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Submission Date AUCC approval Date

For Administrative Purposes

Project No. Signature (only on approval)

This form is !s"# o$ %h" s&"'ifi'!%io$s i$ %h" So(%h Afri'!$ N!%io$!) S%!$#!r# (SANS 10*+,-200+). /Th" C!r" !$# Us" of A$im!)s for S'i"$%ifi' P(r&os"s01 2hi'h #"fi$"s !$im!) !s /)i3"1 s"$%i"$% $o$h(m!$ 3"r%" r!%"1 i$')(#i$4 "44s1 fo"%(s"s !$# "m r5os1 %h!% is1 fish1 !m&hi i!$s1 r"&%i)"s1 ir#s !$# m!mm!)s1 !$# "$'om&!ssi$4 #om"s%i' !$im!)s1 &(r&os"- r"# !$im!)s1 f!rm !$im!)s1 2i)#)if" !$# hi4h"r i$3"r%" r!%"s s('h !s %h" !#3!$'"# m"m "rs from %h" C"&h!)o&o#! !$# D"'!&o#!06 This !&&)i'!%io$ m(s% " %5&"#6 I% m(s% " si4$"# 5 %h" Pri$'i&!) I$3"s%i4!%or (%h" !&&)i'!$%) !$# o%h"r &"rso$s 2ho !r" 3o('hi$4 for s&"'i!)is"# !s&"'%s of %h" "7&"rim"$%!) #"si4$ ("646 s%!%is%i'i!$1 s!f"%5 offi'"r1 !$# &"rso$s r"s&o$si )" for s(&"r3isi$4 %h" (s" of s'h"#()"# m"#i'i$!) s( s%!$'"s) !s i$#i'!%"#6 A&&)i'!%io$s %h!% h!3" $o% ""$ si4$"# 2i)) $o% " 'o$si#"r"#6 Th" !&&)i'!%io$ $""#s %o " 2ri%%"$ sim&)51 ri"f)5 !$# is $o% %o "7'""# %h" )imi%!%io$s i$#i'!%"#6 Th" !&&)i'!%io$ sho()# " "-m!i)"# or f!7"# %o %h" AUCC 'o-or#i$!%or !% !(''8(&6!'69! or 012 :2; +*006 Th" mo$%h)5 #"!#)i$" for s( missio$s is %2o 2""<s &rior ! m""%i$46 Th" #!%" !% 2hi'h %h" si4$"# h!r#'o&5 !rri3"s !% %h" AUCC offi'"s 2i)) #"%"rmi$" 2h"$ %h" !&&)i'!%io$ 2i)) " 'o$si#"r"#6 To m""% %h" r"=(ir"m"$%s of SANS1 ! &ro4r"ss r"&or% 2i)) " r"=("s%"# !$$(!))5 T")"&ho$" "$=(iri"s o$ !$5 AUCC r")!%"# m!%%"rs m!5 " #ir"'%"# %o "i%h"r %h" Ch!irm!$ of %h" AUCC !%. 012-:2;+:>; or %h" 'o-or#i$!%or !%. 012-:2; +?*?




Co$%!'% N(m "r

(Corresponding author

"-m!i) !##r"ss

Yes No Co$%!'% A##r"ss

C(!)ifi'!%io$s A&&ro&ri!%" "7&"ri"$'" i$ !$im!) r"s"!r'h C. SUPERVISORBCORRESPONDING AUTHOR (if !&&)i'! )") (Corresponding author Yes No N!m" Co$%!'% N(m "r "-m!i) !##r"ss Co$%!'% A##r"ss C(!)ifi'!%io$s A&&ro&ri!%" "7&"ri"$'" i$ !$im!) r"s"!r'h


Co-DOREERS (i$3o)3"# #ir"'%)5 2i%h &ro'"#(r"s o$ A$im!)s

Co$%!'% N(m "r "-m!i) !##r"ss Co$%!'% A##r"ss

C(!)ifi'!%io$s A&&ro&ri!%" "7&"ri"$'" i$ !$im!) r"s"!r'h N!m" Co$%!'% N(m "r C(!)ifi'!%io$s A&&ro&ri!%" "7&"ri"$'" i$ !$im!)

