 1. General description of surgery procedure (anatomical site, skin preparation, tissues incised, closure, suture material): 2. Anesthetic(s) (agents, route, dosage, signs of surgical plane and repeat dosage): 3. What room will be used (Surgical Room in Animal Facility, or other?):_________ 4. Recovery monitoring, signs and analgesic drugs including dose, route and repeat dosage: 5. Will the animal be involved in any procedures after surgery? [ If Yes, describe procedures: ] Yes [ ] No 6. If the animal is to be euthanized following surgery, describe the method of euthanasia: Special Methods (describe any special methods for diet restriction, prolonged restraint, tumor transplantation, administration of radioactive substances, carcinogens, mutagens or hazardous substances and provide scientific justification for such methods. (Note: UMB does not currently allow the use of infectious agents in animals.): Diet restriction (food or water): [ ] No [ ] Yes. If “Yes”, describe methods: Feeding special diet (e.g., high v. low fat, etc.): [ diet(s) and methods: ] No [ ] Yes. If “Yes”, describe Prolonged restraint (more than 30 minutes in a device): [ describe device and duration: A.U.P. 6/1/2014 RH ] No [ ] Yes. If “Yes”, Induced disease: [ ] No [ ] Yes. If “Yes”, describe disease being induced: Animal behavior/exercise: [ ] No [ ] Yes. If “Yes”, describe methods: Radioactive substances: [ ] Yes. If “Yes”, list substances: ] No [ Chemical carcinogens or mutagens: [ obtain MSDS information for your files: Hazardous substances: [ information for your files: ] No [ ] No [ ] Yes. If “Yes”, list substances and ] Yes. If “Yes”, list substances and obtain MSDS Will any animal activity images be created or used? Imaging of animal activities must conform to the UMB Policy on Imaging for Research, Teaching and Testing. Other special methods (describe in detail): Endpoints, Technical Problems and Adverse Reactions (describe the criteria that indicate objective has been attained, that a technical problem has occurred, or adverse reaction occurred): Euthanasia of Animals (describe agent, method of administration, method of verifying death and list specific personnel authorized by PI to perform euthanasia. When physical methods are used, the technique must be demonstrated to conform to the AVMA Guidelines on Euthanasia. The method of euthanasia must also be described for animals which become clinically affected from untoward causes, but must be humanely euthanized and removed from research, teaching or testing. (Note: The Manager of the Animal Facility is also authorized to perform euthanasia if the PI or personnel authorized by the PI cannot be reached): Agent(s) or methods used: Method of administration: Method of verifying death: Personnel authorized to perform euthanasia by PI (list): Personnel from Animal Facility who may perform euthanasia in an emergency (list): A.U.P. 6/1/2014 RH Personnel Authorized by PI to Participate in Animal Activities 1. Name:___________________________________________________________ Activity (describe):__________________________________________________ Qualifications( research experience): ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ 2. Name:___________________________________________________________ Activity (describe):__________________________________________________ Qualifications: ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ 3. Name: __________________________________________________________ Activity (describe):_________________________________________________ Qualifications: ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ 4. Name: __________________________________________________________ Activity (describe):_________________________________________________ Qualifications: ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ 5. Name: __________________________________________________________ A.U.P. 6/1/2014 RH Activity (describe):_________________________________________________ Qualifications: ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ 6. Name: __________________________________________________________ Activity (describe):_________________________________________________ Qualifications: ____________________________________________________ CITIprogram.org date: _______________ LATAnet.com date: _______________ Read protocol(s) date: _______________ PI Assurance Statement: I have provided accurate information on my qualifications, description of all animal activities, required documentation, personnel qualifications and training and other documentation related to the animal activities in this application. I, and the assigned personnel listed in this application, will work with the IACUC and UMB Animal Care Staff to ensure that all animal activities, described herein, will be performed in accordance with UMB Policies and Standard Operating Procedures. I understand that significant changes in animal activities must be approved by the IACUC before any such changes in animal activities can take place. I hereby acknowledge ownership of the animals to be used and accept, in part, responsibility for UMB’s compliance with provisions of all Federal regulations and guidelines, including the “Animal Welfare Act,” the PHS "Policy on Humane Care and Use of Animals," and the ILAR “Guide for the Care and Use of Laboratory Animals.” I have read the above statement and understand my responsibility to provide assurance of compliance with UMB standards. Principal Investigator: Signature: ______________________________ ______________________________ (print name) Date: ___________________________________ A.U.P. 6/1/2014 RH Advisors Signature: (for student work) Signature: ______________________________ ______________________________ (print name) Date: ___________________________________ Department Chair: Signature: ______________________________ ______________________________ (print name) Date: ____________________________________ Certification of Animal Ownership: Signature: ______________________________ ______________________________ (print name) Date: _____________________________________ A.U.P. 6/1/2014 RH