Ten Top Tips for Animal Ethics Application Success - Melbourne ...

Ten Top Tips for Animal Ethics Application Success - Melbourne ...

Ten Top Tips for Animal Ethics Application Success - Melbourne ...


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<strong>Ten</strong> <strong>Top</strong> <strong>Tips</strong> <strong>for</strong><br />

<strong>Animal</strong> <strong>Ethics</strong> <strong>Application</strong><br />

<strong>Success</strong><br />

<strong>Melbourne</strong> Research Office

<strong>Ten</strong> <strong>Top</strong> <strong>Tips</strong> <strong>for</strong> <strong>Animal</strong> <strong>Ethics</strong><br />

<strong>Application</strong> <strong>Success</strong><br />

by Richard Whittome<br />

The University of <strong>Melbourne</strong> takes its responsibility to animal welfare seriously,<br />

and through its <strong>Animal</strong> <strong>Ethics</strong> Committee (AEC) system strives to uphold and<br />

further best practice in animal-based science, while reflecting the expectations of<br />

the broader community. All proposed animal work is assessed with a particular<br />

emphasis on the 3Rs – Replacement, Reduction and Refinement. Our goal is to<br />

use animals only in well-designed and argued research and teaching projects.<br />

University of <strong>Melbourne</strong>, <strong>Animal</strong> Welfare Committee<br />

Between 2004 and 2007 only 53%* of animal ethics applications were approved at<br />

the first University of <strong>Melbourne</strong> <strong>Animal</strong> <strong>Ethics</strong> Committee (AEC) to which they were<br />

submitted. The remainder were sent back to the applicants <strong>for</strong> modification be<strong>for</strong>e<br />

eventual resubmission. Furthermore, many “first meeting” approvals were contingent<br />

upon the provision of clarification or additional in<strong>for</strong>mation by the applicants be<strong>for</strong>e final<br />

approval could be granted.<br />

These delays are frustrating, particularly as they are often caused by communication or<br />

presentational issues, rather than poor experimental design or any unwillingness on the<br />

part of the researchers to incorporate animal welfare considerations into projects. So<br />

what can we do to address this situation? This brochure aims to provide some helpful<br />

advice <strong>for</strong> researchers, based on an analysis of past AEC decisions.<br />

(Note: Throughout this brochure, all references to “researchers” includes teaching staff.)<br />

1. Writing with the purpose in mind ............................................................................... 1<br />

2. Writing <strong>for</strong> a non-scientific audience ......................................................................... 1<br />

3. Providing a clear narrative and chronology .............................................................. 3<br />

4. Including and reconciling all scientific in<strong>for</strong>mation .................................................... 3<br />

5. Justifying and minimising animal numbers ............................................................... 4<br />

6. Assembling the right team ........................................................................................ 5<br />

7. Piloting and/or staging the project? .......................................................................... 5<br />

8. Monitoring and documenting the animals ................................................................. 6<br />

9. Getting surgery and pain management right ............................................................ 7<br />

10. Making the endpoint clear......................................................................................... 8<br />

References ...................................................................................................................... 8<br />

Contacts .......................................................................................................................... 9<br />

* This figure falls to 44.5% <strong>for</strong> submissions emanating from the following (combined) departments: Pathology,<br />

Anatomy & Cell Biology, Microbiology & Immunology, Dental Science, Medicine (RMH), Pharmacology,<br />

Physiology, Biochemistry & Molecular Biology, and Bio21 Institute.

