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INSTITUTE OF BIOSCIENCES AND TECHNOLOGY
TEXAS A&M HEALTH SCIENCE CENTER
Research Proposals Involving Animal Subjects
Research investigators are entrusted with an essential role in assuring the humane care and use of animals. In activities they conduct or which are conducted under their supervision, they have a direct and continuing responsibility to ensure that animals are adequately cared for and used in a humane fashion. Investigators must ensure that discomfort, pain and injury to the animals are avoided or minimized, consistent with sound experimental design; that no more animals are used than are necessary to reach sound scientific conclusions; and that, when appropriate, animals are painlessly sacrificed in accordance with methods of euthanasia approved by the Panel on Euthanasia of the American Veterinary Medical Association.
Certain issues in animal use may require additional justification and or clarification.
Please check below if your research protocol involves any of the following:
Captured wild animals [Complete Section IIB]Surgery [Complete Attach. 1: Surgery Procedures.]
Multiple major survival surgery [Provide rationale in Attach. 1.]
Aversive stimuli [Describe and justify use in Section IIID.]
Use of adjuvants [Complete the following form: http://researchcompliance.tamu.edu/IBC_PACKET_8_13_03.pdf]
Death (without euthanasia) as an experimental endpoint [Complete Section IIID.4]
Decapitation or cervical dislocation without anesthesia [Provide rationale in Section IIE.]
Use of hazardous materials in vivo [Complete Attach. 2: Hazardous Substances.]
a) Agents infectious for personnel. See http://researchcompliance.tamu.edu/IBC_PACKET_8_13_03.pdf for current form.
b) Hazardous chemicals (including chemical carcinogens)
c) Recombinant DNA or genetically altered materials. http://researchcompliance.tamu.edu/IBC_PACKET_8_13_03.pdf
d)Radioactivematerialshttp://researchcompliance.tamu.edu/IBC_PACKET_8_13_03.pdf
Complete the Information Below:
Investigator Name: / Department:Protocol Title:
Is this a modification or resubmission of an approved IBT Animal Use Protocol ? / Yes / No:[If yes, please list previously assigned protocol #
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FOR COMMITTEE ACTION ONLY
Pain Stress Category Assigned:
USDA Category Assigned:
Approved by IACUC / Date / Signature:Disapproved (see attachment)
Amendment to Protocol: (Must be in writing: see attachments)
Date / Modification: / Approved by :Date / Modification: / Approved by:
Date / Modification: / Approved by :
Funding Source: / Protocol Number:
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INVESTIGATOR'S ASSURANCE
Federal regulations hold Texas A&M Health Science Center responsible for the conduct of animal research at the IBT Animal Facility. In response to this requirement, the Program for Animal Resources complies with the Animal Welfare Act, the Public Service Policy for the Humane Care and Use of Laboratory Animals, and all other federal, state, and local laws that impact the care and use of animals and has developed a training manual for activities within the animal facility. Investigators, staff, and students at this facility accept responsibility for determining that their research involving animals follows these policies and regulations.
* APPROVAL OF AN ANIMAL USE PROTOCOL by the Institute of Biosciences and Technology Animal Care Committee (IACUC) is required for all vertebrate animal use. Each protocol is approved for a three year period and requires two annual reviews. Each annual review is due on the anniversary of the initial IACUC approval. A new protocol approval is required for continuation beyond the three year period.
* AMMENDMENTS Any proposed change in personnel, species usage, animal procedures, anesthesia, post-operative care or biohazards procedures that would significantly impact upon the animal portion of a study must be reported in writing to the IACUC. Committee approval of the proposed changes is required prior to proceeding with the revised animal procedures.
* INFECTIOUS BIOHAZARDS, RECOMBINANT DNA All animal research projects involving infectious biohazards and recombinant DNA, including procedures such as introduction of recombinant organisms into animals and generation of transgenic or knockout animals must be registered and approved by the TAMU Institutional Biosafety Committee
(IBC). Failure to follow the approved biohazard protocol could result in withdrawal of authorization to continue the research.
* UNANNOUNCED INSPECTIONS and observations of animal quarters and/or experimental procedures may be performed by the attending veterinary staff. Where animals are in significant, unrelievable distress, institutional veterinarians are authorized to humanely euthanize that animal. (Note: Veterinarians will always make a concerted effort to discuss such situations with investigators prior to initiating such action.)
* TRAINING OF PERSONNEL All personnel working with animals must be qualified by training and/or experience to properly do so. Such training and/or experience should be documented in the animal use protocol. All techniques will be performed as detailed in the protocol.
Signature below indicated that the investigator agrees to the terms above, that the attached protocol contains the final version of the animal care section which is to be forwarded to the granting agency.
Grant Name(s) and Number(s):Typed Name Of Investigator / If NIH funded, include a copy of Section I.C.7.F. (use of vertebrate animals) with your submission.
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Signature / Date************************************************************************************************************************************
The person designated below has provided independent scientific peer review of this study and agrees that this study is scientifically valid and worthy of investigation.
Typed Name: Signature: Date:
Title and Address if other than an IBT employee:
Funding Source: / Protocol Number:(Assigned by IACUC)
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ANIMAL USE PROTOCOL (AUP)
(Used for Institutional Review Only)
Instructions to Investigators: Answer all questions, entering "not applicable" (N/A) where appropriate. All entries are to be typewritten or of letter quality.
