Download Report

National Guidelines
for the Care & Use of Animals in
Research & Education
in Kenya
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Copyright © Consortium for National Health Research
(CNHR)
All rights reserved. Use and or distribu on of material presented
is encouraged by CNHR, provided that the original text is not
altered, that the original source is properly and fully
acknowledged , and that the objec ves of the redistribu on is not
for commercial gain. Please contact CNHR if you wish to
reproduce, redistribute or transmit, in any form or by any means,
this work or any por on of it.
National Guidelines on the Care & Use of Animals in
Research, Education & Training in Kenya
ISBN 978-9966-034-15-1
© Consor um for Na onal Health Research (CNHR)
Oﬀ Ngong Road, on Suna Road,
Opposite Adams Arcade Shell Petrol Sta on
PO Box 29832-00202 KNH Nairobi Kenya
Telephone: +254 713 781 814 +254 733 572 803
Email: [email protected]
Website: www.cnhrkenya.org
1
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
TABLE OF CONTENT
Abbrevia ons.......................................................................................3
Deﬁni ons...........................................................................................4
Preamble..............................................................................................6
1.0
Introduc on...............................................................................9
2.0
Ins tute Policies And Responsibili es........................................12
2.6
Veterinary Care.........................................................................17
3.2
Clinical Care And Preven ve Medicine.......................................20
5.0
Guidelines For Care And Use Of Non-human Primates In
Research......................................................21
6.0
Humane Endpoints...................................................................27
7.0
Veterinary Medicines/drugs Storage And Control......................29
8.0
Animal Housing, Environment And Management......................32
9.0
Physical Plant...........................................................................41
10.0
Training, Accredita on And Cer ﬁca on..................................44
References..........................................................................................46
Appendices.........................................................................................48
2
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
ABBREVIATIONS
3Rs
Reﬁnement, Reduc on and Replacement
AAALACAssocia on for the Assessment and Accredita on of Laboratory Animal Care
ACUC
Animal Care and Use Commi ee
ANDI
African Network for Drugs and Diagnos cs Innova on
AV
A ending Veterinarian
AVMA
American Veterinary Medical Associa on
CADA
Commission for Access to Administra ve Documents
CEO
Chief Execu ve Oﬃcer
CITES
Conven on for Interna onal Trade in Endangered Species
DDA
Dangerous Drugs of Addic on
DGR
Dangerous Goods Regula ons
EMP
Emergency Management Plan
EU
European Union
FELASA
Federa on of European Laboratory Animal Science Associa ons
LAFHA
Laboratory Animal Facility Housing Areas
GLP
Good Laboratory Prac ce
HOP
Head of Programme
IATA
Interna onal Air Transport Associa on
IO
Ins tute Oﬃcer
IPR
Ins tute of Primate Research
IPS
Interna onal Primatological Society
IRC
Ins tu onal Review Commi ee of IPR
IUCN
Interna onal Union for Conserva on of Nature
KVB
Kenya Veterinary Board
KWS
Kenya Wildlife Service
LAS
Laboratory Animal Science
LAT
Laboratory Animal Technologist
MSR
Medicine Storage Room
NACOSTI
Na onal Commission for Science, Technology and Innova on
NBA
Na onal Biosafety Authority
NBC
Na onal Bioethics Commi ee
NEMA
Na onal Environment Management Authority
NHPs
Nonhuman primates
NMK
Na onal Museums of Kenya
OECD
Organiza on of Economic Coopera on and Development
OIE
World Organiza on for Animal Health
OSHA
Occupa onal Safety & Health Act
RUM
Return of Unwanted Medicines
SOPs
Standard Opera ng Procedures
UEAP
Unit Emergency Ac on Plan
WHO CC
World Health Organiza on Collabora ng Centre
3
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
DEFINITIONS
Accredita on is recogni on of competence in a speciﬁed subject or area of exper se, and of the
integrity of an agency, ﬁrm, group, or person, awarded by a duly recognized and respected
accredi ng organiza on
Animal biosecurity refers to all measures taken to iden fy, contain, prevent, and eradicate
known or unknown infec ons that may cause clinical disease or alter physiologic and behavioral
responses or otherwise make the animals unsuitable for research
Cer ﬁca on is formal procedure by which an accredited or authorized person or agency assesses
and veriﬁes (and a ests in wri ng by issuing a cer ﬁcate) the a ributes, characteris cs, quality,
qualiﬁca on, or status of individuals or organiza ons, goods or services, procedures or
processes, or events and or situa ons, in accordance with established requirements or standards
Distress may be deﬁned as an aversive state in which an animal fails to cope or adjust to various
stressors with which it is presented
Euthanasia in the context of these guidelines, refers to the act of inducing humane death in an
animal
Laboratory animal is any vertebrate animal including tradi onal laboratory animals; agricultural
animals, wildlife, and aqua c species produced for or used in research, tes ng and teaching.
Laboratory Animal Science (LAS) is the scien ﬁc, legally approved and ethically acceptable study
of animals for biomedical purposes comprising gene cs, physiology, microbiology, ecology,
pathology, sociology and animal experimental technology
Pain / Painful procedure is any prac ce or procedure that is likely to cause pain equivalent to, or
higher than, that caused by the introduc on of a needle according to good veterinary prac ce
Procedure means any use, invasive or non-invasive, of an animal for experimental or other
scien ﬁc purposes, with known or unknown outcome, or educa onal purposes, which may cause
the animal a level of pain, suﬀering distress or las ng harm equivalent to, or higher, than that
caused by the introduc on of a needle according to good veterinary prac ce.
Project means a set of interrelated tasks having a deﬁned scien ﬁc objec ve and involving one or
more procedures
The Program as referred herein, also called animal care and use program, shall comprises all
ac vi es conducted by and at an ins tu on that have a direct impact on the well-being of
animals and animal handlers, including all physical, procedural, medical, and human resources
required to ensure that animals are cared for and used “in ways judged to be scien ﬁcally,
technically, and humanely appropriate”
Training means organized ac vity aimed at impar ng informa on and/or instruc ons to improve
the recipient's performance or to help him or her a ain a required level of knowledge or skill.
Unwanted medicines refer to pharmaceu cal supplies, including drugs, which are no longer
required at an ins tu on.
Veterinary care in the context of this document refers to ac vi es that culminate in the well-
4
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
being and clinical care of animals star ng from acquisi on, during use in research, tes ng,
teaching and produc on and ends in safe disposal
5
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
PREAMBLE
Recognizing that animal welfare is a value of the Kenyan state as enshrined in the Cons tu on of
Kenya 2010, the Na onal Guidelines on Laboratory Animal Science, herea er called Na onal
Guidelines, acknowledge and aﬃrm that suﬃcient scien ﬁc knowledge is available to guide and
ensure animal welfare is upheld. Animals have rights and an intrinsic sen ent value which must
be respected especially their capacity to sense and express pain, suﬀering, distress, las ng harm,
and even conscious natural behavior. The scien ﬁc community is obliged to respect the concerns
of the general public as regards the use of animals in scien ﬁc procedures and educa on.
Therefore the use of animals in such procedures should be restricted to areas which may
ul mately beneﬁt human or animal health, or the environment, and then only in situa ons
where a non-animal alterna ve is not available. Their use should be out rightly prohibited in all
situa ons where the an cipated beneﬁts to humans, animals or the environment are not clear. It
has therefore become necessary to reformulate requirements to improve the welfare of animals
used in scien ﬁc and educa onal procedures in Kenya by raising the minimum standards for their
protec on in line with the latest scien ﬁc developments (Kimwele et al, 2011; Gilbert et al, 2012;
Franco, 2013) and standards set by the World Organiza on for Animal Health (OIE) on the welfare
of animals used in research and teaching (OIE 2010; OIE 2012). As a member state of the OIE,
which is one of the three interna onal standards se ng organiza ons (ISSOs) of the World Trade
Organiza on (WTO), Kenya is under obliga on to set na onal standards on animal health and
welfare that comply with those set by the OIE. The other related ISSOs, of which Kenya is also a
member, are the Interna onal Commission for Phytosanitary Standards (IPPC) and the Codex
Alimentarius Commission (CAC or Codex).
The use of live animals in scien ﬁc and educa onal purposes con nues to be necessary to
protect human and animal health and the environment. The Na onal Guidelines therefore
represent an important step forward for the country to place the expanding research sector that
u lizes animals for scien ﬁc and educa onal purposes on a path of regula on for the beneﬁt of
human and animal welfare. It is the inten on to have regular reviews of these Na onal Guidelines
in light of evolving scien ﬁc knowledge and interna onal best prac ce in animal care and use. It is
envisaged that, based on these Na onal Guidelines, a policy document will be dra ed that will
pave way for legisla on enforceable with penal es and sanc ons for oﬀenders.
The care and use of live animals for scien ﬁc purposes is governed by interna onally established
principles of Replacement, Reduc on and Reﬁnement (3Rs) as espoused by Russell and Burch
(1959). These Na onal Guidelines are an a empt to ensure that animals are sourced, bred,
transported, cared for, used and disposed of in procedures that are in line with interna onal
regula ons, policies and best prac ces; their applica on will be advocated, encouraged and
eventually become enforceable as a major approach to enhancing animal welfare in Kenya. Thus,
ins tu ons using animals for scien ﬁc and educa onal purposes will be required to implement
the 3Rs principles through a strict hierarchy of use of alterna ve methods, reduc ons in animal
numbers, reﬁnements in methods and protocols to achieve best scien ﬁc results, and
replacement wherever necessary. Where no alterna ve method is recognized by current
scien ﬁc knowledge, the numbers of animals used may be reduced by resor ng to other
methods and by implemen ng tes ng strategies, such as the use of cell and ssue culture,
sta s cal analysis and computer modeling that would reduce and reﬁne the use of animals. The
central role of the Ins tu onal Animal Care and Use Commi ee is clearly deﬁned as the focal
point in adhering to the Na onal Guidelines.
6
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
The Na onal Guidelines on LAS require that the choice of experimental species and methods
follow a hierarchical approach since the species to be used have a direct impact on both the
numbers of animals used and their welfare. The methods selected should use the minimum
number of animals that would provide reliable scien ﬁc results and require the use of species
with the lowest capacity to experience pain, suﬀering, distress or las ng harm. As far as possible,
death should not be used as an end-point due to the severe suﬀering experienced during the
period before death. It should therefore, be subs tuted by pre-determined humane end-points,
which may include moribund status, based on clinical signs and other non-invasive parameters
that determine impending death. Moribund animals or animals experiencing severe pain and
distress should be promptly euthanized in a manner that produces the least possible amount of
addi onal pain and distress. The Na onal Guidelines require that only the most appropriate
methods of euthanasia, applied by qualiﬁed personnel are used in order to achieve least possible
amount of pain and distress to the animal as well as the operator. It is an cipated that training
courses accredited with the Na onal Bioethics Commi ee (NBC) will be formulated and applied
to all workers and personnel who handle and work with laboratory animals, to ensure the highest
level of competence in execu on of animal experiments to underline compliance to set animal
welfare guidelines.
The Na onal Guidelines require adherence to the interna onal agreements on use of animals as
listed by the Interna onal Union for Conserva on of Nature (IUCN) (IUCN, www.iucnredlist.org).
Only animals not on the endangered and/or threatened species list shall be used in general
scien ﬁc procedures. On the other hand, animals on the endangered and/or threatened IUCN
lists shall only be used a er thorough jus ﬁca on and only if the scien ﬁc ques on being
inves gated is for the purposes of 'saving the species' and/or contribu ng to its general welfare.
The overriding emphasis is to ensure that the use of animals in scien ﬁc procedures does not
pose a threat to the country's biodiversity.
The Na onal Guidelines impose special restric ons on the use of non-human primates (NHPs) in
scien ﬁc and educa onal procedures. NHPs are, evolu onarily, the closest to human primates
and exhibit many aspects of physiology and development that are relevant to understanding
human biology and disease. Apprecia ng that the use of NHPs in biomedical research is an
emo ve issue, there are clear jus ﬁca ons that are now well documented where NHPs provide
the best model for inves ga ons of medical interven on tools. However, NHPs require expensive
and complex husbandry which can only be available at specially designated facili es that meet
strict na onal and interna onal standards. The Na onal Guidelines recommend the sharing of
these specialized facili es through collabora on and such other arrangements to enhance
adherence by ensuring that animals in such experiments are housed in the best condi ons and
given the op mal care through a concentrated core personnel.
There is also a strong economic and business argument for formula ng the Na onal Guidelines.
Many interna onal standards require that, in order to manage risks to human and animal health
and the environment, substances and products can be marketed only a er appropriate safety
and eﬃcacy data have been submi ed to licensing/regulatory authori es. Some of those
requirements can be fulﬁlled only by resor ng to animal tes ng (also known as regulatory
tes ng). In order for Kenya to a ract such investments, u lize its resources for the beneﬁt of its
people, and conduct responsible science, it is necessary to introduce speciﬁc and veriﬁable
measures of interna onal standards to regulate the Laboratory Animal Science Industry. Kenya
provides a special case for use of NHPs being a resource-rich country that allows their use without
7
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
deleterious transporta on-stress of the animals to specialized facili es elsewhere. The Na onal
Guidelines includes a special sec on developed for reference to care and use of NHPs.
8
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
1.0 INTRODUCTION
While it is well known that animals are used for research, tes ng and training in Kenya, there is a
dearth of informa on on documen ng the source, types and species, numbers, microbiological
and gene c characteris cs of the animals and the procedures to which the animals are subjected.