1. Writing with<br />

the purpose in<br />

mind<br />

Seasoned applicants appreciate the<br />

true purpose of an AEC application. It<br />

is fundamentally different in nature to a<br />

research proposal, or a submission to a<br />

scientific publication. Its singular function<br />

is to enable the AEC to decide if the use<br />

of animals is justified - based on whether<br />

the scientific or educational value of the<br />

work outweighs the potential impact on<br />

the animals being used. To do this the<br />

committee must understand:<br />

• why the work is proposed<br />

• why animals are needed<br />

• what will be done to the animals<br />

• what impact the work will have on the<br />

welfare of the animals.<br />

As in<strong>for</strong>mation that is extraneous to this<br />

core rationale should not be included<br />

in the application, the wholesale<br />

“lifting” of text from previous research<br />

documentation can be inappropriate.<br />

Photo by A/Professor Geoff Shaw, Department of Zoology<br />

2. Writing <strong>for</strong> a<br />

non-scientific<br />

audience<br />

AECs are constituted of both scientific<br />

and lay members, and decisions<br />

about applications must be made on<br />

the basis of all-member consensus.<br />

Submissions that are unduly complex, or<br />

are loaded with dense scientific jargon<br />

and abbreviations, make it difficult <strong>for</strong><br />

lay (and sometimes scientific) members<br />

to understand the purpose of the study,<br />

and the overall impact of the procedures<br />

on animals.<br />

The application project summary,<br />

which includes the background/<br />

context, statement of aims and<br />

description of what will be done<br />

to the animals, must be expressed<br />

in plain English that is readily<br />

understandable to an interested,<br />

intelligent person without a scientific<br />

background. The title should also be<br />

concise and similarly expressed in<br />

lay language.<br />

In other sections of the application, such<br />

as the more detailed project description,<br />

the proposal should also be expressed<br />

in plain English, as far as is possible.<br />

Where this cannot be achieved,<br />

specialist terms should be defined where<br />

they first appear within the text, or a<br />

lay definition should be included in the<br />

glossary. The use of a medical/scientific<br />

dictionary is useful <strong>for</strong> this purpose.<br />

As well as avoiding unnecessary<br />

complexity, applicants should also:<br />

a. Use direct and explicit language.<br />

For example, AECs prefer the term<br />

“killed” to “sacrificed”, or the term<br />

“died” to “succumbed” or “were lost”.<br />

b. Avoid statements that are<br />

unsubstantiated or indecisive.<br />

The words “should’ or “might” do not<br />


2<br />

inspire confidence and statements<br />

such as “previous work suggests this<br />

number may be adequate” should<br />

be avoided. Similarly unquantified<br />

measurements such as “a few<br />

days” or “a prolonged period” are<br />

unacceptable.<br />

c. Read through the application to<br />

identify spelling, grammar and<br />

phrasing errors. Often something<br />

as simple as a typographic error or<br />

poor phrasing can cause enough<br />

ambiguity within an application to<br />

prevent an approval. A couple of<br />

read-throughs, and/or proofing by a<br />

colleague, should help to avoid this.

