Complete Laboratory Notebook - Research Animal Resource Center

Information Resources for Institutional Animal Care and Use Committees 1985-1999
U.S. Government 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 to:
I. The transportation, care, and use of animals should be in accordance with the Animal
Welfare Act (7 U.S.C. 2131 et. seq.) and other applicable Federal laws, guidelines, and
policies.
II. 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.
III. 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.
IV. Proper use 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.
V. 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.
VI. 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.
VII. 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 or other scientist
trained and experienced in the proper care, handling, and use of the species being
maintained or studied. In any case, veterinary care shall be provided as indicated.
VIII. Investigators and other personnel shall be appropriately qualified and experienced
for conducting procedures on living animals. Adequate arrangements shall be made for
their in-service training, including the proper and humane care and use of laboratory
animals.
IX. Where exceptions are required in relation to the provisions of these Principles, the
decisions should not rest with the investigators directly concerned but should be made,
with due regard to Principle II, by an appropriate review group such as an institutional
animal care and use committee. Such exceptions should not be made solely for the
purposes of teaching or demonstration.
280 Enzyme Institute
1710 University Ave.
Madison, WI 53726
UW-Madison New PI Introduction Page !
The Ethics of Animal Use
•
Utilitarianism: The view that an action is right if and only if it produces a better
balance of benefits and harms than available alternative actions
•
Consider the “U.S. Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training”
UW Animal Research Program Organization
•
All Campus Animal Planning and Advisory Committee (ACAPAC): makes
policy for the UW- Madison animal care program. Among its members are the
chairs of the 5 School and College Animal Care and Use Committees (ACUC).
o College of Agriculture and Life Sciences (CALS)
o Graduate School
o College of Letters and Sciences (L&S)
o School of Medicine and Public Health (SMPH)
o School of Veterinary Medicine (SVM)
•
Animal Care Units: provide daily animal care; receive funding from the animal
users and Schools/Colleges
o Laboratory Animal resources (LAR)
o Animal Resource Center (ARC)
o Primate Center
o Biochemistry
o Etc.
•
Research Animal Resources Center (RARC): provide administrative and
veterinary support to the Animal Research Program
o Operations: Protocol management, training, other
o Veterinary Unit: Veterinary care/consultation, Pathology/Histology
o Strategic planning
RARC v04/13
Documenting Laboratory-Specific Training
The Investigator’s Responsibility
The Laboratory Notebook
The All Campus Animal Planning and Advisory Committee (ACAPAC) is asking Investigators to
document training of their research staff. The documented training will include procedures and
techniques on live animals that are taught by the Investigator or their qualified designee. The Principal
Investigator will be held responsible for all activities that occur under the lab’s approved Animal Care and
Use Protocol. Documenting training can protect the Investigator and their staff if a situation would arise
in which an individual’s training is challenged. For example, the ACAPAC, external regulators (USDA
Veterinary Medical Officers), or organizations such as the Association for Assessment and Accreditation
of Laboratory Animal Care (AAALAC) may request training documentation.
For your convenience, a record for documenting laboratory specific training is included in the Training
Records section. Additional copies can be found on RARC’s website: www.rarc.wisc.edu
A PI may designate an individual associated with the protocol to provide training to the lab personnel.
Documentation that indicates this designated individual’s training proficiency in the described
technique(s) is required.
The training records must be kept current and remain in the laboratory.
Included in the Protocol and the Laboratory SOP section, employees will find forms to record when these
respective documents are reviewed.
Thank you for your cooperation and for your commitment to the animal care program at UW-Madison.
RARC Training Division v04/2013
New Employee Checklist
The Laboratory Notebook
As a new employee, there are many administrative tasks you must complete before
starting your job. If you will be working with research animals, use the following
checklist to ensure you have completed the necessary training, thus allowing you to work
with research animals on the University of Wisconsin campus and it’s associated animal
facilities. Having a good understanding of how your lab functions as well the approved
animal procedures will ultimately lead to a safe work environment.