In 1989 the ﬁrst na onal guidelines (Guidelines for Care and Use of Laboratory Animals in Kenya)
developed by the Kenya Veterinary Associa on and the Kenya Laboratory Animals Technicians
Associa on, in associa on with na onal and interna onal research organiza ons, universi es
and government departments (Ministry of Health and the Department of Veterinary Services)
(Ins tute of Primate Research, 1989). The uptake and applica on of these guidelines was poor
mainly because there was no legal requirement to enforce them. Implementa on of the
guidelines was based on enthusiasm and voluntarism of responsible scien sts. To date there is
s ll no na onal legisla on to address laboratory animal science unlike the case in OECD countries
where this science is well established. Lack of standardiza on is, inevitably, likely to lead to
individual worker and ins tu onal varia ons in the care and use of laboratory animals due to
diﬀerent husbandry and housing prac ces in various ins tu ons.
This edi on of Na onal Guidelines is cra ed to address this shor all by benchmarking at
interna onal level based on OIE Guidelines by prescribing the minimum na onal standards to be
enforced by Na onal Commission for Science, Technology and Innova on (NACOSTI) as the
government agency responsible for science, technology and innova on. The NACOSTI shall do
this by designa ng na onal centers of excellence that promote animal welfare. Already,
NACOSTI, through the Na onal BioethicsCommi ee (NBC), has accredited ins tu ons for review
of research proposals that u lize laboratory animals. This is expected to spur the growth and
development of a core of resources and disciplines that are directly and indirectly intertwined in
the establishment of science, technology and innova on as the basis for na onal development in
line with Vision 2030. In the future, it is an cipated that professional bodies such as architects
and engineers would be available to supervise the design and construc on of animal houses
unlike the case now when all these are sourced from outside the country. This should ensure that
Kenya's laboratory animal science matches interna onal best prac ce and thereby aﬀording the
country an edge in compe on as a resource-rich country for such animals like nonhuman
primates that would be housed at their natural habitats and environment.
These guidelines have been developed in line with the relevant laws of Kenya, which have been
consulted extensively. The speciﬁc laws and regula ons consulted are listed under the schedule
of references and include the following: Radia on Protec on Act, 1982; Guidelines for Care and
Use of Laboratory Animals in Kenya, 1989; Environmental Management and Co-ordina on Act,
1999;Pharmacy and Poisons Act, 1956; Use of Poisonous Substances Act,1957; Occupa onal
Safety and Health Act,2007; Direc ve 2010/63/EU on the protec on of animals used for scien ﬁc
purposes; Veterinary Surgeons and Veterinary Paraprofessionals Act, 2011; Animal Diseases Act,
1965; Preven on of Cruelty to Animals Act, 1962; Public Health Act, 1921; and Drugs and
Chemical Substances Act, 1965. At the regional level, the Catalogue of East African Standards
(East African Community, 2010) reveals that standards are yet to be developed in the areas of
laboratory science / medicine and veterinary medicine. However, relevant standards have been
developed in the area of environmental health protec on and safety, to which these guidelines
are compliant. In any case, all East African countries are members of OIE and may only remain
members if they develop regula ons for the care and use of animals that are within the provisions
of the OIE guidelines. The guidelines are also in conformity with the recommenda ons of the First
9
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
East African Conference on Laboratory Animal Science held in 1993 (Ins tute of Primate
Research, 1993).
1.1
Scope of animals
The Na onal Guidelines incorporate the tradi onal laboratory animals as well as exo c animals.
Research has demonstrated that the preponderant category of research animals in Kenya is the
farm animals. Based on the number of ins tu ons known to use the tradi onal laboratory
animals, the low number is, perhaps, due to lack of consolidated data. The use of aqua c animals
in research may not be widespread in Kenya but globaliza on of research means that
collabora on with established ins tu ons outside the country is likely to become more and more
widespread hence the inclusion of a sec on on aqua c animals. The Na onal Guidelines require
the Ins tute Oﬃcer (IO) to ﬁle annual returns on animals used in their ins tutes for research,
tes ng and training with the NBC.
1.2
Regulation, policies and principles
The Na onal Guidelines comprise the regula on, policies and principles for the care and use of
laboratory animals in Kenya. Each ins tu on that uses laboratory animals shall be required to
adopt and follow the guidelines. It is an cipated that in all instances these guidelines shall serve
to safeguard the sen ent value and welfare of laboratory animals with a careful and balanced
harm/beneﬁt analysis of their use for research, tes ng and teaching.
The Na onal Guidelines are prescribed as general statements of recommenda ons to allow their
applica on in diverse ins tu ons and se ngs. This approach requires that users and Ins tu onal
Animal care and Use Commi ees (IACUC) apply professional judgment to uphold the underlying
tenets during implementa on of ac vi es that are mandatory (must be done), strongly
recommended (shall be done) and what is suggested (may be done). On this basis,
recommenda ons on appropriate ac on, including prosecu on of oﬀenders when viola ons
occur, may be made. In order to enhance compliance a na onal policy shall be developed to guide
the establishment of a legal framework.
1.3
Ethics and 3Rs Principles
The use of animals, especially as experimental subjects or teaching tools, evokes sen mental
emo ons. Therefore, careful considera ons on ethical implica ons must be evaluated at all
mes. This must at all mes be dictated by the 3Rs Principles of replacement, reﬁnement and
reduc on when considering experimental design in laboratory animal research as elucidated by
Russell and Burch(1959). This shall apply to animals in both laboratory and farm where evalua on
is carried out prior to, during and post-approval monitoring of animals in experiments or
teaching.
1.4
Accreditation
Good animal care and use go hand in hand with technical ability and passion. The Na onal
Guidelines prescribe basic and professional requirements not only for persons working with
laboratory animals but also the facili es where these animals may be kept. This would, therefore,
generate a na onal inventory that is regularly evaluated as a public body to reﬂect na onal
aspira ons and public programs. A na onal task force and inspec on mechanism is proposed.
The 4-step accredita on process for the animal care and use programshallbe as depicted in Figure
1. It starts with the review and approval of the protocol/proposal of the program followed by
accredita on of the animal facility, the personnel and ins tu onal policies and, ﬁnally,
accredita on of the IACUC.
10
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Figure 1: Accredita on process for the animal care and use program (the Program)
11
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
2.0 INSTITUTION POLICIES AND RESPONSIBILITIES
2.1
The Program
An eﬀec ve Animal Care and Use Program will possess adequate components, appropriate
linkages, and a mechanism for monitoring and evalua ng Program func ons on a con nuing
basis.It is the responsibility of each ins tu on to establish and maintain a Program that meets all
the performance standards.Such a programformalizes the best prac ces already employed by
most animal users, and provides a tool for training both within and outside of the ins tu on. An
eﬀec ve Program should have the features listed here below.
2.2
Policies, Principles, and Procedures
For an eﬀec ve Program, policies, principles and procedures should be in place and shall
subscribe to the following principles:
i.
Considera on of alterna ves (in vitro systems, sta s cal analysis, computer
simula ons and/or mathema cal modeling) to reduce or replace the use of animals
ii. Design and performance of procedures on the basis of relevance to human, animal or
environmental health
iii. Advancement of knowledge, or the good of society
iv. Use of appropriate species, quality, and number of animals
v. Avoidance or minimiza on of discomfort, distress, and pain
vi. Use of appropriate seda on, analgesia, and anesthesia
vii. Establishment of humane endpoints
viii. Provision of adequate veterinary care
ix. Provision of appropriate animal transporta on and husbandry
x. Conduct of experimenta on on living animals exclusively by qualiﬁed persons
2.3
Administrative Structure and Responsibility of the Program
An eﬀec ve Program requires clearly deﬁned roles that align responsibility with regulatory and
management authority. At the very minimum, each ins tu on should establish oﬃces of the
ins tu onal oﬃcial (IO), the head of Program (HOP), the a ending veterinarian (AV), the
laboratory animal technologist (LAT) and the Ins tu onal Animal Care and Use Commi ee
(IACUC). Interac ons with regulatory and funding agencies and accredita on organiza ons are
an integral part of the Program. The roles of these elements must ﬁt in a deﬁned organiza onal
structure where the repor ng rela onships, authori es, and responsibili es of each are clearly
deﬁned.
2.3.1 Institutional Oﬃcial (IO)
The ul mate responsibility for the animal care and use program shall rest with the Ins tu onal
Oﬃcer (IO) who shall usually be the Chief Execu ve Oﬃcer (CEO) of the ins tu on. For prac cal
purposes the IO delegates this responsibility to the Head of Program (HOP), who in many
instances is the head of laboratory animal science. The IO shall coordinate development and
implementa on of policy regarding the ins tu on's Program with the users of laboratory
animals.
The use of animals in biomedical research is almost always met with interest from the general
public and special interest groups. There is therefore need to provide to the public objec ve
informa on and insight into the essen al use of animals in biomedical research. The IO shall
12
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
submit an annual report to the NBC on animals used in research, tes ng and training as part of the
Public Programs.
2.3.2 The Head of Program (HOP)
The Head of Program (HOP) shall be responsible for the health and well-being of all laboratory
animals at the ins tu on. The ins tu on shall provide the HOP with suﬃcient authority to ensure
that the Program complies with the Na onal Guidelines. All technical pronouncements with
respect to acquisi on, transporta on and veterinary care at the ins tu on shall be disseminated
by this oﬃce. The HOP shall provide the link between laboratory animal facility management (the
Program) and the IO, the IACUC/OSHA func on and the users of laboratory animals at the
Ins tute.
2.3.3 The A ending Veterinarian (AV)
The A ending Veterinarian(AV) shall oversee the veterinary medical care of animals at the
ins tu on through a 24/7 service. In all situa ons the AV shall report to the HOP. The AV shall
primarily;
· have veterinary access to all animals and their medical records,
· provide regular veterinary visits to facili es where animals are housed and used,
· have provisions for appropriate and competent clinical, preven ve, and emergency
veterinary care
· consult with HOP in all ma ers concerning animal procurement and transporta on
The Ins tu onal mission, programma c goals, including the nature of animal use at the
ins tu on, and program size will determine whether full- me, part- me, or consulta ve
veterinary services are needed.
2.3.4 Laboratory Animal Technologist (LAT)
The Laboratory Animal Technologist (LAT) shall oversee the rou ne day-to-day ac vi es of
husbandry in centrally- and satellite- located animal facili es. Several cadres of animal technicians
may operate under the oﬃce of LAT.
2.3.5 Institutional Animal Care and Use Commi ee (IACUC)
The IACUC shall oversee all ins tu onal research and instruc on that involves animals, in order to
ensure that the highest ethical and animal welfare standards are met. It is the responsibility of the
IO to provide suitable orienta on, background materials, access to appropriate resources, and, if
necessary, speciﬁc training to assist IACUC members in understanding their roles and
responsibili es and in evalua ng issues brought before the commi ee in order to comply with all
na onal and interna onal regula ons.
2.3.5.1 Composition of IACUC:
The appoin ng authority shall be the IO, guided by accredita on requirements of the NBC, thus;
i. A registered veterinarian
ii. The HOP
iii. A representa ve of the Ins tu onal Ethical Review Commi ee
iv. At least one prac cing scien st experienced in research involving animals
v. At least one head of other relevant departments
vi. At least one member from a nonscien ﬁc background, drawn from inside or outside the
ins tu on
vii. At least one public member to represent general community interests in the proper care
13
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
and use of animals.
The Commi ee shall have a chair and secretarywho shall be elected at its ﬁrst mee ng
2.3.5.2 Functions of IACUC:
Overall the IACUC shall review all animal projects/protocols for compliance with the
requirements of the laws cited here, and enacted and/or reviewed from me to me, to govern
animal care and welfare. The IACUC shall be the source of authority on all scien ﬁc and teaching
procedures u lizing laboratory animals.
Speciﬁcally, IACUC shall hold regular mee ngs and provide a vital service to the Ins tu on by:
i. Conduc ng semiannual inspec ons and program reviews of facili es and laboratories
that house and/or use animals in their ac vi es
ii. Reviewing protocols for research, teaching and tes ng ac vi es that involve and require
the use of animals
iii. Conduc ng post-approval monitoring on all approved protocols for compliance with the
approved guidelines and making appropriate recommenda ons to IO where viola ons
have been established
iv. Ensuring that ins tu onal policies on humane treatment of animals that are involved in
the facility's research programs are complied with
v.
Reviewing, inves ga ng and addressing issues concerning the humane care and use of
animals brought to the a en on of the commi ee, through various means including the
Animal Care and Use Repor ng Form (Appendix 1)
vi. Hold joint mee ngs with other relevant commi ees of the ins tute, such as OSHA, so as
to op mize the outcome of the review process
vii. Submit an annual report to the IO.