3. Providing a<br />

clear narrative<br />

and chronology<br />

The AEC must know exactly what is<br />

happening to each individual animal<br />

or group of animals within a project<br />

(including controls) from the time the<br />

animals are obtained until the project<br />

is completed. The researcher must<br />

clearly illustrate: the number and type<br />

of procedures to be per<strong>for</strong>med on<br />

each animal; the time interval between<br />

each; and the potential impacts on the<br />

animals’ welfare associated with each<br />

procedure. However, particularly where<br />

multiple procedures are per<strong>for</strong>med on<br />

animals, the narrative and chronology<br />

of events often becomes jumbled and<br />

confused within an application, leading<br />

to inconsistency and omission.<br />

An excellent preliminary step <strong>for</strong> any<br />

project application is there<strong>for</strong>e the<br />

construction of a timeline (or flow<br />

diagram) which clearly illustrates<br />

the nature, number and method of<br />

procedures per<strong>for</strong>med on animals,<br />

and the time interval between each. A<br />

timeline acts as a comprehensive point<br />

of reference when developing the textual<br />

elements of the application, helping the<br />

creator to: avoid omission; reconcile<br />

in<strong>for</strong>mation across all sections of the<br />

application; and reduce superfluous<br />

detail. When attached to the application<br />

it also creates a powerful visual aid <strong>for</strong><br />

committee members, giving them a solid<br />

framework in which to understand textual<br />

descriptions across an application.<br />

A timeline can also focus an application<br />

on critical animal welfare issues, such<br />

as the incorporation of sufficient rest<br />

periods <strong>for</strong> animals between procedures,<br />

and the demarcation of project duration<br />

in terms of clear start and end-points <strong>for</strong><br />

individual or groups of animals.<br />

4. Including<br />

and reconciling<br />

all scientific<br />

in<strong>for</strong>mation<br />

A problem commonly identified by AECs<br />

is inadequate application detail relating<br />

to scientific procedures, particularly<br />

drug administration. Where such detail<br />

is included, it is sometimes applied<br />

inconsistently across the application. For<br />

all agents administered, applicants<br />

must ensure that details of dose<br />

rates, infusion rates, volumes,<br />

needle gauges and routes/methods<br />

of administration are included and<br />

reconciled across all sections of<br />

the application. Applicants should<br />

also provide a brief description of the<br />

mechanism of action and the anticipated<br />

impact on animals of each agent.<br />

Inclusion of such in<strong>for</strong>mation in the<br />

timeline would be advantageous.<br />

Scientific details, such as needle<br />

gauge, dose rates and volumes, timepoints,<br />

routes/methods of administration,<br />

and the number of repeats, must<br />

also be clearly justified in terms<br />

of experimental design and best<br />

practice. For example, needle-gauges<br />

are often questioned as inappropriate<br />

<strong>for</strong> use with certain animals or in specific<br />

circumstances. Where there is doubt<br />

about current best practice the <strong>Animal</strong><br />

Welfare Officer † is available <strong>for</strong> advice.<br />

† The <strong>Animal</strong> Welfare Officer is appointed by the<br />

University. Their key responsibility is to review<br />

experimental protocols and provide clinical advice to<br />

researchers. See page 9 <strong>for</strong> contact details.<br />


4<br />

5. Justifying<br />

and minimising<br />

animal numbers<br />

The number of animals requested <strong>for</strong> use<br />

in a project must be clearly justified in<br />

terms of statistical considerations and/or<br />

further requirements in the experimental<br />

design. This number must be definitive<br />

and not an approximation ‡ . Justification<br />

of animal numbers needs to be made<br />

from the point of view of gaining data<br />

rather than simply representing what is<br />

achievable in terms of work schedule or<br />

financial considerations.<br />

The application should there<strong>for</strong>e<br />

include, as appropriate, statistical<br />

power analysis or an explanation of<br />

numbers based on requirements <strong>for</strong><br />

tissue sampling, logistics/equipment<br />