Before working with animals have you:
❐
Completed the UW Animal User Orientation
❐
Completed the Occupational Health training
❐
Completed Species-Specific animal training
❐
Completed Lab Animal Surgery, if applicable
❐
Read your lab’s animal care and use protocol as it pertains to the procedures you
will be performing
❐
Read your lab’s Standard Operating Procedures (SOPs)
❐
Read the procedure for reporting sick animals
❐
Familiarized yourself with the requirements for recording controlled substances
(if applicable)
RARC Training Division v12/2010
Protocol
It is important that all employees read and understand their laboratory’s Animal Use Protocols.
For your convenience, records for documenting this training have been provided in this section.
Documented training records must be kept current and remain in the laboratory notebook.
Additional copies can be found on RARC’s website: www.rarc.wisc.edu
!
Research Animal Resources Center
Training Division
University of Wisconsin-Madison
Protocol Documentation Page
Listed below are University of Wisconsin personnel who have read their laboratoryʼs protocol (a separate page is
required for each protocol).
PI:_______________________________ Protocol Number:___________________________
Employee Name (print)
v12-2010
Signature
Date
Job Title/Position
Laboratory SOP’s
It is important that all employees read and understand the laboratory’s Standard Operating
Procedures (SOP’s). It is a useful training tool and a reminder to staff of the correct laboratory
procedures. For your convenience records for documenting this training have been provided in
this section.
Documented training records must be kept current and remain in the laboratory notebook.
Additional copies can be found on RARC’s website: www.rarc.wisc.edu
!
Research Animal Resources Center
Training Division
University of Wisconsin-Madison
Standard Operating Procedures (SOPs) !
!
!
Documentation Page
Listed below are University of Wisconsin personnel who have read their laboratoryʼs SOP.
PI:_______________________________"
Employee Name (print)
v4/1/13
"
SOP Name/Number:___________________________
Signature
Date
Job Title/Position
Training Records
Procedural and technique training performed on live animals in the laboratory setting by a
designated individual must be documented. For your convenience, records for documenting this
training have been provided in this section. Additional copies can be found on the RARC
website.
Documented training records must be kept current and remain in the laboratory notebook.
Additional copies can be found on RARC’s website: www.rarc.wisc.edu
!
Research Animal Resources Center
Training Division
University of Wisconsin-Madison
Training Documentation Page
Listed below are University of Wisconsin personnel trained in:_______________________________
PI:_______________________________!
Trainee (print)
v12-2011
Trainee signature
!
Protocol Number________________
Procedure/Technique
Trainer
Date
Mar$
2013$
RARC Guidelines for Animal Researchers *
Use of Controlled Substances
Controlled substances are frequently used in animal research for anesthesia, pain relief, and humane
euthanasia. Increased oversight on the part of state and federal authorities has resulted in the
requirement for researchers to obtain their own licenses to purchase, possess, and administer controlled
substances. In Wisconsin, researchers must have both a Drug Enforcement Administration (DEA)
registration (federal) and a Controlled Substance Special Use Authorization (SUA) issued by the State of
Wisconsin Controlled Substances Board.
WI Dept. of Safety and Professional Services (DSPS#) Controlled Substance SUA
#
formerly known as the Department of Regulation & Licensing (DRL)
•
WI Controlled Substance SUA must be obtained FIRST, before applying for DEA registration.
•
Forms can be obtained from the WI Dept. of Safety and Professional Services (WI DSPS) under
Controlled Substances Special Use Authorization or the Controlled Substance Board Page. The
direct link is: http://dsps.wi.gov/Default.aspx?Page=4629c414-43ce-4f3d-b1d3-7365d37e4a50
•
Researchers must use Form #2184 “Application for Research, Analytical Laboratory,
Industrial/Commercial Processing, Instructional Activities, and Other.”
•
There is no fee for employees of state institutions.
•
Application forms must be printed out, completed, and mailed in hard copy.
•
Form #2275 provides instructions for filing a new application or amendment. Form #2277
outlines the physical security requirements for storage of controlled substances.
•
A complete WI Controlled Substances SUA application will include
 1. completed Form #2184
 2. signed checklist Form #2836 (you must mail the initialed checklist back to DSPS)
 3. detailed 1-page layman’s description of IACUC-approved study that: describes the use of
each controlled substance listed, and includes calculations that led to the requested
amounts (do not send the entire IACUC protocol)
 4. copy of the IACUC approval letter, which can be sent directly to WI DSPS by the protocol
managers in the RARC IACUC Office upon email request from PI on protocol
•
SUAs must be renewed annually. No renewal notice is given by the WI DSPS but the SUA will
expire if not renewed 8 – 12 weeks prior to the expiration date of the current SUA. The
application procedure for SUA renewals is identical to that for initial applications.
