California State Polytechnic University, Pomona Animal Care and Use Committee (acuc)



Download 263 Kb.
Page2/3
Date08.07.2018
Size263 Kb.
1   2   3

A
accredited since 1997
nimal Use Protocol Application


The 3Rs applied to animal research: reduce, refine, replace


Submission date:

is this a revision?


RESPONSIBLE INVESTIGATOR (must be a faculty member)

Name:




Affiliation (college/dept.):




Campus phone number:




Emergency contact number:




E-mail (CPP, not Gmail or other):





ANIMAL USE PROTOCOL

Title of protocol:




Type of protocol:

___ research ___ teaching

Type of application:

___ new (de novo) ___ renewal of protocol #:

___ amendment to protocol #: _______



(use the MSWord track changes function to the approved protocol when submitting)

Responsible technician(s) (name and phone number):




Grant information (title and #, funding source and dates):




see also section IX, part 2


DECLARATION BY THE RESPONSIBLE INVESTIGATOR (faculty member): I affirm that, to the best of my knowledge, the information provided in this Animal Use Protocol Application is complete and accurate. No significant (details) changes (which would require an amendment) will be made without prior approval from the Cal Poly Pomona ACUC. I will address issues of training, safety, grant funding, and compliance with other applicable regulations.
I approve of the manner in which animal subjects will be used and will exert every effort to ensure that students and associates involved in the project are properly trained and will use the animals in a manner that is compliant with the procedure(s) described in this application. I have addressed any concerns of safety and occupational health associated with this protocol. I agree to submit the required ACUC Annual Renewals in a timely manner.
Please indicate your understanding of the above statements by entering your initials here: .


Responsible investigator (faculty)

Signature (original required)

Date











ADDITIONAL PERSONNEL: Other personnel (research associates, students, teaching assistants, volunteers, etc.) involved in this study must sign here to affirm that they have read and understood the proposed animal use procedures as well. They further affirm that they will use the animals in a manner that is compliant with the procedures described in this application. Indicate that their training with the care and use of animals has been documented within this protocol and the date when the Risk Assessment Safety Questionnaire (RASQ) was submitted. This is all required for protocol approval and animal usage.

Name

Training documented?

Date of eRASQ submission

E-mail address

(CPP, not Gmail or other)

Signature











































































































ACUC OFFICE USE

Date received:

Protocol #:

Approval date:

Renewal date:

Review type: designated member full

animal numbers

Assigned to:




This protocol has been reviewed and approved by the ACUC, California State Polytechnic University, Pomona.

A. Kristopher Lappin, PhD Date:

ACUC Chair


I. PROPOSED SPECIES, NUMBERS OF ANIMALS TO BE USED, SEX, AND HOUSING LOCATION. Complete the table below. Additional species may be added to the justification narrative below.

Species and strain

Number per year

Overall amount for 3 years

Sex

Housing location




























































Justify both the choice of species and the quantity (numbers) ‘planned’ to be used.

- For research, in each planned experiment, be sure to explicitly account for each experimental and control group and, where appropriate, statistical analyses. If animals are in short supply (e.g., an endangered species), provide a rationale (here and see Section IX, part 16) for their selection and their numbers. If any requirements exist for age and/or weight of animals, please provide justification for these specifications.

II. RATIONALE FOR THE PROPOSED USE OF ANIMALS. State briefly the broad objectives and specific aims of this animal use application intended either for teaching or research purposes. Explain succinctly, in lay terms, why these animals will be used in teaching, what knowledge will be gained by their use, or their relevance in improving human and/or animal health in a research project. Write it as if it were to be published in a community newspaper. Convince the public why animals are needed, why they must be used instead of an alternative.

III. DESCRIPTION OF THE PROPOSED USE OF ANIMALS. Provide a concise description of this teaching or research protocol with sufficient detail to allow its evaluation by the ACUC. Emphasize the animal aspects; include lab (bench) methods only as pertinent to understanding the animal usage and welfare. From the ILAR Guide: “a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee.”

A. For all proposals, be sure to include the laboratory and/or classroom location where the animal work will be performed. Will animals – live or dead – be taken away from the designated animal facility? Include, as attachments, reference materials (SOPs, lab procedures, descriptions of animal use, etc.) as part of this application. That is, do not refer to another document -- this application package must be complete and stand alone. Literature should be cited in section IX, part 19.). Include any special requests of animal facility personnel, e.g., the need for transportation of animals.


