university of wyoming institutional animal care and use committee

University of Wyoming Institutional Animal Care and Use Committee

Scientist InvolvementScientist Involvement 1950- Animal Care Panel (ACP)1950- Animal Care Panel (ACP) 1951- 1951- Proceedings of the ACP Proceedings of the ACP publishedpublished 1952- Institute of Laboratory Animal Resources1952- Institute of Laboratory Animal Resources 1960- Animal Facilities Certification Board1960- Animal Facilities Certification Board 1963- 1963- Guide for Laboratory Animal Facilities and Guide for Laboratory Animal Facilities and

CareCare 1965- AAALAC incorporated1965- AAALAC incorporated 1965- 21965- 2ndnd edition of “The Guide” published; 7 edition of “The Guide” published; 7thth

edition published in 1996edition published in 1996 1967- ACP became AALAS1967- ACP became AALAS

Government InvolvementGovernment Involvement 1962- NIH Contract – First “Guide”1962- NIH Contract – First “Guide” 1966- Laboratory Animal Welfare Act1966- Laboratory Animal Welfare Act 1970- Animal Welfare Act (’70, ’76, ’85’ 1970- Animal Welfare Act (’70, ’76, ’85’

90, 2002)90, 2002) 1971- NIH “Policy”1971- NIH “Policy” 1973- Public Health Service Policy (’79, 1973- Public Health Service Policy (’79,

’85)’85) 1985- PHS Act (Health Research Extension 1985- PHS Act (Health Research Extension

Act)Act)

1966 Laboratory Animal Welfare 1966 Laboratory Animal Welfare ActAct

Focus on preventing theft of dogs Focus on preventing theft of dogs and catsand cats

Holding areas emphasizedHolding areas emphasized Only developed specific areas of Only developed specific areas of

standardsstandards Housing, Feeding, Watering, Sanitation, Housing, Feeding, Watering, Sanitation,

Shelter, Separation of species, Shelter, Separation of species, Ventilation, Veterinary careVentilation, Veterinary care

Animal Welfare ActAnimal Welfare Act 1970 the LAWA changed to AWA1970 the LAWA changed to AWA Extended to the laboratoryExtended to the laboratory Reported number of animals by pain Reported number of animals by pain

categorycategory Required appropriate use of Required appropriate use of

anestheticsanesthetics No ACUC yetNo ACUC yet

1971 NIH Policy1971 NIH Policy Institutions had to have “Assurances”Institutions had to have “Assurances” Annual inspectionsAnnual inspections Compliance with AWACompliance with AWA Follow the “Guide”Follow the “Guide” 1973 Public Health Service Policy 1973 Public Health Service Policy

followedfollowed

1979 PHS highlights1979 PHS highlights IACUC now requiredIACUC now required Assurance required before funding Assurance required before funding

receivedreceived All live vertebratesAll live vertebrates Annual reports requiredAnnual reports required

Recommended to have protocol reviewsRecommended to have protocol reviews

1985 AWA Amendments1985 AWA Amendments Established the IACUCEstablished the IACUC Assigned responsibility to Institutional Official Assigned responsibility to Institutional Official

(IO)(IO) Protocol reviewProtocol review Semiannual inspection and program reviewSemiannual inspection and program review Search for alternatives to painful proceduresSearch for alternatives to painful procedures Personnel qualificationsPersonnel qualifications Environmental enrichmentEnvironmental enrichment Exercise for dogsExercise for dogs

1985 PHS Policy1985 PHS Policy More detailed AssuranceMore detailed Assurance IO ultimately responsibleIO ultimately responsible IACUC members are appointed by CEOIACUC members are appointed by CEO Minimum of 5 membersMinimum of 5 members Protocol reviews requiredProtocol reviews required Semiannual reports of program reviewSemiannual reports of program review Detailed training program descriptionDetailed training program description

