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GUIDELINES Version: Responsibilities of the Principle
Investigator
ACUC Records and Reporting Requirements Reports to
Institutional Official (IO) Reports to Office
for Laboratory Animal Welfare (OLAW) Reports to United
States Department of Agriculture (USDA) ACUC Records Personnel Qualifications and
Training
Personnel
Requiring Training Training Program
Content Occupational Health and Safety of Personnel Laboratory
Inspections Institutional
Program for a Safe and Healthy Workplace Role of the Office of Environmental
Health and Safety (EHS) and Healthcare Provider Role of Principal Investigators and
Department Supervisors Veterinary Care
Animal Use Protocols
Required Signatures and Scientific
Merit Review Justification for Using
Animals Justification for Using a
Particular Species Justification of Animal
Numbers Justification for
Performing Potentially Painful Procedures The Principal Investigator Protocol Forms Protocol
Submission Protocol
Submission Deadlines Protocol Review Process Emergency Designated Reviews Tissue
Sharing
Reporting Animal Concerns
Animal Procurement and Housing Ordering
Animals
Animal
Environment, Housing and Management
Animal Transfer To/From Facilities
Outside of the Animal Health and Procedure Records Procedures
Anesthesia/Euthanasia Gas Anesthesia and/or Euthanasia Use of Carbon Dioxide for Euthanasia Anesthesia for Rodent Pups Hypothermia Embryo Removal Pain Management Surgery Post-surgical Care Food
Deprivation Animal
Identification Antibiotics Avian
Field Studies Ascites
Production Use
of Complete Freunds Adjuvant Blood
Draws, Volume and Frequency Tail
Biopsy Tumor
Burden Expired
Materials Genetic Manipulations
This document outlines guidelines drafted by the Responsibilities of the Principle Investigator
The
privilege of using animals in research and teaching at the The
Principal investigator is: · required to have a current animal use protocol, approved by the University of Miami ACUC, before any activities involving live or dead vertebrate animals is begun. · required to comply with all Federal regulations, laws and policies. · required to assure that all participants on this protocol will follow the policies set forth in the Guide for the Care and Use of Laboratory Animals (The Guide). ·
required to comply with all · responsible for the conduct of the work and to assure that all co-investigators, technical staff, students and visiting fellows or collaborators comply with all federal regulations and Institutional policies. · responsible for assuring that all participants in animal research studies under their supervision are properly trained in the humane care and use of animals in research and in the procedures used in the current model system according to Institutional policy. · responsible for keeping the animal use protocol accurate and up to date. PI’s must inform the IACUC when there are changes in personnel and funding. · responsible to assure that the work follows the approved protocol. All changes in the protocol or procedures must be reviewed and approved before the procedure can be implemented. · responsible for maintaining animal records in a secure but, accessible location. Records must be available at all time for review by the attending veterinarian, the ACUC, the USDA and/or PHS. · responsible for assuring that all pharmaceuticals, reagents and devices used in animal research are appropriate for the research and are within the manufacturer’s expiration date. The use of expired reagents or devices must be approved in advance by the ACUC. Under no circumstances can expired anesthetics, analgesics or antibiotics be used in either survival or non-survival surgery. All expired reagents should be clearly marked “expired - do not use” and returned to the DVR for disposal. · responsible for assuring that all controlled substances are stored in a safe and secure manner. · responsible for assuring that all animals in the protocol are properly identified and described using DVR cage cards. · responsible for obtaining approvals from Radiation Safety, Occupational Health and Safety and/or the Recombinant DNA Committee prior to beginning animal activities regulated by these campus agencies. As
the PI, I agree to assume the responsibilities listed above. Further, as the PI, I agree to adhere to
the PHS Policy on Humane Care and Use of Laboratory Animals, the ILAR Guide
for the Care and Use of Laboratory Animals, USDA regulations as defined
in the Animal Welfare Act and it’s amendments. The 1) is responsible for
oversight and evaluations of institution's animal care and research program, 2) conducts
semiannual evaluations of the Institutional Animal Care and Use (IACUC)
program, 3) conducts
semiannual inspections of all institutional animal care
and use facilities; 4) reviews and
investigates concerns about animal care and use at the university; 5) establishes
procedures for the review, approval and suspension of animal activities; 6) establishes
procedures for review & approval of significant changes to approved
activities; 7)
establishes policies for the
review of procedures (e.g. restraint, multiple survival surgery, fluid and
food restriction, painful procedures) that require exemption from federal
regulations, guidelines and policies. 8) reports to the ACUC