"-m!i) !##r"ss

Co$%!'% A##r"ss

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)


Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)




Mor!) Phi)oso&h5 The ethical review of proposed animal experiments is predicated upon the acceptance by UP that non-human animals are organisms fully worthy of moral concern and as such their interests must be protected as far as possible in their use for advancement of biological knowledge and for the promotion of the health and welfare of animals and humans and protection of the environment. A$im!) I$%"r"s%s n the use of laboratory animals! animal interests obligate scientists and educators to" not allow animals to be used for research and#or to be killed for trivial! irrational! un$ustified or inappropriate reasons% permit animals to live! reproduce and grow under conditions that are comfortable and reasonably natural to their species% keep animals free from disease! parasitism! in$ury and pain by prevention! rapid diagnosis and treatment% allow animals to be able to express normal behaviour through providing as far as possible sufficient space! proper facilities in which to live and in the company of the animal&s own kind recognising the inherent social nature and hence the necessity of a social relationship for many species% protect animals from fear! deprivation! stress! distress and pain by ensuring that their living conditions! handling and treatment will be such that it will either minimise or eliminate the causation of these states upon those animals! that are used for research! teaching and testing% H(m!$"$"ss The principles of humane experimental techni(ue proposed by )ussell * +urch must be followed in the planning and conduct of animal experiments. These comprise" R"&)!'"m"$% of animals with non-sentient research systems! i.e. researchers must strive to avoid using of laboratory animals if alternative methods can yield the data they need. R"#('%io$ of the numbers of animals that are to be used to a minimum by design in order to achieve only sufficient statistical power to allow the ob$ects of the experiment to be achieved. R"fi$"m"$% of the experimental methodology to be adopted by the implementation and if necessary by the improvisation of procedures which will have the least distressing or harmful effect to the animals and when this is not avoidable to counter those effects by the use of ataractics ,tran(uillisers-! neuroleptics ,dissociative agents-! anaesthetics! analgesics and other effective strategies. A$im!) Pro%"'%io$ /nimals should be protected from research designs that involve pain! illness! isolation! mutilation ,whether by surgery or otherwise- and#or premature death until such research can be demonstrated to be absolutely imperative and related to health! welfare and environmental problems! which are potentially catastrophic in nature and for which alternative designs using non sentient systems are not feasible. S4524/12
Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)





R")"3!$'" /nimal based teaching and research must address an important (uestion relevant to UP&s ob$ectives in advancing knowledge! education! science and human and animal welfare through research! be based on plausible hypothesis and have a reasonable prospect of yielding good results.

,6 R"s&o$si i)i%5 t is the responsibility of everyone using animals! for experimentation! testing diagnosis! teaching! sourcing of tissues or body fluids to assure that the animals that they use are afforded the highest levels of welfare and protection from abuse. >6 U$i3"rsi%5 Po)i'i"s The University of Pretoria has a number of policies in place that may be relevant to the application. 1our attention is specifically drawn to the Policy and Procedures for ethical research ,2.34'#33! available at http"! the policy on Preservation and )etention of )esearch 8ata ,)t'39#3:! available at http"';23Preservation;23of7research;23data.doc-! and the )ules for <ontract )esearch and <ontract =ork ,)t.03#>:! available at http">:ktrakeng.html-. +6 P"rso$!) D"')!r!%io$ 4.1 =e! ,full name- ??????????????...?????..! as Principal nvestigator and ????????????.???....! as 2upervisor in this application! hereby declare that we are familiar with the precepts! policies and responsibilities outlined under 2ection @ and will personally undertake to ensure that these are upheld in the conduct of this study! should it be approved. 4.2 =e undertake not to deviate from the approved application without obtaining prior approval by the /U<< for any desirable or necessary significant changes that may need to be made in the methods used! which may affect the welfare of the animal sub$ects.

??????????????..? Si4$!%(r" of A&&)i'!$%

???????????? D!%"

4.' n my opinion! all persons named and working under my supervision have the appropriate training and skills needed to carry out their responsibilities for experimental procedures! care and handling of the species being used.

?????????????? Si4$!%(r" of S(&"r3isor,=hen applicableS4524/12

???????????? D!%" 4

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)



,@very application should be supported by a declaration that it has undergone prior scientific review
outside of the applicant&s Unit or 6roup. O$" of the following ' statements must be completed.This research protocol has been reviewed by a scientific review committee ???????????.. ????????????????????..,please specify- of the , nstitute#Unit- ???????? ????????????????????. on ,date- ????????.?? and has been $udged to be relevant! designed in accordance with accepted scientific practices and norms and is in the opinion of the reviewers likely to be successful in achieving its ob$ective.

???????????????.. N!m" !$# D"si4$!%io$

??????????. Si4$!%(r"

???.????..?? D!%"


Aunding for this research pro$ect has been received from ?????.???. ,agency- that re(uires a review process prior to funding research pro$ects. 6rant holder" ??????????????????????????????????.???.. Type of grant" ????????..??????.6rant number" ???????????????..

???????????????.. Gr!$% ho)#"r

??????.????. Si4$!%(r"

??????...??? D!%"


! in my capacity as Bead of 8epartment ???.???????????! confirm that this application has been $udged to be relevant! designed in accordance with accepted scientific practices and norms and in my opinion is likely to be successful in achieving its ob$ective.