2.4
Animal Care and Use Protocol Review
The IACUC shall develop and regularly review a protocol review form for use by applicants. The
protocol review form shall address the following topics/issues:
i. Ra onale and purpose of the proposed use of animals
ii. A clear, concise and sequen al descrip on of the procedures involving the use of animals
that is easily understood by all members of the commi ee
iii. Availability and/or appropriateness of the use of less invasive procedures, other species,
isolated organ prepara on, cell or ssue culture, or computer simula on
iv. Jus ﬁca on of the species and number of animals proposed; whenever possible, the
number of animals and experimental group sizes should be sta s cally jus ﬁed
v. Non-standard housing and husbandry requirements
vi. Impact of the proposed procedures on the animals' well-being
vii. Appropriate seda on, analgesia, and anesthesia with clear indices of pain or
invasiveness of the procedures
viii. Conduct of surgical procedures, including mul ple opera ve procedures
ix. Post-procedural care and observa on/assessment
x. Descrip on and ra onale for an cipated or selected endpoints
xi. Criteria and process for mely interven on, removal of animals from a study, or
euthanasia if painful or stressful outcomes are an cipated
14
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
xii. Method of euthanasia or disposi on of animals, including planning for care of long-lived
species a er study comple on
xiii. Adequacy of training and experience of personnel, with clearly deﬁned roles and
responsibili es in the procedures used
xiv. Use of hazardous materials and provision of a safe working environment
xv. Provision for disaster planning and emergency preparedness
2.5
Disaster Planning and Emergency Preparedness
Laboratory animals must be observed and taken care of by qualiﬁed personnel everyday
including weekends and holidays to ensure their health and well-being, as well as to promote
sound research prac ces. Names and telephone numbers of those assigned these
responsibili es should be prominently displayed in the facility.
A disaster plan should be part of the overall facility safety plan which takes into account both
personnel and animals in the event of a failure. Every ins tu on is required to prepare an
emergency planning guide. This document provides instruc ons for the ins tu on on how to
prepare their Unit Emergency Ac on Plan (UEAP), which is a support document of the
Ins tu onal Emergency Management Plan (EMP). The UEAP enables Units to plan for disaster
mi ga on, preparedness, response and recovery, and for the Ins tu on to maintain the viability
of cri cal opera ons during and a er any emergency or covered incident.
2.5.1 Disaster Planning
The Ins tu onal disaster plan should include the animal facility, and must be detailed and speciﬁc
enough to include a compila on of cri cal resources that are helpful in a variety of crisis events.
Disaster plans should be established in conjunc on with the responsible inves gator(s), taking
into considera on both the priori es for triaging animal popula ons and the ins tu onal needs
and resources.
2.5.2 Emergency Preparedness
In addi on to the development of a Disaster Plan, an animal facility should consider approaching
disaster preparedness from the comprehensive, risk-based, emergency management
programme consis ng of mi ga on, preparedness, response and recovery as deﬁned here below
for clarity.
· Mi ga on
ac vi es related to preven ng or minimizing future emergencies
· Preparedness incorpora on of the planning and prepara ons i.e. Disaster Plan
· Response
Disaster Plan put into ac on
· Recovery
the ac ons needed to return to normal
2.6
Veterinary Care
Veterinary care is an essen al part of an animal care and use Program. The primary focus of the
veterinarian is to oversee the well-being and clinical care of animals used in research, tes ng,
teaching, and produc on. This responsibility extends to monitoring and promo ng animal wellbeing at all mes during animal use, and at mes during the animal's life. Well-being is
determined by considering physical, physiologic, and behavioral indicators, which vary by
species. The number, species, and use of animals housed in an ins tu on may inﬂuence the
complexity of the veterinary care program, but a veterinary program that oﬀers a high quality of
care and ethical standards must be provided, regardless of the number of animals or species
15
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
maintained as per the Veterinary Surgeons and Veterinary Para-professionals Act (2011). It is
essen al that such ins tu ons develop an ins tu onal animal care and use policy.
2.6.1 Aspects of Veterinary Care
An adequate veterinary care program consists of assessment of animal well-being and eﬀec ve
management of:
· animal procurement and transporta on
· preven ve medicine (including quaran ne, animal biosecurity and surveillance)
· clinical disease, disability, or related health issues
· protocol-associated disease, disability, and other sequelae
· surgery and periopera ve care
· pain and distress
· anesthesia and analgesia
· euthanasia and disposal
2.6.2 Accreditation
Na onal and interna onal accredita on of the Program is desirable and whenever sought should
involve a peer ins tu on of unequivocal standing. Interna onal accredita on should be
maintained by ascribing to the Associa on for the Assessment and Accredita on of Laboratory
Animal Care (AAALAC Interna onal).The overarching goals are to assure that laboratory animals
at research and training ins tu ons receive the highest quality care and to protect the health of
people who work with and around animals. Accredita on serves to provide a level of evalua on
that is external to the ins tu on. Excellence in research and teaching requires excellence in the
animal care and use program.
2.6.3 Training
All personnel involved with the care and use of animals must be adequately educated, trained,
and/or qualiﬁed in basic principles of laboratory animal science to ensure quality science and
animal well-being. The IACUC shall establish and demand minimal training requirements rela ve
to general care and use of animals in research, tes ng and teaching and on how to report animal
welfare concerns at the Ins tu on. All Program personnel training should be documented.
2.7
Occupational Safety And Health (osh) Program
The Ins tu onal OSH Program and Policies shall include the animal facility, and must be detailed,
speciﬁc and consistent with Occupa onal Safety & Health Act of parliament (OSHA, 2007)
focusing on maintaining a safe and healthy workplace. Animal Care Workers, for the purpose of
this document, are personnel, including students and any volunteers, who work directly or
indirectly with laboratory animals.
The IACUC shall work with HOP to ensure that all individuals with animal contact are trained and
monitored for preven on of animal-associated injuries, illnesses and infec ons. Provision of
resources to support training is the responsibility of the Ins tu on Oﬃcer (IO).
16
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
3.0
VETERINARY CARE
The thrust of veterinary care program shall stem from the Veterinary Policywhich is an
ins tu onal requirement alluded to in Chapter 2. Veterinary care program has two main
components; animal procurement and transporta on and clinical care and preven ve medicine.
3.1
Animal Procurement and Transportation
3.1.1 Compliance with Regulations and Standards for Animal Procurement
All animals must be acquired lawfully, and the receiving ins tu on should ensure that all
procedures involving animal procurement are conducted in a lawful manner and from approved
suppliers. Approved suppliers should regularly provide informa on on the gene c and
microbiological characteris cs of their colonies or individual animals. In-house breeding colonies
should be established based on need and managed according to the 3Rs principles.The HOP has
the ul mate responsibility for ensuring procurement of healthy animals.
3.1.2 Sourcing of Animals
Procurement of animals should be linked to the prior approval of animal use, by species and
number, by the IACUC.Appropriate records and other prescribed forms of documenta on should
be maintained by the ins tu on.Addi onally, prior to ordering or procurement of specialized
animals, the inves gator must complete and return to the IACUC the request for specialized
animals and approval by NBC/NBA/NEMA through the Oﬃce of Research Compliance (Appendix
2). Research protocols that require speciﬁc breeding shall also need special evalua on and
approval (Appendix 3).
Animals shall be transported in a humane manner that is compliant with all provisions in law and
other relevant regula ons (IATA, CITES, CADA)A checklist of issues regarding transporta on
method, environment and personnel is given in Table 1while the long checklist for regula ons
and guidelines for use of animals in research and training are provided in Appendix 4.
Animals should be inspected regularly during transporta on. The Ambient temperature ranges
for safe transporta on of common adult research, and Behavioral and physiological signs of
thermal status are as given in Table 2 and Table 3, respec vely.
Table 1: Checklist of issues to consider when arranging transporta on of animals used for
research and training
Shipping Container
Shipping Company
Environmental
Condi ons
Trained, experienced
personnel
· Is the shipping container appropriate for the expected condi ons?
· Does the container comply with Kenyan standards set for warm -blooded
vertebrates except rats, mice, and birds?
· Does the container comply with Interna onal Air Transport Associa on (IATA)
standards if transport includes air travel?
· Will the same company be transpor ng the animals during all legs of the journey, or
will a third-party carrier or subcontractor be used for some legs?
· Are environmentally controlled vehicles used for all segments of gro und
transporta on?
· If environmentally controlled vehicles will not be used, or air travel is involved, does
the shipping company have con ngency plans for maintenance of the animals if the
ambient temperature is below or exceeds acceptable ranges?
· Does the shipping company have standard opera ng procedures for ensuring that
animals are not exposed to extreme environmental condi ons during transfer
between vehicles and at the end des na on?
· Does the company provide specialized training for all employees involved in
transporta on of animals?
· If a third-party carrier or subcontractor is involved in the transporta on, are they
also trained?
17
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
3.1.3 Quarantine and Acclimatization
All animals should undergo an appropriate period of quaran ne and acclima za on before
alloca on for scien ﬁc procedures. Quaran ne areas should be subject to extra vigilance in
monitoring the animals and in maintaining good records, in order to detect and respond to any
health problems in quaran ned animals. Dura on of quaran ne should be appropriate to ensure
that the health of the animals under quaran ne, and that of the co-speciﬁcs already resident at
the research facility, is assured. Animals shall be housed separately by species and health status
during and a er quaran ne. HOP shall conduct surveillance, diagnosis, treatment and control of
diseases on all animals from recep on to endpoint of experimental procedure. It is the
responsibility of the HOP to declare the end of quaran ne.
3.2
Clinical Care And Preventive Medicine
Veterinary care and use of laboratory animals shall be provided by a veterinarian and veterinary
para-professionals, duly registered by the Kenya Veterinary Board (KVB) in accordance with the
provisions of the Veterinary Surgeons and Veterinary Para-professionals Act (VSVP) 2011. As
proof of competence to provide care to laboratory animals, these professional caregivers shall
require to be accredited with the NBC as provided for in the sec on on Training andAccredita on
of these guidelines.
Table 2: Ambient temperature range s for safe transporta on of common adult research
animals
Animal species
Ambient Temperature Range for Safe
Transporta on( °C)
Mouse
Rat
Guinea pig
Rabbit
Hamster
Macaca mula a
Dog
Pig
Cat
Sheep
Beef cow
Dairy cow
Stallion
Mare
Goat
4 to 34
6 to 33
4 to 34
4to 33
6to 34
6to 35
–10to 28
–20 to 35
5to 30
–12to 25
–18 to 23
–15 to 26
5to 25
5 to 25
–13to 21
Table 3: Behavioral and physiological signs of thermal status
Species
Signs of Thermogenesis
Signs of Heat Loss
Rodents
Piloerec on, cutaneous vasoconstric on
(paleness of skin of ears or feet), shivering,
drawing limbs close to body (curling up)
Dogs and cats
Piloerec on, cutaneous vasoconstric on,
shivering, drawing limbs close to body
Agricultural animals
(cows, sheep, goats,
and horses)
Piloerec on, cutaneous vasoconstric on,
shivering, drawing limbs close to body
Swea ng, closed-mouth pan ng
Birds
Piloerec on, cutaneous vasoconstric on,
shivering, drawing limbs close to body
Open-mouth pan ng
Saliva spreading, cutaneous vasodila on
(redness of skin of the ears or feet),
closed-mouth pan ng (increased
respiratory frequency)
Open-mouth pan ng, extending limbs
(maximizing surface area), cutaneous
vasodila on
18
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
3.2.1 Veterinary Care Programme
The veterinary care programme is the responsibility of the IO, HOP and AV with the IACUC
providing oversight. The con nuing educa on of the veterinarian is an essen al component of
maintaining competence. The characteris cs of the veterinary care programme will depend on
several factors, such as:
i. Number of animals
ii. Species used, and
iii. Nature of the experimenta on conducted
3.2.2 Preventive Medicine
A comprehensive veterinary medical care and biosecurity programme shall incorporate disease
preven on currently in force, as prescribed in various policies and procedures that relate to
animal health, from recep on to endpoint.
3.2.3 Animal Biosecurity
Animal biosecurity shall apply to all species especially when housing large numbers of animals in
intensive housing condi ons in considera on of physical plant layout and opera onal prac ces. In
order to ensure a successful animal biosecurity programme the following shall be observed:
i. Only animals of a desired and deﬁned health status shall be kept in the facility
ii. The facility shall incorporate prac ces that minimize the likelihood of cross
contamina on with infec ous agents
iii. A comprehensive system for evalua ng animals' health status, including access to all
animals, is ensured
iv. Containment and eradica on, if desired, of introduced infec ous agents
v. Procedures for evalua ng and selec ng appropriate animal suppliers are developed
vi. Treatment of animals or their products at entry to minimize disease risks
vii. A comprehensive pest control programme that may include evalua on of the health
status of feral animals is included
viii. Procedures to ensure that all biologicalsubstances administered to animals are free of
contamina on
ix. Procedures for intra- and inter-facility animal transport
19
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
4.0
CLINICAL CARE AND MANAGEMENT
4.1 Clinical Care
The HOP shall provide a structured clinical care scheme appropriate for the laboratory animal
facility with adequate number and competencies of veterinarians and animal technologists. For
animals on research protocols, the AV shall discuss any problems with the principal inves gator
to determine the most appropriate course of treatment or ac on. However, the welfare of the
animal shall be the overriding considera on. Recurrent or signiﬁcant problems involving
experimental animal health should be communicated to the IACUC, and all treatments and
outcomes should be documented.
4.2 Emergency Care
See Sec on 2.5 above
4.3 Surgery
Surgical procedures shall require appropriate a en on to pre-surgical planning, personnel
competence, anesthesia, asep c surgical approach, use of analgesics, monitoring of animal
physiological status during all phases of a protocol involving surgery and postopera ve care.
4.3.1 Surgical facilities
Unless an excep on is speciﬁcally jus ﬁed as an essen al component of the research protocol
and approved by the IACUC, asep c surgery shall be conducted in designated facili es or spaces.
Generally, agricultural animals maintained for biomedical research should undergo surgery with
techniques and in facili es compa ble with the guidelines set forth in this sec on. However,
some minor and emergency procedures commonly performed in clinical veterinary prac ce and
in commercial agricultural se ngs may take place under ﬁeld condi ons so long as these
procedures are carried out under appropriate asep c techniques, seda ves, analgesics,
anesthe cs, and condi ons commensurate with the a endant risk to the animal's health and
well-being.
