Institutional Animal Care and Use Committee (Iacuc) s4

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

987830 Nebraska Medical Center

Omaha, NE 68198-7830

402/559-6046

Fax 402/559-3300

IACUC Annual USDA Review_1.11

USDA Annual Review

IACUC#:

TITLE OF PROTOCOL:

PRINCIPAL INVESTIGATOR:

DEPT:

CAMPUS ZIP:

PHONE:

EMAIL ADDRESS:

I. PROTOCOL STATUS: Indicate the status of this project.

Request Protocol Termination - If termination is requested, complete Section I only and submit to the IACUC.

1. Inactive - project never initiated.

2. Currently inactive - project initiated but will not be completed.

3. Completed - no further activities with animals will be performed on this protocol.

Note: If you check 1-3 above, the IACUC will terminate your protocol!

Request Protocol Continuance - If continuance is requested, complete Sections II-III.

4. Active - project on-going.

5. Currently inactive - project was initiated but is presently inactive.

6. Inactive - project never initiated but anticipated start date is .

II. REVIEW INFORMATION (PROTOCOL CONTINUANCE) - The IACUC requests the following information, as applicable, if you are requesting protocol continuance. Information must be typed. Use additional pages as necessary.

A. Consideration of Alternatives. Federal regulations require that investigators consider whether new or alternative techniques or methods are available that would allow for replacement, reduction, or refinement of animal use. These include methods that use non-animal systems or less sentient animal species to partially or fully replace animals, methods that reduce the number of animals to the minimum required to obtain scientifically valid data, and methods the refine animal use by lessening or eliminating pain or distress. Any method that could reduce animal use or animal pain or distress without affecting the research outcome should be incorporated into a protocol.

1. Replacement of Animals. Have alternatives to the use of animals that could be employed to achieve any of your specific aims become available?

YES

If YES, please explain and justify, why the use of these alternatives can not

be substituted to achieve your specific aims.

IACUC Annual USDA Review_1.11

2. Reduction of Numbers of Animals Used. The number of animals used should be the minimum required to obtain scientifically valid data. Your animal numbers were justified in the original application and/or Request for change and approved. Since the last IACUC approval has anything changed that would allow for a reduction in the animals numbers?

YES

If YES, please explain and justify, why the use of these alternatives can not

be substituted to achieve your specific aims.

IACUC Annual USDA Review_1.11

3. Refinement of Technique-Alternatives to Potentially Painful/Distressful Procedures. Please address the following if your project is a Pain Category D1, D2 or E protocol. Have alternatives that are potentially less painful and distressful that could be used to achieve any of your specific aims become available?

YES

If YES, please explain and justify, why the use of these alternatives can not

be substituted to achieve your specific aims.

IACUC Annual USDA Review_1.11

B. Duplication. Activities involving animals must not unnecessarily duplicate previous experiments. Provide written assurance that the activities in this project remain in compliance with the requirement that there must be no unnecessary duplication.

IACUC Annual USDA Review_1.11

C. Problems/Adverse Events. During the last year, have any unanticipated adverse events, morbidity or mortality occurred?

YES

If YES, describe the circumstances, causes (if known), and resolution of the

problem(s)

IACUC Annual USDA Review_1.11

D. Exceptions. Does the protocol include previously approved exceptions as listed below to regulations/guidelines/polices?

YES, continuation of an approved exception is requested.

If YES, please mark all that apply

IACUC Annual USDA Review_1.11

Housing outside the centralized

facility for > 12 hours

Use of non-pharmaceutical grade

agents

Physical restraints on awake

animals

Use of an animal in more than one

major survival surgery

Exception to Non-Human Primate

Behavior Management Program

Exception to the Dog Exercise Plan

Exception to standard space requirements

Exception to standard temperatures

Exceptions to standard cleaning or sanitation

Exceptions to standard lighting cycle

Use of expired drugs/devices

Use of food/fluid restriction

Other:

IACUC Annual USDA Review_1.11

E. Progress Report. Provide a brief progress report covering the last year for this project. Include specific aims you have addressed to date and results obtained. Include references to any publications that have resulted from this research.

IACUC Annual USDA Review_1.11

F. Comments.

IACUC Annual USDA Review_1.11

III. Study Personnel: Responsibilities, Qualifications and Experience. On a separate page for each individual listed on the protocol complete sections 1-5 for an updated summary of responsibilities, qualifications, and experiences. Note: All individuals who will perform procedures must be knowledgeable about the biology of the species under study and must be fully qualified by training and experience to carry out the procedures assigned to them OR have a proposed training plan. All individuals who lack specific procedural qualifications or training may be trained under the direct supervision of qualified experienced personnel.

DO NOT USE THIS SECTION TO ADD NEW PERSONNEL.

Any addition of personnel requires the submission of a request for change form.

Personnel designated to receive copies of IACUC correspondence:

Email:

For each person, address all the following, in sequence.

1. Name:

Choose a Role:

__ Principal Investigator __ Secondary Investigator

__ Research Associate __ Postdoctoral Associate

__ Technician/Technologist __ Student __ Faculty Advisor

2. Responsibilities: Indicate the specific responsibilities of this named individual for this protocol. Each of the procedures must be fully described in the appropriate sections of the IACUC application (do not repeat a detailed description of each procedure). Ensure that all responsibilities and procedures listed in the protocol are assigned to an individual. Do not include any responsibilities that are not relevant to this protocol.

__ Supervision of the Protocol

__ Breeding Colony Management

__ Surgical (Identify the specific surgery):______

__ Non-Surgical (Identify the specific procedure):______

__ Preparative regimen

__ Pain Control

__ Post-procedure monitoring

__ Euthanasia

__ Care of the Animals

__ Other

(Specify):______

3. Relevant Training and Experience.

a. For each responsibility identified in section 2, describe how this named individual received his/her training/experience.

b. For each responsibility, provide the length of time the individual has performed/supervised the procedure(s).

c. For each responsibility, provide the number of times the individual has performed/supervised the procedure(s).

4. Knowledge of Species

a. Describe the educational background that has provided this individual with his/her knowledge of the biology (i.e. behavioral, physiological, and/or anatomical characteristics) of the selected species and/or strain?

b. Provide the length of time this individual has worked with this species.

5. Proposed Training (if applicable) If this individual has not received the necessary training for any

listed responsibilities assigned in section 2, describe the following:

a. Responsibilities listed in section 2 for which they will be trained.

b. Detailed description of the training they will receive.

c. Expected date of completion of the training.

d. Experienced personnel who will provide the training.

Note: Upon completion of the training, you must submit a “Documentation of Training” form to the IACUC. Until that form has been submitted, the PI must ensure that all listed study personnel that are to be trained will be supervised by qualified individual(s). Submission of this form certifies that the individual is qualified to work independently.

6. List Personnel to Be Deleted (PI should ensure that responsibilities of these personnel are covered by remaining or added personnel):

IACUC Annual USDA Review_1.11

IV. CERTIFICATION OF PRINCIPAL INVESTIGATOR - My signature below or electronic submission of this form certifies that:

· I understand the requirements of the PHS Policy on Humane Care and Use of Laboratory Animals, applicable USDA regulations and UNMC/UNO policies governing the use of live vertebrate animals for research or teaching purposes.

· I will continue to conduct the project in full compliance with the aforementioned requirements.

· The IACUC-approved protocol, including all amendments, is accurate and up to date.

IACUC Annual USDA Review_1.11

Signature: ______Date: ______

IACUC Annual USDA Review_1.11