TABLE OF CONTENTS

1.      Animal use protocols: Terrestrial vertebrate eggs in research

2.      Animal use protocols: Blood withdrawal

3.      Animal use protocols: Changes requiring amendments versus new protocols

4.      Animal use protocols: Deferral to subcommittee

5.      Animal use protocols: Feed/water restriction

6.      Animal use protocols: Fish in research

7.      Animal use protocols: Granting reciprocity for protocols approved by other IACUCs

8.      Housing of Animals from Other Institutions

9.      Animal use protocols: Justification of numbers

10.    Animal use protocols: Type A, B, and C

11.    Wet lab training

12.    Clinical research: Regulatory oversight

13.    East Baton Rouge Animal Control Center Animal Use

14.    Facility inspections and programmatic review: Frequency and timing

15.    IACUC: Training of new members

16.    IACUC: New member recruitment

17.   IACUC: Investigators appearing before the IACUC

18.    IACUC: Proposal Routing and Approval Form (PRAF)

19.    IACUC: Submission of late protocols

20.   IACUC: Approval of studies involving known zoonotic agents and human pathogens in animal  rooms

21.    LSU owned herd: Oversight

22.    Rules and Regulations course: Failure to attend

23.    Minimizing Research Animal Use

 

POLICY #1

Title:  Animal use protocols: Terrestrial vertebrate eggs in research

Purpose:      To establish that projects utilizing unhatched terrestrial vertebrate embryos at or after 80% of mean incubation period, require IACUC approval.

Background:

1.1     The NIH/OLAW has issued the following interpretation of PHS Policy for research involving avian embryos,

AThe PHS Policy is applicable to proposed activities that involve live vertebrate animals. While embryonal stages of avian species develop vertebrae at a stage in their development prior to hatching, OPRR (now OLAW) has interpreted >live vertebrate animal= to apply to avians (e.g., chick embryos) only after hatching.@

1.2     In AThe IACUC Handbook@, the authors add the following,

A... However, the risk of eggs hatching and producing chicks (requiring food, water, proper housing, and veterinary care and placing them under the purview of PHS Policy) dictates that IACUCs consider developing policies for different aged avian embryos, newly hatched birds, and the point at which bird embryos are considered vertebrate animals. For chickens, the last 3 days of incubation (incubation days 18 to 21) represent the last stage of embryo development and coincide with the chick drawing the yolk sac into the body and having sufficient pulmonary maturation to handle oxygen and carbon dioxide exchange. During this period of time, some chicks may hatch normally and some prematurely hatched chicks could survive outside of the egg with little additional care.@

Policy:

In consideration of the above, the IACUC requires submission of an animal use protocol for projects utilizing pre-hatched terrestrial vertebrates at or after 80% of mean incubation period has been reached.

Date established/amended:      April 15, 2004

 

POLICY #2

Title:  Animal use protocols: Blood withdrawal

Purpose:      To protect animal well-being by establishing limits to the volume, frequency, and site of blood collection from animals used on approved teaching and research protocols.

Background:

1.1     Most mammals contain ~6.7ml blood/100 gm body weight. Studies have shown that hemodynamic changes result from losses >30% of total blood volume.

1.2     Studies in rats, dogs, and horses have shown that when erythrocytes are returned and plasma replaced, up to 33% of blood volume may be removed weekly for several months without causing harm to the animal.

1.3     Recent advances in the humane care of laboratory animals have included recommendations that blood be removed from the facial artery of mice (“submandibular” bleeding), as a humane alternative to retro-orbital sinus bleeding, which is considered more stressful to mice, and has the potential to result in greater tissue damage and pain versus submandibular bleeding.

Policy:

2.1     The maximum volume of blood that can be safely collected from an animal is that volume which represents 1.5% of the animal=s body weight over the course of two weeks. This figure was derived as follows: Blood volume = 6.7% of body weight; 22% of blood volume can be safely removed from an animal each two weeks. Blood collection in excess of 1.5% of body weight in a two week period may be approved by the IACUC if scientific justification is provided by the investigator.