4.3.2 Surgical procedures
Surgical procedures are categorized as major or minor and, in the laboratory se ng, can be
further divided into survival and non-survival. When a emp ng to categorize a par cular
surgical procedure, the following shall be considered:
i. the poten al for pain and other postopera ve complica ons
ii. the nature of the procedure as well as the size and loca on of the incision(s)
iii. the dura on of the procedure
iv. the species, health status, and age of the animal evaluated on a case-by-case basis by the
veterinarian/surgeon and IACUC
Emergency situa ons some mes require immediate surgical a en on under less than ideal
condi ons. Such situa ons shall be guided by the obtaining veterinary medical judgment. In nonsurvival surgery where an animal is euthanized before recovery from anesthesia, it may not be
necessary to follow all the techniques outlined in this sec on. Survival surgery shall require
postopera ve monitoring un l the animal recovers from anesthesia. Appropriate
documenta on shall be maintained.
20
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
4.4
Pain and Distress
An integral component of veterinary medical care is preven on or allevia on of pain and distress
associated with procedural and surgical protocols. Pain is a stressor and, if not relieved, can lead
to unacceptable levels of stress and distress in animals. In addi on, stress and distress in animals
are likely to aﬀect the outcomes of experiments. For these reasons, the proper use of anesthe cs
and analgesics in research animals is of ethical and scien ﬁc impera ve. It is therefore essen al
to determine the manifesta ons and indicators of pain in the laboratory animal species in use.
Personnel caring for and using animals must consequently be well trained in determining speciesspeciﬁc and individual clinical, behavioral, physiologic, and biochemical indicators of animal wellbeing.
Distress on the other hand may be deﬁned as an aversive state in which an animal fails to cope or
adjust to various stressors with which it is presented. While distress may not induce an
immediate and observable pathologic or behavioral altera on, inherently it is more diﬃcult to
monitor and evaluate the animal's state when in distress. Implementa on of clear, appropriate,
and humane experimental endpoints for animals, combined with close observa on during
invasive periods of experimenta on, will assist in minimizing distress experienced by animals
used in research, teaching, tes ng, and produc on. Condi ons and situa ons that are likely to
result in pain and distress and the signs to look out for are listed in Text Box 1, Tables 4 and 5,
respec vely.
Text Box 1: Procedures which may have the poten al to cause pain or distress include
1.
3.
5.
7.
9.
Physical restraint
Food or water restric on
Noxious s muli
Tumor burdens
Adverse environmental condi ons.
2.
4.
6.
8.
Survival surgeries
Death as an endpoint
Skin or corneal irritancy tes ng
Intra-cardiac or orbital sinus blood sampling
Table 4: Clinical signs that may indicate pain
Sign
Guarding
Vocaliza on
Mu la on
Restlessness
Swea ng
Recumbency
Depression
Abnormal appearance
Explana on
A emp ng to protect, move away, or bite
Crying out when palpated or forced to use aﬀected area
Licking, bi ng, scratching, shaking, or rubbing
Pacing, lying down and ge ng up, or shi ing weight
In species that sweat (horses)
Unusual length of me
Reluctance to move or diﬃculty in rising
Head down, tucked abdomen, hunched, facial distor on, or pallor
4.5 Anesthesia And Analgesia
The selec on of appropriate analgesics and anesthe cs should reﬂect professional veterinary
judgment as to which best meets clinical and humane requirements as well as the needs of the
research protocol. Because of wide individual varia on in response to analgesics, regardless of
the ini al plan for pain relief, animals should be closely monitored during and a er painful
procedures and should receive addi onal drugs, as needed, to ensure appropriate analgesic
management. Non-pharmacologic control of pain, such as appropriate nursing care and quiet
recovery place, may be eﬀec ve and should not be overlooked as an element of post-procedural
21
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
or peri-opera ve care for research animals. Guidelines for the selec on and proper use of
analgesic and anesthe c drugs should be developed and periodically reviewed and updated as
standards and techniques are reﬁned. Agents that provide anesthesia and analgesia must be
used before their expira on dates.
Non-pharmacologic treatments should also be employed. This may include special housing
considera ons, dietary and other environmental enrichments, adjustments and careful
suppor ve care.
Table 5: Signs, degree and length of surgically produced pain
Surgical site
Signs of pain
Degree of pain
Length of pain
Head, ear, eye, mouth
A empts to rub, scratch, self mu la on, shaking, reluctance to
eat, drink or swallow, reluctance to
move
Rubbing, licking, bi ng, abnormal
bowel movement or excretory
behavior
Reluctance to move, lameness,
abnormal posture, guarding, licking,
self-mu la on
Moderate to high
Intermi ent
or con nual
Moderate to high
Intermi ent
to con nual
Moderate to high:
upper parts of axial
skeleton (humerus,
femur) especially
painful
Not obvious to
moderate
Sternal approach, high;
lateral approach, slight
to moderate
Moderate to severe
Intermi ent
Slight
Short
Rectal area
Bones
Abdomen
Thorax
Spine, cervical (neck)
Spine, thoracic or lumbar
Abnormal posture (hunched),
anorexia, guarding
Reluctance to move, respiratory
changes (rapid, shallow), depression
Abnormal posture of head and
neck, reluctance to move, abnormal
gait
Few sign, o en moving immediately
Short
Con nual
Con nual
Based on observa ons of dogs
22
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
5.0
GUIDELINES FOR CARE AND USE OF NON-HUMAN PRIMATES
IN RESEARCH
The aim of this sec on is to underscore the rules that allow more stringent and transparent
measures in the area of animal experimenta on that u lize non-human primates.
5.1
Justiﬁcation for use of NHPs
Having regard to the present state of scien ﬁc knowledge, the use of non-human primates in
scien ﬁc procedures is s ll necessary in biomedical and biological research. Due to their gene c
proximity to human beings and highly developed social skills, the use of non-human primates in
scien ﬁc procedures raises speciﬁc ethical and prac cal problems in terms of mee ng their
behavioral, environmental and social needs in a laboratory environment or life in cap vity.
Furthermore, the use of non-human primates is of the greatest concern to the public. Therefore
their use should be permi ed only in those biomedical areas essen al for the beneﬁt of human
beings and the NHPs themselves, for which no other alterna ve replacement methods are yet
available.
5.2
Use of great apes in research
Although the country does not have wild popula ons of great apes, it is possible for researchers
to gain access to these animals for scien ﬁc and educa onal purposes through animals held in
sanctuaries, or regional collabora ve arrangements with neighboring source countries. The use
of great apes (e.g. Chimpanzees and Gorillas), as the closest species to human beings with the
most advanced social and behavioral skills, will only be permi ed for the purposes of research
aimed at the preserva on of those species, and where ac on in rela on to a life-threatening,
debilita ng condi on endangering human beings is warranted (e.g. inves ga on of deadly
disease outbreaks or surveillance of zoono c pathogens through non-invasive methods); and
where no other species or alterna ve method would suﬃce in order to achieve the aims of the
procedure. The scien ﬁc or educa onal ins tu on reques ng such a need must provide the
necessary informa on to the ethical commi ees and regulatory authori es to enable them to
take a decision.
5.3
Use of wild caught NHPs and captive breeding
The Na onal Guidelines recognize that the country has an abundance of certain species of NHPs
which pose serious threats as agricultural pests to communi es living in marginal areas and
earning a livelihood from their small holder farms, hence requiring management of numbers to
alleviate the human-primate conﬂicts. The capture of abundant species of least concern for
conserva on (IUCN list) such as baboons, African Green monkeys and Sykes monkeys will
con nue to be a source of animals for scien ﬁc and educa onal purposes in Kenya for the
foreseeable future. However these guidelines acknowledge that the capture of NHPs from the
wild is highly stressful for the animals concerned and carries an elevated risk of injury and
suﬀering during capture and transport. Therefore this ac vity will only be carried out under
license by the Kenya Wildlife Service, and only by competent designated primate facili es in the
country that meet na onal and interna onal guidelines for capture, transport, quaran ne,
housing, husbandry and general welfare of NHPs.
These guidelines further acknowledge that future sourcing of NHPs from the wild may be
unsustainable, and will increasingly come under heavy scru ny through public discourse and
societal sensi vi es on use of wild-caught animals for scien ﬁc and educa onal purposes. In
order to end the capturing of animals from the wild for research purposes, designated primate
23
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
ins tu ons in the country will be encouraged and supported to establish, over the next 10 years,
cap ve-bred, self-sustaining colonies of NHPs, using stock animals captured from the wild. A
feasibility study should be carried out to that eﬀect and a transi on period adopted if necessary.
The feasibility of moving towards sourcing non-human primates only from self-sustaining
colonies as an ul mate goal should also be explored.
The move towards use of cap ve-bred NHPs is also supported by good scien ﬁc prac ces. It will
allow NHPs used in procedures to be bred speciﬁcally for that purpose so that their gene c,
biological and behavioral background is well-known to researchers undertaking the procedures.
Such knowledge both increases the scien ﬁc quality and reliability of the results and decreases
the variability, ul mately resul ng in fewer procedures and reduced animal use. When cap vebred animals eventually become available they will limit the use of animals taken from the wild
only to cases where the scien ﬁc ques ons cannot be answered using animals bred in cap vity,
which is a further reﬁnement for reasons of animal welfare and conserva on.
5.4 Ethical approval for research with NHPs
Par cularly for NHPs, it is essen al, both on moral and scien ﬁc grounds, to ensure that each use
of an animal is carefully evaluated as to the scien ﬁc or educa onal validity, usefulness and
relevance of the expected result of that use. The likely harm to the animal should be balanced
against the expected beneﬁts of the project (harm-beneﬁt analysis). Therefore, an impar al
project approval and evalua on system that is independent of those involved in the study should
be carried out as part of the authoriza on process of projects involving the use of live NHP
animals. Speciﬁcally, only ethics commi ees or Ins tu onal Animal Care and Use Commi ees
(IACUC) that are cons tuted in line with interna onal recommenda ons (e.g. WHO guidelines for
ethics commi ees), and which must be registered with Kenya's Na onal Commission for Science,
Technology and Innova on (NACOSTI) can approve projects that u lize NHPs. Eﬀec ve
implementa on of a project evalua on should also allow for an appropriate assessment of the
use of any new scien ﬁc experimental techniques as they emerge.
5.5 Speciﬁc provisions for use of NHPs in research:
1.
Non-Human primates will only be used where there is scien ﬁc jus ﬁca on to the eﬀect
that the purpose of the procedure or research ques on cannot be achieved by the use of
other species
2.
Procedures using NHPs may be carried out for the following purposes only:
(a) Basic research;
(b) Transla onal or applied research with any of the following aims:
(I) The avoidance, preven on, diagnosis or treatment of disease, ill-health or other
abnormality or their eﬀects in human beings, animals or plants
(ii)
The assessment, detec on, regula on or modiﬁca on of physiological
condi ons in human beings, animals or plants or
(iii)
The welfare of animals and the improvement of the produc on condi ons for
animals reared for agricultural purposes
(c) For any of the aims in point (b) in the development, manufacture or tes ng of the quality,
eﬀec veness and safety of drugs, foodstuﬀs and feed-stuﬀs and other substances or
products;
(d) Protec on of the natural environment in the interests of the health or welfare of human
beings or animals;
24
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
(e) Research aimed at preserva on of the species;
(f) Higher educa on, or training for the acquisi on, maintenance or improvement of
voca onal skills;
(g) Forensic inquiries.
5.6 Animal records:
Designated Primate Centers shall ensure that they keep records of at least the following:
a) Number and the species of animals captured in the wild, bred, acquired, supplied, and
used in procedures.
b) Origin of the animals, including whether they are captured in the wild or bred for use in
procedures;
c) Dates on which the animals are acquired or supplied;
d) Source from whom the animals are acquired;
e) Name and address of the recipient of animals at the speciﬁc ins tu on;
f) Number and species of animals which died or were killed in each establishment.
g) For animals that have died, the cause of death shall, when known, be noted;
h) In the case of users, the projects in which animals are used.
Each NHP shall have an individual history ﬁle, which follows the animal as long as it is kept at the
facility. The ﬁle shall be established at birth or as soon as possible therea er and shall cover any
relevant reproduc ve, veterinary and social informa on on the individual animal and the
projects in which it has been used.
The records referred to above shall be kept for a minimum of ﬁve years and made available to the
competent authority upon request.
5.7 Marking of NHPs
1.
Each NHP shall be provided, at the earliest me of acquisi on or weaning, with a
permanent individual iden ﬁca on mark in the least painful manner possible
2.
Where a non-human primate is transferred from one breeder, supplier or user to another
before it is weaned, and it is not prac cable to mark it beforehand, a record, specifying in
par cular its mother, must be maintained by the receiver un l it is marked
3.
Where a non-human primate, which is weaned, is received by a breeder, supplier or user
it shall be permanently marked as soon as possible and in the least painful manner
possible.
4.
The breeder, supplier and user shall provide, at the request of the competent authority,
reasons for which the animal is unmarked.
5.8
Accommodation and environment enrichment
Due to their complex social interac ons, NHPs in cap vity must be provided with a complex and
s mula ng environment that supports health, physiological well being and the opportunity for
social interac on, exercise and expression of behaviors appropriate to the species. Social housing
is one of the most important factors inﬂuencing the well being of NHPs since it promotes speciestypical behaviors and reduces the occurrence of abnormal behaviors. When NHPs must be
housed singly, it must be with a strong jus ﬁca on and for the shortest me possible. In many
jurisdic ons the minimum permissible is pair housing.