Records and Reporting Requirements Reports to
Institutional Official (IO) The ACUC transmits reports of
the semiannual program review & facility inspections to the IO. These reports describe departures from the Guide or PHS Policy, reasons for
departure, distinguish between significant and
minor deficiencies, and include plans and or schedules for correction
of each deficiency. Each report to the
IO includes minority ACUC views, if they exist. Reports to Office
for Laboratory Animal Welfare (OLAW) The ACUC submits annual reports to OLAW that document
program changes & dates of ACUC semiannual reviews and inspections;
advises OLAW of serious/ongoing Guide deviations
or PHS Policy noncompliance; advises OLAW of any suspension of activity by
the ACUC, and such reports include any minority ACUC views. Reports to United
States Department of Agriculture (USDA) The ACUC submits an annual
report to the USDA, which in addition to required information, details
species -specific animal usage tabulated according to the level of pain and
distress. The ACUC is required to
explain ACUC approved deviations from the AWA and USDA regulation. Further the ACUC is required to report the
details of any ACUC directed suspension of animal usage. ACUC Records The
ACUC maintains copies of the minutes of
ACUC meetings and semiannual reports for 3 years. ACUC protocol review documentation is
maintained for 3 years after end of approved study. Personnel Qualifications and Training
Personnel
Requiring Training
The
Training Program
Content The
content of the animal use training program includes humane practices of
animal care (e.g. housing, husbandry, handling), humane practices of animal
use (e.g. research procedures, use of anesthesia, pre- & post-operative
care), research/testing methods that minimize animal pain and distress, and
the use of hazardous agents. Occupational
Health and Safety of Personnel Laboratory
Inspections All areas where
animal experimentation is performed are required to have a current (annual)
approval from the Office of Environmental Health and Safety before IACUC
protocols involving those areas will be activated. Institutional
Program for a Safe and Healthy Workplace The 1.
Annual audiogram for employees in a hearing conservation program 2. Annual respiratory protection
training and fit testing for employees who are authorized to wear respirators 3. Annual tuberculosis and allergy
testing; semi-annual testing may be required for contact with some animal
species 4.
Baseline health assessment 5.
Exposure incident evaluation and follow-up 6.
Follow-up health assessment, as required 7. Phlebotomy for serum banking at the
time the employee begins work involving recurrent animal contact 8.
Pregnant woman counseling 9. Vaccinations, laboratory tests, and
titers as required according to the need of the individual and the animal
species for which there is contact Role of the Office of
Environmental Health and Safety (EHS), and Healthcare Provider The Office of Environmental Health and
Safety (EHS), and the designated healthcare provider, shall provide the
following functions: 1.
Baseline health assessment 2.
Exposure incident evaluation and follow-up 3.
Follow-up health assessment 4.
Laboratory tests as required 5.
Maintenance of medical records 6.
Monitor Hearing Conversation Program 7.
Monitor Respiratory Protection Program 8.
Periodic tuberculosis screening 9.
Phlebotomy for serum banking 10. Pregnant woman counseling and consultation
with employee’s obstetrician 11.
Vaccinations as required Role
of Principal Investigators and Department Supervisors It is the policy of the 1.
Inform covered employees of this occupational health program 2. Notify IACUC and EHS with the names
and identification numbers of all employees participating in any activity
involving recurrent contact with animals. 3. Provide EHS with the following: Employee’s
name, work phone number, social security or employee identification number,
department name and the animal species with which each employee will have
contact. 4. Names of employees who no longer
have contact with animals. 5. Names of employees who work in areas
that have been identified to require hearing protection 6. Names of employees who are required
to wear a respirator during work duties. 7. Ensure proper
completion of necessary forms. 8. Allow
necessary time away from work duties to enable employees to participate in
this program. 9. Ensure that
covered employees’ participation in this program is at no cost to the
employee. 10. Provide
appropriate personal protective equipment. 11. Provide
employee training in proper use of personal protective equipment. 12.
Ensure that employees having contact with animals receive information
regarding: ·
Health
hazards associated with animal species with which they have contact. ·
Safe
work practices. ·
Follow-up
procedures for an exposure incident. The Institutional Animal Care and Use
Committee requires the following: 1. Principal Investigators to provide a
listing of all employees who participate in each animal research protocol to
IACUC. 2. Principal
Investigators to provide EHS with the employee’s name, work phone number,
employee identification number, department name and the animal species with
which each employee will have contact 3.
