09 - Animal Care Handbook
09 - Animal Care Handbook
09 - Animal Care Handbook
HANDBOOK
July, 2016
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3.6 General Rules to Prepare a Protocol for IACUC Review 17
University of Agriculture Faisalabad IACUC pain code classifications 18
3.7. Rules and Regulations Regarding Protocols Reviewing 18
A. Approve protocols 19
B. Withheld pending protocols 19
C. Denial protocols 19
D. Questions and appeals regarding IACUC reviewing 19
3.8. Rules and Regulations Regarding Changes or Modifications in 19
Approved Protocols
3.9. Approval Period 20
3.10. Annual Reports for Protocol Status 20
3.11. Triennial Resubmission 20
3.12. Process for Investigation 20
A. Non-compliance and/or harms investigating process 20
B. Reporting concerns about animal care and use 21
3.13. ICACUC Member Training 21
4. ESTABLISHING AN IACUC, UNIVERSITY OF 28
AGRICULTURE, FAISALABAD
Proposed IACUC for The University of Agriculture, Faisalabad 29
5. DEFINITIONS AND ABBREVIATIONS 30
5.1. Definitions 30
5.2. Abbreviations 31
6. REFERENCES 32
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Chapter 1
BACKGROUND
As per an international norm, proper care and humane treatment of the animals used in
research, teaching and training is included in the policy of any leading educational and
research institution. Through an onerous commitment of its faculty, University of
Agriculture, Faisalabad (UAF) has clinched 98th rank among the World's Agricultural
Universities. Notwithstanding this coveted position however, is the glaring paradox that
this institution lacks any committee and/or guidelines for ensuring a responsible use of
animals in research, teaching and product testing. In the context of research involving the
use of animals, American Veterinary Medical Association (AVMA) defines the word
"responsible" as encompassing two fundamental imperatives viz. the treatment of the
animals during research, teaching etc be humane and that the motive of the research be
noble and meaningful (Matushek, 1996). The leading universities of the world not only
have well defined animal use guidelines in place but also offer short duration training
programs for responsible animal use and handling before the commencement of any
biological research involving the use of experimental animals.
As far as could be ascertained, an attempt (half measures so to speak) was made in 2010
to jot down the following 5 points of animal handling which are incomplete and fall short
of what is expected by editorial boards of journals and the international funding agencies:
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Chapter 2
In the light of above perspective, the humane and responsible use of animals was
the dire need of the scientists of the UAF for bringing their research and proposals as par
with the internationally acceptable standards as well as for getting their research findings
published in international journals and to vie for international grants. The committee
constituted with reference to Academic Section vide no A-4/220-84/31827 dated 08-08-
2014 is as follows:
After the series of in-house meetings, the committee prepared the guidelines for:
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ii. Making research proposals at par with the internationally acceptable
standards and to have published faculty/students research findings in
International Journals Guidelines are prepared consistent with the essential
requirements of the following international institutions and documents:
The committee framed the guidelines revolving around the core themes of 3Rs viz.
Replacement, Reduction and Refinement" (UFAW) for responsible use of animals in the
biological research, teaching and training at the UAF.
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Chapter 3
The IACUC is responsible to review all the projects (Faculty and graduate student study)
involving use of animals. whether that is a laboratory work or research. Reviewing
animal use in teaching (e.g. surgery practical) is also the responsibility of IACUC. After
approval, a project would be continuously monitored by the: IACUC to ensure the
compliance of standard protocol and animal care program. The facilities regarding animal
care would also be: inspected by IACUC. The outcomes of review will be: shared with
the concerned institutional officials for their consideration to take necessary actions.
Generally, the: main responsibilities of IACUC will revolve around:
Although, in a project, whole staff should have adequate knowledge about the project and
they must be well trained to carry out the research; but, it is 1:ht~ responsibility of
Principal: Investigator (PL/Team Leader (TL/Project Manager (PM)/Team Manager
(TM) to ensure the enactment of the: standard protocol according to the policies IOf
IACUC of UAF. All the: correspondence of IACUC regarding project reports, review,
results" annual surveys and their implications in a project must be carried out through
PI/TL/PM/TM and! he/she will be responsible for all the aspects of the project. Although,
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PI/TL/PM/TM is the person who is responsible f(I)O activities of the project but the main
responsibilities are:
The members of the research team must he mentioned in the protocol which can be
comprised of PI/TL/PM/TM, Co-PI/Co·.'['L/Co-PM/Co-TM, research associates,
research assistants, students and technicians. Every member of the team will be
responsible to ensure that animal use in the research and teaching is consistent with the
guidelines of IACUC. Therefore, the whole research team of the project should have
adequate knowledge of the project and they must be well trained and dedicated to carry
out the research and teaching with a humane handling of animals.