25
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
5.9
Project evaluation, authorization for NHPs
Like other laboratory animals, a system for evalua on, approval and post-approval monitoring of
research projects using NHPs should be put in place to ensure that procedures are carried out as
approved. Wherever possible lessons should be drawn and improvements made in subsequent
procedures.
26
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
6.0
HUMANE ENDPOINTS
All study protocols must be accompanied by a clear statement on fate of animals and
predetermined humane endpoints to be approved by the IACUC. Research and tes ng studies in
laboratory animals some mes involve pain that cannot be relieved with chemical agents because
they would interfere with the scien ﬁc objec ves of the study. Accordingly, the IACUC should
ensure that discomfort to animals is limited to that which is unavoidable for the conduct of
scien ﬁcally valuable research, and that unrelieved pain and distress will only con nue for the
dura on necessary to accomplish the scien ﬁc objec ves. Animals that would otherwise suﬀer
severe or chronic pain and distress that cannot be relieved should be painlessly killed at the end
of the procedure, or if appropriate, during the procedure.
An important feature of declared humane endpoints is that they should ensure that study
objec ves are met even though the study is ended at an earlier point, ideally, before the onset of
pain and distress during studies. The plan should include detailed wri en criteria for the humane
endpoints that will be used to determine when animals can be removed from the study, treated,
or euthanized. There should be clear direc ons concerning who can make the decision to
euthanize or treat animals, including procedures to follow if a situa on arises on weekends,
holidays, or in the absence of the responsible principle inves gator. Establishing and
implemen ng humane endpoints is best achieved by a collabora ve eﬀort on the part of
inves gators, veterinarians, and animal care staﬀ. However the overall responsibility for relief of
pain and determina on of me point when animal may not be kept alive further without relief
rests with the AV.
6.1
Moribund condition as a humane endpoint
Moribund has been deﬁned as “in the state of dying,” or “at the point of death”. A moribund
condi on may be an appropriate humane experimental endpoint for some studies where there is
induc on of severe disease states and high rates of mortality. While death is not a required
endpoint for rou ne toxicity tes ng, animals are o en found dead during studies. Such
observa ons should be noted and reported. Procedures should be established and followed to
detect and humanely euthanize moribund or pre-moribund animals to reduce the number of
animals that die spontaneously;Text Box 2 provides some typical signs indica ve of moribund
condi on in laboratory animal. Euthanasia of animals that are moribund or experiencing severe
pain and distress should always be done using a technique that produces the least possible
amount of addi onal pain and distress.
6.2
Death as an endpoint
Since it provides an objec ve and unequivocal data point, death has historically been used as an
endpoint in cancer, infec ous disease and other animal studies, especially for regulatory
purposes such as drug safety/eﬃcacy studies. Increased public interest and regula on
necessitates a re-evalua on of this prac ce. All in all, euthanasia is preferable to death for both
scien ﬁc and ethical reasons. For this reason, use of death as an endpoint is discouraged and
must always be jus ﬁed.
6.3
Euthanasia
It is the responsibility of the HOP to ensure that if an animal's life is to be taken, it is done with the
highest degree of respect, and with an emphasis on making the death as painless and distressfree as possible. Euthanasia techniques should result in rapid loss of consciousness followed by
cardiac or respiratory arrest and the ul mate loss of brain func on. In addi on, the technique
should minimize distress and anxiety experienced by the animal prior to loss of consciousness.
27
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
The absence of pain and distress cannot always be achieved. Therefore, the use of professional
judgment is impera ve.
In evalua ng methods of euthanasia, the following criteria shall be used:
i. Ability to induce loss of consciousness and death without causing pain, distress, anxiety,
or apprehension
ii. Time required to induce loss of consciousness
iii. Reliability to cause death
iv. Safety of personnel
v. Irreversibility of ac on
vi. Compa bility with requirement and purpose
vii. Emo onal eﬀect on observers or operators
viii. Compa bility with subsequent evalua on, examina on, or use of ssue
ix. Drug availability and human abuse poten al
x. Compa bility with species, age, and health status
xi. Ability to maintain equipment in proper working order, and
xii. Safety for predators/scavengers should the carcass be consumed
Personnel who perform euthanasia must have appropriate cer ﬁca on, proﬁciency and training,
experience with the techniques to be used, and experience in the humane restraint of the species
of animal to be euthana zed, to ensure that animal pain and distress are minimized during
euthanasia. Whenever situa ons that are not clearly deﬁned arise, a veterinarian experienced
with the species or a person with vast exposure should be consulted. In all circumstances, the
euthanasia method should be selected and used with the highest ethical standards and social
conscience. It is impera ve that death be veriﬁed a er euthanasia and before disposal of the
animal.
6.3.1 Agents and methods of euthanasia
Euthanizing agents cause death by three basic mechanisms:
i. Hypoxia, direct or indirect
ii. Direct depression of neurons necessary for life func on, and
iii. Physical disrup on of brain ac vity and destruc on of neurons necessary for life.
These Na onal Guidelines propose that any method used for euthanasia be referenced to the
American Veterinary Medical Associa on (AVMA) guidelines that describe methods of
euthanasia that are acceptable, condi onally acceptable and unacceptable categorized by
species (AVMA, 2013) to take on board important factors such as the research objec ves in
addi on to the basic need for humane outcomes.
Text Box 2: Clinical signs indica ve of a moribund condi on in a laboratory animal typically include one or
more of the following
1. Impaired ambula on which prevents the animal from reaching feed or water,
2. Excessive weight loss and emacia on,
3. Lack of physical or mental alertness,
4. Diﬃcult labored breathing, and
5. Inability to remain upright.
28
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
7.0
VETERINARY MEDICINES/DRUGS STORAGE AND CONTROL
The use of medicine in research in laboratory animals must be carried out in a manner that is
consistent and legally guided by the relevant laws in Kenya.
7.1
Drug storage layout
All pharmacy items shall be categorized (by method of administra on and storage requirements)
and stored appropriately as under-listed:
i. refrigerated
ii. medicine safe
iii. oral
iv. injectable
v. topical
vi. infusion
vii. inhala onal
viii. non-Drug
7.2
Drug Storage Room Standards
Drug storage rooms must have the following features:
i. Keypad locks or a lockable room
ii. Adequate ligh ng (240 lx luminance or more)
iii. A room temperature of 20 - 25°C for medicines to be stored under room temperature
condi ons
iv. A purpose built vaccine refrigerator (+4 - +8°C) for storage of vaccines, an -venom and
point-of-care equipment consumables
v. A nominated refrigerator for cold storage of pharmaceu cal products requiring
refrigera on, in addi on to the vaccine refrigerator
vi. A dangerous drugs cupboard and so labeled
vii. A secure and separate area for storage of restricted drugs when these cannot ﬁt in the
dangerous drugs cupboard
viii. Adequate shelving for appropriate storage of the diﬀerent categories of drugs used at the
ins tu on for use on animals
ix. A workbench with an impervious top
x. An adjustable swivel chair on castors, if the workbench is low
xi. A stainless steel sink with impervious surrounds, preferably with elbow controlled taps
xii. Two RUM containers as per Return of Unwanted Medicines:
· in excess of required stock level
· that are expired
· have been returned from a user
· that have their integrity/viability in doubt due to damage or uncertain storage
xiii. A soap dispenser and paper towel holder
XIV. A portable, non-slip step or a sturdy two rung ladder, if shelving is above shoulder height
xv. Op onal features that may be located in the drug storage room or elsewhere in the
ins tu on e.g. a networked computer with access to electronic records
7.3
Medicine Storage Room Resources
The following must be available in the Medicine Dispensing / Storage room:
i. Dangerous Drugs of Addic on Register (DDA Register)
29
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
ii.
iii.
iv.
v.
Restricted Medicines Register
Relevant pharmacy related reference manuals as per Standard Reference List
Current Vaccine Cold Chain Graphs (displayed on vaccine refrigerator)
Packaging requirements including DDAs, labels, paper bags, me of administra on
s ckers (sun and moon s ckers)
vi. Appropriate dispensing aids such as puriﬁed water, measuring devices, medicine cups,
paper cups, syringes, pill cu ers, and mortar and pestle.
7.4
Medicine Storage Room Security and Access
To comply with the provisions of the various relevant Acts, all drugs must be safely stored and not
be accessible to the public. This means that drug storage rooms in ins tu ons must be kept
locked at all mes unless an authorized person is present. Where keypads are not yet installed,
the HOP or delegate person must hold the key.
7.5
Medicine Storage Room Stock Control
Pharmacy supplies must be moved to the drug storage room as soon as they arrive and be
unpacked as soon as possible. To uphold quality standards in medicine storage rooms:
i. Rotate stock so that the stock closest to expiry date is kept in front
ii. When new stock arrives circle the expiry date or write it clearly on the box or other
container and place it behind stock with an earlier expiry date
iii. Where the expiry date is only printed on the external packaging, keep the unmarked
stock inside the package un l it is going to be used or, if the unmarked items have to be
removed from the packaging, write the expiry date on each separate item
iv. As far as possible, keep drugs and pharmaceu cal products in the drug storage room un l
they are required. The record of receipt and dispensing shall be maintained in a proper
schedule; the recommended format is shown in Table 6.
Table 6: Medicines usage Report Form
Note:
All entries should be made in indelible INK only
Fill in ALL rows & columns with each use
Container
ID #
Substance Name,
Manufacturer & Supplier
Contents
(Units/Container)
Controlled
Substance
Content (each
Unit)
Lot # and
Expira on
Date
Date
Dispensed
User’s Ini als
Project #
Amount Used
Amount
Remaining
Disposal
date
7.6
Medicine Storage Room: Safety of Clients and Staﬀ
The responsibili es of staﬀ to consider their own safety and that of others under the provisions of
the Public Health Act shall apply at all mes in the medicine storage room (MSR). Staﬀ must
ensure that:
i. The medicine storage room is kept locked when not in use
ii. All drugs and medicine containers are labeled with the name, strength, batch number
and expiry date
iii. There are no expired drugs or other pharmaceu cal products in the storage room
30
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
iv. Refrigerators contain only pharmaceu cal products according to SOPs
v. The drug storage room is reserved for pharmacy related func ons only
vi. Floors, walls, sinks, benches, shelves, containers and dispensing bo les are clean and
free of anything likely to contaminate drugs
vii. Benches and surroundings are free of items not required for prepara on or packaging of
medicines
viii. Floors are free of stock or other obstruc ons.
7.7
Disposal of Drugs and Medicines
Expired, spilt or contaminated medicines must be disposed of properly according to the
approved SOPs developed in line with Kenyan laws and approved by NEMA. Records of the
medicines that were disposed, the reason for disposing, the method of disposal, and the
personnel that disposed and the date of disposal must be kept for at least 3 years.
31
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
8.0
ANIMAL HOUSING, ENVIRONMENT AND MANAGEMENT
8.1
Terrestrial Species
8.1.1 General Principle
The design of animal facili es combined with appropriate animal housing and management are
essen al contributors to animal well-being, the quality of animal research and produc on,
teaching or tes ng programs, and the health and safety of personnel. An appropriate program
provides environments, housing, and management that are well suited for the species or strains
of animals maintained and takes into account their physical, physiologic, and behavioral needs,
allowing them to grow, mature, and reproduce normally while providing for their health and wellbeing.
8.1.2 Terrestrial Environment
The microenvironment (primary housing) of a terrestrial animal is the physical environment
immediately surrounding it. It includes the cage or pen, illumina on, noise, vibra on,
temperature, humidity, and gaseous and par culate composi on of the air.
The macroenvironment is the room, barn, or an outdoor habitat within which is contained the
primary housing of the animal.
Temperature and Humidity: Animals should be housed within temperature and humidity ranges
appropriate for the species, to which they can adapt with minimal stress and physiologic
altera on. The thermoneutral zone (TNZ) is the ambient temperature range in which mammals
are most comfortable; it is bound by the lower and upper cri cal temperatures (LCTs and UTCs).
The LCTs and UTCs for common laboratory animals are shown in Table 7, the acceptable range of
rela ve humidity is considered to be 30% to 70% for most mammalian species.
Ven la on and Air Quality: The primary purpose of ven la on is to provide appropriate air
quality and a stable environment. Speciﬁcally, ven la on provides an adequate oxygen supply;
removes thermal loads caused by the animals, personnel, lights, and equipment; dilutes gaseous
and par culate contaminants including allergens and airborne pathogens; adjusts the moisture
content and temperature of room air; and, where appropriate, creates air pressure diﬀeren als
(direc onal air ﬂow) between adjoining spaces. Modern hea ng, ven la on, and air
condi oning (HVAC) systems allow ven la on rates to be set in accordance with heat load and
other variables. Recycling of exhaust air though energy saving should be avoided due to the risk of
cross-contamina on.
Illumina on: Light can aﬀect the physiology, morphology, and behavior of various animals.Light
in animal holding rooms should provide for both adequate vision and neuroendocrine regula on
of diurnal and circadian cycles. While a me-controlled ligh ng system should be used to ensure a
regular diurnal cycle, and system performance, this may not be necessary in the tropical se ng
where a regular 12/12 Light/Dark cycle is the case. However, whenever studies deem this
necessary it is important that it is complied with.