???????????????.. HOD

?????.?????. Si4$!%(r"

?????????? D!%"



s this pro$ect fully funded 8oes the funding of the pro$ect depend on the pro$ect being approved by the @thics <ommitteeC


<ontract Aor degree purposes 8egree

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)



@xperiments on embryonated eggs or cephalopods and decapods


2tudies on vertebrate animals during the course of routine examination! teaching procedures and treatment. E7!m&)"s. Animals held under proper conditions for later use or for teaching non)in&asi&e procedures* +bser&ational studies e*g* on ,ild animals in the field*

Procedures on vertebrate species that are expected to produce stress but no pain re(uiring anaesthesia. E7!m&)"s. -ild animals caught in the field, caged . transported for obser&ation* Administration of medication* Collection of blood samples* /ectal e0amination


@xperiments that produce minor or shortduration pain re(uiring the use of pain relieving drugs. E7!m&)"s. Subcutaneous implants* Doc1ing in sheep* Collection of tissues from animals after euthanasia*


@xperiments that involve significant but unavoidable stress or pain re(uiring anaesthesia or a humane endpoint. E7!m&)"s. Non)sur&i&al surgery in teaching* Sur&i&al surgical procedures* Infecti&ity or to0icity studies ,ith a high probability of producing disease. Large animals 1ept in boma

Procedures that involve inflicting severe pain at or above the pain tolerance threshold and the use of pain relievers are contra-indicated. E7!m&)"s. 2o0icity3&irulence testing ,here death is the endpoint* Disease3cancer models in&ol&ing chronic clinical signs*

*Definitions from Special Issue, Laboratory Animal Science, anuary !"#$, p !%

I. 16

PRO@ECT Comm"$'"m"$% of r"s"!r'h

@xpected <ompletion 8ate

@xpected 2tarting 8ate

declare that the pro$ect has not commenced without approval


Ari"f G(s%ifi'!%io$
,Provide a brief introductory statement DET @F<@@8 D6 033 =E)82 and supported by rele&ant scientific literature that explains what problems! (uestions! needs or scientific or clinical observations or new ideas have led to the planning of the experiment.- ('lease type(

*6 AimBs of %h" &ro&os"# s%(#5

,2tate these briefly and succinctly.- ('lease type(

?6 Po%"$%i!) "$"fi%s of %h" r"s"!r'h fi$#i$4s

,These are re(uired to aid the reviewing committee in performing a harm#benefit assessment.('lease type(

:6 H5&o%h"sis
, f a hypothesis is being tested give the postulate#s ,null hypothesis and alternates- to aid the reviewers in following the rationale of the proposed study.- ('lease type(

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)


A$im!) r"=(ir"m"$%s
Total Dumber )e(uired +ody mass 2ource of /nimals

/nimal 2pecies
('lease state ,hether domesticated or not(

2train 6ender" Hale Hicrobial 2tatus



>6 @(s%ifi'!%io$ for %h" (s" of s"$%i"$% !$im!)s

,+riefly $ustify the use of animals! the choice of species! the numbers to be used. f there is limited availability! or large numbers are to be used! provide additional rationale for their selection and numbers. 2tate also what non-sentient model#s were considered and on what grounds they were re$ected.- ('lease type(

+6 R"#('%io$ of %h" $(m "r of !$im!)s %o ! mi$im(m %o !'hi"3" s'i"$%ifi' o G"'%i3"s

,8escribe how this was determined either by calculation ,statistical design- or by specification ,i.e. use of a validated testing protocol- or any other strategy.- ('lease type(

;6 A$im!) ho(si$4 !$# '!r"

,+riefly describe how the animals will be housed ,penned! stabled! caged or confined in any other way! kept in metabolic crates or cages! etc.-! their nutrition ,feeding and watering- and what provisions have been made for the physical and psychological wellbeing i.e. comfort! socialisation! behavioural needs and enrichment of their immediate environment.- ('lease type(


106 S%!%"m"$% of !$im!) '!r" 'om&"%"$'"1 "7&"r%is" !$# "7&"ri"$'"

,Provide a short statement of the scientific knowledge competence and experience of the person,sappointed to ensure the comfort! health and humane treatment of the animal sub$ects in this studyand provide their registration credentials either with the 2outh /frican Ieterinary <ouncil! the Bealth Professions <ouncil of 2outh /frica or the 2outh /frican <ouncil for Datural 2ciences Professions! and any in-house accreditation obtained.- ('lease type(

116 E7&"rim"$%!) #"si4$

,@xplain the reasoning behind the study design and experimental planning! with particular reference to determination of sample si5e and statistical analysis. 8escribe how the animals will be allocated to experimental and control groups and where applicable! how the experimental treatments will be assigned to each group. The use of flow charts is recommended. The information should be presented in an easily accessible manner.- ('lease type(

126 R"s%r!i$% of %h" !$im!)s

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)

,8escribe the methods of physical ,manual procedures and use of special restraint e(uipment- or chemical restraint to be used on the animals and state who the animal handler#s will be.- ('lease