2.2     When erythrocytes are returned to the animal, up to 33% of total blood volume (2.2% of body weight) may be removed weekly.  Plasma should be replaced with an equal volume of lactated Ringer’s solution, normal saline, or suitable volume expander.

2.3     For mice, acceptable sites of blood collection include the facial artery (submandibular bleeding), saphenous vein, heart (under anesthesia), or tail artery. Retro-orbital bleeding (under anesthesia) may only be performed by trained personnel when justified for scientific reasons and when approved by the IACUC.

Date established:  April 15, 2004/Revised May 11, 2006

 

POLICY #3

Title:  Animal use protocols: Changes requiring amendments versus new protocols

Purpose:      To provide guidance concerning when changes in research projects warrant protocol amendments versus submission of a new animal care and use protocol.

Policy:

1.1     As a general guideline, in determining when a protocol amendment is warranted, versus a new protocol submission, the IACUC should evaluate whether the proposed changes are significant or minor, and if and how the changes affect the intent and focus of the research. In general, if the intent and focus of the research is altered by the proposed changes, a new protocol should be submitted. In contrast, if the proposed changes do not alter the intent and focus of the research, but simply extend the scope of the project, an amendment is sufficient. Also, significant changes require submission of a new protocol, whereas minor changes may be approved through submission of an amendment.

1.2     Examples of significant changes requiring submission of a new protocol (as cited by NIH/OLAW) include:

1.2.1  Changes in the study objectives.

1.2.2  Change from non-survival to survival surgery.

1.2.3  Change in the degree of invasiveness of a procedure or level of discomfort that will be experienced by an animal.

1.2.4  Change in class of animal used.

1.3     Examples of significant changes requiring only a protocol amendment include:

1.3.1  Addition of another strain, species, genus, family, or order of animal.

1.3.2  Change in sex or number of animals to be used.

1.3.3  Need to repeat an experiment.

1.3.4  Change in duration, frequency, or number of procedures performed, such as addition of minor surgery or additional noninvasive sampling.

1.3.5  Addition of a course to an approved protocol.

1.3.6  Transfer of animals from one approved protocol to another.

1.3.7  Change in adjuvant.

1.3.8 Change in route of immunization.

1.3.9  Change in anesthetic agent(s), method of euthanasia, or the use or withholding of analgesics.

1.4     The IACUC should be notified, though approval does not need to be requested, when the following changes in administrative information occur:

1.4.1  Changes in personnel.

1.5     Examples of activities requiring neither protocol submission nor IACUC notification:

1.5.1  Activities for which the primary purpose is exhibition or demonstration of privately owned animals or continuing education activities where no experimental or manipulative instructional procedures will occur.

Date established/amended:      April 15, 2004

 

POLICY #4

Title:  Animal use protocols: Deferral to subcommittee

Purpose:      To describe the circumstances under which submitted animal care and use protocols are deferred to subcommittee for review and approval.

Background:

1.1    Often, animal care and use protocols or protocol amendments are found lacking information, thereby precluding approval. In keeping with federal guidelines, the IACUC then requires modifications in the protocol or amendment in order to secure approval. To accomplish this, protocols or amendments may be deferred until the next regularly scheduled meeting of the IACUC, may be deferred to a subcommittee of at least one person, or may be approved pending specific information agreed upon by the IACUC.

Policy:

2.1    Protocols and amendments will be deferred to one or more designated reviewers when the IACUC agrees in principle on the changes required for approval, but wants to ensure that the specific changes proposed by the investigator are appropriate. In contrast, when the IACUC requests proscribed information that does not require specific expertise for verification, those protocols or amendments can be approved pending receipt of specific information. If any IACUC member requests full committee review of the protocol or amendment after changes have been made by the investigator, that protocol or amendment will be reconsidered at the next regularly scheduled meeting.

Date established/amended:      September 9, 2004

 

POLICY #5

Title:  Animal use protocols: Feed/water restriction

Purpose:      To provide for the humane care of animals used in teaching and research by ensuring that feed and water restrictions are of appropriate degree and duration so as not to compromise the health or well-being of the animals involved.

