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LATEST UPDATE: November 2007
Just in Time Rule -- updated April 2006 (WLS)
The National Institutes of Health changed the Public Health Service Policy on Humane Care and Use of Laboratory
Animals (PHS Policy) to permit institutions with PHS Animal Welfare Assurances to submit verification of IACUC
approval for competing applications after peer review, but prior to receiving an award. This change in PHS Policy was
effective as of 1 September 2002 [Federal Register 67, 51289-51290 (7 August 2002)]. Therefore, investigators who apply
for funding from NIH agencies may choose to utilize the "just in time" rule when processing proposals through Research
Administration by checking "Pending" in the approval date block. The NSF subsequently adopted this policy, and as of
2005, OCAST has endorsed the use of the "just in time rule". When funding is to be awarded or notification of the
likelihood of funding is received, the AUS must be processed and approved by the IACUC; the funding agency is then
notified. If discrepancies are identified in the AUS protocol during the IACUC review, these must be corrected and the
funding agency notified.
Disposal of Biological Material --May 2007 (WLS)
We have had maintenance problems with the LAR incinerator and for safety reasons it will be out of commission
for an indefinite period. We will be using a commercial biomedical disposal service; however, the protocol for delivery of
biological wastes will remain the same (SEE SOP COPIED BELOW) with the exception of large volume situations. The
PI/instructor will continue to deliver the bagged and labeled material for disposal to the Animal Facility. The single exception
will be to accommodate the end of the semester volume from Comparative Anatomy - The Department of Zoology has made
special arrangements for direct pick up at Sutton Hall and these arrangements will be independent of the LAR normal procedures.
Disposal of biological waste which results from research on non-LAR related materials will be by special arrangement with the PI
and direct charges will be billed to the PI's account.
___________________________________________________________________________________________________________
All Investigators must follow the appropriate procedures of the University of Oklahoma, Norman Campus LAR for
procurement, use, and disposal of laboratory animals.
Ordering
a. Complete the animal order form (see Web) and send to LAR.
b. Receive confirmation from LAR to proceed with order.
c. Call in order as described.
d. Be available to receive the animals at delivery location.
Receiving
a. Receive animals and place in the appropriate cages.
b. Investigators will be responsible for the welfare of animals until
they are delivered to the Animal Facilities.
Housing
a. Housing location will be determined by the Office of Lab
Animal Resources, with the Investigator's concurrence.
b. Location of the research and well-being of the animals
will be primary considerations.
Disposal
-- Deliver to the freezer in the Animal House for disposal.
-- Carcasses will be placed in plastic bags; no laboratory or surgical trash should be included.
-- Identify contents on a label, include investigator's name, and whether contents have biohazards,
infectious, or radioactive materials.
[1] SOP-1, Nov 2003
_________________________________________________________________________________________
Security for Animal Care Facility -- August 2004 (WLS)
The Animal care facility will have all doors maintained in the full-lock mode so that each entry will require a key.
Commercial deliveries can be made by using the door bell to alert animal care personnel. The security alarm system
will be active after working hours.
NIH Anesthesia/ Analgesia Formulary - October 2007 (WLS)
NIH has provided summary of drugs commonly used in animal research. The list is organized by species with
a brief description of anesthetics and analgesics. To access this formulary, visit the NIH website:
(http://oacu.od.nih.gov/ARAC/tablesbyspecies.pdf).
Anesthetics for Fishes -- Updated - October 2006(WLS)
The fish anesthesia that is currently approved for use in food fishes is MS222; however, it requires a 21-day
withdrawal period after use. See link on to Field projects for general use. Also reference AVMA report on euthanasia
(www.avma.org/resources/euthanasis.pdf) and visit the website for the Southern Regional Aquaculture Center to
access "Anesthetics in Aquaculture" (SRAC Publication/FACT Sheet 3900) (http://www.msstate.edu/dept/srac/index.htm).
Clove oil or eugenol are being increasingly recognized as being effective and user friendly in fish anesthesia. However,
efficacy does not ensure that the drug is approved relative to the application. A substance can be cleared for use as a food
additive based on being General Regarded as Safe (GRAS) -- Sodium Chloride and Clove Oil are GRAS substances, both
used in food for humans -- but neither is cleared for fish disease treatment, nor as an anesthetic for fishes, respectively.
The mechanism for obtaining clearance of a particular drug for a specified purpose is through the Investigational New
Animal Drug (INAD) mechanism; however, an INAD is usually issued to a company or an agency for sponsorship, and
a lead investigator to coordinate data gathering toward registration. Because the fishes used in our institutional research
are not destined for human consumption, nor for restocking, the use of Clove Oil as a fish anesthetic will be considered
acceptable by the IACUC based on its GRAS status.