etc. Contrary to what researchers may<br />

think, the AEC might ask <strong>for</strong> more animals<br />

to be used in order that the results<br />

‡ An exception to this may be ecology projects<br />

where exact numbers are dependent upon the<br />

success of trapping.<br />

obtained are more meaningful, and<br />

less waste is caused in the long term.<br />

Requested numbers should include pilot<br />

and control animals, and should explain<br />

what animals are <strong>for</strong> contingencies at each<br />

stage of the experiment. Total numbers<br />

of animals should be reconciled<br />

across text, tables, sub-totals and<br />

attachments, as there are often<br />

discrepancies in applications.<br />

AECs need to be convinced that serious<br />

thought has gone into the optimisation/<br />

minimisation of animal use, and the<br />

replacement of animals in projects (the<br />

“3 Rs” of Refinement, Replacement and<br />

Reduction). One area that is traditionally<br />

weak in applications is the identification<br />

of potential alternatives to animal use.<br />

Committees and their institutions are<br />

keen to hear when such alternatives are<br />

realised, and this is an opportunity <strong>for</strong><br />

researchers to share their achievements<br />

in this area with the AEC. If the use of<br />

alternatives is unsuitable due to the<br />

nature of the project, researchers need to<br />

explain why in terms that go beyond stock<br />


6. Assembling the<br />

right team<br />

During the initial planning stage the<br />

project supervisor must assemble a<br />

team that is competent to per<strong>for</strong>m every<br />

task and procedure associated with live<br />

animal work. The AEC needs to know<br />

who is responsible <strong>for</strong> ALL the work<br />

with animals, including husbandry<br />

and monitoring. Specific tasks need<br />

allocating to named individuals who in<br />

turn have documented skills to carry out<br />

these tasks. For each person named on<br />

an application the following details must<br />

be included:<br />

• What they will do to the animals.<br />

• What experience they have of<br />

procedure(s) they will carry out on<br />

live animals, and in the specific<br />

techniques described in the project.<br />

• What training they will need, and how<br />

such training will be provided.<br />

Be<strong>for</strong>e the animal ethics application is<br />

lodged with the AEC it is vital that all<br />

members of the project team are aware<br />

of the details of the project and have<br />

agreed to their allocated responsibilities<br />

via signed approval.<br />

7. Piloting and/<br />

or staging the<br />

project?<br />

Where novel techniques or experimental<br />

designs are proposed, and it is not clear<br />

what initial results will show (or whether<br />

adverse reactions may occur), AECs<br />

are typically cautious about allowing<br />

full animal numbers to be engaged in<br />

a project. In these circumstances, it<br />

is advisable to build an exploratory<br />

pilot into the project, or to apply<br />

<strong>for</strong> a stand-alone preliminary pilot<br />

study. This will confirm (or otherwise)<br />

the efficacy of the animal model/<br />

experimental design, and establish<br />

details such as humane endpoints, dose<br />

rates/timings, or bias caused by gender/<br />

age issues, ahead of the full-blown<br />

project.<br />

Similar approaches may be built into<br />

a staged experimental design. For<br />

instance, doses can be administered<br />

and assessed sequentially (i.e. from<br />

lowest to highest) to minimise use of<br />

animals if one of the lower doses proves<br />

effective.<br />

Photo by Dr Steve Swearer, Department of Zoology<br />


8. Monitoring<br />

and<br />

documenting the<br />

animals<br />

The monitoring of research animals,<br />

both in terms of who does it and how it<br />

is achieved, is an issue that continually<br />

arises in AEC meetings. On the question<br />

of responsibility the Australian code<br />

of practice <strong>for</strong> the care and use of<br />

animals <strong>for</strong> scientific purposes1 is clear.<br />

It stipulates that, once animals are<br />

allocated to a project, investigators are<br />

responsible <strong>for</strong> the day-to-day monitoring<br />

of their well-being, NOT animal facility<br />

staff. Accordingly applications must<br />

clearly indicate those investigators<br />

who have primary responsibility<br />

<strong>for</strong> monitoring animals allocated to<br />

the project – both during weekdays<br />