•
Your RARC veterinarian is available for consultation regarding drug types, dosages, routes of
administration, formulations, commercial products, and other medical issues.
•
Contact Sarah Johnson ([email protected]) or [email protected] for assistance with SUA
and DEA applications, registration procedures, controlled substance management, or if you have
waited for more than 8 weeks for a response to your SUA application.
* Procedures differ for Practitioners (MDs, DVM, and others). Please contact << [email protected] >>
for information about using controlled substances in research if you hold a Practitioner’s license.
RARC Controlled Drug Guide Mar 2013.docx
Page 1 of 2
Federal Drug Enforcement Administration (DEA) Registration
•
Researchers can only apply for DEA registration once a WI SUA number has been issued.
•
Researchers apply for DEA registration from the DEA Office of Diversion Control. The direct link
for the online application is
http://www.deadiversion.usdoj.gov/drugreg/reg_apps/onlineforms_new.htm
•
DEA applications are better submitted online, but the forms can also be printed and completed in
hard copy. Do not submit both online and hard copies.
•
Researchers* need to complete DEA Form #225 “Manufacturers, Import/Export, Distributors,
Researchers, Dog Handlers, Labs.”
•
State employees are usually exempt from the DEA registration fee. The certifying official for feeexemption status is typically the Associate Dean for Research in the school or college.
•
The Milwaukee DEA Office may send an additional informational questionnaire prior to issuing a
DEA registration number. Contact RARC for help completing the supplemental application.
•
DEA Registration for Research lasts 1 year. The DEA typically provides a reminder to renew.
Lockbox Information
•
Both the State of WI and the Federal DEA have physical security requirements with state
requirements being more stringent. Compliance with WI DSPS ensures compliance with the DEA.
•
WI DSPS requires a wall-mounted or floor-bolted lockbox. Locked drawers or cabinetry are NOT
adequate. The security requirements from WI DSPS can be found on their website as Form
#2277, “Physical Security Requirements” http://dsps.wi.gov/Default.aspx?Page=4629c414-43ce4f3d-b1d3-7365d37e4a50
•
An approved (small) double locking cabinet can be ordered through Health Care Logistics: 1-800848-1633 or www.healthcarelogistics.com, Item #3707-01: “Slim Line Narcotic Cabinet” for
~ $150.00. Contact FP&M or your building manager for mounting and associated costs.
Record-keeping
•
DEA requires a complete inventory of controlled substances to be completed at least every 2
years. Consult the DEA Office of Diversion Control website for the current inventory requirements.
•
The WI Controlled Substance Board requires that users keep detailed records of each controlled
substance on hand including: their use, disposition, and total weight in grams. Users should also
include Animal ID, dose, concentration of drug, time, date, and person administering drug.
•
To aid in capturing the required information in your records, a template that represents RARC’s
understanding of current state and federal regulations is provided on the RARC website under
Training >> Lab Notebook >> Controlled Substances Documentation.
•
The WI Controlled Substance Board also requires retention of purchase records (including
receipts), and any documentation related to discrepancies in inventory and use (including
investigation of such discrepancies).
•
All records must be kept for 4 years after expiration of the SUA and must be readily retrievable.
Disposal
•
Controlled substances must be disposed of properly. Only the DEA Special Agent in Charge can
authorize disposal of controlled substances. Researchers cannot transport the drug to an
unauthorized location or transfer drugs to unauthorized persons under any circumstances.
•
For RARC guidelines regarding Controlled Substance disposal, contact Sarah Johnson
[email protected].
* Procedures differ for Practitioners (MDs, DVM, and others). Please contact << [email protected] >>
for information about using controlled substances in research if you hold a Practitioner’s license.
