IACUC Instructions for Protocol Submission

IACUC Instructions for Protocol Submission

Principal Investigator

The protocol, c.v., and appropriate supporting literature must be typed. Handwritten protocols will not be reviewed by the IACUC.

Submit the protocol to your Department Chair, who will sign it and forward it to the IACUC.

All correspondence related to the protocol will be addressed to the Department Chair.

One form can be used for multiple species. When completely different procedures are planned for different species, then multiple forms and protocols should be submitted.

If the animal procedures are identical, one protocol can be used to support several research projects or classes.

The title of the protocol may be included in the IACUC minutes, which, if requested, are available to the public. Therefore, the title should not contain proprietary or other confidential information.

If the protocol includes proprietary information, the PI should notify the IACUC via the Chair in writing. The IACUC will seek legal counsel and notify the PI via the Chair before responding to any request for release of this information.

Department Chair

The Department Chair will keep a copy of the protocol's first page (Statement of Assurances) before the protocol is forwarded to the IACUC.

The Department Chair obtains all appropriate signatures before submitting the protocol to the IACUC.

The third and fourth pages, items 2-7, which contain animal care information for the appropriate animal technician, should be forwarded by the Department Chair to the technician, and should not be released to anyone else.

California StateUniversity, Sacramento

Institutional Animal Care and Use Committee Protocol

Statement of Assurances

COURSE/PROJECT: ______DURATION: ______EXPIRES: ______

1.University Assurances for the Humane Care and Use of Vertebrate Animals

PRINCIPAL INVESTIGATOR/COURSE INSTRUCTOR STATEMENT:

I have read and agree to abide by CaliforniaStateUniversity, Sacramento’s and related guidelines as contained in A Manual for Facilities and Care of Animals Used in Research and Instruction. I further agree to abide by any IACUC decisions related to this protocol. The project will be conducted in accordance with the NIH Guide for the Care and Use of Laboratory Animals except as explained below. I will abide by all federal, state, and local laws and regulations governing the use of animals in research and teaching. I will advise the Institutional Animal Care and Use Committee in writing of anything other than minor changes in the procedures described in this protocol.

______

Principal Investigator/Instructor Title/RankDate

DEPARTMENT CHAIR/DEAN/DIRECTOR STATEMENT:

The personnel conducting this project are appropriately qualified and trained in the subject area under study. Personnel with substantial animal contact may be required to participate in a medical surveillance program as proscribed by Environmental Health and Safety (EHS).

______

Department Chair (Dean/Director if applicable)Date

The Department Chair is to keep this page on file (do not release or forward this page.)

Note: Copies of the NIH Guide and the university’s Manual may be obtained from the Office of Research Affairs website:

COURSE/PROJECT: ______DURATION: ______EXPIRES: ______

2.Personnel Information:

Principal Investigator/Instructor: ______

Phone: ______Department: ______E-mail: ______

Co-Investigator: ______

Phone: ______Department: ______E-mail: ______

Technician: ______

Phone: ______Department: ______E-mail: ______

Student(s): ______

Phone: ______Department: ______E-mail: ______

Student(s): ______

Phone: ______Department: ______E-mail: ______

3.Location of animal housing (building and room or vivarium): ______

a. overnight: ______

b. day use only: ______

4.Abstract of research/teaching plan for use by the animal facilities staff. (Give a brief layman’s description of the procedures employed on the animals in this project.)

5.Exceptions, if any, to NIH Guidelines

1. Are there special requirements for maintaining the animals?

[ ] NA [ ] Yes [ ] No

If Yes, indicate your requirements below. If you have no special requirements, animals will be maintained according to the standard operating procedure approved by the IACUC as specified in this protocol.

1. Temperature (oF): o___; humidity (%): %___; hrs. light: ____; hrs. dark: ____

1. Caging: type: ______size: ______

filter tops? ______cage changes per week: ______

1. Bedding/litter: type ______

autoclaved? ______bedding changes per week: ______

d. Type of water (e.g., sterile, deionized, acidified, tap):______

e. Diet and feeding requirements: What diet? ______

If other than ad lib feed and water, state amounts: ______

f. Other special instructions for animal care staff:

7.Special requirements (Check all applicable boxes): [ ] NA Reason: ______

______

Instructions for Disposition Instruction for Disposition Pest control

of Sick Animals of Dead Animals Requirements

[ ] Call Investigator [ ] Call Investigator [ ] None

[ ] Clinician to treat [ ] Clinician to treat [ ] Pest Strip

[ ] Terminate [ ] Bag for disposal [ ] Pyrethrin

Specify ______

The Department Chair is to forward these two pages to appropriate department animal technician only (not to be released or forwarded to any one else).