UW IACUCUW IACUC Bill Gern, Institutional OfficialBill Gern, Institutional Official Dorothy Yates , Liaison to Institutional OfficialDorothy Yates , Liaison to Institutional Official Linda Osterman, CoordinatorLinda Osterman, Coordinator Colette Kuhfuss, CoordinatorColette Kuhfuss, Coordinator Dave Evertson, Attending VeterinarianDave Evertson, Attending Veterinarian Dan Rule, IACUC Chair, Animal ScienceDan Rule, IACUC Chair, Animal Science Scott Seville, Zoology and PhysiologyScott Seville, Zoology and Physiology Sreejayan Nair, School of PharmacySreejayan Nair, School of Pharmacy Myrna Miller, Veterinary SciencesMyrna Miller, Veterinary Sciences Bob Boysen, Unaffiliated member Bob Boysen, Unaffiliated member Ashley Guritza, UW General Council,Ashley Guritza, UW General Council, Tara Evans, UW General CouncilTara Evans, UW General Council

IACUC Protocol PreparationIACUC Protocol Preparation

FOR IACUC USE Approved for period (one year maximum) Approved ______________ to ________________ Copy to PI ________________________________ Copy to Animal Care Worker _________________

DHHS/NIH/OLAW ASSURANCE #A-3216-01 EFFECTIVE: 08/26/05-08/31/09 UNIVERSITY of WYOMING INSTITUTIONAL ANIMAL CARE and USE COMMITTEEPROTOCOL APPROVAL FORM Submit completed form to the IACUC, Office of Research, Room 308, Old Main. RESEARCH SHALL NOT BEGIN BEFORE THIS FORM IS APPROVED. New project ____________ Revised protocol ____________ Date________Title of project : Project leader(s): Department(s):Phone:Email:Type: Research _____ Instruction ______ Location of animal room: Building/Room number Location of animal care log book/medical records: Building/Room numberDuration of project: Begin End (Project will be approved for one year from date of IACUC approval. An update form must be submitted annually if project extends beyond one year.) Sponsoring agency (if applicable):UW Budget ID/Project Grant number (if applicable): Name person(s) and/or unit responsible for animal care: Name: Phone: Email:

Animal species (genus, species, common name) (one species per protocol form):Number to be used/year: Total animal days/year (# animals x #days): Number to be used/project: Total animal days/project:Source of animals:

Animal species (genus, species, common name) (one species per protocol form):Number to be used/year: Total animal days/year (# animals x #days): Number to be used/project: Total animal days/project:Source of animals:

Commonly overlooked

Is simple math, but quite often the number of animalsindicated on this page does not match up with the numbersindicated in the description of the research

Proposal category: A _____ Live animals will be humanely killed without any treatments, manipulations, etc., but will be used to obtain tissue, cells, sera, etc.

B _____Live animals will have manipulations, surgery, etc. performed while anesthetized. The animals will be humanely killed at termination of the experiment without regaining consciousness (non-survival surgery).

C _____ Live animals will receive a painful stimulus of short duration without anesthesia behavior experiments with flight or avoidance reactions) resulting in a short-term traumatic response. Other examples in this category are blood sampling, injections of adjuvant, etc.

D _____ Live animals will have significant manipulations, surgery, etc., performed whileanesthetized and will be allowed to recover (survival surgery). Such procedures (e.g., chronic catheters, surgical wounds, implants) cause a minimum of pain and/or distress. Also included are mild toxic drugs or chemicals, tumor implants (including hybridomas), tethered animals, short-term restrained animals.

E _____ Live animals will have significant manipulations, surgery, severe discomfort, etc. without benefit of anesthesia, analgesics or tranquilizers. Examples are toxicity testing, radiation sickness, irritants, burns, trauma, biologic toxins, virulence challenge, prolonged restriction of food or water intake, cold exposure, restraint, or drug addiction. All use of paralytic agents (curare-like drugs) must be included in this category.

O _____ Other: Standard husbandry practices, weighing, observation, insemination.