RARC Controlled Drug Guide Mar 2013.docx
Page 2 of 2
RARC Guidelines for Animal Researchers
Disposal of Controlled Substances
JUNE%
2013%
Controlled substances must be disposed of properly when they expire (if used for live
animals), when a study ends, or if permission to use controlled substances expires or is
suspended by the State of Wisconsin or by the Federal Drug Enforcement Administration
(DEA). At the UW-Madison campus, the DEA Registrant assumes responsibility for
controlled drug disposal.
Only the DEA Special Agent in Charge can authorize for disposal of controlled
substances. Researchers cannot dispose of controlled substances before receiving DEA
authorization via DEA Form 41, cannot transport the drug to an unauthorized location,
and cannot transfer drugs to unauthorized persons under any circumstances. UWMadison Chemical & Environmental Safety officers are not authorized to pick up
controlled substances.
Contacting Milwaukee DEA Office for Disposal Authorization:
The DEA Special Agent in Charge typically authorizes one disposal event per year for
each registrant*. The usual process for researchers disposing of small amounts of
controlled substances, used in animal work, is as follows**:
*See below for information on proper storage while awaiting disposal
authorization.
**The DEA may change procedures at any time.
1. Registrant (DEA license holder) must complete DEA Form 41: Registrants Inventory
of Drugs Surrendered. Direct Link:
http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/index.html
a. Fill out columns 1 through 4, as instructed on page 2 of the form.
i. Please, disregard instruction number 5 on page 2 of the form, unless
specifically instructed to ship materials by the DEA Special Agent in
Charge.
b. Add the registrant’s DEA number but DO NOT SIGN in the box (Signature of
applicant) at this time.
2. Contact the Milwaukee DEA Office of Diversion Control, Special Agent in Charge:
a. Call (414) 336-7370 to initiate the disposal authorization process, and wait
for further instruction. Staff normally responds to messages within one
business day.
3. Once directed by the Milwaukee office, fax a copy of DEA Form 41 to the appropriate
investigative assistant.
a. The Special Agent in Charge will review the disposal request and instruct the
applicant, in a written letter, to dispose of the controlled substance in one of
the following manners:
i. By delivery to an agent of the Administration or to the nearest office
of the Administration.
ii. By destruction in the presence of an agent of the Administration or
other authorized person/witness (usually sink disposal, see below).
1. Witness can be any reliable person at least 21 years of age.
iii. By other such means as determined by the Special Agent in Charge.
4. Upon receipt of authorization, dispose of substance(s) as directed by the Special
Agent in Charge, and complete the required signatures on the original DEA Form 41.
a. Be sure a proper witness is present if necessary.
1
5. Retain 1 copy of the completed DEA Form 41 for your inventory records.
6. Mail 2 copies of the original completed DEA Form 41 to the Milwaukee DEA office
(one copy will be returned to you as a receipt).
DEA Milwaukee District Office
4725 W Electric Ave
Milwaukee, Wisconsin 53219
(414) 336-7370
(414) 336-7300
(414) 727-5454
(Diversion Group)
(General Information)
(Diversion Fax)
Suitability of Authorized Sink/Sewer Disposal
If the amount of a controlled substance is very small, the Special Agent in Charge may
allow for sewer disposal with an authorized witness present. Contamination of ground
water by medications and pharmaceuticals is a concern for the DEA and citizens, but the
UW-Madison is served by a high-quality, high-throughput water treatment system. The
UW-Madison Environmental Health & Safety Office has determined that treatment of
wastewater is adequate for processing small volumes of dilute solutions of water-soluble
drugs at physiological concentrations, and a letter to this effect is on file with Dr. Janet
Welter, UW-Madison Chief Campus Veterinarian.
The DEA and the UW-Madison Environmental Health & Safety Office have approved
alternatives to sewer disposal. Waste drug can be mixed with kitty litter, animal
bedding, or used coffee grounds and sealed in a container or heavy-duty bag, and
placed with solid waste. Consult with the Environmental Health & Safety Office for
disposal options. Once you have determined an appropriate method of disposal,
remember to secure DEA disposal authorization (see instructions above) before
proceeding.
Maintenance of Expired or Waste Controlled Substances Awaiting Disposal
Since the DEA typically authorizes only one disposal event per year, users of controlled
substances may need to store expired or waste controlled drugs for a period of time.
