GUIDE TO FOTS - Universitetet i Bergen · Guide til FOTS version feb 2014 23 . Describe the...

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


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


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


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

10

Applicant

Other participants

Name position/education

FELASA course Y/N

contact info etc.


11

•  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


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.


•  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.


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


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

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astin

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cted

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by

an in

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/63

AN

NE

X V

III


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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)


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)


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)


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!


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

21

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!


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).


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


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

24

Describe method of euthanasia, and give a rationale for selection of method


•  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)


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


Attachments •  Score sheets •  Illustrations of surgical

procedures •  Activity maps •  GMO •  Risk evaluation

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