B. Summarize the husbandry requirements (caging, feed, bedding, temperature, humidity, water for drinking and for aquatics, provisions for enrichment, lighting, etc.). Note any special care or veterinary concerns. Per the ILAR Guide, single housing of social species should be the exception; to not provide for social housing must be justified and approved by the ACUC.


C. For teaching protocols, include information about the course and who will teach it. Describe the training – specific to the animals, procedures, and techniques in other sections (e.g., under euthanasia in V.D and generally in VIII).


D, For research protocols, include, as appropriate, the research design, outline of the experimental procedures (e.g., breeding, surgery, manipulation, what tissues or other samples will be collected, the kinds of observations in behavioral or field studies), description of other methods to be used, data analysis, and literature references.



IV. PROCEDURES TO LIMIT DISCOMFORT, PAIN, OR DISTRESS. Complete the table below.

For "Pain Classification," indicate one of the following:

"A" for procedures which involve no pain or minimal distress to the animals studied (e.g., demonstrations, most nutrition studies, injections, venipuncture, tail biopsy at less than 30 days of age).

"B" for procedures where pain or distress will be controlled by the use of anesthetics, analgesics, or tranquilizers (e.g., surgical techniques, blood sampling under tranquilizer, tail biopsy at more than 30 days of age). Complete Section IX, subsection 6.

"C" for studies where pain relieving drugs cannot be used to control pain (e.g., pain studies, or experiments where drug use would negate the design). Complete Section IX, subsections 3, 4, and 5, as relevant.

Species and strain

Number per year

Total number for 3 years

Sex

Pain classification

A, B, or C





























































V. METHOD OF EUTHANASIA. All applications must include this section, even if euthanasia is not the intended means of disposal of animals when ending the protocol, as it may become necessary in an emergency or as the result of an irreversible decline in the health of an animal. Note: death must be assured before discarding the carcass.



  1. Planned number of animals to be euthanized – zero is acceptable:


  1. Describe the procedure to be employed, including the name, dosage, and route of administration if a chemical agent is to be used.


  1. How will death be assured? (one method is to open the thoracic cavity of each animal and cut into the heart)


  1. Who will perform the euthanasia task? Name the individual(s) and describe their qualifications (specific experience and training). (It is not acceptable to say, for example, the vet tech will do it.)


  1. Does the procedure comply with guidelines appropriate to the animal (link to the American Veterinary Medical Association Guidelines on Euthanasia for typical species; consult other guidelines for non-traditional species)? Yes or No: .

If not, please justify:

VI. ALTERNATIVES TO THE USE OF LIVE ANIMALS. According to federal law, alternatives to the use of live animals must be considered by the PI. Alternatives – the 3 Rs - have been broadly defined to include: procedures that reduce the number of animals used (e.g., special statistical designs, sharing animals/specimens with several projects, etc.); refinements that decrease the pain or distress experienced by the animal; and methods that replace animals with non-animal alternatives or employ the use of animals with a lower taxonomic status. In some cases the 3Rs may actually entail using more animals to obtain significance and reduce the amount of pain and distress suffered by a single animal.

  1. If your protocol includes any procedures to reduce or refine, please describe briefly.


  1. If any alternatives (reducing, refining, or replacing) are available, and they are not being used, you must explain what they are and why they are not being used. This may be the case with some teaching protocols, where hands-on activity is required, or federally-mandated animal testing. Further, in the case of painful and/or distressful procedures, this must be justified per USDA’s policy 12 (http://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf).


  1. If no alternatives (reducing, refining, or replacing) are available, please explain why.


  1. For pain class 'B' and 'C' proposals, if no alternatives are available (as indicated in Section VI. C), then you must fully explain the basis for this assertion. If an electronic literature search constitutes part of the basis for this assertion, please provide:

  1. The approximate date(s) you conducted the search:



  1. What source(s) were searched:



  1. What key words were used in the search:



  1. The date range (time period, e.g., 2005 thru 2016) of the search:


VII. UNNECESSARY DUPLICATION. Federal regulations prohibit the unnecessary duplication of animal uses. The ACUC at Cal Poly Pomona recognizes that, sometimes, duplication may be necessary (e.g., pilot projects, teaching laboratory exercises, and student research projects that are intended to provide hands-on experience with techniques or equipment or to stimulate the students' intellect).

