Creighton University Protocol for Animal Use

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Continuing Review

Federal regulations require that all protocols involving the use of vertebrate animals be reviewed at least annually by the

Institutional Animal Care and Use Committee (IACUC). As part of this process, Creighton’s IACUC asks investigators whether new techniques or approaches are available that would allow animal use to be reduced or eliminated, or that would refine painful or potentially painful procedures. The Animal Welfare Act (AWA) requires that, whenever possible, researchers should Replace , Reduce, and Refine (the three R’s) animal use. This means:

Replacing animals in part or full with non-animal systems (e.g., in vitro, computer or mathematical models) or less sentient animal species (e.g., insect or molluscan models instead of mammalian models).

Reducing the number of animals to the minimum required to obtain scientifically valid data through a priori consideration of appropriate experimental and statistical design (e.g., more advanced statistical tests, power analyses).

Refining procedures to lessen or eliminate pain or distress, thereby enhancing animal well-being (e.g., lessinvasive surgical techniques, terminating experiments during earlier rather than later stages of morbidity).

Investigators on all categories of protocols are encouraged to conduct regular searches of appropriate journals and databases for new methods that would support these goals. Such a search is required on an annual basis for all

Category E protocols. Any techniques or approaches that could reduce animal use or animal pain or distress without adversely affecting experimental outcomes should be incorporated into a protocol.

The Continuing Review form is not applicable to protocols that have reached their end dates. Renewal of expiring protocols requires submission of a newly completed Protocol Application.

Modifications to Protocols

The Continuing Review process offers investigators the opportunity to request modifications of their protocols, including modifications in support of the three R’s. All changes should be requested by amending the approved version of your protocol. Please ensure that any previously approved changes are incorporated into the protocol as well. If you have questions or require assistance in determining the category of desired changes, please contact the IACUC Chair at iacuc@creighton.edu

or the IACUC office at 280-2082.

Submission

This completed form must be submitted to the IACUC office no later than 5:00 p.m. on the first Monday of the month prior to the anniversary date of the protocol (unless requested earlier by IACUC). Failure to submit the Animal Protocol

Continuing Review form on time will result in the protocol being placed on administrative hold until the next regular IACUC meeting. While on administrative hold, no experimental work shall be performed and no new animals shall be ordered under the protocol, but animals already on campus may be maintained. If the Continuing Review form is not submitted by

5:00 p.m. on the first Monday of the month following the anniversary month of the protocol, the protocol will be closed at the end of that month.

Submit pages 2 & 3 of completed form to:

IACUC Office

Revised February 2010

1. Project Title:

IACUC Protocol Number:

Date of Last Review:

2. Principal Investigator:

Department/School:

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Date of Initial Approval:

Date of Expiration:

3. Protocol Status: Indicate (X) the status of this project.

Request Continuance for Active Protocol (Work ongoing)

Request Continuance for Currently Inactive Protocol (Project was initiated but is presently inactive)

Request Continuance for Inactive Protocol (Project never initiated)

Request Protocol Termination

4. Animal Welfare:

Alternatives to Animal Use: Since the last IACUC approval, have non-vertebrate or non-animal alternatives to the use of living vertebrates become available that could be substituted to achieve your project goals?

No Yes

Alternatives to Painful or Potentially Painful Procedures: Since the last IACUC approval, have alternative techniques become available that are potentially less painful or distressful and that could be used to achieve your project goals?

This question is not applicable for Category B or C protocols.

N/A No Yes

5. Duplication: Since the last IACUC approval, has other work been published or conducted that makes this protocol duplicative?

No

Yes – changes are requested in the protocol.

Yes – protocol will be conducted as currently approved. (Explain why this duplication of work is scientifically necessary below)

Yes Teaching/Breeding

6. C ATEGORY E P ROTOCOLS

If your protocol is Category E, have you conducted a search of appropriate journals and databases for new methods that would replace, reduce, refine animal use. No Yes N/A

If yes, provide a description of the methods and sources used to determine that alternatives to painful or distressful procedures are not available and/or are scientifically unacceptable, and to determine that duplication either is not occurring or is scientifically necessary. A search of at least two relevant databases is the recommended method for this determination. To document your search indicate a) names of the databases searched, b) date the search was performed, c) dates covered by the search, and d) keywords and/or the search strategy used. See Instructions for

Protocol Application, Section E 9, for more information.

Revised February 2010

7. Changes in Personnel: Any changes in personnel should be requested by amending the approved version of your protocol. Please ensure that any previously approved changes are incorporated into the protocol as well. As a reminder, the addition of personnel to a protocol must take place before that person conducts any activities under the protocol.

8. Grant Support: Indicate the current grant or grants (if any) supporting this protocol.

Funding Agency:

Submission Date:

Title:

Grant or contract number:

Effective Date:

9. PI Certification and Signature:

In signing this form, I certify that:

The animals authorized for use in this protocol will be used only in the activities and in the manner described herein. Any changes in the procedures described must receive prior approval from the IACUC.

For Category D or E procedures, alternatives have been thoroughly reviewed, and no valid alternatives to those procedures that may cause more than momentary slight pain, discomfort, or distress (whether relieved or not) have been found.

Current and future faculty, staff, and students who will participate in this protocol are qualified or will be adequately trained to conduct the described work in a humane manner. All personnel on the protocol will receive a copy of the approved protocol. I will notify IACUC when removing or adding personnel to this protocol and will not allow anyone to conduct any procedures under this protocol until they have met all

IACUC and ARF training requirements.

 I will comply with Creighton’s Assurance of Compliance, the Animal Welfare Act, the Public Health Service

Policy on Humane Care and Use of Laboratory Animals, the Guide for the Care and Use of Laboratory

Animals, the Animal Resource Facility’s Standard Operating Procedures (SOP) and other applicable

University policies and procedures.

I understand that I am responsible for any and all activity conducted by me or my staff under this protocol. I further acknowledge that any failure to comply with federal, state or University requirements related to the use of animals may result in corrective action including, but not limited to, suspension of this protocol, destruction of data collected under this protocol, and/or termination of future rights to use animals at Creighton University.

Signature of Principal Investigator

FOR IACUC USE ONLY:

Date

Continued activity under this protocol has been approved / disapproved by the IACUC

IACUC Chair Date Attending Veterinarian Date

Revised February 2010

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