Choice of category??Choice of category?? If not clear on which category to If not clear on which category to

check, be conservativecheck, be conservative Check the next highest category to Check the next highest category to

make sure the project is covering the make sure the project is covering the bases adequatelybases adequately

The IACUC review will compare The IACUC review will compare procedures with category chosenprocedures with category chosen

1) a. Purpose (in lay terms)

b. Scientific objective(s)

Potential for use of in vitro systems or computerized models instead of live animals

i. Elaborate on current availability of animal data that could be used to predict outcomes

ii. Elaborate on the uniqueness of the study such that the requirement for live animal research is necessary

Purpose – in “lay terms”Purpose – in “lay terms” Should be written at a high school levelShould be written at a high school level The nature of the study and the relevant The nature of the study and the relevant

benefactors should be indicatedbenefactors should be indicated For example, if the study is to benefit For example, if the study is to benefit

agricultural production, say soagricultural production, say so BiomedicalBiomedical Veterinary medicalVeterinary medical Environmental, zoological, etc.Environmental, zoological, etc.

1) a. Purpose (in lay terms)

b. Scientific objective(s)

Potential for use of in vitro systems or computerized models instead of live animals

i. Elaborate on current availability of animal data that could be used to predict outcomes

ii. Elaborate on the uniqueness of the study such that the requirement for live animal research is necessary

This is where you justify the use of animals for the research. - “In vitro or comperized models cannot be use because…” - “The current animal data indicates….; however,…..” - “The proposed study is unique because….; therefore, new animal research is necessary to address the problem.”

2) Describe all procedures: Description should allow the IACUC to understand the experimental course of an animal from its entry into the experiment to the endpoint of the study.Overview of procedures(Reference citations for b-e)

b. Type and duration of restraint

c. Name and dose of anesthesia and/or tranquilizer (contact attending veterinarian)

d. Surgical procedures i. pre-operative procedures

ii. asceptic methods to be used: surgical attire

iii. who will perform surgical procedures

iv. where will surgical procedures be performed

v. non-survival/survival surgery

vi. justification if more than one surgical procedure per animal

Post-surgical carei. Recovery facility

ii. Name, dose, route of administration and regimen for analgesia;(investigate literature for pain management for species used;consult attending veterinarian)

Describe proceduresDescribe procedures Be thoroughBe thorough Address each itemAddress each item If not conducting surgery, address with If not conducting surgery, address with

“N/A”“N/A” A “copy and paste” would work here, A “copy and paste” would work here,

but be succinct – no need for numerous but be succinct – no need for numerous paragraphs and pages from your grant paragraphs and pages from your grant proposalproposal

3) Justification for species chosen (lowest possible species on phylogenetic scale)

““lowest species on the phylogenetic lowest species on the phylogenetic scale”scale”

Example – you propose to use sheepExample – you propose to use sheep Why can’t you use a mouse?Why can’t you use a mouse? Some examples of why have included the Some examples of why have included the

specialized GI tract; the presence of a specialized GI tract; the presence of a large enough pituitary to study; large enough pituitary to study; characteristic reproductive cyclescharacteristic reproductive cycles

Start the sentence with “The (species) is Start the sentence with “The (species) is the lowest species on the phylogenetic the lowest species on the phylogenetic scale because……” finish the sentencescale because……” finish the sentence

4) Statistical justification for the specified number of animals (assistance to determine the appropriate number of animals per treatment)

a. Justification for number of animals per experiment

b. Justification for number of experiments per year (as stated on page 2)

c. Literature cited/reviewed for justification of number of animals proposed

Statistical JustificationStatistical Justification The same statistical justification used in The same statistical justification used in

a grant proposal should be used herea grant proposal should be used here Examples of what Examples of what NOTNOT to use include: to use include:

Number chosen based on number of cages Number chosen based on number of cages or pensor pens

Based on available financial resourcesBased on available financial resources Based on what you used last timeBased on what you used last time

