GUIDE TO FOTS Forsøksdyrutvalgets tilsyns- og søknadssystem The Norwegian Animal Research Authority's monitoring and application system
Guide til FOTS version March 2014 1
THE AIM WITH THIS PRESENTATION IS TO CLARIFY FOR APPLICANTS THE EXPECTATIONS TO A FOTS APPLICATION
Guide til FOTS version feb 2014 2
http://www.uib.no/fg/dyreavdelingen/forskning/brukerinformasjon-for-forsok/soknad-om-dyreforsok
Access to FOTS
Guide til FOTS version feb 2014 3
For UoB go to http://www.uib.no/dyreavdelingen/forskning/soknad-om-dyreforsok
Contact your ansvarshavende or FDU to get access to FOTS
MUST have Completed
“FELASA C” course demanded
for access to FOTS
4 Guide til FOTS version feb 2014
Must be a post doc or scientific
employee at Univ of Bergen in a permanent
position to get user account
ARRIVE GUIDELINES The FOTS guideline is adapted to cover important issues in the ARRIVE guidelines
http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1000412
6
The ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines are intended to improve the
reporting of animal experiments. They have been published in the journal
PLoS Biology and eleven other journals.
Guide til FOTS version feb 2014
http://cdn.elsevier.com/promis_misc/ARRIVE.pdf
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Fill in “Project title” here
Select animal Unit
Select type of experiment
Project is funded by?
Project start and project end
”Save”
Non-technical project summaries : Article 43 EU dir 2010/62: (a) information on the objectives of the project, including the predicted harm and benefits and the number
and types of animals to be used; (b) a demonstration of compliance with the requirement of replacement, reduction and refinement.
c) State it clearly if any procedures are required by law, or of test are demanded by public authorities. THIS SUMMARY WILL BE AVAILABLE FOR PUBLIC ACCESS
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What are you
going to do
If yes, specify which information here, together with a short justification
Public access
Does the application include confidential information you want to withdraw from public access? N/Y
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Name, education
Local competent person
Work address e-mail address
telephone
fax
name Position and academic degree
FELASA C course in lab animal science Y/N
List all other participants in the project
Applicant and participants
“FELASA C” equivalent course demanded for ALL participant in the
project
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Applicant
Other participants
Name position/education
FELASA course Y/N
contact info etc.
Guide til FOTS version feb 2014
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• Give a presentation of the background and purpose with the experiment using commonly terms. Include sufficient scientific background (including relevant references to previous work) to understand the motivation and context for the study, and explain the experimental approach and rationale.
• Clearly describe the primary and any secondary objectives of the study, or specific hypotheses being tested.
Background and purpose
Guide til FOTS version feb 2014
Why are going to do this
Characterization of the animals
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• A complete description of animals includes:
• Species, strain, sex, developmental stage (e.g. mean or median age plus age range) and weight (e.g. mean or median weight plus weight range).
• Further relevant information such as the source of animals, genetic modification status (e.g. knock-out or transgenic), genotype, health/immune status, drug or test naïve, previous procedures, etc.
Guide til FOTS version feb 2014
• Species • Line/strain international strain nomenclature • Number • age/weight . mean or median age plus age
range
Animals (species, medication and pain assessment)
• Sex
• # of animals that will be reused according to §15
Genetic altered animals: • Do the animals have any congenital disease (Pathogenic phenotype) that may impair their welfare or any other abnormalities
• If yes: how should the animals be treated to maintain their welfare (painkiller, special diet, Specific substitution therapy???)
• Such actions are not necessary
Provide details of the animals used, including species, strain, sex,
developmental stage (e.g. mean or median age plus age range) and
weight (e.g. mean or median weight plus weight range).
b. Provide further relevant information such as the source of animals,, genetic modification status (e.g. knock-out or transgenic), genotype, health/immune
status, drug or test naïve, previous procedures, etc.
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15 Animals (species, medication and pain assessment)
Drug
Induction dose
Maintenance dose
Administration route
Pre/inter/post op
Other medicalions or testsubstances used
Use of neuromuscular blocker?
If yes: Justify the need for neuromuscular blockers
Evaluation of pain and discomfort for the animal
Degree of pain Duration of pain
Justification for not using analgesics
Evaluation of pain
Experiments causing severe or long-lasting pain has to be handled by the
National Animals Research Authority
Guide til FOTS version feb 2014
Classification of severity of procedures 16
SE
VE
RIT
Y C
LAS
SIF
ICAT
ION
OF
PR
OC
ED
UR
ES
Th
e se
verit
y of
a p
roce
dure
sha
ll be
det
erm
ined
by
the
degr
ee o
f pai
n, s
uffe
ring,
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tress
or l
astin
g ha
rm
expe
cted
to b
e ex
perie
nced
by
an in
divi
dual
ani
mal
du
ring
the
cour
se o
f the
pro
cedu
re.
EU
dir
2010
/63
AN
NE
X V
III
Guide til FOTS version feb 2014
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Animals (species, medication and pain assessment)
• Explain how and why the animal species and model being used can address the scientific objectives and, where appropriate, the study’s relevance to human biology.