Animals right under human control revolve around their five freedoms which are
a. Freedom from hunger or thirst
i. Availability of quality feed to experimental animals ad libitum
ii. Provision of impurity free filtered water to experimental animals
iii. Feed and water requirement of the experimental animal must be
mentioned in the protocol
b. Freedom from discomfort
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i. Experimental animal must be kept in a well-controlled
environment with proper provision of temperature, humidity,
scheduled light intensity and ventilation. It must also be pathogens
and pest free and specific sanitation schedule is adopted,
ii. Experimental animals must be: well housed with proper bedding
material
c. Freedom from pain, injury or disease
i. Pain or injury to experimental animal must be as minimum as
possible
ii. Ideally animal experimentation must be pain free for animal but if
pain is exerted then it must be mentioned in protocol according to
UAF- IACUC pain code classifications with justification
d. Freedom to express (most) normal behavior
i. Experimental animals must be provided with proper space and they
must not be overcrowded
ii. Extra space: should be provided to animals as males can be more
aggressive.
iii. Proper facilities must be provided in housing system according to
the specie: behavior
iv. Accompany own kind in housing. Isolated hosing may cause up to
30% increase of the stress
c. Freedom from fear and distress
i. Must be: fret: from loud noises and vibrations
ii. Must be free from ultrasonic calls of predators
iii. Frequent changing of cages may also cause distress
II. Transport of dogs and cats
For transportation of animals to the: experiment site the following rules must be
considered
a. Animals can only be transported to experiment site if they are healthy. A.
certificate to this affect must be obtained from the local veterinarian
b. Animals in the advanced pregnancy must not be transported
c. In a container" animals of same species can be transported
d. With adult animals, unweaned puppies and kittens must not be transported
e. Transportation of female animals with males in the breeding season is not
permitted.
f. Separate cages must be used in a container for the transportation of vicious
animals
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g. For long distance: transportation, special attention must be given to the
feeding and watering of the: animals. They must be offered water every
six hours in the winter and four hours in the summer, Adult animals must
be fed after every twelve hours while" for young animals, it must be after
every four hours.
h. Animals must be exercised as late as possible before transportation.
i. An attendant must accompany animals if they have to be transported
through rail for a long distance of more than six hours.
j. On-roof transportation of animals should not be practiced, rather they
must be transported only inside: the vehicle with an attendant being there
for their care and management.
k. For transportation through air, container must be cleaned and. disinfected
and should have sufficient bedding material. Compartments must be
provided with controlled temperature for the international transportation of
the animals.
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3. At least 6 cm thick padding of straw should be placed on floor to
avoid any chance of injury,
4. For provision of proper ventilation to animals, the upper door of
one side must be opened.
5. Cattle wagon must be in the middle of the train and cooking in the
wagon must be prohibited in the train.
6. Milch animals must be milked twice a day and sufficient milk must
be provided to calves.
7. For loading and unloading of the animals, suitable ramps must be
used.
8. If possible, animals must be transported during night,
i. Following precautions must be observed for transporting animals through
goods vehicle:
1. Vehicles with special padding around sides and tail board should
be used and animal number must not be more than six in a vehicle,
2. A vehicle must be used only for animal transportation (cannot be:
used for other purpose).
3. An attendant must accompany the animals: for their care: and
management,
4. Animals must face the engine to avoid them being injured or
frightened
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f. In a wagon only the animals of the same specie must be transported and
partition should be provided if sheep and goats have: to be transported
together in a single wagon
g. Necessary ventilation should be provided in the transporting vehicle,
h. For long distance transportation, special attention must be: given to the
feeding and watering of the animals and ample amount of water and feed
must be provided to cope with any emergency.
i. At least S cm thick paddling of straw should be placed on the floor to
avoid any chance (If injury.
j. Animals can be fettered only if there is any chance of animal jumping,
k. Space requirements for goat should be equal to wooled sheep which is
given in Annexure 1 for both goods vehicle and railway transportations.