Policy:

1.1     For pre-surgical preparation, investigators are encouraged to fast dogs, cats, and other large, non-ruminant species overnight. Ruminants should be fasted for two days. Water restriction should be limited to the day of the surgery in all animal species larger than a rabbit. There is no need to fast or water deprive rodents or rabbits prior to surgery. Neither rodents nor rabbits can vomit stomach contents, and rabbits can store a gastric food bolus for up to 12 days.

1.2     For experimental studies, short-term withholding of food or water is allowed when specified in the animal use protocol.  A description of monitoring procedures must be included. Short-term feed and/or water deprivation means deprivation for up to16 hours in non-ruminants, and 48 hours in ruminants, since these periods are equivalent to those adopted for pre-surgical preparation. Feed and/or water restriction beyond these limits must be justified for scientific reasons.

1.3     It should be noted that some species (e.g. rats), normally only feed in the dark phase of their photoperiod. Therefore, withholding food overnight results in a fast that includes the period of the previous day, roughly an additional 10 hours.

1.4.    Other species not specifically identified will be considered on a case-by-case basis as described in the approved animal care and use protocol.

Date established/amended:      September 9, 2004

 

POLICY #6

Title:  Fish in research

Overall Purpose:    To provide I.A.C.U.C. and fish researchers with information and guidelines for evaluating and submitting Animal Care and Use Protocols involving research with fish.

Section 1.0:         Fish larvae in research

Purpose:      To describe the stage at which the use of larval fish of oviparous species must be covered by an approved protocol.

Background:

1.1.1  Occasionally, investigators propose to conduct experiments using newly hatched fish larvae. It is known that larvae obtain sustenance from their yolk sac post-hatching. Thereafter, they must feed or starve.

1.1.2  The age at which fish become sufficiently neurologically mature to require approval of an animal care and use protocol varies widely by species.

 Policy:

The LSU I.A.C.U.C. requires approval for projects involving fish after they begin to consume food.

Section 2.0:         Field studies involving fish

Purpose:      To ensure that I.A.C.U.C. and field researchers utilize sound scientific and professional guidelines in evaluating and submitting animal use protocols for field investigations involving fish and to promote the principle of humane euthanasia of fish involved in field studies.

Background:

2.1.1 American Fisheries Society (ASF) has produced Guidelines for the Use of Fishes in Research (2004). http://www.fisheries.org/html/guidelines.html 

2.1.2  The LSU I.A.C.U.C. supports the policies in this guideline with regard to collecting methods, live capture techniques, field restraint (anesthesia and other chemical restraint), handling and transport, physical facilities for temporary holding and maintenance, field acclimation, collection of blood and other tissues, and marking and tagging and field euthanasia.

Policy:

2.2.1 Protocols should adhere to the procedures outlined in the AFS guidelines to the extent possible within the constraints of the scientific investigation or field survey and protocols should state their adherence to these guidelines.

2.2.2 In instances where the proposal would not adhere to AFS guidelines the protocol should provide scientific justification for the proposed variance.

2.2.3 In instances where field manipulations of fishes are not covered by policies in the AFS guideline, the investigator should provide background information/references that support the proposed methods of handling and manipulating fishes.

2.2.4 Investigators collecting fish in the field are encouraged to anesthetize fish with MS222 or other suitable anesthetics as in the guidelines prior to euthanasia. The committee recognizes that this may be unfeasible when working with larger specimens or in remote locales.  For small fishes, immediate immersion in an ice slurry may be substituted.  For larger specimens, the investigator must provide scientific justification for not anesthetizing fish prior to euthanasia.

2.2.5  Investigators are advised that fish anesthetized with MS222 cannot be released into natural waters for 21 days in accordance with EPA rules, in order to prevent human consumption of previously anesthetized fish.