Notify Principal Investigators of the Occupational Health Program for Animal
Research Personnel. The
employee shall: 1. Complete acknowledgement form for
the occupational health program for animal research personnel. 2.
Immediately report an exposure incident to their supervisor and EHS. 3.
Use appropriate personal protective equipment as provided by their department
and as trained. Veterinary Care
The
University of Miami Division of Veterinary Resources (DVR) has full time
veterinarians on staff with training and
experience in laboratory animal medicine.
DVR veterinarians have access to all animals. Provision for backup veterinary care is
provided. Veterinarians provide guidance on handling, immobilization,
sedation analgesia, anesthesia, and euthanasia. Veterinarians also provide
guidance/oversight on surgery programs, and oversight of post-surgical
care. The DVR attending
veterinarian(s) has authority on all veterinary care aspects of the animal
care and use program at the Animal
Use Protocols
Required Signatures and Scientific
Merit Review
All work with animals requires written approval by the
Animal Care and Use Committee prior to the start of
the project. Projects, which will not be
subjected to peer review by an external funding agency, require verification
of review for scientific merit by the Departmental Chairman, as signified by
the presence of his/her signature on the protocol form. If the Departmental Chairman is either the
principal or a co-investigator on the study, scientific merit of the study
should be verified by the Vice Provost for Research. Only an original signature of the
appropriate individual is acceptable. ACUC protocol review includes reviews for
scientific merit and for compliance with OHRP Policy and USDA regulations. Justification
for Using Animals Requests for the use of animals will only be considered if
non-animal alternatives (e.g., cell lines) have been carefully evaluated and
rejected. The scientific basis for rejecting the use of non-animal
alternatives must be explicitly described in the protocol. Justification for Using a Particular Species Use of a particular species of animal must be justified in the
animal use protocol form. For example,
Investigators may choose a particular species due to a) the extensive
knowledge base concerning that species that is critical for the proposed
research; b) a similarity between the biological systems of that species and
the analogous human system, etc. Lower financial cost is not an acceptable
justification for the use of one species or another. Justification for the
number of animals requested. Protocols must justify the number of animals requested, by
describing the proposed study groups, the numbers of animals per group and
replicate groups. The methods
(statistical, non-statistical) for determining study group size must be
included. The rationale has to be based on previous (published) work or a
recent statistical analysis of pilot data.
A modest allowance for attrition (model failure) may be acceptable if
justified. If such attrition is
>20% explain what you will be doing to REFINE and model so that the number
of animal subjects may be REDUCED in the future. New work, for which previous
data do not exist, may be proposed as a small pilot study. Justification
for Performing Potentially Painful Procedures Unrelieved
pain/distress with chronic damage to tissue that is innervated, even if such
pain/distress is unknown (pilot work), anticipated, expected or predicted,
requires prophylactic analgesia unless specifically and scientifically
justified, with research references included where indicated on the protocol
form. The
Principal Investigator It is the policy of the Protocol Forms
A longform
must be submitted: ·
For
all new projects involving animal use (including "tissues only"
projects). ·
If
it has been 3 years since the last ACUC approval on an existing project. ·
If
there has been a substantial change in the methods or scope of an existing
project. A shortform
should be completed: ·
For
yearly renewals (required of all principal investigators), ·
If
the PI has previously completed a longform protocol
application, and is resubmitting the same grant proposal to a different funding
agency with new funding intervals (dates), ·
If
the PI is resubmitting a grant proposal to the same funding agency with new
funding intervals (dates), or ·
If
the PI is making clerical "changes" in the original protocol, such
as the Project Title, the Principal Investigator, Investigators or staff. An
addendum may be sufficient if: ·
The
PI is requesting approval of minor
methodological changes to an existing, approved protocol, or ·
If
the PI is requesting additional animals/tissue on an existing, approved
protocol. Protocol Submission
Protocols are to be submitted in duplicate, or
electronically (preferred method). If
submitted via floppy disk, a signed original must be on file in the Office of
Animal Care and Use prior to approval of the
protocol. Protocol Submission
Deadlines
The deadline for submission of protocols to the ACUC
office is 2 weeks prior to the meeting.