California State University, Sacramento

PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE ANIMALS

Federal animal welfare regulations require that the Institutional Animal Care and Use Committee (IACUC), MUST review and approve all activities involving the use of live “covered” animals PRIOR to their initiation. This includes animals used or intended to be used in research, tests (including teaching and production), or experiments. Protocols must be reviewed every six months, approved yearly, and (if the research or instruction is to continue) re-written every three years.

1.Protocol Title (should be descriptive of the animal use activity):

2.Project Duration (3 years unless otherwise specified):

3.Principal Investigator/Study Director:

Department:

c.v. Included?Yes____No____

Others involved in procedural activities using live animals: (students, technician, others)

1. Name:______

Department:______

c.v. Included?Yes____No____

1. Name:______

Department:______

c.v. Included?Yes____No____

4.Section 2.31(e)(1) Primary species to be used:______

Number of animals to be used:______

Are special permits needed? Yes____ No____

Sex:____Age or WeightRange:______

Secondary species to be used:______

Number of animals to be used:______

Are special permits needed? Yes____ No____

Sex:____Age or WeightRange:______

1. Methods used to validate this research, training, or testing protocol.

1. Commonly accepted procedure (textbooks, etc.):

1. Expert review (consultant, when, etc):

1. Collaboration with colleagues (who, date, etc):

1. Educational seminar covering this subject (what, date, where):

1. Databases searched, literature reviewed:

Date:

Years covered:

KeyWords/Category:

1. As per Section 2.31(d)(i)(ii)(iii),(e)(2) answer the following:

1. The protocol is necessary and is refined as much as possible and does not duplicate previous work: Yes____ No____

Explain:

1. The principal investigator has searched for the replacement of animals and the use of animals is appropriate:

Yes____No____

Explain:

1. The principal investigator has searched for the lowest animal species available:

Yes____No____

Explain:

1. The number of animals to be used has been reduced as much as possible:

Yes____No____

Explain:

1. A search was conducted for alternatives to painful procedures (acute and chronic) and alternatives are not available: Yes____ No____

Explain:

1. Section 2.31(e)(3)(4): Provide a complete description of the proposed use of animals in the space below:

a.Will the animals be exposed to radioactive materials, infectious agents, or known carcinogenic or highly toxic chemicals which may pose a risk to personnel or to other animals? Section 2.31(c)(1) Yes____ No____

If yes, explain risk and safety procedures to be followed by laboratory personnel (for infectious agents also indicate the appropriate biosafety level):

b.Will unanesthetized animals be catheterized, intubated or have blood collected? Yes____ No____

If yes, describe (method, amount, frequency):

c.Will animals be anesthetized or tranquilized during the study other than for surgical procedures? Yes____ No____

If yes, describe:

d.Will unanesthetized animals be restrained by chairs, slings, tethers, stanchions or other devices? Yes____ No____

If yes, explain

• Method of restraint:
• Duration of restraint:
• Frequency of restraint:
• Observation during restraint:

e.Will animals be deprived of food or water for greater than 24 hours?

Yes____No____

If yes, explain. Provide justification and description of monitoring procedures:

f.Are surgical procedures employed?Yes____No____

If no, go on to “g”. If yes, complete this section. (All survival surgery must be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major survival surgery on non-rodents, including rabbits, must be conducted in an aseptic surgical suite location in the animal facility. Non-major survival surgery, and all surgery on rodents, may be performed outside of the surgical suite but must be performed using aseptic procedures). Section 2.31(d)(2)(ix)

(1) Check the statement that describes your project:

___Non-survival surgery (animals are euthanized under anesthesia without regaining consciousness.

___Minor survival surgery.

___Major survival surgery (penetration and exposure of a body cavity, or resulting in a permanent impairment of physical or physiological functions).

(2)Describe surgical procedure:

(3)Location where surgical procedures will be performed:

(4)Preoperative care, anesthesia, and monitoring/supportive care during surgery and post-operative care. Procedures are to be determined and performed in consultation with the Campus Veterinarian.

a)Preoperative care (type, dose, route of administration of antibiotics, sedatives, medications prior to induction of anesthesia or any special care such as fluids, fasting, etc.):

b)Anesthesia/analgesia (type, dose, route of administration of anesthetics, analgesics or sedative/tranquilizing agents employed to prevent pain and distress during surgery):

c)Monitoring and supportive care during surgery (fluids, oxygen, antibiotics, etc.):

d)Post-operative support care and drug therapy (fluids, antibiotics, analgesics, etc., including route of administration, frequency and dose.):

g.Section 2.31(e)(5) euthanizing animals?Yes____No____

If yes, describe procedure. Include method, product, dose, and route of administration.