For more information on drug use in aquaculture, see recent (2003) white paper "Drugs used in the US aquaculture
industry" (http://www.aquanic.org/asap/white_pages/drugs.pdf).
For current status of drug approval and registration, see Center for Veterinarian Medicine, Division of Therapeutic
Drugs for Food Animals (http://www.fda.gov/cvm/index/aquaculture/aqualibtoc.htm).
For information on the approval process, see U.S. Fish and Wildlife Service, Animal Drug Approval Partnership (AADAP)
Program (http://fisheries.gov.aadap). For license requirements and information for researchers, see information on this
website "drug licensing". NOTE: Also see below - USDA Policy # 3 Revision, for update on information concerning drug
management.
Institutional Assurance Compliance Document (IACD)-- February 2005 (WLS)
In accordance with Federal guidelines, Institutional Animal Care and Use Programs must operate with a current IACD
and USDA Registration. The IACD must be revised, reviewed and approved every four years. The Office of Laboratory
Animal Welfare (OLAW) of the Public Health Service is responsible for reviewing the IACD to determine its compliance
with PHS Policy and Animal Welfare Regulations (AWR). The approved IACD is the basis for measuring compliance for
the Institutional Animal Care and Use Program. Two significant exceptions that were made during the OU IACD review were:
1) An AUS can no longer be extended beyond the original approval period, and this period begins with the IACUC review.
Note, this is a significant justification for using the "Just in Time Rule" to its fullest.
2) Training provided by the IACUC MUST include instruction on the minimization of the number of animals required to
obtain valid results and mimization of animal distress.
Note: this is the application of the PHS and AWR requirement to consider "Alternatives" to procedures that can cause
more than slight or momentary pain or distress in animals.
Consideration of "Alternatives" is based on application of the principles of the "3-Rs" (Replacement, Reduction, Refinement).
For more information on this complicated and extensive subject area and for actual searches for alternatives, visit the Animal
Welfare Information Center (AWIC) website (http://www.nal.usda.gov/awic) and the USDA National Agricultural Library.
Animal Ordering - 11 March 2005 (WLS)
Animal users who order from commercial suppliers are reminded to use the Animal Order Confirmation form available in
the LAR section of this website. This form is the mechanism to alert animal caretakers to the arrival of animals so that housing
facilities are prepared. Note that the PI is responsible for ordering, receiving delivery, notifying LAR of the arrival, and paying
for the animals. LAR responsibility begins when the animals are housed in animal care facilities. The Order Confirmation Form
will be processed in the LAR office when the animals are ordered; a copy of the approved form will be returned to the PI, and to
the LAR Animal Facilities Manager. Also a copy will be filed in the folder with each active IACUC-approved AUS protocol.
Animal Use Protocol for Graduate Student Projects - 29 March 2005 (WLS)
Thesis research projects that involve vertebrate animals are subject to all the Animal Welfare Regulations and Guidelines
that govern research and teaching activities of faculty. A graduate student may conduct research that is supported by a faculty
grant, however, the student must be identified in an AUS approval letter from the IACUC. This document is required by the Graduate
College upon submitting a thesis or dissertation reading copy; the Graduate College submission form has a check-off statement -
"The research in this thesis involves vertebrate animal subjects and has been...... submitted for approval by the Institutional Animal
Care and Use Committee (IACUC)." The reading copy will not be accepted by the Graduate College without this letter. The AUS
involvement should be accomplished during the thesis planning period, e.g. during a committee advisory conference or similar
activity. The AUS approval letter from the IACUC always includes the reminder to save a copy of the letter for submission to the
Graduate College with the thesis reading copy.
Technicians and Student Training - September 2005 (WLS)
Graduate Student training is accomplished for new graduate student during campus-wide orientation. New faculty are introduced
to the animal welfare program as they enter the University. Undergraduates and Research Technicians who begin work with animals
do so on an irregular schedule, consequently it is the responsibility of the individual PI to see that individuals under their supervision
receive the appropriate training. This will vary, however, the basic requisites involve those items that are identified on the check sheet
which appears at the end of the Training Outline on this Website. Depending on the level of responsibility of each individual, ongoing
training may be required, especially for new techniques or procedures included in new Animal Use Protocols. Note that this phase of
training is coordinated through the Animal Care Manager, however, if you have questions contact the LAR Office.
Scientific Collectors Permit - May 2006 (WLS)
Scientific Collectors Permits for the State of Oklahoma must be renewed on the first of January each calendar year through
the Oklahoma Department of Wildlife Conservation. Students must have their own permit to conduct their research. Students
in field classes with an instructor present are not required to possess a permit as they are collecting under the authority of the
instructor who must hold a valid and current permit. Special permits may be required depending on the organism and the collection
site. A federal permit from the U.S. Fish and Wildlife Service is required for species under federal jurisdiction such as migratory
water fowl or for federally listed species. Collections on a refuge or park must have the permission of the agency, such as Oklahoma
Parks Department or the U.S. Forest Service.