and after hours. When explaining<br />

the monitoring regime applications<br />

should be realistic about what can<br />

be achieved by specific individuals.<br />

<strong>Animal</strong> facility staff may be named to<br />

assist in this role but should not be made<br />

responsible <strong>for</strong> monitoring animals after<br />

allocation to a project.<br />

In broad terms research animals must<br />

be monitored at least daily, with the<br />

precise frequency varying according<br />

to type of animal, their circumstances,<br />

and the nature and invasiveness of<br />

the procedures to which they are<br />

subjected. For instance, there is a need<br />

<strong>for</strong> researchers to distinguish between<br />

requirements <strong>for</strong> monitoring during<br />

and immediately after a procedure, as<br />

opposed to quieter periods between<br />

these intense experimental phases.<br />

The monitoring of animals in field<br />

activity also brings its own set of unique<br />

considerations, with specific issues<br />

around trapping, handling, marking,<br />

preventing recapture, and re-release.<br />

6<br />

Monitoring checklists are a<br />

mandatory element of an animal<br />

ethics application and enable the<br />

identification of all individual animals,<br />

in terms of the procedures they have<br />

undergone, when these occurred,<br />

and the condition of the animal. The<br />

checklist prevents inappropriate reuse<br />

of animals and maintains sufficient rest<br />

periods, while allowing researchers to<br />

establish signs of discom<strong>for</strong>t, distress<br />

and deterioration in animals, and apply<br />

criteria <strong>for</strong> euthanasia where applicable.<br />

They must also include the frequency of<br />

monitoring.<br />

Monitoring sheets need to be kept<br />

near animals, either within or close to<br />

rooms housing the animals, and readily<br />

accessible to all responsible personnel.<br />

While template monitoring sheets<br />

are available from the <strong>Melbourne</strong><br />

Research Office website, these<br />

must be adapted to the specifics of<br />

individual projects. Too frequently<br />

AECs receive non-customised<br />

template sheets, which are not fit <strong>for</strong><br />

purpose. The <strong>Animal</strong> Welfare Officer<br />

is available to advise on all issues<br />

relating to monitoring arrangements and<br />


9. Getting<br />

surgery and pain<br />

management<br />

right<br />

Where a project involves surgery<br />

on animals, the application must<br />

provide precise details of the surgical<br />

procedures including description<br />

of incision sites and wound closure<br />

techniques/materials. When nonterminal<br />

surgical procedures are to<br />

be per<strong>for</strong>med the application must<br />

also describe the aseptic technique<br />

to be used during surgery, including<br />

the preparation of the animals,<br />

instruments and surgeon. Typically,<br />

surgical instruments must be autoclaved<br />

or prepacked sterilised instruments<br />

rather than alcohol cleaned. For<br />

full recommended procedures refer<br />

to ANZCCART Factsheet Practical<br />

Guidelines <strong>for</strong> Aseptic Surgery in<br />

Rodents and the Management of<br />

Surgical Facilities in a Laboratory 2 .<br />

Researchers must realistically<br />

indicate the expected level of pain<br />

or distress experienced by animals<br />

during the project, and explain<br />

what specific signs, exhibited by the<br />

animals, will characterise this at various<br />

levels. This assessment must be<br />

based on the assumption that animals<br />

experience pain in a manner similar to<br />

humans, unless there is evidence to<br />

the contrary. Researchers should not<br />

intentionally understate the level of<br />

pain experienced. However, the AEC<br />

will be alert to unreasonable exposure<br />

of animals to pain, and will expect<br />

researchers to include measures to<br />

reduce such exposure, both in terms of<br />

time and level.<br />

Pain management regimes may be<br />

drug-based (analgesia/anaesthesia),<br />

or involve simple pain minimisation<br />

strategies, such as the rotation of<br />

injection sites <strong>for</strong> frequent drug<br />

administration. Where anaesthesia is<br />

used during procedures some indication<br />

of how the depth of it is measured will<br />

be expected. Where post-operative<br />

analgesia is required the researcher<br />

should explain how it will be monitored<br />

