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Animal Research Information and Application/Registration Forms

(FORMS at end of this page)

Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals


Chapman University, hereinafter referred to as Institution, hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.

I. Applicability

This assurance is applicable to all research, research training, experimentation, and biological testing and related activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at this institution, or at another institution as a consequence of subgranting or subcontracting of a PHS-conducted or supported activity by this institution.

II. Institutional Policy

A. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.

B. This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."

C. This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance. As partial fulfillment of this responsibility this institution will make a reasonable effort to insure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.

D. This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals.

III. Institutional Program for Animal Care and Use

A. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy begin with the individual investigator. The investigator submits relevant research and teaching applications and progress reports to the Institutional Animal Care and Use Committee (IACUC). This committee is composed of five members in accordance with PHS Policy at IV.A.3.b. This committee will provide monthly reports to the University Institutional Review Board (CUIRB). The veterinarian of the IACUC will provide independent reports to the IRB or to any other requesting official of the College. The IRB will report at least once a month to the Vice President of Academic Affairs. Final reports will be provided to and final decisions will be provided by the Executive Vice President.

B. Veterinary care will be provided by a licensed Doctor of Veterinary Medicine with over eighteen years of private practice and clinical experience. The veterinarian is very familiar with the animal colonies at the institution and has provided both routine care and acute and chronic treatment of colony animals over the past two years. The veterinarian will provide ten to fifteen hours per week of treatment and supervision in addition to any emergency care and to participating in all IACUC meetings. The veterinarian will operate in complete conformance with Section 3 of the Guide to the Care and Use of Laboratory Animals. This includes: a) daily observations of colony animals to assess their health and welfare; b)use of appropriate preventative, diagnostic, control, and treatment methods; c)guiding users in animal handling, immobilization, anesthesia, analgesia, and euthanasia; and d)monitoring surgical and post-surgical care.

C. This institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures. The IACUC consists of at least five members, and its membership meets the compositional requirements set forth in the PHS policy at IV.A.3.b. Appendix A contains a list of the names, position titles, earned degrees and other credentials of the IACUC chairperson and members.

D. The IACUC will:


1.  Review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation.

2.  Inspect at least once every six months all of the institution's animal facilities using the Guide as a basis for evaluation.

3.  Prepare reports of the IACUC evaluations as set forth in PHS Policy at IV.B.3. and submit the reports to the chancellor of the university.

4.  Review concerns involving the care and use of animals at the institution.

5.  Make written recommendations to chancellor of the University regarding any aspect of the institution's animal program, facilities, or personnel training.

6.  Review and approve, require modifications in (to secure approval) or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C.

7.  Review and approve, require modifications in (to secure approval) or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C.

8.  Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in PHS Policy at IV.C.4.

9.  Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.

E. The Procedures which the IACUC will follow to fulfill the requirements set forth in the PHS Policy at IV.B. are as follows:

1.  The IACUC will meet the third Wednesday of each month at 3:00 p.m. It shall be the purpose of these meetings to review new proposals and progress reports and to conduct and evaluate site visit reports on continuing research.

2.  The IACUC will inspect the primary animal facility at least every three weeks. Inspections will not be advertised, and they may occur more frequently if deemed necessary at any level of the reporting process as specified in Section III.A. of this Assurance. The inspection committee will be composed of at least three members of IACUC, including the veterinarian. The inspection committee will be designated at the first IACUC meeting of the academic year.

3.  The inspection of animal facilities will include, but not be limited to the following major areas:


a.  Inspection of animal cages. All animals shall be housed in IACUC-approved cages. Excrement trays will be fully covered with sanitary, 24 hours old bedding.
b. Cage sanitizer will be inspected to insure satisfactory operation.
c. Inspection of dishwasher and autoclave. Glassware, plastic water bottles shall be inspected for soap residue and cleanliness. Cultures will be taken randomly from water bottles and evaluated in the College laboratories for the presence of microbial contamination. Reports will be provided directly to the IACUC.
d. Inspection of air conditioning and heating systems. Air circulation and temperature will be evaluated.
e. Inspection of bedding and food. Bedding and food will be kept in a separate storage closet, which will be routinely inspected in terms of adequacy. Random samples of food will be collected and evaluated in the College laboratories for the presence of contamination. Reports will be provided directly to the IACUC.
f. Safety inspection. The facility will be evaluated for compliance with local and state occupational safety codes. Included will be the assurance that all hazardous materials are kept in approved containers and stored in an area separate from the animal housing area.

4.   The Inspection Committee shall complete an evaluation form which will be filed with the IACUC. A separate Veterinary Report will be completed by the IACUC veterinarian and filed with the IACUC. The Veterinary Report will be filed weekly. The IACUC shall review the Inspection Committee Report. Where concerns are indicated, the following actions will occur:

a. The Facilities Director will be notified in writing by IACUC. The director will have five (5) days upon receipt of notice from the IACUC to file a report to the IACUC indicating either that the problem has been corrected or indicating a schedule for correcting the problem.
b. The principal investigator of all affected projects will be notified in writing by the IACUC.