Noise and Vibra on: Noise produced by animals and animal care ac vi es is inherent in the
opera on of an animal facility and noise control should be considered in facility design and
opera on.Exposure to sound louder than 85 decibels (dB) can have both auditory and nonauditory eﬀects such as eosinopenia, increased adrenal gland weights, and reduced fer lity in
rodents, and increased blood pressure in nonhuman primates.
32
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Table 7: Recommended dry-bulb macro-environmental temperatures for common laboratory
animals
Animal Species
Mouse, rat, hamster, gerbil, guinea pig a
Rabbit
Cat, Dog, Nonhuman primate
Farm animals, poultry
Dry-Bulb temperature
0
C
F
0
20-26
16-22
18-29
16-27
68-79
61-72
61-81
61-81
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
a
Dry-bulb room temperature se ngs for rodents are typically set below the animals’ LCT to avoid heat
stress, and should reﬂect diﬀerent species
-speciﬁc LCT values. Animals should be provided with
adequate resources for thermoregula on (nes ng material, shelter) to avoid cold stress.
Note:
Dry-bulb temperature (DBT) is the temperature of air measured by a thermometer freely exposed to
the air but shielded from radia on and moisture
8.1.3 Terrestrial Housing
The micro environment should have condi ons that provide suﬃcient space as well as
supplementary structures and resources required to meet physical, physiologic, and behavioral
needs. Environments that fail to meet the animals' needs may result in abnormal brain
development, physiologic dysfunc on, and behavioral disorders that may compromise both
animal well-being and scien ﬁc validity. An appropriate housing space or enclosure should also
account for the animals' social needs.
Appropriate housing strategies for a par cular species should be developed and implemented by
the animal care management, in consulta on with the animal user and HOP/AV, and reviewed by
the IACUC.
8.1.3.1 Environmental Enrichment
The primary aim of environmental enrichment is to enhance animal well-being by providing
animals with sensory and motor s mula on, through added structures (perches, visual barriers,
shelves, shelters, etc.) and manipulable resources (foraging objects, toys, chewable s cks, etc.)
that facilitate expression of species-typical behaviors and promote psychological well-being
through physical exercise, manipula ve ac vi es, and cogni ve challenges according to speciesspeciﬁc characteris cs. Novelty of enrichment through rota on or replacement of items should
be a considera on; however, changing animals' environment too frequently may be stressful.
8.1.3.2 Sheltered or Outdoor Housing
Sheltered or outdoor housing is a primary housing method for some species and is acceptable in
many situa ons. Animals maintained in outdoor housing, or other large enclosures must have
protec on from extremes in temperature or other harsh weather condi ons and adequate
opportuni es for retreat. Shelters should be large enough to accommodate all animals housed in
the enclosure, be accessible at all mes to all animals, have suﬃcient ven la on, and be designed
to prevent buildup of waste materials and excessive moisture.
8.1.3.3 Sanitation of sheltered or outdoor housing
It is important Naturalis c Environment is maintained: Areas such as pastures and islands may
provide a suitable environment for maintaining or producing animals and for some types of
research. Their use results in the loss of some control over nutri on, health care and surveillance,
33
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
and pedigree management. These limita ons should be balanced against the beneﬁts of having
the animals live in more natural condi ons. Animals should be added to, removed from, and
returned to social groups in this se ng with appropriate considera on of the eﬀects on the
individual animals and on the group.
Adequate supplies of food, fresh water, and natural or constructed shelter should be ensured.
8.1.3.4 Space
Space alloca ons should be assessed, reviewed, and modiﬁed as necessary by the IACUC
considering the performance indices (e.g., health, reproduc on, growth, behavior, ac vity, and
use of space) and special needs determined by the characteris cs of the animal strain or species
(e.g., obese, hyperac ve, or arboreal animals) and experimental use (e.g., animals in long-term
studies may require greater and more complex space). The recommended minimum space for
commonly used laboratory animals is provided. The recommended minimum space for various
species is given in Tables 8 - 12.
Table 8: Recommended minimum space for commonly used laboratory rodents housed in groups
Animals
Weight (g)
Mice in
groupsc
<10
Up to 15
Up to 25
>25
Female +
li er
Rats in
groupsc
Guinea pigsc
≥15 (≥96.7)
51 (330)
(recommended space
for the housing group)
<100
Up to 200
Up to 300
Up to 400
Up to 500
>500
Female +
li er
Hamsters c
Floor Area/Animala
In2. (cm2)
6 (38.7)
8 (51.6)
12 (77.4)
<60
Up to 80
Up to 100
>100
Up to 350
>350
17 (109.6)
23 (148.35)
29 (187.05)
40 (258.0)
60 (387.0)
≥70 (≥451.5)
124 (800)
(recommended
space for the
housing group)
10 (64.5)
13 (83.8)
16 (103.2)
≥19 (≥122.5)
60 (387.0)
≥101 (≥651.5)
Cage Heightb
In. (cm)
5 (12.7)
5 (12.7)
5 (12.7)
5 (12.7)
5 (12.7)
7 (17.8)
7 (17.8)
7 (17.8)
7 (17.8)
7 (17.8)
7 (17.8)
7 (17.8)
6 (15.2)
6 (15.2)
6 (15.2)
6 (15.2)
7 (17.8)
7 (17.8)
Comments
Larger animals may require more space
to meet the performance standards
Other breeding conﬁgura ons may
require more space and will depend on
considera ons such as number of adults
and li ers, and size and age of li ers
Larger animals may require more space
to meet the performance standards
Other breeding conﬁgura ons may
require more space and will depend on
considera ons such as number of adults
and li ers, and size and age of li ers.
Larger animals may r equire more space
to meet the performance standards.
Larger animals may require more space
to meet the performance standards
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
a
Singly housed animals and small groups may require more than the applicable mul ple of the indicated ﬂoor space per
animal. bFrom cage ﬂoor to cage top. cConsidera on should be given to the growth characteris cs of the stock or strain
as well as the sex of the animal. Weight gain may be suﬃciently rapid that it may be preferable to provide greater space
in an cipa on of the animal's future size. In addi on, juvenile rodents are highly ac ve and show increased play
behavior. dOther considera ons may include culling of li ers or separa on of li ers from the breeding group, as well as
other methods of more intensive management of available space to allow for the safety and well-being of the breeding
group. Suﬃcient space should be allocated for mothers with li ers to allow the pups to develop to weaning without
detrimental eﬀects for the mother or the li er.
34
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Table 9: Recommended minimum space for rabbits, cats, a nd dogs housed in pairs or groups
Animals
Rabbits
Cats
Dogse
Weight a
kg
<2
Up to 4
Up to 5.4
>5.4c
<4
>4d
<15
Up to 30
>30d
Floor Area/
Animalb 2 (m2)
1.5 (0.14)
3.0 (0.28)
4.0 (0.37)
≥5.0 (≥0.46)
3.0 (0.28)
≥4.0 (≥0.37)
8.0 (0.74)
12.0 (1.2)
≥24.0 (≥2.4)
Heightc
in. (cm)
16 (40.5)
16 (40.5)
16 (40.5)
16 (40.5)
24 (60.8)
24 (60.8)
—
f
—
f
—
f
Comments
Larger rabbits may require more cage height to
allow animals to sit up.
Ver cal space with perches is preferred and may
require addi onal cage height
Cage height should be suﬃcient for the animals
to comfortably stand erect with their feet on the
ﬂoor
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
a
To convert kilograms to pounds, mul ply by 2.2.
b
Singly housed animals may require more space per animal than recommended for pair- or grou housed animals.
c
From cage ﬂoor to cage top.
d
Larger animals may require more space to meet performance standards.
e
These recommenda ons may require modiﬁca on according to body conforma on of individual animals and
breeds. Some dogs, especially those toward the upper limit of each weight range, may require addi onal space to
ensure compliance with the regula ons of the Animal Welfare Act. These regula ons (USDA 1985) mandate that the
height of each cage be suﬃcient to allow the occupant to stand in a “comfortable posi on” and that the minimal
square feet of ﬂoor space be equal to the “mathema cal square of the sum of the length of the dog in inches
(measured from the p of its nose to the base of its tail) plus 6 inches; then divide the product by 144.”
f
Enclosures that allow greater freedom of movement and unrestricted height (i.e., pens, runs, or kennels) are
preferable.
Table 10:: Recommended minimum space for avian species housed in pairs or groups
Body Weight a
(kg)
Animals
Pigeons
Quail
Chickens
—
—
<0.25
Up to 0.5
Up to 1.5
Up to 3.0
>3.0c
Floor area/animalb
2
(m2)
0.8 (0.07)
0.25 (0.023)
Height
Cage height should be suﬃcient for
the animals to comfortably stand
erect with their feet on the ﬂoor.
0.25 (0.023)
0.50 (0.046)
1.00 (0.093)
2.00 (0.186)
≥3.00 (≥0.279)
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
b
Singly housed birds may require more space per animal than recommended for pair- or groupc
housed birds. Larger animals may require more space to meet performance standards (see
text).
35
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Table 11: Recommended minimum space for nonhuman primates housed in pairs or groups
Animals
Monkeys c (including baboons)
Group 1
Up to 1.5
Floor area/animala
2
(m2)
Weight
(kg)
2.1 (0.20)
3.0 (0.28)
4.3 (0.4)
6.0 (0.56)
8.0 (0.74)
10 (0.93)
15 (1.40)
≥25 (≥2.32)
Group 2
Up to 3
Group 3
Up to 10
Group 4
Up to 15
Group 5
Up to 20
Group 6
Up to 25
Group 7
Up to 30
Group 8
>30d
Chimpanzees (Pan troglydites)
Juveniles
Up to 10
Adultse
>10
15 (1.4)
≥25 (≥2.32)
Heightb
in. (cm)
30 (76.2)
30 (76.2)
30 (76.2)
32 (81.3)
36 (91.4)
46 (116.8)
46 (116.8)
60 (152.4)
60 (152.4)
84 (213.4)
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
a
Singly housed primates may require more space than the amount allocated per animal when group housed.
From cage ﬂoor to cage top.
c
Callitrichidae, Cebidae, Cercopithecidae, and Papio.
d
Larger animals may require more space to meet performance standards.
e
Apes weighing over 50 kg are more eﬀec vely housed in permanent housing of masonry, concrete, and wire-panel
structure than in conven onal caging.
b
Note
Cage HEIGHT should be suﬃcient for the animals to comfortably stand erect with their feet on the
ﬂoor. Baboons, patas monkeys, and other longer-legged species may require more height than
other monkeys, as might long-tailed animals and animals with prehensile tails. Overall cage
volume and linear perch space should be considera ons for many neotropical and arboreal
species. For brachia ng species cage height should be such that an animal can, when fully
extended, swing from the cage ceiling without having its feet touch the ﬂoor. Cage design should
enhance brachia ng movement.
For other apes and large brachia ng species cage height should be such that an animal can, when
fully extended, swing from the cage ceiling without having its feet touch the ﬂoor. Cage design
should enhance brachia ng movement.
8.1.4 Behavioral and Social Management
Animals' natural behavior and ac vity proﬁle should be considered during evalua on of suitable
housing or behavioral assessment. Forced ac vity for reasons other than a empts to meet
therapeu c or approved protocol objec ves should be avoided.
36
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Table 12: Recommended minimum space for agricultural animals
Animals/Enclosure
Sheep and Goats
1
2-5
>5
Swine
1
2-5
>5
Ca le
1
2-5
Horses
Ponies
1-4
>4/Pen
Floor Area/Animala
Body Weight(Kg)
<25
Up to 50
>50c
<25
Up to 50
>50c
<25
Up to 50
>50c
10.0 (0.9)
15.0 (1.35)
<15
Up to 25
Up to 50
Up to 100
Up to 200
>200c
<25
Up to 50
Up to 100
Up to 200
>200c
<25
Up to 50
Up to 100
Up to 200
>200c
8.0 (0.72)
12.0 (1.08)
15.0 (1.35)
24.0 (2.16)
48.0 (4.32)
≥60.0 (≥5.4)
6.0 (0.54)
10.0 (0.9)
20.0 (1.8)
40.0 (3.6)
≥52.0 (≥4.68)
6.0 (0.54)
9.0 (0.81)
18.0 (1.62)
36.0 (3.24)
≥48.0 (≥4.32)
<75
Up to 200
Up to 350
Up to 500
Up to 650
>650c
<75
Up to 200
Up to 350
Up to 500
Up to 650
>650c
24.0 (2.16)
48.0 (4.32)
72.0 (6.48)
96.0 (8.64)
124.0 (11.16)
≥144.0 (≥12.96)
20.0 (1.8)
40.0 (3.6)
60.0 (5.4)
80.0 (7.2)
105.0 (9.45)
≥120.0 (≥10.8)
144.0 (12.96)
—
—
<200
>200c
2
(m2)
≥20.0 (≥1.8)
8.5 (0.76)
12.5 (1.12)
≥17.0 (≥1.53)
7.5 (0.67)
11.3 (1.02)
≥15.0 (≥1.35)
72.0 (6.48)
60.0 (5.4)
≥72.0 (≥6.48)
Source: Adopted from Guide for the Care and Use of Laboratory Animals, Eighth Edi on, 2011. AALAC Interna onal
a
Floor area conﬁgura on should be such that animals can turn around and move freely without touching food or water
troughs, have ready access to food and water, and have suﬃcient space to comfortably rest away from areas soiled by
urine and feces. cLarger animals may require more space to meet performance standards including suﬃcient space to
turn around and move freely.