Capacity of rail wagon for animals has been given in Annexure II
l. Maximum of 40 animals can be kept in a goods vehicle having capacity of
4.5 to 5 tons.
m. Separate panels must be provided for goats, ewes, kids and lambs of less
than six months of age.
i) General requirements
a. Cleaned and sterilized container should be used for poultry transportation.
b. Poultry should be prevented from exposure to rain, sunlight and air blast
c. Favorable temperature for poultry transportation should be in the range:
from 15-25 C.
d. Birds' container must he properly ventilated.
c. Rigid non-collapsible material must be used for the transporting container.
f. Each consignment must be properly labelled with details of consigner and
consignee including their names, telephone numbers" and addresses.
Vehicle number and its arrival time: must be informed to consignee as
well as to IACUC of UAF.
g. Birds must not be transported over six hour journey continuously; rather
they must be inspected after every six hours.
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b. Watering and feeding of poults and chicks should be avoided before and
during transportation
iii) Requirements for poultry except turkey poults and day-old chicks
a. Poultry c:an only be: transported to the experiment site if they are healthy.
A certificate to this affect must be obtained from the local veterinarian,
h. In a container, only 1birds of same species and age must be transported,
c. Birds should be watered and fed before transportation and these facilities
must also be available during the transportation
d. Male and female stock cannot be transported together
e. In case of road travel, birds containing containers should not be piled up.
f. For rail transportation, an attendant must accompany the birds for their
care and management if transportation period is more than 12 hours.
g. For air transportation container must be provided with controlled
temperature and oxygen.
h. Space requirements for birds during transportation an: given in Annexure
III
Vl. Rules for keeping animals for breeding purpose
a. No constituent section of UAF is permitted to perform business of animal
breeding without prior approval from IACUC, UAF"
b. Hygienic measures must be adopted in animal houses. squalid
management conditions an: not permissible.
c. Animal cages must be comfortable and overcrowding must be: avoided
d. A trained attendant must be accompanied. the animals for their care and
management
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B. Preserved vertebrates and procured tissue use in research
If preserved vertebrates mod procured tissues are proposed for use in the research, these
do not require approval from IACUC. Preserved tissues can be obtained from salvaged
animals, commercial sources and museums. However, a statement need to be submitted
to IACUC, UAF, confirming the use of preserved vertebrates/tissues in research with
their potential biohazards (if any).
C. Special considerations
Field studies involving animals in research requiring blood collection or other invasive
procedures to conduct such kinds of field research, approval of protocol from IACUC is
necessary. So, Investigators must submit an animal use protocol to the IACUC for
approval.
New PI/TL/PM/TM must meet the: IACUC Chair to discuss for the preparation of new
protocols. The protocols formulated by the new PI/TL/PM/TM should also be approved
before the commencement of the research involving animals. If an external grant is
transferred from another institution to UAF, the new PI/TL/PM/TM should take approval
from IACUC even if the animal use protocol has received approval at another institution.
If the: PI/TL/PM/TM is changed within the UAF, the new PI/TL/PM/TM should got the
approval of protocols transferred to his/her name: before starting the project activities
related to the use of animals.
B. Requirements upon arrival of new principal investigators/team
leader/project manager/team manager
New PI/TL/PM/TM along with the research team must seek familiarity with the Rules
and regulations of IACUC as early as possible. This can include:
a. They have completed the basic training regarding animal use in the
research
b. They have gained adequate knowledge about the miles and regulations of
IACUC
c. PI/TL/PM/TM must make sure that all the team members an: listed in the
protocol
d. PI/TLIPM/TM must ensure that new staff is. familiar with the protocols.
For reviewing in the monthly meeting (or as scheduled by the IACUC, UAF), the
PI/TL/PM/TM must submit the proposed protocol at least 10 days before the meeting
time.
Initially, the Secretary at IACUC will review each protocol and return it back to
PI/TL/PM/TM if protocol is found incomplete in any aspect. The PI/TL/PM/TM would
be requested to present the protocol in front of the committee before the: initiation of the:
technical review. Majority of IACUC members must vote: in favour of the protocol for
its approval. Committee may approve, withhold pending/delay or reject the proposed
protocol after necessary review process.