5.   The IACUC will report to the Institutional Official assuring PHS compliance within three (3) days of each IACUC meeting. The Institutional Official will be informed of any problems or deficiencies, and a timetable will be given for the correction of problems and for the resumption of compliance with IACUC guidelines.

F. The individual(s) authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals is Steven Schandler, Ph.D., Chair, Chapman College Institutional Review Board.

G. The health program for personnel who work in laboratory animal facilities or have frequent contact with animals includes:

1.  Medical examinations by College medical staff every academic semester.

2.  Seminars in animal care and handling by the IACUC Veterinarian presented to animal care personnel every academic semester. These seminars cover the importance of appropriate laboratory garments (lab coats, masks, gloves), cleanliness of garments, and the importance of personal hygiene before and after animal contact. Basic first aid is also covered.

3.  In-service courses covering correct washing and sterilization procedures, animal handling and feeding, cage maintenance, microbial assay (culturing), and room cleaning.

H. The animal care facility contains 250 square feet (21,600 square inches). The largest animals contained will be 3 Kg rabbits. These animals will be housed in 20" X 40" cages. There will be two animals per cage, and there will never be more than six (6) animals housed in the facility. Rats and mice currently are housed in 12" X 12" cages, with two animals per cage, and no more than 20 animals in the facility. The walls of the facility are shower tile-type with central drainage for cleaning and dedicated heating and air-conditioning units. All cages are PHS-approved, and they are cleaned and sanitized daily with a sterilized water delivery system. Facility staff are sensitive to housing animals with compatible behavior qualities.

I. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, and use are offered by the Vivarium staff during regular seminars, and by those academic departments directly involved in the sponsoring of animal research. All research will be evaluated by the Institutional Review Board to insure that animal distress will be minimized and that the minimum number of animals will be used to obtain valid results. The IRB guidelines and relevant forms are supplied in Appendix B.

IV. Institutional Status

As specified in the PHS Policy at IV.A.2., as Category 1, all of the institution's programs and facilities (including satellite facilities) for activities involving animals are being evaluated for accreditation by the American Association for Accreditation of Laboratory Animal Care. All of this institution's programs and facilities for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months.

V. Recordkeeping Requirements

A. This institution shall maintain for at least three years:

1.  A copy of this Assurance and any modifications thereto, as approved by PHS.

2.  Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.

3.  Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.

4.  Records of semiannual IACUC reports and recommendations as forwarded to Hans Jenny, Ph.D., Executive Vice President of the College.

5.  Records of accrediting body determinations.

B. This institution will maintain records that relate directly to application, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the activity.

C. All records shall be accessible for inspection and copying by authorized OPRR or other PHS representatives at reasonable times and in a reasonable manner.

VI. Reporting Requirements

A. At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to the Office for Protection from Research Risks (OPRR):


1.  Any change in the status of the institution (e.g., if the institution becomes accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution's program for animal care and use as described in this Assurance, or any changes in IACUC membership. If there are no changes to report, this institution will submit a letter to OPRR stating that there are no changes.

2.  Notification of the date that the IACUC conducted its semi-annual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to Hans Jenny, Ph.D., Executive Vice President of the College.


B. The IACUC, through the Institutional Official, will provide the OPRR promptly with a full explanation of the circumstances and actions taken with respect t

1.  Any serious or continuing noncompliance with the PHS policy.

2.  Any serious deviations from the provisions of the Guide.

3.  Any suspension of an activity by the IACUC.

C. Reports filed under VI.A.2. and VI.B. above shall include any minority views filed by members of the IACUC.
 

U.S. INTERAGENCY RESEARCH ANIMAL COMMITTEE

Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training

The development of knowledge necessary for the improvement of the health and wellbeing of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered t


1.  The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et.sep.) and other applicable Federal laws, guidelines, and policies.*

2.  Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.

3.  The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.

4.  Proper uses of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.

5.  Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.

6.  Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.

7.  The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian.

*For guidance throughout these Principles, the reader is referred to the "Guide for the Care and Use of Laboratory Animals" prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences.


PROJECT SUBMISSION INFORMATION

          Animal protocols require 1 month for review.


FORMS


Download Required Information: "Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training" (Word) (PDF)

Download Form: Application for Research with Animal Participants (Word) (PDF)

Download Form: Instuctor's Application for Classroom Assignments Involving Animal Research Subjects (Word) (PDF)

Download Form: Notice of Adverse Event or Complication (PDF)

Download Form: Request for Modification (Word) (PDF)

Download Form: Project Continuation/Termination Request and Completion Report (Word) (PDF)

getacro These PDF forms require Adobe Acrobat Reader. Click here for free download.

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