37
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
8.1.4.1 Social Environment
When selec ng a suitable social environment, a en on should be given to whether the
animals are naturally territorial or communal and whether they should be housed singly, in
pairs, or in groups. Dogs, cats, rabbits, and many other animals beneﬁt from posi ve human
interac on.
8.1.4.2 Procedural Habituation and Positive Reinforcement Training (PRT)
Habitua ng animals to rou ne husbandry or experimental procedures should be encouraged
whenever possible as it may assist the animal to be er cope with a cap ve environment by
reducing stress associated with novel procedures or people.
8.1.5
Husbandry
8.1.5.1 Feeds and feeding
Animals should be fed palatable, uncontaminated diets that meet their nutri onal and behavioral
needs at least daily, or according to their par cular requirements, unless the protocol in which
they are being used requires otherwise. Animal colony managers should ensure that food is
handled in a manner that minimizes the introduc on of diseases, parasites, poten al disease, and
chemical contaminants. Ins tu ons should have feed manufacturers to periodically provide data
from laboratory-based feed analyses for cri cal nutrients. When animals are housed in groups,
there should be enough space and enough feeding points to minimize compe on for food and
ensure access to food for all animals, especially if feed is restricted as part of the protocol or
management rou ne.
Food stocks should be stored oﬀ the ﬂoor on pallets, racks, or carts in a manner that facilitates
sanita on. Careful a en on should be paid to quan es received in each shipment, and stock
should be rotated such that the oldest food is used ﬁrst.
8.1.5.2 Water
Animals should have ad lib access to potable, uncontaminated drinking water provided in
appropriate drinking devises, unless the experimental protocols require otherwise. Regular water
quality control should be maintained.
8.1.5.3 Bedding and Nesting materials
Animal bedding and nes ng materials are controllable environmental factors that can inﬂuence
experimental data and improve animal well-being in most terrestrial species. The AV or HOP, in
consulta on with inves gators, should select the most appropriate bedding and nes ng
materials.
8.1.6 Sanitation
Environmental condi ons conducive to health and well-being of animals should be maintained.
Soiled bedding should be removed and replaced with fresh materials as o en as necessary to
keep the animals clean and dry and to keep pollutants, such as ammonia, at a concentra on below
levels irrita ng to mucous membranes. The goal of any sanita on program is to maintain
suﬃciently clean and dry bedding, adequate air quality, and clean cage surfaces and accessories.
8.1.6.1 Cleaning and disinfection of the microenvironment
In general, enclosures and accessories, such as tops, should be sani zed at least once every 2
weeks. Solid-bo om caging, bo les, and sipper tubes usually require sanita on at least once a
week. Primary enclosures can be disinfected with chemicals, hot water, or a combina on of both.
38
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
8.1.6.2 Assessing the eﬀectiveness of sanitation
Monitoring of sanita on prac ces should ﬁt the process and materials being cleaned and may
include visual inspec on and microbiologic and water temperature monitoring.
8.1.6.3 Waste disposal
Conven onal, biologic, and hazardous waste should be removed and disposed of regularly and
safely. Adequate numbers of properly labeled waste receptacles that are leak-proof and
equipped with ght-ﬁ ng lids as well as cold storage should be strategically placed within the
facility. Biosafety and radioac ve waste should be kept in properly labeled containers and their
disposal coordinated with safety specialists. Disposal of hazardous waste should comply with
OSHA regula ons.
8.1.6.4 Pest control
Pest Control Programs are essen al and should be designed to prevent, control, or eliminate the
presence of or infesta ons by pests in an animal environment. A regularly scheduled and
documented program of control and monitoring should be implemented. Pes cides can induce
toxic eﬀects on research animals and interfere with experimental procedures. They should be
used in animal areas only when necessary and inves gators whose animals may be exposed to
them should be consulted beforehand. Use of pes cides should be recorded and coordinated
with the animal care management staﬀ.
8.2
Aquatic Species
8.2.1 General principle
To provide op mal care for aqua c animals used in research and produc on, teaching or tes ng
programs, may need housing outside of the terrestrial Laboratory Animal Facility (LAF).
Maintaining aqua c animals outside of LAF requires IACUC approval.
8.2.2
Aquatic Environment
8.2.2.1 Water
Water quality parameters and life support systems should be appropriate to the animal species.
Water quality control and maintenance should be in place. Records should be available at the
housing site for IACUC inspec on at all mes.
8.2.2.2 Temperature, Humidity, and Ventilation
Temperature, humidity and ven la on should be controlled at the appropriate levels and
monitored regularly. A system should be in place such that the person responsible for the animals
and/or LAF is no ﬁed immediately.
8.2.2.3 Illumination
Ligh ng should be appropriate to support normal physiological func on.
8.2.2.4 Noise and Vibration
A system for monitoring noise and vibra on should be in place.
39
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
8.2.3
Housing
8.2.3.1 Environmental enrichment
Housing should allow for the normal physiological and behavioral needs including:
· Conspeciﬁc social interac ons,
· Maintenance of appropriate water quality and quan ty.
· Access to adequate food and removal of waste.
8.2.3.2 Space
Space recommendations and housing density vary extensively with the species, age, and size of the
animals, the life support system and the type of research. For example, zebraﬁsh requires 1 liter of
water for 5 adult ﬁsh, while Xenopus laevis frogs will require 2 liters of water per 1 adult frog. The
needs of each situa on must be evaluated by the IACUC in consulta on with the HOP and
Principle Inves gator to determine appropriate housing space. Advice from experts may be
advisable. 8.2.4 Husbandry
Aqua c animals must receive daily care from qualiﬁed personnel who have suﬃcient
understanding of the appropriate housing system. They should have also access to staﬀ who can
respond to system failure.
8.3
Breeding And Genetics
Gene c characteris cs are important with regard to the selec on and appropriate management
systems of animals for use in breeding colonies and in biomedical research to minimize gene c
contamina on resul ng from muta on and misma ng.
Gene cally Modiﬁed Animals (GMAs) require special considera on in their popula on
management.Newly-generated genotypes should be carefully monitored and new phenotypes
that nega vely aﬀect well-being should be reported to the IACUC.
Poten al housing sites for GMAs must be inspected and approved by the IACUC prior to
acquisi on of animals.
40
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
9.0
PHYSICAL PLANT
9.1
General principles
A well planned and maintained physical facility is an important element in good animal care. The
designs and the physical condi ons, including the characteris cs of building materials used,
determine the eﬃciency of the opera ons. The veterinarian is in charge of all opera ons for the
beneﬁt of both human and animals in a bid to control zoonoses, occupa onal hazards as well as
nutri on and sanita on of the facility. There should be Animal Ethics Commi ee and Bio-safety
Commi ee to synthesize all the issues surrounding the experiments in accordance with good
laboratory prac ce and to promote humane care of animals.
9.2
Location
Animal facili es should be located away from human habita ons but not exposed to dust, smoke,
noise, wild rodents, insects, and birds. Dis nct separa ons of personnel areas, such asoﬃces,
conference rooms, etc., should be drawn. However, animal compound can be a separate wing,
ﬂoor or building.
Where animals are kept near laboratories they should be separated from them by barriers,
corridors and locks. Animal rooms should cover 50 to 60% of the total area constructed. The
remaining 40% should include:
· Stores and washing areas
· Oﬃce and machine rooms
· Receiving areas, quaran ning and corridors
The size of the facility is determined by the size of animals being used. The animal area should be
big enough to allow;
· Separa on of various species
· Receiving and quaran ning and isola ng animals
· Animal housing
The animal facility is best centralized such that support, care, and use areas are adjacent to the
animal housing space to ease opera ons. Also, Decentralized animal facili es generally cost more
to construct and manage.
9.3
Functional areas
These include:
1. Main laboratories
2. Surgery- situated near animal housing area that should include;
i. Intensive Care Unit
ii. Radiography
iii. Experimental areas
iv. Treatment areas
v. Diagnos c lab
3. Equipment area- for hazardous agents to be used
4. Receiving/storage area- for food and beddings
5. Pharmacy and other supplies
6. Administra on/supervision area
7. Showers, sinks, lockers and toilets for personnel
41
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
8.
9.
10.
11.
12.
13.
Washing area- for sterilizing equipments
Auto-clave for equipments
Holding soiled/cleaned equipments
Repairing cages and equipments
Store for waste before incinera on or removal
Incinerator - away from animal and human areas
The graphical representa on of the Surgery in rela on to other Func onal Areas and the ﬂow of
work is shown in Figure 2.
9.4
The Physical Facilities
The facili es should be durable, moisture-proof and ﬁre resistant with the following important
considera ons in design and construc on;
i. Corridors- wide enough to allow movements of both personnel and equipments
ii. Water drains and electrical connec ons- should be accessible through corridors and
not animal rooms
iii. Animal room doors- should be rust, moisture, and dust proof, well ﬁ ed with an
observa on window
iv. Exterior windows- recommended in large animals. However, this is not
recommended in small animals which should have a back-up for alterna ve power source
to provide ligh ng and ven la on
v. Floors- should be smooth, moisture-proof, non-absorbent, skid-proof and resistant to
solvents and detergents. Able to support equipment without cracks and unnecessary
joints
vi. Drains- Floors should be sloped and drain pipes covered with non-corrosive free
mesh. Drainage must be adequate to allow rapid ﬂow of water and drying of services
to prevent high humidity
vii. Walls and ceilings- free of cracks or imperfect junc ons and should be capable of
withstanding scrubbing with detergents and water under pressure
viii. Storage area- should be designed for food, beddings and cages not in use.
ix. Refrigerated storage- would be necessary for storing dead carcasses and other animal
ssue wastes before they are incinerated
x. Cages and equipment area - for sani zing equipments with adequate water supply.
xi. Experimental area- where all experiments are carried out separate from animal
housing. For large animals other facili es for asep c surgery should include;
· Surgical support
· Prepara on area
· Opera on rooms
· ICU
· Suppor ve treatment
42
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Figure 2 : Graphical representa on of the Surgery in rela on other Func onal Areas
THEATRE
9.5
Security and access Control
Animals maintained for research may be vulnerable to infec on with adven ous agents and
therefore access to them should be strictly controlled and made available only to personnel who
have received appropriate training and have a legi mate need for access. Animals used in studies
with hazardous materials require special precau ons for personnel before access, and staﬀ
entering the animal facility should have completed the ins tu on's occupa onal health and
safety training.
43
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
10.0
TRAINING, ACCREDITATION AND CERTIFICATION
10.1
General principle
The use of laboratory animals in research is widespread in Kenya with varied standards of animal
care and use programs from ins tu on to ins tu on. The Na onal Guidelines require that
ins tu ons with animal facili es for research be inspected, accredited and cer ﬁed along with all
the personnel handling animals, as well as the Ins tu onal Animal Care and Use Commi ee
(IACUC).
10.2
The National Bioethics Commi ee Accreditation Program
The Na onal Bioethics Commi ee (NBC) of the Na onal Commission for Science, Technology
and Innova on (NACOSTI) Accredita on Program evaluates organiza ons that use animals in
research, teaching or tes ng. Those that meet or exceed NBC standards are awarded
accredita on.
The accredita on process includes an extensive internal review conducted by the ins tu on
applying for accredita on. During this review, the ins tu on shall ﬁll-in a comprehensive
document called a “Program Document” which documents all aspects of the animal care and use
program (policies, animal housing and management, veterinary care, and facili es). The Program
Document is submi ed to NBC.
NBC evaluates the Program Document and conducts a comprehensive on-site assessment. The
site assessment report is reviewed by the NBC and accredita on status is determined. A er an
ins tu on earns accredita on, it must be re-evaluated every three years in order to maintain its
accredited status.
10.3
The Program
The approved Animal Care and Use Program includes: animals; facilities; equipment;
professional, technical, and administrative support; and policies and programs for institutional
responsibilities, animal husbandry and veterinary care. Additionally, for a unit to be accredited it
must have reasonable activity levels relative to the space available for animal holding and use that
approach / match the Association for Assessment and Accreditation of Laboratory Animal Care
(AAALAC) International guidelines (AAALAC International, 2011).
10.4
The Standards of Accreditation
The NBC shall establish the speciﬁc standards and requirements for accreditation of the Program,
governed by the following general principles:
a) The Program shall be managed by qualiﬁed persons
b) All animal care personnel shall be suitably qualiﬁed by training and experience in the
care of laboratory animals
c) Physical facilities and the care and use of animals shall allow compliance and
maintenance of animal welfare
d) The National Guidelines shall be the fundamental reference document
e) The accredited unit shall submit an annual report that describes elements of the animal
care and use program as speciﬁed by NBC and including any adverse events during the
reporting period.
Any public or private ins tu on, organiza on, or agency maintaining, using, impor ng, or
producing animals for purposes of scien ﬁc research, teaching, or tes ng shall be required to be
accredited (Appendix 4).
44
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
10.4.1 Academic Institutions
In academic ins tu ons, resource organiza ons that provide animal care and related services are
not permi ed to seek accredita on independently of academic units such as schools, colleges,
independent research components, or other academic units. If such a resource unit serves a
school, college, etc. that is seeking accredita on, then the resource must be included in the
applica on and evaluated. Such a resource may also serve other units that are not accredited.
10.4.2 Private Organizations
In non-academic ins tu ons (e.g., commercial organiza ons, animal vendors, hospitals, and
private laboratories), major divisions or units are eligible to seek accredita on provided they
have independent local administra on and are clearly autonomous in terms of facili es,
personnel, policies, and funding from other divisions or units of the same organiza on.