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A. Approve protocols
C. Denial protocols
Research protocols might be denied because:
a. There are lot of confusions and IACUC reviewers are unable to understand it
b. protocols are not according to the standards of IACUC and justification is not
appropriate
Any PI/TL/PM/TM may attend IACUC meeting (regular or special meeting) after the:
recommendation from the IACUC chair. Generally, this will be all about
If any change in the approved protocol is necessary, then PI/TL/PM/TM of protocol can
submit the amendment to IACUC for approval. PI/TL/PM/TM must submit the:
amendment in written protocol with the detailed reason for changes in protocol. Copy of
supporting documents must be submitted to IACUC. After thorough reviewing new
proposed protocol can be approved, withheld or denied.
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3.9 Approval Period
Validity of an approved protocol will be maximally low years but that may be reviewed
and updated annually.
As mentioned earlier an approved protocol will be valid for a maximum period of five
years. If PI/TL/PM/TM of the project wants to continue after its expiry then then he/she
must resubmit the protocol. with all the amendments made in the previous protocol.
PI/TL/PM/TM may also include additional proposed changes in the: protocol (if any).
After a project expiry, animals in a protocol must be shifted to another IACUC approved
protocol, put up for adoption, released to the wild or donated to a local zoo.
In any protocol animals may be harmed either due to research process or due to
noncompliance of approved protocol. Non-compliance occurs when PI/TL/PM/TM and
team modify the approved protocol without IACUC permission or they prolong the:
research protocol beyond the approved period or they use the animals for research
protocol which is not approved by IACUC. It is: the responsibility of the PI/TL/PM/TM
to inform IACUC about the harms of protocol to animals. If IACUC receives any
complain about it then 1:h1e approved protocol will be suspended temporarily, Initial
investigation 'will be carried by IACUC chair with the help of another member; they may
investigate from PI/TL/PM/TM or his/her team, inspect the equipment and facilities
regarding protocol and refer the case to the committee if evidences will be found with
respect to the animal harms. A special meeting of IACUC to discuss the matter will be
called. PI/TL/PM/TM will be invited there to know his/her point of view. Committee
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may reinstate the temporarily suspended protocol if no harms to the animals under
research are found. Committee may approve: reinvestigation till next meeting or may
terminate the protocol if it is believed that harms to the animals have occurred and may
be harmful to animals if protocol is resumed.
IACUC has the responsibility to ensure the humane use of animals in research. Anyone
from the university can report about the inhumane use of animals in research to IACUC
anonymously. The IACUC will take actions after properly investigating the matter.
Animal-related emergencies should be reported immediately to the animal facilities
manager or the veterinarian.
Training is necessary for every member of IACUC after his/her joining that will be
offered by the IACUC chair or a committee member upon the direction of the chair. The
new member must get familiar with the policies and procedures of IACUC and should
complete appropriate training. In addition, every monthly meeting will be a source for
IACUC member to get familiarity and training in specific areas of animal care and use.
For the orientation session of the IACUC launching and working for the scientists
involved in the animal research" the UAF can offer training time to time as and when
required.
Annexure I: Space requirement per sheep with respect to various age categories
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Annexure II: Capacity of rail wagon for animals
1300 75 35 75 2 growing
1900 55 35 75 1 grown up
5 Chicks - 60 45 12 80
6 Poult - 60 45 12 60
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Annexure IV
………………………………………………………………………
2. Registration number
……………………………………………………………………….
3. Name, registration no" and Address of the breeder whose animals will be used in
………………………………………………………………………………………
………………………………………………………………………………………
…………………………………………………………
5. Experimental Place
………………………………………………………………………...
6. Duration of experiment
…………………………………………………………………….
Both Research Proposal Performa A and B are necessary to be attached with the
2. PI/TL/PM/TM
………………………………………………………………………………… …………
a. Name
……………………………………………………………………………………...
b. Designation
………………………………………………………………………………. …….
c. Institution/Department/
…………………………………………………………………………………….
d. Telephone No
…………………………………………………………………………………….
3. Staff detail
…………………………………………………………………………………………….