• Give a rationale for choice of animals model (species, strain, sex, age, specific properties, gene-modification)
Guide til FOTS version feb 2014
Give a scientific rationale for the number of animals needed in this experiment: Include: desired detectable effect, variance in data Significance level, Desired power of test and type of test (”based on prior experience” without reference to any numbers, is not a valid scientific justification)
For each experiment, give brief details of the study design including: a. The number of experimental and control groups. b. Any steps taken to minimise the effects of subjective bias when allocating animals to treatment (e.g. randomisation procedure) and when assessing results (e.g. if done, describe who was blinded and when). c. The experimental unit (e.g. a single animal, group or cage of animals).
Calculating number of animals
Describe the statistical method you have used to calculate the N of animals q Power analysis or q Resource equation
q Other methods (must be described)
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Name the database and key words you used in your search
Alternatives to animal testing are poorly represented in PubMed.
Search options should also include sources found on: http://www.uib.no/fg/dyreavdelingen/forskning/brukerinformasjon-for-forsok/
soknad-om-dyreforsok/websok-etter-alternativer
Alternatives/3R
Explain why this experiment cannot be replaced by alternative methods
• Substitution for conscious living higher animals of insentient animals?
• or methods not involving animals
(in vitro methods)
Always
Relevant!
Always
Relevant!
Always
Relevant! Describe all Actions to minimize animal the number of animals and get comparable results using fewer animals
See: http://www.3rs-reduction.co.uk Better experimental design and statistical analysis , Techniques like imaging
http://www.nc3rs.org.uk/page.asp?id=7 )
Res
earc
her m
ust p
rovi
de in
form
atio
n on
app
licat
ion
of
met
hods
to re
plac
e, re
duce
and
refin
e th
e us
e of
ani
mal
s
in p
roce
dure
s (A
NN
EX
VI,
EU
dir
2010
/63)
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Refinement: List all actions you have taken to achieve:
refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any
possible pain, suffering, distress or lasting harm to the animals as well as optimize well being for the animal
http://www.nc3rs.org.uk/page.asp?id=7
Alternatives/3Rs continued Always
Relevant!
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Researcher must provide information on application of methods to replace, reduce and refine the use of animals
in procedures (ANNEX VI, EU dir 2010/63)
Alternatives/Refinement continued
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1. Freedom from Hunger and Thirst • By ready access to fresh water and a diet to maintain full health and vigour
2. Freedom from Discomfort • By providing an appropriate environment
including shelter and a comfortable resting area
3. Freedom from Pain, Injury or Disease
• Prevention of pain by rapid diagnosis and treatment.
4. Freedom to Express Normal Behaviour
• By providing sufficient space, proper facilities and company of the animal's own kind
5. Freedom from Fear and Distress • By ensuring conditions and treatment which avoid mental suffering.
Refinement can also be actions to limit violation of the 5 freedoms*:
*Brambell, R., Five Freedoms. 1965, Farm Animal Welfare Council
Always Relevant!
Guide til FOTS version feb 2014
Describe surgical procedures, (enclose illustrations of surgical interventions)
Description of methods Describe methods for each experiment and each experimental group, including controls, Provide precise details of all procedures carried out. For example: a. How (e.g. drug formulation and dose, site and route of administration, b. anaesthesia and analgesia used [including monitoring], c. surgical procedure, method of euthanasia). d. Provide details of any specialist equipment that is implanted in the animals, (like size, weight, volume
of osmotic pumps or implants) including supplier(s). e. When (e.g. time of day) will procedures be performed. f. Where will procedures be performed (e.g. home cage, laboratory, water maze). g. Why (e.g. rationale for choice of specific anaesthetic, route of administration, drug dose used).
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Preparation of animals before the procedure starts, (Catching-, restraint-, id-, transport methods, acclimatization)
Describe surgical procedures • Minor procedures: injections, blood sampling • Superficial surgery: Tissue samples skin and superficial tissues • Invasive surgery: In abdomen, Thorax, Brain (enclose illustrations of surgical interventions)
Description of methods
• List parameters you measure in the experiment like tumor size, blood pressure, immune response…etc
• Focus on parameter sampling that will compromise the animal welfare or cause stress/discomfort like restraint, handling, blood sampling, weighing, single housing, meabolic cages etc
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Describe the monitoring of animals in the duration of the experimental period, (post-surgery and during disease progression) Refer to activity map and score sheets if applicable
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Describe method of euthanasia, and give a rationale for selection of method
Guide til FOTS version feb 2014
• Give details of all important adverse events in each experimental group.
• List end point criteria here and Include Score sheets http://www.humane-endpoints.org/2nd_proceed.html
Specify how humane endpoints are are going to reduce unnecessary negative impact (harm) on animals • Stop procedure (reduse dose/exposure) • Treat symptoms (pain, infections, dehydration, feeding problems) • Kill the animal (if symptoms cannot be treated)
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All applications on severe experiments (i.e. tumors, infectious diseases) must be followed by a score sheet defining the endpoints
http://www.mattilsynet.no/fdu/incoming/article87694.ece
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Attachments • Score sheets • Illustrations of surgical
procedures • Activity maps • GMO • Risk evaluation
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Submit aplication
Guide til FOTS version feb 2014
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