10.4.3 Change of Accreditable Unit
During the period immediately prior to determina on of accredita on status or during
provisional accredita on, proba onary accredita on, proposed revoca on of accredita on, or
appeal, ins tu ons may not change their organiza onal structure, as deﬁned in the Applica on
for Accredita on or as amended in annual reports, so as to remove deﬁcient facili es from
evalua on. However, facili es previously used for animal care and use may be permanently
abandoned for such purposes at any me.
10.4.4 Contiguous Facilities
On occasion, programs being evaluated have con guous animal care and use facili es (same
ﬂoor or building) which are assigned to other units not par cipa ng in the accredita on
program. The extent to which con guous facili es are evaluated is at NBC's discre on.
10.4.5 Centralized and Satellite Facilities
Ins tu ons with both central and satellite facili es shall be required to declare the facili es that
they intend to accredit with NBC.
10.4.6 Contract Facilities
Host ins tu ons with contractual agreements for speciﬁc aspects of animal care ac vi es with
external collaborators have ul mate responsibility in animal care and use. In all situa ons, NBC
accredita on shall not extend beyond the host ins tu on.
10.4.7 Institutional Animal Care and Use Commi ee
Ins tu onal Animal Care and Use Commi ee (IACUC) shall be required to be accredited before
undertaking any research protocol review, oversight and rou ne evalua on of the Program.
10.5
Personnel
The concept of cer fying professional exper se is generally understood and prac ced among
professions, and is widely recognized and accepted by the public. The Na onal Guidelines
require that all those engaged in the use of laboratory animals shall have appropriate educa on
and training. This is to ensure that staﬀ has the proper a tude and competencies to ensure
compliance and maintenance of animal welfare. The minimum educa on levels shall match the
standards set by FELASA (1999). The review by NBC shall include staﬀ numbers, training and
professional development.
45
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
REFERENCES
th
1.
AALAC Interna onal (2011). Guide for the Care and Use of Laboratory Animals, 8
Edi on.
2.
American Veterinary Medical Association - AVMA (2013). Guidelines for the Euthanasia
of Animals: 2013 Edition
3.
East African Community (2010). Catalogue of East African Standards, 2010 February:
4.
FELASA (1995). Recommendations on Education and Training of Persons working with
laboratory animals: Category A and C. Laboratory Animals, 29:121-131
5.
FELASA (1999). Guidelines for education of specialists in laboratory animal science.
Laboratory Animals, 33:1-15
6.
FELASA (2002). Recommendations for Accreditation of laboratory animal science
education and training. Laboratory Animals 36:373-377
7.
Gilbert S., Kabenick G. and T. Murray (2012). Animal Research Ethics: Evolving Views
ad Practices. The Hastings Centre Special Report, 2012
8.
Government of Kenya. Environmental Management and Coordination Act, 1999.
Chapter 387of the Laws of Kenya.
9.
Government of Kenya. Food, Drugs and Chemical Substances Act, 1965. Chapter 254 of
the Laws of Kenya
10.
Government of Kenya. Occupational Safety and Health Act, 2007. Chapter 514 of the
Laws of Kenya.
11.
Government of Kenya. Pharmacy and Poisons Act, 1956. Chapter 244 of the Laws of
Kenya.
12.
Government of Kenya. Prevention of Cruelty to Animals Act, 1962. Chapter 360 of the
Laws of Kenya
13.
Government of Kenya. Public Health Act, 1921. Chapter 242 of the Laws of Kenya.
14.
Government of Kenya. Radiation Protection Act, 1982. Chapter 243 of the Laws of
Kenya.
15.
Government of Kenya. Use of Poisonous Substances Act, 1957. Chapter 247 of the Laws
of Kenya.
16.
Government of Kenya. Veterinary Surgeons and Veterinary Paraprofessionals Act, 2011.
Chapter 366 of the Laws of Kenya
17.
Government of Kenya (2010). Directive 2010/63/EU on the protection of animals used
for scientiﬁc purposes
18.
Government of Kenya. Animal Diseases Act, 1965. Chapter 364 of the Laws of Kenya
19.
ICLAS (1989). Laboratory Animals Science into the Next Century: Proceedings of the
46
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
First East African Conference on Laboratory Animal Science, Nairobi, Kenya
20.
Institute of Animal Technology (2011). QCF Syllabus levels 2-3:
21.
Institute of Primate Research (1989). Guidelines for Care and Use of Laboratory
Animals in Kenya. ISBN: 9966-9847-5-5
22.
Ins tute of Primate Research (1993). Laboratory Animal Science into the Next
Century. Proceedings of the First East African Conference on Laboratory Animal
Science, Nairobi, Kenya. Suleman, M. A., Muchemi, G. and Eley, R. M. (Eds.). ISBN
9966-9847-7-1
23.
International Animal Research Regulations: Impact of Neuroscience Research, 2012
24.
International Primatological Society (IPS) (2007). International Guidelines for the
nd
Acquisition, Care and Breeding of Nonhuman Primates, 2 Edition
25.
International Union for Conservation of Nature (IUCN). IUCN Redlist of Threatened
Species. (www.iucnredlist.org)
26.
Kimwele C, Matheka D & Ferdowsian H (2011). A Kenyan perspective on the use of
animals in science education and scientiﬁc research in Africa and prospects for
improvement. Pan African Medical Journal, 2011; 9:45 (also available at
27.
Laboratory Animal Houses: A guide to the design and planning of animal facilities,
ISBN 0 901053 03 1, 1979
28.
NC3Rs Guidelines (Primate accommodation, care and use), 2006
29.
Nuno Henrique Franco, Animals (2013). Animal Experiments in Biomedical Research:
A historical perspective, 3:238-273
30.
31.
OIE (2010). Guidelines on Use of Animals in Research and Education
OIE (2012). Guidelines on Responsible and Prudent use of Antimicrobial Agents in
Veterinary Medicine
32.
Russell WMS, Burch RL. (1959). The Principles of Humane Experimental Technique.
London: Methuen and Co. [Reissued: 1992, Universities Federation for Animal
Welfare, Herts, UK].
33.
Southwest Foundation for Biomedical Research (2008). Nonhuman Primate
Environment Enhancement Plan of the Southwestern National Primate Research
Centre. San Antonio, Texas, USA
47
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
APPENDICES
Appendix 1: Animal Care and Use Reporting Form
A. TO BE COMPLETED BY PERSON REPORTING CONCERN
The General Nature of the Concern is:
Animal Use/Protocol
Occupa onal Health & Safety
1. General Informa on: Principal Inves gator (PI):
Husbandry
Housekeeping
Protocol ID #:
Species Involved:
Loca on of Animals (Facility, Building, Room #):
Veterinary Care
Other:
Date:
# Involved
Animal ID
2. Please brieﬂy describe your concern:
Date Concern Report Form submi ed to ACUC
Name of Person Repor ng Concern (op onal):
B. TO BE COMPLETED BY PERSON INVESTIGATING THE CONCERN
Name:
3. Was there a nega ve impact on the health of the animal(s)? No
Yes
(Explain impact and ac ons taken):
4. Who was contacted to discuss this concern (include date and me; if more than one person, list each individually):
A. Person Contacted:
Date:
B. Person Contacted:
Date:
C. Person Contacted:
Date:
Time:
Time:
Time:
5. Summarize the issues which were discussed (please correlate to names in item 4 above):
Person A: discussion:
Person B: discussion:
Person C: discussion:
6. Describe any correc ve ac ons needed and or performed:
7. Is there a possible protocol viola on?
8. Was a correc ve ac on agreed upon?
9. IACUC no ﬁca on:
Yes
No
No
If yes, describe:
Yes (If yes, please describe the ac ons):
Request for immediate subcommi ee review and ac on
10. Inves ga ng ACUC Oﬃcial Signature:
For report at regular IACUCmee ng
Date:
C. TO BE COMPLETED BY ACUC OFFICE ONLY
Date Animal Care and Use Repor ng Form received in IACUC Oﬃce:
Date to IACUC Review #1:
Ac on Taken:
Date to IACUC Review #2:
Ac on Taken:
Date to IACUC Review #3:
Ac on Taken:
Received by:
…
48
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Appendix 2: Laboratory Animal Facility Housing Areas (LAFHA)
Form A must be posted in the housing area, and staﬀ responsible for the care of LAFHA animals
must have read and known the informa on in Form A
Please provide contact informa on for the personnel responsible for the LAFHA.
Phone Number:
Email:
Provide an explana on and ra onale for the need for laboratory housing of animals:
(Note: “Convenience” or “cost” is not an appropriate jus ﬁca on.)
Loca on of LAFHA (Room number and building):
How long will animals be maintained in this LAFHA?
If cages, pens, etc. are used to house the animals, iden fy the type of cages, pens, etc. requested.
Describe the type of cages, pens, pastures etc (include size, material, etc.) that will be used.
List personnel responsible for care of t hese animals (Animals must be observed every day, including
weekends and holidays).
Describe the food and how it will be provided. Include the type, brand, or source of food, the nutrient
content of the food, and how and where the food will be stored.
Describe the source of water for the animals, how it will be provided, and if not cont
frequency that fresh water will be provided.
inuous, and the
Describe bedding (Include type, how used, how and where stored, frequency of changes)
49
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Describe the sanita on procedures and the equipment used for sanita on of the primary
enclosure/cages, the feeders, and the watering devices. Indicate frequency of sanita on.
Describe how eﬀec veness of the sanita on procedures is monitored.
Describe the handling, storage, frequency of disposal, and ﬁnal dispo
refuse, and animal carcasses.
sal loc a on for soiled bedding
Describe procedures for providing emergency weekend and holiday care:
Describe provisions for veterinary care and supervision:
Describe any planned environmental condi ons o f the ARFHA that deviate from the standards provided
in regulatory documents.
Condi ons:
Ra onale:
Dura on:
Method of monitoring:
50
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Appendix 3: Protocol Speciﬁc Breeding
1. Please explain the need for animal breeding on this protocol.
2. List the species and strains of animals to be produced in this breeding program:
3. An cipated total number of oﬀspring for each species that will be produced:
Animal Numbers
Species:
Breeders:
Species:
Breeders:
Species:
Breeders:
Total for 3 years
Oﬀspring:
Oﬀspring:
Oﬀspring:
(Sugges on: Be sure this number matches the numbers provided in the Animal Request Table in Sec on
1 of the Animal Care and Use Protocol form.)
4. An cipated number of oﬀspring that will be used for experiments:
5. What will be done with the surplus animals?
(Note: Certain animals may be donated to the Animal Rehabilita on Center in lieu of euthanasia .)
Breeding Gene cally Modiﬁed Animals
Note: Important to consider Biosafety
6. DNA/transgene or gene to be disrupted:
7. Are there any inherent problems for the animal associated with the gene cally modiﬁed phenotype?
No.
Yes.
If yes, describe:
8. Method of monitoring presence of transgene in the animals. (Please note that if tail snipping is used it
must be performed according to IACUC guidelines).
51
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
9. Describe any special care or monitoring that may be required for these animals:
1. Describe who will perform this monitoring?
2. How long are the founders maintained?
3. What are the criteria for euthanasia of the founders?
52
National Guidelines for the Care & Use of Animals in Research & Education in Kenya
Appendix 4: Checklist of regulations and guidelines for use of animals in
research and training
Ques ons
Is the species to be transported a live, warm -blooded
animal other than a bird or an animal of the genus
Ra us or Mus?
Is the species to be imported or exported considered
wildlife (including all CITES
-listed species and
nonhuman primates)?
Is the species to be transported (exported, imported,
or inter -county trade) listed as threatened or
endangered by KWS?
Is an animal wild
-caught listed under CITES as
aspecies, and being transported interna onally?
Is an animal to be transported interna onally:
·
listed under CITES (Appendix II species) OR
·
a cap ve -born animal and listed under
CITES?
Is the species to be imported a dog or cat?
Is the species to be imported a nonhuman primate or
others species prohibited by
receiving
laboratory/country?
Is the species to be imported a live bat
or animal,
insect, or animal ssue that contains an e ologic
agent?
Does the animal to be transported contain poisonous,
radioac ve, or infec ous material?
Is the animal to be transported within Kenya a
nonhuman primate or other species prohibited by
receiving laboratory/country?
Is the animal being transported by air?
Answer is YES
Comply with Kenyan regula ons
Subject to inspec on by Kenyan
authori es
Obtain KWS permits, consult
Comply with Kenyan Regula ons
Comply with IATA LARs.
Subject to inspec on by KWS.
Obtain KWS permits.
Subject to inspec on by KWS.
Comply with IATA LARs.
Obtain importa on and exporta on
permits from the appropriate countries.
Obtain KWS permits.
Subject to inspec on by KWS.
Obtain export permit from country of
export.
Obtain KWS permits.
Subject to inspec on by KWS.
Dogs require proof of rabies vaccina on.
Subject to inspec on by
cer ﬁed
veterinarian in receiving
laboratory/country?
Obtain permit, wri en permission, or
registra on from Veterinary authority ?
Quaran ne.
Subject to inspec on by
cer ﬁed
veterinarian
Obtain Import permit from
Veterinary
authority.
Answer is NO
No ac on
required
Contact receiving laboratory for further
requirements.
If shipped by air, comply with IATA DGRs.
Submit wri en request for permission
from Veterinary Authority
No ac on
required
Comply with IATA LARs(all species)
No ac on
required
No ac on
required
No ac on
required
No
ac on
required
No ac
required
on
No ac on
required
No ac on
required
No ac on
required
No ac on
required
53