Expired or waste drugs must be kept in a drug lockbox and must be physically
segregated from in-date and in-use drugs, by placing them in a small container or
plastic bag. For users with large stocks of expired or waste controlled substances, a
second lockbox may be necessary to provide segregation from in-use supplies.
The expired or waste materials must also be clearly labeled “Expired – Awaiting
Disposal. Do Not Use in Animals.” Stickers with this labeling are available from the
RARC Pharmacy at no charge: e-mail [[email protected]] for assistance.
Alternatively, you may print your own stickers; a template can be found on the RARC
website under ‘Services’ > ‘Pharmacy’ > ‘Expired Materials’.
For non-controlled drug disposal, contact UW-Madison Chemical & Environmental
Safety:
Call 265-5000 or complete a request for pickup online at:
http://www.ehs.wisc.edu/chem-chemicaldisposalsurpluschemicalwastesurpluspickuprequestform.htm
Please contact your RARC Veterinarian or Sarah Johnson [[email protected]]
with any questions or concerns about these guidelines.
2
Research Animal Resources Center
!
Training Division
University of Wisconsin-Madison
Date Received _____________ ! !
Drug _____________________ ! !
Received By _______________! !
Date
Time
Animal ID
Controlled Substances Documentation Page
Date Completed __________________!!
Strength/Concentration ___________ !
!
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Weight
(kg)
Species
v01/2013: trainers/Lab Notebook Folder/Lab Notebook updated 2013
Use
Vial/Record Number ______________
Vial/Bottle Size___________________
Beginning wt/grams ______________
Administered
by
Dosage
mg/kg
Balance
(in grams)
Returned
Discarded
RARC
Training Information
Training classes and opportunities offered by the Training Division at the Research
Animal Resources Center (RARC).
UW Animal User Orientation
This course covers the rules and regulations regarding the use of animals in
biomedical research. Animal User Orientation is required for all animal users. Go
to www.rarc.wisc.edu to register.
Biomethodology of the Mouse
Learn mouse handling and restraint and other useful techniques such as oral
gavage, injections, anesthesia, and blood collection. Also covered: basic
breeding, colony management and more.
Biomethodology of the Rat
Learn rat handling, restraint and other useful techniques such as oral gavage,
injections, anesthesia, and blood collection. Also covered: basic breeding
techniques, husbandry and rodent behaviors.
Lab Animal Surgery
Anesthesia & Analgesia, Aseptic Technique, Basic Suturing & Wound Closure and
Introduction to Surgery will be offered in this intensive, one-day seminar. Class size
is limited and walk-ins are prohibited. This seminar fills up fast, so register early.
Firm attendance commitment is required.
Biomethodology of the Nonhuman Primate
Participants will learn the many facets of working with the nonhuman primate.
The course consists of 2 sections:
1. Primate Orientation
2. Primate Health Procedures
AALAS Learning Library
Gerbils, Reptiles, or Ferrets are a few of the less commonly used research animals
found on the UW-Madison campus. As part of a commitment to provide
species-specific training for all research animals, the Trainers at RARC are now
offering online training opportunities in conjunction with the AALAS Learning
Library.
ALAT Classroom and Self-Study
Information about signing up for AALAS classes or obtaining resource materials
for the ALAT, LAT or LATG levels can be found on our web site.
To sign up for classes (a valid Net ID and Password is required)
Classes are reserved for UW-Madison faculty, staff, and students listed on an
approved animal care and use protocol that need mandatory species-specific
training. If you have any questions about registration or class requirements please
contact: [email protected].
For those already listed on an approved protocol:
1. Go to www.rarc.wisc.edu
2. In the left column, click on “Training”
3. Login to the RARC website
4. Read and follow the directions provided
5. Click on the class name located in the left column. Register!
Questions? Contact the Trainers at: [email protected]
RARC Contact Information for:
Animal Program Assessment Specialists
Diagnostic Lab
Histology Lab
Occupational Health and Safety
Pathology Lab
Protocol Office
Trainers
Veterinary Staff
Go to the RARC home page: www.rarc.wisc.edu click on “contacts”.
After Hours Emergency Veterinary Service: 608-262-2122
Research Animal Resources Center
Training Divisi on
University of Wisconsin-Madison
RARC Training Division v01/2011