Meeting dates and protocol submission deadlines are published on the Protocol Review
Process
Each protocol is assigned a number upon its
receipt. The ACUC Chair then assigns the protocol for preliminary review,
prior to the monthly ACUC meeting. All reviews are conducted
anonymously. “Tissues only” protocols
and addenda are reviewed by at least 3 ACUC members, including one
veterinarian and two additional members.
Long form protocols are reviewed by 3 to 6 members, including at least
one veterinarian. Comments from the
reviewers are collected, collated, and returned to the PI along with a letter
summarizing the reviewer’s comments, concerns, and queries. The PI then has
the opportunity to resolve reviewer concerns, in writing, before the protocol
is added to the agenda of the monthly ACUC meeting for approval action. Revisions in the protocol and/or written
responses from the PI are then delivered to the reviewers for
re-consideration. If the reviewers
approve the protocol, the protocol is placed on the agenda of the monthly
ACUC meeting and discussed by the full committee. Emergency Designated
Reviews
Emergency
designated reviews can be conducted by the ACUC at the direction of the ACUC
Chair. Consideration for an “expedited
review” of a protocol will be entertained by the ACUC Chair upon receipt of
written justification from the PI.
Emergency designated reviews are not routinely granted and are
conducted only under extremely extenuating circumstances. If an expedited review is deemed justified,
the protocol is assigned an ACUC number and submitted to reviewers as
described above. After all concerns are addressed by the PI, the ACUC
membership is poled to determine if there are any objections to granting an
approval. All committee members are
provided access to the protocol. If
there are no objections from the ACUC membership, the protocol can be
approved by the Chair. If on the
other hand, any of the ACUC members believe that the protocol should be
discussed at the full ACUC meeting, the protocol cannot be approved until sufficient
deliberation occurs at the next scheduled meeting of the ACUC. Tissue Sharing
In
addition to the required forms, the ACUC encourages Investigators to fill out the
Tissue Sharing Donor and Recipient Survey Form and return it via e-mail to
the ACUC. Information from this form can be used to promote the Tissue
Sharing Program. This tissue-sharing
program provides the opportunity to practice the concept of “Reduction”, a
decrease in the number of animals used in research at the U of M. The
humane care and use of animals in research and teaching at the U of M is of
paramount importance to the ACUC. Concerns regarding the health and welfare
of animal subjects used at the U of M can be reported anonymously and without
fear of reprisal. Concerns should be reported to the DVR and/or to the
University Animal Care and Use Committee, by contacting one of the following
individuals: Paul
Braunschweiger, Ph.D., Chair, University of Miami Animal Care and Use
Committee, 1600 NW 10th Avenue 1134A, Miami, FL 33101, (305) 243-2311, (305) 243-3922 fax;
(305) 243-6650.
pbraunsc@med.miami.edu. Bobby
Collins, D.VM. Director, Division of Veterinary Resources, Mary
Eaton, Ph.D., Asst. Professor, The Miami Project to Cure Paralysis,
University of Miami, 1095 14th Terrace, Miami, FL 33136, (305) 243-7136 Jennifer
Daniels, The Office of Research, (305) 243-6415 Individuals
reporting concerns should try to be as specific as possible and include the
date, time, species, specific animal identification numbers, and the names of
any University personnel involved. Routine animal husbandry concerns should
be discussed with the animal caretaker supervisor of the facility. If the
concern is not resolved promptly or reoccurs, the Division of Veterinary
Resources should be contacted immediately (305-243-6802). If the problem
remains unresolved, contact the Animal
Procurement and Housing Ordering
animals All
vertebrate animals for approved protocols that do not involve collections of
wild animals are ordered through the Division of Veterinary Resources. All domesticated animals used in research
programs must be obtained from commercial vendors. If the DVR fails to find a
commercial source from which to obtain animals for an approved protocol, DVR
will inform the PI and the ACUC of such, and alternative arrangements may be
considered, at the discretion of the ACUC. Investigators proposing to collect
wild animals must justify these collections in the appropriate section of the
protocol form. Animal Environment, Housing and Management
Minimum
space requirements and details of housing must conform to the “Guide for the
Care and Use of Laboratory Animals”.