SECTION I. PROJECT IDENTIFICATION
A. / Investigator Name / Dept.Work Phone # / E-mail address:
Address: / City/ St, Mail Stop
B. Title of Project:
C. / Project Contact Person [Who is to be contacted in case of an animal emergency]:WorkPhone: / Emergency Phone:
D. Show the name(s) and extension(s) of each person (including the PI) working with the animals. Indicate the date(s) of the MOST RECENT investigator training session for each person. Each person should sign or initial next to his/her name to certify that the participant understands the requirements on Page 2, has the skills necessary for its performance, and has full knowledge of this protocol.
NAME & PHONE NO. / E-mail address and initials / Date of PAR Training / Add / DeleteE. Abstract: Please provide a brief statement, IN LAY TERMINOLOGY, outlining the purpose of the experimental procedures of this protocol [Provide a rationale for the experiments you wish to conduct.]
F. Animal Procedures: Describe in narrative form, using LAY TERMINOLOGY, the experimental procedures and manipulations that will be performed on the animals. [Be brief and specific in describing the animal procedures.]
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G. Justify why you chose to use this (these) species in your research. [Describe characteristics of the animal model that make it appropriate for use in your studies. This might include considerations of body size, comparative data from prior studies or unique physiological features. Cost alone is not an acceptable justification for selection of the animal model.]
H. Describe the number of animals per experiment. Include a breakdown within experiments of animals per treatment condition [include number of replications and relevant controls.] Explain why you chose a certain number of animals per treatment condition [taking into account known variation of the dependent variable, subject losses, etc. Statements such as "that required for statistical significance" are not adequate answers.]
SECTION II. ANIMAL PROCUREMENT/MAINTENANCE INFORMATION
A. Describe the total number of animals used for the duration of a 3-year protocol.
Number of Animals Used FOR the Research ProtoCOL
Species (Common Name & Scientific Name): / Number / Sex / Animal Vendor/Source: (e.g., breeding colony, transfer)B. List the strain(s) of animal(s) to be used and their phenotypic characteristics.
C. In which of the approved animal housing sites will you house your animals?
[List Room Number :]
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E. Describe any special housing, environment or other requirements necessary for this study, or diet. For special diets, provide assurance that the nutritional value is adequate. Provide details of frequency of recording diet/water administration.
F. What will happen to the animals after you complete the experiment? [If you plan to transfer the animals at the end of your study, please complete an animal transfer form prior to such a transfer. If the animals are to be euthanized, please describe the agent and method employed. Decapitation without anesthesia requires written justification below.]
Animal transferEuthanasia [Complete the section below.]
Method:
Agent:
Dose: / Route:
Justification of decapitation or cervical dislocation without anesthesia. References or personal data must be provided:
G. Name (s) of individual(s) administering euthanasia. [Note: Other than Program for Animal Resources staff, only the persons listed below will be authorized to perform the euthanasia procedure.]
H. Specify the education, training or experience which qualifies each of the persons named in Section IIG above to perform euthanasia.
SECTION III. ANIMAL PROCEDURES (Other than post-mortem tissue collection)
A. Where will you conduct the animal procedural work? [List Bldg. and Room #]:
Building: / Room:B. Briefly indicate below any nonsurgical procedures to be used. Identify each species involved [If more than one]:
1. Method of obtaining blood or other tissues: [Indicate below the technique to be used, the volume to be collected, the frequency of collection and the interval between collections. Retro-orbital and terminal bleeds require use of a suitable anesthetic.]
2. Agents to be administered (other than anesthetics/adjuvants), including dose, volume, route, & frequency:
3. Method & duration of restraint:
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4. Other procedures such as food or water deprivation, administration of noxious stimuli or substances/procedures which might induce clinical illness.
C. Anesthesia/Analgesia.
1. If anesthesia is necessary, please describe the agent to be used, dosage and route of administration for each species. [Also indicate any other preanesthetic procedures, such as duration of fasting from food and water.]
Preanesthetic: / Dosage: / Route:Anesthetic: / Dosage: / Route:
Analgesics : / Dosage: / Route:
Other Procedures:
2. Name(s) and qualifications [include education, training and experience] of individual(s) who will administer/monitor anesthesia:
D. Assessment of Pain and Distress
1. Does the project involve the use of painful procedures or paralytic drugs without the benefit of anesthetics or analgesics?
Yes / No[If yes, justify below why anesthetics/analgesics are inappropriate for your experiments]:
2. Will the procedures of your studies cause animal subjects to experience more than momentary or slight pain or distress?
Yes / No[If yes, describe the methods and sources you used to determine that alternatives to these procedures are not available. These might include computerized database searches (Medline, PubMed, Agricola).]
3. If the procedures of this experiment are expected to produce signs of clinical illness in the animals, describe those effects and explain at what point (and by what criteria) the animals may be euthanized. Also describe the frequency per day that your or your staff will observe the animals after treatment administration.
4. Is death (without euthanasia) the endpoint of the study? Yes: _; No: __
[If yes, justify why an earlier end point is not acceptable.
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E. Alternative Methods: If alternative models (other than vertebrate animals) exist, explain the reason for not using these models. If no alternatives exist, please furnish a brief explanation. “No alternatives” is not an acceptable explanation. The databases Medline, PubMed, or Agricola may be used to search for alternative methodology.
Database(s) searched: Date searched:
Search period covered:
Key words used:
Short synopsis of results of search(es):
F. Duplication of Research
1. A statement as to whether the research being conducted is/is not duplicative of other research as revealed by a detailed perusal of the literature. If duplication of research efforts is indicated, a statement of justification is required.