1*6 E7&"rim"$%!) !$im!) &ro'"#(r"s

,8escribe briefly in short annotated sentences D 2@JU@D<@! all the steps that will be performed in conducting the proposed experiment. These include" duration of animal holding and animal use! the collection of samples ,if body fluids give routes of collection and volumes-! operative procedures! etc.- ('lease type(

1?6 A#mi$is%r!%io$ of !)) m"#i'i$"sBs( s%!$'"s

,Kist all substance administrations to the animals and give routes of administration! dosages per body mass including anaesthetics! analgesics and euthanasing agents. 2tate who is legally responsible for prescribing and directing the administration of the controlled 2cheduled ' L 9 medicinal substances and other controlled substances and provide their acceptance of this responsibility by signature.- ('lease type(

R"s&o$si )" &"rso$ (&ri$% $!m") C(!)ifi'!%io$ A''"&%!$'" of r"s&o$si i)i%5. SIGNATURE H DATE.

1:6 S"3"ri%5 of "ff"'%s of %h" "7&"rim"$%!) &ro'"#(r"s o$ %h" !$im!)s

,Kist the procedures that may cause deprivation! fear! distress and pain. 8escribe what sensations the animal may feel. <ategorise these as minimal! intermediate or high.M 6ive their likely duration in time. 8escribe what specific steps will be taken to alleviate these conditions through the use of ataractics! dissociative agents! analgesics! anaesthetics or other methods. @stimate how effective these are likely to be.- ('lease type(
Laboratory Animals %45 "$ 6 !78, !""8(*

1,6 F!%" of !$im!)s !$# %h"ir #is&os!) !% %h" "$# of %h" s%(#5
,+riefly state the fate ,e.g. rehabilitation and release! return to stock! euthanasia- of the experimental animals at the end of the study! what method of euthanasia is to be used! what humane rationale supports this choice and how the animals or animal carcasses are to be disposed of in a responsible and ecologically sound manner.- ('lease type(

1>6 S%!%is%i'!) !$!)5sis

,8escribe briefly how the data obtained from the study will be analysed statistically! explain this decision and state by whom the analyses will be performed.- ('lease type(

1+6 R"fi$"m"$%
,8escribe the specific steps that have been taken to refine the experimental procedures to make them as humane as possible i.e. minimising the impact of the proposed procedures on the animals& wellbeing.- ('lease type(

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)

1;6 Mo$i%ori$4 of ')i$i'!) 'h!$4"s i$ "7&"rim"$%!) !$im!)s

,8escribe who will be responsible for the pre! intra- and post operative ,or experimental period- care of the animals and give an indication of their experience and competence. +riefly state what clinical and behavioural criteria will be specifically monitored to assess the animal&s wellbeing.- ('lease

206 E$# &oi$%s for "7&"rim"$%s %h!% i$#('" i))$"ss or &!i$ i$ !$im!)s
,6ive the endpoints of data collection in experiments or procedures that may cause animals to become ill! lose weight! become distressed and experience pain. Nustify these in terms of the needs of the experiment to attain its ob$ectives.- ('lease type(

216 G"$"r!) 3"%"ri$!r5 '!r"

,Provide details! including emergency contact details! of the veterinarian who will be responsible to provide the general veterinary care and who will have the authority to enforce the endpoints stipulated under Point 23. The veterinarian must be registered or authorised with the 2/I< and is preferably independent of the research group.- ('lease type( I% is %h" r"s&o$si i)i%5 of %h" 3"%"ri$!ri!$
%o !rr!$4" for ! )o'(m if h"Bsh" is $o% !3!i)! )"

P@)2ED )@2PED2 +K@ AE) I@T@) D/)1 </)@ EA /D H/K2 @H@)6@D<1 <ontact details 2ignature * 8ate

226 A(%hori9!%io$ of UPARC

, n the case of experimental work conducted at the UP+)< the responsible veterinarian must authori5e the UP+)< veterinary staff to act on his#her behalf in the case of an emergency.-

hereby authori5e the UP+)< veterinary staff to act on my behalf



2*6 P"rso$$") !'%i3i%i"s

,8escribe the specific responsibilities and duties of @/<B P@)2ED who will be involved with the procedures on animals! preferably in a tabular format.- ('lease type(

2?6 Aioh!9!r# s%!%"m"$%

,8oes the pro$ect pose any ha5ards to other animals and staff from the use of infective agents! toxic substances! carcinogenic agents or ionising radiationC f it does! state the specific safety procedures to be followed to contain these ha5ards and provide an approval statement in the space below from the nstitutional 2afety Efficer. f available! you may append the laboratory&s relevant 2EPs and policies.- ('lease type(


Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)

Replace S4566/10; S4555/09; S4283/08; S403/04 (amended) & S2598/01(amended)