Proposed temporary deviations from this standard must be approved by
the ACUC. Animal Transfer To/From Facilities
Outside of the Transfer
of animals (live or dead) to the U of M from
external facilities requires prior approval from the DVR. The attending veterinarian may require
that the PI document the health status of the animals being brought into any
U of M facility. An approved animal
use protocol must be on file with the ACUC before animals may be brought into
the U of M. Further, if animals are
coming from other than a registered vendor, a letter from the ACUC of the
“sending” institution indicating approval of the activity must also be filed
with the U of M ACUC. The transfer of animals (live or dead) from the U of M to other
research institutions requires prior approval of the DVR and the ACUC. The ACUC requires that the responsible
individual at the receiving facilities have an approved protocol to conduct
the proposed studies. Animal Health and Procedure Records
Records
of animal health and observations must be maintained and made available for inspection. Animal records are to be kept in the animal
colony in order to facilitate health monitoring, unless alternative
arrangements are explicitly otherwise permitted by DVR and the ACUC. Important records
would include, but not be limited to, surgery records, anesthesia records,
drug administration records, observation times and analgesia administration
records. Records must be readily
available for review by the attending veterinarian and USDA inspectors. Animal Procedures
Euthanasia - Euthanasia procedures must conform
to the guidelines set forth by the AVMA panel on euthanasia (2000). Procedures must accomplish a swift
unconsciousness and painless death.
The panel describes euthanasia methods as approved, conditional
approval and non-approved.
Non-approved methods are unacceptable. PI’s that want to use a
conditionally approved method must provide clear scientific justification for
using the method. Decapitation is not
an acceptable means of euthanasia unless anesthesia is provided. Clear scientific justification must be
provided to withhold anesthesia prior to decapitation. A copy of the report of the AVMA Panel on
Euthanasia is available at the U of M ACUC website.
Anesthesia methods must conform to the normal standards of
veterinary care. PI’s should consult
with the DVR staff to make the appropriate choice in anesthesia for their own
purpose. Information on acceptable
agents and dose for specific species is available at the U of M ACUC
website. Withholding anesthesia and analgesia for procedures which have
the potential to cause more than momentary pain and distress in animal
subjects requires rigid scientific justification before the procedure will be
approved by the ACUC. Anesthesia
for Rodent Pups Anesthesia
for neonate rodent pups (less than 10 days after birth) will be immersion in
ice until unresponsive to external stimuli.
Surgical procedures must be performed before responsiveness returns
(usually 5-10 min). No pup with hair
will be anesthetized by this method; other anesthetics will be required. Pups
will be re-warmed on heating blanket (37 OC) before returning to
the dam. Hypothermia
Hypothermia may be an
acceptable anesthesia for neonatal mice and rats. Appropriate monitoring and rewarming following completion of the procedure is
essential. Hypothermia is not an
acceptable method of anesthesia/analgesia for rodent dams, or reptiles.
Embryo Removal Removal
of embryos from a rodent dam requires that the dam be adequately
anesthetized, the depth of anesthesia checked by non-responsiveness to
noxious stimuli, before removal of embryos. The dam will them be exsanguinated before disposal. Hypothermia is an unacceptable means of
anesthetization/analgesia for dams. The dam will be anesthetized with CO2;
Embryos will be decapitated at the time of removal, if possible, before removal from the dam. Gas
Anesthesia and/or Euthanasia
If a volatile anesthetic is used such
as halothane (Fluothane~), or isoflurane
(Forane~, AErrane~), an
appropriate method (acceptable to Environmental Health and Safety) to
scavenge the waste gas must be in place. Although diethyl ether is an effective
anesthetic, it must be used with care because it is flammable and explosive.
Ether is irritating to mucous membranes and causes excessive salivation in
many species.
It should not be used in survival surgery procedures. The use of ether
as an anesthetic agent will require clear scientific justification and will
be reviewed on a case-by-case basis.
For all inhalation anesthetics, adequate scavenging system must be in
place. All animals should be "air washed" under an appropriate hood
prior to being transported to the DVR for disposal. Chloroform is a known hepatotoxin, a suspected carcinogen, and is unacceptable
as a euthanasia agent according to the AVMA. Its use must be justified and
will require more rigorous review by the ACUC. Although chloroform is non‑explosive,
its use in the presence of a flame may result in the production of phosgene
gas. Because of its significant hazards to human beings, work with chloroform
must be performed in a working chemical fume hood, with sash lowered to the
rated face velocity mark and gloves must be worn during the procedure.