If no, describe the disposition of the remaining animals:

Does the procedure meet the recommendations of the AVMA Panel on Euthanasia? ( Yes____ No____

1. Section 2.31(1)(iv)(B) The attending veterinarian, or designee, was consulted in the planning of these potentially painful/distressful procedures.

______

Signature of Campus Veterinarian Date

1. Principal Investigator Statement of Assurance: Please check the appropriate answer (Note: A negative answer to any statement requires a detailed, written explanation):

1. Section 2.31(1)(iv)(A)(C): The procedures are designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals (unrelieved pain/distress must be justified for scientific reasons and should continue for only the necessary period of time). Yes____ No____

1. Section 2.31(d)(1)(iv)(c) Paralytics will not be used without appropriate anesthesia.

Yes____No____

1. Section 2.31(d)(1)(v) Animals that would otherwise experience severe or chronic pain/distress that cannot be relieved will be euthanized at the end of the procedure, or if appropriate, during the procedure.

Yes____No____

d.Section 2.31(d)(1)(vi) The animal’s living conditions, includinghousing, feeding, and non-medical care, will be appropriate for the species, contribute to their health and comfort, and will not deviate from USDA standards.

Yes____No____

e.Section 2.31(d)(1)(vii) Medical care for animals will not be withheld and will be available and provided or supervised as necessary by a qualified veterinarian.

Yes____No____

1. Section 2.31(d)(1)(viii) Personnel conducting animal procedures will be appropriately qualified and trained in those procedures and the training and qualifications of such personnel have been appropriately documented.

Yes____No____

1. Section 2.31(d)(1)(x) No animal will be used in more than one major operative procedure from which it is allowed to recover unless scientifically justified or required as a veterinary procedure.

Yes____No____

______

Signature of Principal InvestigatorDate

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1. Principal Investigator Statement of Assurance of Completion of Required Training

Principal investigators with active protocols must complete the online CITI Basic IACUC Course every three years. This training will be verified by the IACUC at the time of each new protocol approval and at the annual renewal of all active protocols.

For information on registering a new CITI account go to the following link:

and view the IACUC page under the Research Integrity and Compliance tab.

Please initial and provide the date of completion of the required course.

CITI Basic IACUC Course Date Completed PI Initial

Animal Subjects Investigators and Staff

In addition to the basic course listed above, PIs must also complete any of the following species specific courses IF they are relevant for the proposed research:

Date Completed PI Initial

Working with Amphibians in Research Settings

Working with Zebrafish in Research Settings

Working with Mice in Research Settings

Working with Rats in Research Settings

Working with Fish in Research Settings

Working with Reptiles in Research Settings

1. Principal Investigator Assurance of Required Training of Student and Staff Assistants

It is ultimately the responsibility of the principal investigator to ensure that any students or staff providing assistance on an approved protocol receive the proper training.

Students and staff assisting PIs are required to complete the Animal Subjects Investigators and Staff CITI course described above.

______

Signature of Principal InvestigatorDate

1. To be completed by the IACUC Chair or designee. The Principal Investigator or committee member who is involved in the activity may NOT review or vote on the approval of the project. Assuming a committee quorum is present, a majority of those members in attendance may approve the activity at the meeting. Section 2.31(d)(2)

1. Protocol Number:______
2. Date:______

c.Type of Review*DMR ____New Protocol ____ Annual Rev. ____

d.Protocol Approved: Yes____No____

e.PI has met CITI training requirements: Yes____No____

Note: If training requirements have not been completed PI must be notified that the protocol has been placed in an inactive state until training is completed.

f.Signature of reviewer(s). (Can be chair or designee).

______

______

______

______

1. USDA Reporting Category (Annual Report APHIS Form 7032) Section 2.36 (to be completed by Campus Veterinarian)

______ Column C – No Pain/Distress.

______Column D – Pain/Distress relieved by use of drugs or other means.

______ Column E – More than momentary pain or distress that is unalleviated by drugs or other means due to experimental necessity.

h.Department Chair notified in writing on ______Section 2.31(d)(4)

(The Department Chair may forward this page to the Principal Investigator.)

i.Conditions of Approval/Modifications

*Designated Member Review (DMR) of new protocols or modifications toprotocols can be performed by the campus veterinarian and if necessary an additional member of the IACUC designated by the Chair. Prior to DMR the new protocol or modification will be distributed to the entire IACUC for a period of 5 business days and if any voting member requests full committee review then that method must be used. Protocols receiving DMR approval will be given full committee review at the next IACUC meeting.

Comments/Notes by Research Administration:

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