Revision of USDA Animal Care Policy # 3 - September 2006; update 16 October 2007 (WLS)
To read policy in full access USDA Animal Care Home Page via links and open 'Policy Manual'
This Animal Care Policy revision deals with Veterinary Care, but addresses specific issues within this context on drug and
expiration of medical supplies, surgery, pre- and post-procedural care, and euthanasia. Anesthesia and analgesia must be in
accordance with the IACUC-approved protocol. Updated NIH guidelines are available on-line (http://oacu.od.nih.gov/ARAC/
tablesbyspecies.pdf). Guidelines for acceptable euthanasia have been updated (June 2007) by AVMA (http://www.avma.org/
resources/euthanasia.pdf).
Drugs: the issue discussed is the governance of expired drugs or medical materials. Drugs adminstered to
relieve pain or distress must not be used beyond their expiration date.
Surgery: AWA regulations require survival surgeries to be performed using aseptic techniques and for
non-rodents also in dedicated facilities.
Pre- and Post-Procedural Care: Relief of pain and distress following procedures must be specifically
approved by the IACUC and are under continuing supervision by the veterinarian. Records
of mandated analgesics and antibiotics are required.
Veterinarian Care: The program of health care must be reviewed and updated whenever necessary.
Health records reflect the veterinarian care provided must be maintained by the animal care unit.
Euthanasia: The method of euthanasia must be that approved by the IACUC and consistent with the
current procedures published in the Report of the AVMA Panel on Euthanasia.
ANNUAL REVIEW OF APPROVED PROTOCOLS/ PENDING EXPIRATION - 8 January 2007 (WLS)
An annual review for each approved Animal Use Statement (AUS) protocol is required by USDA. We have initiated a process to comply with this policy. Office of Laboratory Animal
Resources (LAR) will send a reminder on the anniversary of the AUS approval. This email message will indicate that the project review should include notification of any sustantive
changes in procedures and personnel changes that have occurred in the interim. A form has been developed that is multipurpose and can be used to update the AUS (see IACUC
application procedure - Reporting -'Annual Reporting Form'); a copy of this form is attached to the email reminder. Modifications to the approved protocol should be reported
before they are made if animal welfare is compromised; these changes must be approved by the IACUC. A form is available on the IACUC website for this purpose (see IACUC
application procedure - Research forms - 'Animal Use Protocol Amendment').
Animal Use Statement Protocols are approved by the IACUC for a period of three years. Upon expiration, a new AUS must be reviewed by the IACUC before the activities continue.
Consequently, the LAR will notify PI's several months prior to the expiration of an approved protocol to determine whether the activity will continue beyond the expiration date.
Nevertheless, it is the responsibility of the PI to maintain currency of the protocol and anticipate the need for renewal, develop a new or modified protocol and submit to the IACUC.
NIH POLICY ON ALLOWABLE COSTS - 12 February 2007 (WLS)
The subject notice from NIH only clarifies policies already in effect; i.e. NIH will only provide funding for projects that are operating at institutions with a valid and current Animal Welfare
Assurance Document (AWAD) (Institutional Assurance Compliance Document - IACD) and for research project for which a valid IACUC approval is in effect You may read the complete
policy by visiting the NIH website (http://grants.nih.gov/grants/guide/notices-files/NOT-OD-044.html). T he University of Oklahoma, Norman Campus has a valid AWAD which is in effect
until 2009 and all protocols are reviewed and approved for a period no longer than three years per federal regulations and as paraphrased in the announcement just above.
New Standard Operating Procedure -- Guidelines for diet control in behavioral studies -- 29 October 2007 (WLS)
This new SOP covers behavioral studies in which water or food is withheld in order to establish an incentive reward to measure a
response. The policy does not include water/food restrictions prior to surgical procedures, nor for periods of less than 24 h and it is
applicable only to homeotherms. See LAR section on this website under 'forms' for description and for log record form.
Annual EHSO Training Update -- 2 November 2007 (WLS)
Update on Environmental Health and Safety (EHSO) annual training due by 31 December 2007. Access website via (http://www.ou.edu/ehso/training.html).
New Publication of the Field Guide for Research on Wild Mammals - 13 November 2007 (WLS)
The update for guide to research on wild mammals published by the American Society of Mammalogists is now available on line.
You may visit the website (http://mammalogy.org) and look in the Journal of Mammalogy 88(3):809-823 - 2007, or view a PDF file
(http:/www.mammalogy.org/committees/commanimalcareuse/ASM%20Animal%20Guidelines.pdf).