Following the procedure the animal carcasses and euthanasia apparatus (i.e., container, nose cone, gloves, etc.) must be left in the hood for a
sufficient amount of time (approximately one hour) to allow the chloroform to
volatilize. Use of Carbon
Dioxide for Euthanasia of Laboratory Animals Carbon dioxide is
acceptable for euthanasia. Compressed CO2 gas in cylinders is preferable to
dry ice because the inflow to the chamber can be regulated precisely. If dry
ice is used, animal contact must be avoided to prevent freezing or chilling.
Carbon dioxide generated by other methods such as from a fire extinguisher or
from chemical means (egg, Alka-Seltzer) is unacceptable. With an animal in
the chamber, an optimal flow rate should displace at least 20% of the chamber
volume per minute. Unconsciousness may be induced more rapidly by exposing
animals to a CO2 concentration of 70% or more by prefilling
the chamber. It is important to verify that an animal is dead before removing
it from the chamber. If an animal is not dead, CO2 narcosis must be followed
with another method of euthanasia. Larger animals, such as rabbits, cats, and
swine, appear to be more distressed by CO2 euthanasia; therefore, other
methods of euthanasia are preferable. In some animals, under deep carbon
dioxide anesthesia, heartbeat can be maintained after visible respiration has
ceased, and the animal might eventually recover. A thoracotomy is recommended to
assure death of animals after CO2 exposure. Assessment of both
respiratory and cardiac arrest prior to discarding the carcass is required. Pain Management The ACUC of the UM endorses a
philosophy that promotes prevention and alleviation of research animal pain
and suffering as an important and tenable therapeutic goal. The ACUC acknowledges that complete
elimination of pain in individual animals may not be obtainable or desirable
(see: exceptions). Rather than being
aimed at eliminating all pain, therapeutic strategies should be aimed at
improving an animal’s ability to cope with pain, thereby decreasing
suffering. Treatment of pain can be
considered successful if the degree of pain does not prevent an animal from
engaging in relatively normal activities, such as eating, sleeping,
ambulating, grooming, and interacting with other members of its species or
its care givers. The ACUC also
recognizes that management of pain in many animals is problematic and may not
be feasible under certain circumstances.
Nevertheless, it is ACUC policy that every attempt will be made to
prevent or alleviate pain in animals unless there are compelling scientific
reasons to withhold relief. Normally, documentation for possible interference
by analgesics, in the form of literature references, is required. As a policy, if a procedure (and the post-operative period) is
painful in human beings, then it is assumed to be painful in animals. It may be useful to draw parallels between
people and animals, but the severity of pain produced by various procedures
is not always similar. Because it is
difficult to compare the experience of pain in animals to that in people, it is ACUC
policy to require administration of analgesics preemptively if there is any
question that a procedure will induce pain in an animal, As a matter of policy, the ACUC assumes that all surgical
procedures (involving tissue/bone damage) will result in at least a temporary
period of pain (varies with the procedure).
It is ACUC POLICY that animals
will be prophylactically treated with appropriate
analgesics for all surgical/traumatic procedures to research animals, unless
justified in the protocol as an exception, described below. Many procedures create long-lasting damage
so that some level of spontaneous/evoked pain is created. Each procedure/protocol/animal must be
examined individually. It's recognized that with the current
research interest in developing strategies and treatments for chronic pain
and preventing/decreasing the outcome of traumatic injury in humans, that
research animals might be required to remain untreated for post-surgical
pain. A number of possible problems may
be encountered with ordinary post-operative analgesics: (1)
Analgesics
might interfere with other interventions to be studied; (2) The increased number of animals to be
used as the controls (+/- analgesics); (3) The likely difficulties with the
interpretation of the results when analgesics are used; and finally, (4) The difficulty in comparing the data
from such analgesic-animals with that found in the literature. None of these
problems could alone serve as criteria for the non-use of analgesics; each
protocol will be CONSIDERED INDIVIDUALLY BY ACUC. In a situation where no
data exists on the effects of analgesics on a particular lesion exists, it is
the policy of the ACUC to encourage PI’s to include analgesia controls. Such information should be made available
to the ACUC to guide future reviews. During immediate post-operative recovery, sternal
recumbency must be attained before an animal is
left alone. Exceptions: include
procedures such as motor paralysis; such procedures MUST have description of
post-op care and records of frequency/care provided. Post-operative analgesia must be provided, unless clearly
justified in the protocol (see below). The time period for analgesics (and
antibiotics) will be determined by the procedure. Animals must be observed for an appropriate period (and
frequency) post-operatively, watching closely for signs and symptoms of
pain/distress, to evaluate the effectiveness of analgesics, and for
post-surgical complications.