Section 3.0:         Laboratory studies involving fish

Purpose:      To ensure that I.A.C.U.C. and laboratory researchers utilize sound scientific and professional guidelines in evaluating and submitting animal use protocols for laboratory investigations involving fish and to ensure the humane euthanasia of fish.

Background:

3.1.1 American Fisheries Society has produced Guidelines for the Use of Fishes in Research (2004).  http://www.fisheries.org/html/guidelines.html 

3.1.2 The LSU I.A.C.U.C. supports the policies in this guideline with regard to acclimation to laboratory conditions, physical facilities, density of animals, feeds and feeding, water quality assurance, restraint and anesthesia, and euthanasia.

Policy:

3.2.1 Protocols should adhere to the procedures outlined in the AFS guidelines to the extent possible within the constraints of the scientific investigation.

3.2.2 In instances where the proposal would not adhere to AFS guidelines the protocol should provide scientific justification for variance from these guidelines.

3.2.3  In instances where laboratory manipulations of fishes are not covered by policies in the AFS guideline, the investigator should provide background information/references that support the proposed manipulations of fishes.

3.2.4 For fish euthanasia, MS222 should be utilized, unless another method can be justified for scientific reasons. If another form of chemical anesthesia will be proposed, suitable scientific background information should be provided in the protocol or consultation with the attending veterinarian should be described.

Date established/amended:      This policy is a compilation of former policies #6 (approved September 9, 2004) and #8 (February 10, 2005). Approved November 9, 2006.

 

POLICY #7

Title:  Animal use protocols: Granting reciprocity for protocols approved by other IACUCs

Purpose:      To establish a system for recognizing the approval of animal use protocols granted by an IACUC at a different institution.

Background:

1.1     Occasionally, LSU faculty and staff conduct portions of sponsored research at other institutions (performance site), but funds are controlled by LSU. In these cases, work involving animals is approved by the IACUC at the performance site.

1.2     The IACUC recognizes that a system should be in place for recognizing animal care and use protocols approved by the IACUC of the performance site.

Policy:

2.1     The procedure for LSU IACUC recognition of an animal use protocol approved by another institution will be as follows:

2.1.1  The principal investigator submits a cover letter requesting LSU IACUC recognition of approval by the IACUC of the performance site. The letter must indicate whether the performance site: a) has an approved Assurance Statement on file with OLAW, b) is registered with the USDA as a research facility, and c) is accredited by AAALAC International.

2.1.2  The investigator must provide a copy of the approved protocol and a copy of the approval letter from the IACUC at the performance site.

2.1.3  At the time of submission of the required material, the IACUC Secretary will assign the protocol an LSU protocol number.

2.1.4  The IACUC Chairperson will review the submitted material and make a determination whether to honor the approval of the IACUC at the performance site. A letter so stating will be sent to the investigator and to the person at the performance site who signed their approval letter.

2.2     It should be noted that under the above arrangement, the performance site retains full responsibility for ensuring that animals used in their institution are cared for according to all applicable standards. This responsibility is to be clearly indicated in the approval letter sent to the investigator and to the IACUC of the performance site.

Date established/amended:      February 10, 2005

 

POLICY #8

Title:  Housing of animals from other institutions

Purpose:      To establish a policy that will stipulate the conditions under which animals owned by other research institutions may be housed in LSU facilities.

Background:

1.1     The IACUC recognizes that shortage of space, specialized facilities, or pathogen status may occasionally result in faculty of other institutions requesting that animals be housed in LSU animal facilities.

1.2     The LSU IACUC must ensure that animals housed in LSU, regardless of the institution owning the animals, will be conducted in accordance with accepted standards of animal care and use, including the Guide for the Care and Use of Laboratory Animals (Guide), the Animals Welfare Act (AWA), and the 2000 AVMA Panel on Euthanasia.

Policy:

2.1     Animals from other institutions may be housed in LSU animal facilities following approval by the Director of the DLAM, and following receipt, review, and approval by the Chair of the LSU IACUC, of a copy of an approved animal use protocol and a letter of protocol approval issued by the IACUC of the guest institution.