Statistical JustificationStatistical Justification If you need to add animals because If you need to add animals because

of expected mortality, say soof expected mortality, say so Don’t add animals just because more Don’t add animals just because more

would be betterwould be better The idea is to use enough to obtain The idea is to use enough to obtain

data worthy of interpretationdata worthy of interpretation Too few or more than necessary Too few or more than necessary

could be a red flagcould be a red flag

Statistical JustificationStatistical Justification If previous studies demonstrate how the If previous studies demonstrate how the

proposed number is appropriate to test your proposed number is appropriate to test your hypotheses, cite the workhypotheses, cite the work

If the number is larger than capacity, If the number is larger than capacity, propose to replicate the treatments to propose to replicate the treatments to achieve the appropriate numberachieve the appropriate number

If no data are available, propose the study If no data are available, propose the study as a pilot trial to obtain base line data that as a pilot trial to obtain base line data that can be used to calculate the appropriate “n”can be used to calculate the appropriate “n”

Power testsPower tests Power tests are often used to establish Power tests are often used to establish

“n”“n” Some data are required Some data are required Pilot studies, literaturePilot studies, literature Statistics books, stat analysis softwareStatistics books, stat analysis software Research Office web page linksResearch Office web page links Consult (collaborate) with a statisticianConsult (collaborate) with a statistician Power test may not be best approachPower test may not be best approach

Will animals be subjected to euthanasia?

a. Method of euthanasia

b. Drug and dosage

c. If using drugs for euthanasia, describe disposal of animal remains.

d. If animals will not be euthanized, describe plan for future use or other dispersal.

Landfill disposalLandfill disposal If euthanasia method includes use of drugs for If euthanasia method includes use of drugs for

which residues could be consumed by birds of which residues could be consumed by birds of prey, such as eagles, this could be a problemprey, such as eagles, this could be a problem

Indicate that landfill personnel will be Indicate that landfill personnel will be instructed to bury the remains immediatelyinstructed to bury the remains immediately

There is a charge for the service, so a contract There is a charge for the service, so a contract could be neededcould be needed

For rodents, incineration at the Pharmacy For rodents, incineration at the Pharmacy facility is a good approachfacility is a good approach

If the proposal category checked is D or E, then the experimental procedures may cause more than momentary or slight pain or distress. Address the following: Provide written narrative description, including methods and sources used in search, of how it was determined that alternatives to potentially painful or distressful procedures are not available.

Including i: Literature cited; database references must include name of databases searched, the date of the search, period covered, and keywords used.

And/Or ii: personal communications

Please refer to Animal Welfare Act 9CFR Section 2.31 (d) (1) (ii)

Category D and ECategory D and E Requires the most attentionRequires the most attention Requires a thorough search for and discussion of Requires a thorough search for and discussion of

alternative proceduresalternative procedures Search key words should include in the list Search key words should include in the list

“alternatives” along with key words pertinent to the “alternatives” along with key words pertinent to the research arearesearch area

Alternative procedures that could be less painful and Alternative procedures that could be less painful and less stressful might not be appropriate for your study; less stressful might not be appropriate for your study; indicate whyindicate why

Your procedure might be a less painful and stressful Your procedure might be a less painful and stressful modification of published procedures – i.e. the modification of published procedures – i.e. the alternative. If so state that it is the alternativealternative. If so state that it is the alternative

Addressing the issue of Addressing the issue of “D” and “E” category“D” and “E” category

Be thoroughBe thorough Actually look for alternativesActually look for alternatives Who knows, you might find Who knows, you might find

something usefulsomething useful If not, at least you tried, and this is If not, at least you tried, and this is

what is most important for the what is most important for the protocol reviewerprotocol reviewer

Explain why this research does not involve unnecessary duplication of previous research or experiments.

Describe the literature search method.

a. If using a web-based database search, indicate date of search, name of database, keywords used, and number of responses.

b. Discuss relevant literature to justify why unnecessary duplication of previous research is not involved.