Observations and the use of analgesics will be recorded as part of that
animal’s health record, and will be made available for inspection by the
ACUC, if requested. Protocols that might be
considered as exceptions to the above policies include: 1. Studies of therapeutic
interventions for pain; 2. The mechanisms of the
initiation, development, and maintenance of acute, 3.
Where analgesics
will cause changes in the animal at the cellular level or in 4. Studies where injuries or
interventions require an untreated (with analgesics) animal. A guideline for what should be included in such protocols, and
will function as criteria are:
Surgery
In
general, unless an exception is specifically justified as an essential
component of the research protocol and approved by the ACUC, nonrodent aseptic surgery should be conducted only in
facilities intended for that purpose. Functional components of aseptic
surgery include surgical support, animal preparation, surgeon's scrub,
operating room, and postoperative recovery. In compliance with the Guide, UM
policy is that all major survival surgery on nonrodent
species must be performed in approved surgical suites that meet all
accreditation requirements. Post-surgical Care According to the Guide, appropriate facilities and equipment
should be available for post surgical care. An important component of
post-surgical care is observation of the animal and intervention as required
during recovery from anesthesia and surgery.
Adequate care (the responsibility of the PI) requires close monitoring
of the organism during the acute postoperative period. All animals should be
observed continuously until they are conscious (arousable
to an alert and responsive state), able to maintain sternal
recumbency, and are normothermic.
Monitoring is critical for identifying immediate complications such as
hemorrhage, dehiscence of surgical incisions, neuropraxia,
myositis,shock, pain, etc. The immediate
postoperative periods should also be used to assess comfort and identify
those animals requiring postoperative analgesics. At a minimum, temperature,
pulse, mucous membrane color and refill time, and respiratory rate should be
monitored at least every 15 minutes until the animal is conscious. Thereafter, animals must be observed daily
for at least 7 days following any surgical procedure. Animals may be monitored more frequently,
and for a longer postoperative period, as the situation requires, and at the
discretion of DVR veterinarians and/or the ACUC. It
is the responsibility of the investigator to provide and document
postoperative care during the recovery period. A postoperative treatment form
should be filled out and attached to the animal’s clinical record. The form
should contain, at minimum, the following information: animal ID, date, surgical procedure or
behavioral manipulation, observation notes, weight). Upon request, Animal
Resources may be able to provide monitoring and treatment during the recovery
period. Investigators, or their staff, may provide their own monitoring
during recovery as long as the monitoring is continued until the animal meets
the conditions described above and the appropriate records are maintained.
However, failure to provide proper care or maintain complete records will
lead to loss of this privilege at which time Animal Resources personnel will
provide proper care and maintain adequate records at the standard charge. Food
Deprivation Food
deprivation below 85% of ad libitum weight requires
special justification to the ACUC. It
is suggested that for each group of animals ordered, one animal be used as a
free food ad lib control in order to more accurately judge the deprivation
state of the food deprived subjects. Animal Identification
Injection
of microchips, and non-toxic tail or skin/tail marking is preferable to toe
clipping, tail clipping, or ear punching.
If a PI proposes to use any of these methods scientific justification
must be provided and approval will be considered on case-by-case basis. Antibiotics Invasive surgical procedures require the use of prophylactic
antibiotics. Justification for not
using antibiotics must be documented with citations from the
literature or data from the PI's laboratory. Avian Field Studies Birds should be observed at least once per day for signs of
distress or illness. The following are
taken as evidence of illness: Ruffled feathers, or a
“puffy” appearance as when the body plumage is partly erect. Head tucked under wing or
eyes closed when the bird would normally be awake. General inactivity, sitting
on the floor of the cage, or difficulty standing on a perch. Drooping wings or a low stance
while perching Nasal discharges, sneezing
or difficulty breathing Pasting of feces around the
vent and/or feet. Centralized records are
kept of each bord’s history, including date and
place of capture, and signs of illness, hormone treatment, and date and place
of release. In addition, records of
minimum and maximum temperatures are maintained. Reports of captures and releases are
submitted to the state and federal permit-granting agencies, as required. Ascites Production
National
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