2.2     Where zoonotic or human pathogens are to be used, housing of animals from other institutions in DLAM facilities also requires approval of the LSU Inter-institutional Biological and Recombinant DNA Safety Committee (IBRDSC). Following IBRDSC approval, the investigator must provide DLAM with an approved animal room door posting, describing pathogen containment procedures.

Date established/amended:      December 14, 2006

 

POLICY #9

Title:  Animal use protocols: Justification of numbers

Purpose:      To provide guidance on acceptable means of determining appropriate numbers of animals to be used in research protocols.

Background:

1.1     Both the AGuide@ and the Animal Welfare Act require IACUCs to evaluate the Aapproximate number of animals to be used@, as well as the Arationale ... for the appropriateness of the ... numbers used@.

Policy:

2.1     Investigators must provide a rationale for the numbers of animals to be used. Analysis should be based on power analysis, or the rationale can be based on past full experiments, either the investigator=s or others= (published information); or pilot experiments. Where statistical comparisons will not be performed, for example in teaching laboratories or descriptive experiments, animal numbers should be supported by the investigator=s thoughtful estimation of procedural needs.

2.2     Investigators are encouraged to perform power analysis to determine the number of animals needed to demonstrate treatment effects. Several websites have been created which guide investigators through the performance of a power analysis, using formulae embedded in the sites. The IACUC should inform investigators of the availability of these resources, through posting web addresses on the DLAM website.

Date established/amended:      November 10, 2005

 

POLICY #10

Title:  Animal use protocols: Type A, B, and C

Purpose:      To define the conditions under which experiments or teaching exercises involving animals are classified as type A, B, or C.

Background:

1.1     The USDA requires annual reporting of the numbers of covered animals involved in experimentation, teaching, or testing, according to the level of pain and/or distress those animals experience in the course of the covered activities.

Policy:

2.1     Type A projects are those where pain or distress is not induced, or where animals experience Ano more than slight or momentary pain or distress@, or are simply humanely euthanized utilizing methods approved by the AVMA Panel on Euthanasia (2000). Examples of methods causing no more than slight or momentary pain or distress include compound injection; blood (other than by ear punch, tattoo, microchip implantation, and retro-orbital bleeding), urine, or fecal collection; gastric gavage; or tail snips (pre-weaning only).  In all cases listed above, type A classification pertains when procedures are performed by trained persons proficient in the methods used.

2.2     Type B projects are those in which pain and/or distress is likely to be produced, but is prevented or relieved by appropriate therapy. Thus, all protocols that use anesthetics, and/or analgesics, and/or sedatives are Type B. Examples of procedures expected to cause pain or distress include toe clipping; tail snips (at or after weaning); most other minor surgical procedures; and all major surgical procedures.  In addition, due consideration should be given to the emotional distress which may accompany physically non-painful procedures. In determining whether an activity should be classified as type A or B, the investigator and IACUC should consider whether the procedure is likely to be painful and/or distressing in humans.

2.3     Type C projects are those projects in which pain and/or distress is likely to be produced, but cannot be prevented or alleviated by therapy because to do so would invalidate the experiment. In these cases, the investigator must clearly justify for scientific reasons, the need to disallow pharmacological intervention or euthanasia.

Date established/amended:      November 11, 2005

 

POLICY #11

Title:  Wet Lab Training

Purpose:      To describe training required before conduct of procedures involving live animals

Background:

1.1     The “Guide for the Care and Use of Laboratory Animals”, the Federal Animal Welfare Act, and other regulations require that persons utilizing live animals in teaching or research be adequately trained.

1.2     The IACUC has determined that a “wet lab” represents an effective venue for training investigators and their staffs to humanely perform procedures on live animals.

Policy:

2.1     Each Principal Investigator will indicate on the animal care and use protocol whether personnel to be working with animals have or have not been trained in the assigned procedures and the date of that training. Participating personnel will be named on the protocol.

2.2     Prior to commencement of the project, personnel to perform procedures on live animals will schedule a wet lab with the DLAM Chief Clinical Veterinarian. Procedures will be taught utilizing the type of animal named in the protocol, and will include basic handling and restraint techniques, compound injection, blood collection, anesthesia, and other procedures as stipulated in the approved protocol.