4. Funding Agency
………………………………………………………………………………… …………
5. Project Duration
………………………………………………………………………………… …………
6. Animals required
Species
Age
Animals numbers
Any other
a. Surgical procedures,
c. Postoperative care
13. Hazardous agents must be mentioned with justification if they have to be: used
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Research Proposal Performa B
(INVEST1GATOR’S declaration)
1. I certify that I have determined that the research proposal herein is not
unnecessarily duplicative of previously reported research.
2. I certify that all individuals working on this proposal, and experimenting on the
animals, have been trained in animal handling procedures.
3. I shall maintain all the records as per format given below as Form B
Proposal no
…………………………………………………………………………………………
Receiving date
……………………………………………………………………………………...
Approval date
………………………………………………………………………………………
Expiry date
…………………………………………………………………………………………
Name of UAF-IACUC Chairperson
……………………………………………………………….
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THE BREEDING OF AND EXPERIMENTS OF ANIMALS
FORM A
Record of animal bred/acquired
(To be maintained by the breeder or the establishment)
FORM B
Record of animal acquired and experiments performed
To be maintained by the investigator
Signature
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Chapter 4
ESTABLISHMENT AN IACUC,
UNIVERSITY OF AGRICULTURE, FAISALABAD
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Proposed lAC1UtC for the University of Agriculture, Faisalabad
Time Frame:
The time frame for the members of the committee would be three years. However, the
same committee may continue if desired by the Vice Chancellor, UAF.
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Chapter 5
5.1. Definitions
Animal house means a place where animals are reared/kept for experiments or testing
Purposes.
Bio-medical waste means any waste, which is generated during the diagnosis, treatment
or immunization of human beings or animals or in research activities.
Collaborative research means any research undertaken between two or more research
institution on an equal footing which does not involve any financial or monetary
consideration and is undertaken solely for the purpose of advancement of
scientific research and human welfare.
Experiments means any programme/project involving use of animal for the acquisition
of knowledge of a biological, psychological, ethological, physical or chemical
nature.
Institutional animal care and use committee means at body comprising of a group of
persons constituted tor the purpose of control and supervision of experiments on
animals performed in an establishment which is constituted and operated in
accordance with the procedures specified for the purpose 'by the committee.
Major Change means that the changes reviewer suggests in an article are very large.
Minor Change means that the changes you make to an article are very small and no one
would argue with them
Principal Investigator is the lead scientist for a particular well-defined science (or other
research) project, such as a laboratory study or clinical trial.
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Protocol is the original draft of a diplomatic document" especially of the terms of a treaty
agreed to in conference and signed by the: parties
5.2. Abbreviations
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Chapter 6
REFERENCES
Anonymous, 2002. Public health service policy on the humane use and care of laboratory
animals. Office of laboratory animal welfare, National Institute of Health, USA.
Anonymous, 210] 1. Guide for the: can: and use of laboratory animals, 8th edition, The
National Academy of Sciences Press, Washington, D.C., USA
Brown, M.J., PT. Pearson and F.N. Tomson, 1993. Guidelines for animal surgery in
research and teaching. AM. J. Vet. Res. 54(9): 1544-1559.
Dua, K., 2004. Veterinary Ethics and Jurisprudence, Kalyani Publishers, Ludhiana, India.
Green, M. (Ed.), 2012. International guiding principles for biomedical research involving
animals. Council for International Organization of Medical Sciences and the
International Council for Laboratory Animal Science.
http://www.elsevier.com/journals/vaccine/02464-410X/guide-for-authors (assessed on
Apri1 16,2(14)
Matushek, K.L. 1996. Ensuring responsible use of research animals. Journal of American
Veterinary Medical Association, 209: editorial page.
Acknowledgement
Draft is prepared jointly by Prof. (R.) Dr. Ghulam Muhammad, Department of
Veterinary Clinical Medicine and Surgery, UAF and Dr. Muhammad Sobail Sajid,
Assistant Professor, US. Pakistan Centre for Advanced Studies in Agriculture and
Food Security (USPCAS-AFS) & Secretary, Institutional Animal Care and Use
Committee (1ACUC) of the University of Agriculture Faisalabad. The participation of
all other members of the committee is highly acknowledged to complete this task.
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