Please refer to Animal Welfare Act 9CFR Section 2.31 (d) (1) (iii)

……..unnecessary ..unnecessary duplication….duplication….

Appears redundantAppears redundant If the research proposed has not been done If the research proposed has not been done

before, you would or should know thisbefore, you would or should know this Indicate the search engine and key wordsIndicate the search engine and key words Some studies are closely related, but the Some studies are closely related, but the

hypotheses were clearly different so the approach hypotheses were clearly different so the approach would be differentwould be different

Plan to “split hairs” as the difference might not be Plan to “split hairs” as the difference might not be obvious to a reviewer who is not as closely obvious to a reviewer who is not as closely associated with the work as you are – keep the associated with the work as you are – keep the language simple and clearlanguage simple and clear

Training/experience documentation: Federal regulations require appropriate training and experience for all personnel involved in the care and use of animals. An up-to-date "Verification of Training for Animal Work" form must be on file in the Research Office for each person, including the P.I., involved in the care and use of animals to be used in this protocol.

Verification of Training for Animal Work form: http://www.uwyo.edu/Research/forms.htm

For PI(s) (name): attached ___ on file ___ date _____________

For animal care worker/lab technician (name): attached ___ on file ___ date _____________

Graduate student(s) (name): attached ___ on file ___ date _____________

Others (name): attached ___ on file ___ date _____________

Please list specific experience and/or qualifications of each animal care worker necessary to perform the specific techniques and procedures described in this protocol (such as surgery)if not included on the "Verification of Training for Animal Work" form attached or on file.

TrainingTraining Get the training certification from the Get the training certification from the

Research Office web pageResearch Office web page Fill it out and submit itFill it out and submit it Once on file, reference this item as “on file”Once on file, reference this item as “on file” Everyone who is involved in animal Everyone who is involved in animal

research is required to take the CITI online research is required to take the CITI online training to be compliant with UW assurancetraining to be compliant with UW assurance

Principle Investigator Assurance: "I have received a copy of the NIH Guide for the Care and Use of Laboratory Animals and/or The Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching and will provide for the care, use and treatment of the animals used for the purpose described above accordingly. I will use procedures which will avoid or minimize discomfort, distress and pain to animals used in my research. I have considered alternatives to procedures that may cause more than momentary slight pain or distress to the animals. These studies do not unnecessarily duplicate previous experiments. I HAVE CONSULTED AS NEEDED WITH ATTENDING VETERINARIAN (David Evertson 745-7341), OR BACKUP VETERINARIAN ON STAFF AT ALPINE VETERINARY CLINIC,DURING THE PLANNING OF THIS PROJECT AND WILL CONSULT WITH THE VETERINARIAN DURING THE PROJECT. I will inform the attending Veterinarian immediately if any problems occur, including unanticipated pain or distress, injury, morbidity or mortality. I will submit a revised protocol for IACUC approval if any significant deviation from the approved project procedures occurs. I will submit an annual update for IACUC approval for continuation if this project extends beyond one year. I assure the IACUC that all persons involved in the care and use of animals used to conduct this protocol have received the appropriate training and are qualified to perform the procedures described above."

The assuranceThe assurance By signing, the investigator, By signing, the investigator,

department head, ACUC chairman, and department head, ACUC chairman, and IO assure that all indicated will be IO assure that all indicated will be donedone

Is a contractIs a contract The University of Wyoming also has The University of Wyoming also has

submitted assurances that the IACUC submitted assurances that the IACUC must act according to established must act according to established guidelinesguidelines

Annual UpdatesAnnual Updates If there are no changes, indicate If there are no changes, indicate

“No Changes”“No Changes” Indicate the number of animals proposedIndicate the number of animals proposed

for the previous year from the original for the previous year from the original protocolprotocol

Indicate the number actually usedIndicate the number actually used If the numbers used and proposed are If the numbers used and proposed are

different, that is a “Change”different, that is a “Change” Indicate the number proposed for upcoming Indicate the number proposed for upcoming

yearyear

Reminders and helpful hints on commonly overlooked items:

New protocols:

○ Genus and species are indicated.