2.3     The wet lab will be conducted by a DLAM faculty or resident veterinarian or by an expert outside of DLAM with particular proficiency with the animal and procedure to be used. Following successful completion of the wet lab, as determined by the instructor and Attending Veterinarian, the IACUC Secretary will be notified that the employee may carry out their assigned protocol tasks.

2.4     Principal Investigators may request exemption from wet lab training based on previous training and experience, as indicated on the animal care and use protocol. All requests for exemption will be reviewed and a recommendation made to the IACUC by the Attending Veterinarian.

Date established/amended:      March 16, 2006

 

POLICY #12

Title:  Clinical research: Regulatory oversight

Purpose:      To describe the extent to which the LSU IACUC oversees the care and use of privately owned animals used in clinical research studies.

Background:

1.1     The SVM VTH&C has established a committee to oversee the care and use of privately owned animals used in clinical research studies, and housed at their normal residence or in the VTH&C. This committee functions in a manner similar to that of the IACUC, except that housing conditions and daily care of the privately owned animals are not monitored by the committee.

Policy:

2.1     The LSU IACUC assumes no jurisdiction or oversight responsibilities for clinical research studies or activities involving privately owned animals.

Date established/amended:      March 9, 2006

 

POLICY #13

Title:  East Baton Rouge Parish Animal Control Center animals: Use in research

Purpose:      To ensure only the appropriate and agreed upon use of live animals from the East Baton Rouge Parish Animal Control Center.

Background:

1.1     Currently, the East Baton Rouge Parish Animal Control Center (EBRPACC) provides dogs for use in the SVM curriculum. Dogs are used to teach surgical techniques to veterinary students. Dogs so used are not recovered from surgery, but while anesthetized, are euthanized at the completion of the surgery.

Policy:

2.1     The LSU IACUC has entered into an agreement with the Director of the EBRPACC. This agreement states that no live animal will be utilized for any purposes other than the approved teaching exercise, without advance written permission by the EBRACC Director. Activities requiring approval include, but are not limited to, experimentation, collection of tissue samples, or teaching of additional procedures not described in the approved animal care and use protocol.

Date approved:     May 11, 2006

 

POLICY #14

Title:  Facility inspections and programmatic review: Frequency and timing

Purpose:      To ensure the semiannual inspection of animal facilities and review of the LSU animal program in accordance with federal requirements.

Policy:

1.1     In accordance with federal regulations, the IACUC shall inspect the LSU animal facility and review the LSU program for animal use. These reviews will occur semiannually, with no more than six months elapsing between reviews.

1.2     Facility inspections and programmatic reviews will occur in March and October of each year, unless a permanent change in schedule is agreed upon by the IACUC and no more than six months elapses since the last review.

1.3     In accordance with federal policies, a triennial AAALAC site visit may substitute for a semiannual facility inspection and programmatic review by the IACUC.

Date established/amended:      June 8, 2006

 

POLICY #15

Title:  IACUC: Training of new members

Purpose:      To ensure adequate training of new IACUC members.

Background:

1.1     The contents of “The Guide for the Care and Use of Animals”, “Animal Welfare Act”, and the policies and procedures of the LSU IACUC will be reviewed. In addition, new members will be introduced to the AReport of the AVMA Panel on Euthanasia@, the semiannual facility inspection and programmatic review checklists provided by OLAW, the AGuide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching@, ABiosafety in Microbiological and Biomedical Laboratories@, AOccupational Health and Safety in the Care and Use of Research Animals@, the APHS Policy@, and the series of guidelines developed by various associations covering the humane use of specific animal species in field studies. New IACUC members will be instructed in how to access these and other IACUC resources on the internet, and will be made aware of opportunities to attend training meetings and workshops.

Policy:

2.1     Within three months of appointment to the committee, new IACUC members shall attend a training meeting with a member of the DLAM veterinary staff.