  1. Does the proposed use of animals duplicate previous experimentation on the same species by anyone?


  1. If the protocol does duplicate previous experimentation on this species, why is the duplication necessary?


  1. If the protocol does not duplicate previous work, what is the basis for this assertion? (That is, are you familiar with the research in the field by virtue of your acknowledged expertise, as the result of your review of the literature, etc.? If your review of the literature involved a computerized search of one or more literature databases, please provide details of the databases, dates covered, and topics or keywords searched.)

VIII. TRAINING IN PROCEDURES WITH LABORATORY ANIMALS. Complete the appropriate section here, describing the training and hands-on experience of all persons involved with this protocol. Competence is a measure of knowledge, skills, and aptitudes (KSAs). Be specific to the techniques, manipulations, and animals which are to be used in this protocol. Include your (and others’) CITI training transcript number and date of completion. Write as if explaining everyone’s abilities to an auditor or inspector. Describe the roles and responsibilities of persons specifically named as additional personnel on the signature page of this application. The protocol and amendments which add personnel to approved protocols cannot be approved until training is completed and documented.

  1. Research projects: For all participating individuals (principal investigator/faculty member, graduate students, undergraduate students, McNair scholars, collaborators, etc.), summarize the training pertinent to this investigation. Include on-line courses (e.g., AALAS learning library, CITI program), certifications, experience, classroom training, continuing education, workshops, etc. Personal training records must be kept for review, which should include who was trained, who did the training, what type of training was done, and when. In summary form, describe that here. And indicate here who is responsible for maintaining these training records in the lab or environment where the animal usage will occur.


  1. Teaching/laboratory projects: As the instructor (which includes teaching assistants), summarize your specific experience with the animals to be used and the associated procedures. In addition, describe the training to be given to the students relative to laboratory animals, which is not covered in the animal use sections II and III. Attach pertinent documents such as syllabi to the on-line ePS. Because students are being taught, they do not need CITI training, though some instructors assign parts of the curriculum.

IX. SECTIONS TO BE SUBMITTED. From the following list indicate which topics, as appropriate, are to be included in this proposed protocol by placing a check (or X) in front of the subsection number. Do not mark subsections that are not relevant to your protocol. Complete and submit ALL PARTS of the subsections you have checked.




1.

TEACHING LABORATORY EXERCISE




2.

RESEARCH PROJECT (FACULTY OR STUDENT)




3.

PAIN CLASSIFICATION "C" (see definition above)




4.

ALTERNATIVES TO DEATH AS AN END POINT




5.

PROLONGED RESTRAINT




6.

PROCEDURES INVOLVING SURGERY, GENERAL ANESTHESIA, SEDATION, TRANQUILIZATION (must also include subsection 5 of Section IX)




7.

SURGERY FOLLOWED BY RECOVERY (must also include subsections 5 and 6 of Section IX)




8.

REPEATED SURGERY ON THE SAME ANIMAL (must also include subsections 5, 6, and 7 of Section IX)




9.

COLLECTION OF ANIMAL TISSUES OR FLUIDS (from live animals)




10.

MAINTENANCE OUTSIDE OF DESIGNATED ANIMAL HOUSING FACILITIES (> 12 consecutive hours)




11.

AQUATIC SPECIES (fish, amphibia, and aquatic reptiles)




12.

USE OF HAZARDOUS MATERIALS




13.

USE OF BIOHAZARDS




14.

USE OF TEST SUBSTANCES




15.

USE OF CONTROLLED SUBSTANCES




16.

MEANS OF DISPOSAL OR FURTHER USE FOR ANIMALS NOT EUTHANIZED




17.

RESEARCH OR TEACHING UTILIZING WILD ANIMALS




18.

WORK TO BE CONDUCTED OFF-CAMPUS (INCLUDING FIELD RESEARCH AND TEACHING)




19.

COLLABORATORS OR EXPERTS CONTRIBUTING TO THE PROJECT




20.

LITERATURE CITED FOR RESEARCH PROJECT (FACULTY OR STUDENT)




21.

INVESTIGATOR PUBLICATIONS RESULTING FROM PREVIOUS USE OF ANIMALS IN RESEARCH




Share with your friends:
1   2   3


The database is protected by copyright ©dentisty.org 2019
send message

    Main page