and topped-up as required. The <strong>Animal</strong><br />

Welfare Officer is available <strong>for</strong> advice<br />

on issues such as which anaesthetic,<br />

analgesic or tranquillising agent is<br />

appropriate <strong>for</strong> a particular species and<br />

procedure.<br />

<strong>Application</strong>s are also enhanced when<br />

researchers are seen to have considered<br />

and acknowledged the animals’<br />

potential <strong>for</strong> positive experience. The<br />

Department of Primary Industry’s Code<br />

of Practice <strong>for</strong> the Housing and Care<br />

of Laboratory Mice, Rats, Guinea Pigs<br />

and Rabbits 3 , as well as stipulating<br />

minimum requirements <strong>for</strong> housing and<br />

care, describes how the experience<br />

of laboratory animals can be enriched<br />

by various physical and environmental<br />

enhancements. <strong>Animal</strong> Facility<br />

Managers are also a very good source<br />

of in<strong>for</strong>mation on these enrichment<br />

strategies, and on any acclimatisation<br />

issues animals may face following<br />

transportation from a different location.<br />


8<br />

10. Making the<br />

endpoint clear<br />

The fate of all animals must be clear and<br />

rationalised within the application, with<br />

a specific, measurable and scientifically<br />

validated experimental endpoint. If<br />

animals are to be killed, the timepoints<br />

and methodology <strong>for</strong> doing<br />

so should accord with best practice,<br />

and be unambiguous and reconciled<br />

throughout the application. If there is<br />

any doubt about these issues the <strong>Animal</strong><br />

Welfare Officer should be consulted.<br />

Where appropriate the monitoring<br />

checklist needs to include signs/criteria<br />

<strong>for</strong> euthanasia be<strong>for</strong>e the end-point,<br />

dictated by indicators of ill-health, pain<br />

and distress.<br />

High expected mortality rates will<br />

be questioned by AECs, as death<br />

by natural causes rarely occurs<br />

without suffering. Unless specific<br />

Ministerial permission has been gained,<br />

researchers must always avoid “death<br />

as an end-point” methodology, where<br />

death is the deliberate measure <strong>for</strong><br />

evaluation and where the researcher will<br />

not intervene to kill the animal humanely.<br />

References<br />

1 National Health and Medical Research<br />

Council. Australian code of practice<br />

<strong>for</strong> the care and use of animals<br />

<strong>for</strong> scientific purposes (7th Ed.).<br />

Canberra: NHMRC, 2004.<br />

2 Australian and New Zealand Council<br />

<strong>for</strong> the Care of <strong>Animal</strong>s in Research<br />

and Teaching. Practical Guidelines <strong>for</strong><br />

Aseptic Surgery in Rodents and the<br />

Management of Surgical Facilities in<br />

a Laboratory. Adelaide: ANZCCART,<br />

2006.<br />

3 Department of Primary Industries.<br />

Code of Practice <strong>for</strong> the Housing and<br />

Care of Laboratory Mice, Rats, Guinea<br />

Pigs and Rabbits. Attwood: DPI, 2004.

Contacts<br />

<strong>Animal</strong> <strong>Ethics</strong> In<strong>for</strong>mation Officer<br />

<strong>Application</strong>s and administration of <strong>Animal</strong> <strong>Ethics</strong> Committees<br />

tel: 03 8344 2611<br />

<strong>Animal</strong> Welfare Officer<br />

Laboratory animal management, medicine & animal welfare<br />

tel: 03 8344 2075<br />

email: animal-ethics@unimelb.edu.au<br />

address:<br />

<strong>Animal</strong> <strong>Ethics</strong>, <strong>Melbourne</strong> Research Office<br />

Level 5, Alan Gilbert Building<br />

University of <strong>Melbourne</strong><br />

Victoria 3010<br />

www.research.unimelb.edu.au/animalethics/<br />


Authorised by: Vice-Principal (Research)<br />

Published by: <strong>Melbourne</strong> Research Office<br />

Our ref: MRO_Pub33<br />

Copyright: The University of <strong>Melbourne</strong>, March 2008<br />

CRICOS Provider Number: 00116K<br />

All in<strong>for</strong>mation herein was correct at the time of printing.<br />

The University reserves the right to<br />

make changes as deemed appropriate.<br />

<strong>Melbourne</strong> Research Office<br />

The University of <strong>Melbourne</strong>, Victoria, 3010<br />

tel: 8344 2000, fax: 9347 6739<br />

www.research.unimelb.edu.au<br />

Photo this page and cover photos (left & centre)<br />

by A/Professor Geoff Shaw, Department of Zoology

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