○ For blood draws/injections: location on animal; volume; needle dimensions are given.

○ If anesthesia and/or euthanasia are proposed the dosages are indicated along with injection location, volume, and needle dimensions.

○ For all personnel on the protocol each has appropriate CITI training completed.

Reminders and helpful hints on commonly overlooked items:New protocols:○ For a category “D” or “E” protocol, the literature search for alternatives has been done with the search key words including the term “alternatives” in the list along with the search engines used.

○ For statistical justification, calculations of “n” are included with reference(s); for pilot studies the verification of lack of sufficient data or published data from other labs is included.

Reminders and helpful hints on commonly overlooked items:

Annual updates:

○ For annual updates in which the work done was approved as a pilot study, the continuation of the project will likely not be a “pilot” study as sufficient data for calculation of animals numbers; statistical justification of “n” will be needed in the annual update for additional animal experiments.

○ For annual updates, any change in the number of animals is indicated with brief justification.

Indicate the number proposed in the original protocol; the number used during the year of the update, and the number to be used in the upcoming year.

Please remember that all investigators (even DVMs) are required to contact the Attending Veterinarian if any issues regarding the health and well-being of the animals on protocol occur!

Additional ProtocolsAdditional Protocols Teaching protocolTeaching protocol Breeding colony protocolBreeding colony protocol Wildlife in developmentWildlife in development Electronic versions plannedElectronic versions planned

Institutional Animal Care and Use Committee

Phone: 307-766-5320

1000 East University Avenue, Dept. 3355

Fax: 307-766-2608

Room 308, Old Main

email: [email protected]

Laramie, WY 82071

Name: Phone: Title: Fax: Institution:

Email:

Department: Address:

FOR IACUC USE Semester/ year approved for instruction involving the use of animals: __________

UNIVERSITY OF WYOMINGINSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

Required informational sheet for instruction involving the use of animals

The informational sheet must be filled out and submitted by the faculty member instructing the class using the animals before the first day of class during the semester in which the students will be using the animals.

This sheet should be used for class projects or assignments designed to provide students with an opportunity to work with animals as part of a class. If the animals will be used in research, research training, experimentation, biological testing, or exhibition purposes, the faculty member or student must submit a full IACUC protocol. The informational sheet should be submitted to the IACUC in care of:

2) Title, semester of class.

3) Purpose for the use of the animals (in lay terms).

4) Description of the procedures, including:- Overview of procedures- Number of animals and species - Type and duration of restraint- Name and dose of anesthesia and/or tranquilizer (contact attending veterinarian)- Surgical procedures and post-surgical care- Justification for species chosen (lowest possible species on phylogenetic scale)- If euthanasia will be used, include (1) the method, (2) the drug and dosage, and (3) the disposal of the animal remains. If animals will not be euthanized, describe plan for future use or other dispersal.5) Describe the training that will be provided to the students to ensure that they are appropriately qualified and trained to conduct the procedures. 6) Attach a copy of the course syllabus and any other relevant information (e.g., lab manual)

Required TrainingRequired Training CITI training onlineCITI training online Do not have to re-take if done Do not have to re-take if done

previously elsewherepreviously elsewhere Required by everyoneRequired by everyone

SummarySummary IACUC is importantIACUC is important Contact the ACUC with questionsContact the ACUC with questions Expect protocol revisionsExpect protocol revisions The ACUC will try to make the The ACUC will try to make the

process as straight forward as process as straight forward as possible for the researcherspossible for the researchers

university of wyoming institutional animal care and use committee

Documents

laboratory animal facilities

animal care worker

location of animal room

animal sciencescott

iacuc use

project leaders

title of project

new project