Important Information Before Completing the Application Form

Important information before completing the application form:

1. This application is governed by the provisions of the Royal Decree of 29 May 2013 concerning the protection of animals used for scientific purposes and the Regulations of the Ethical Committee for Animal Experiments.
2. The ethical committee for animal experiments (in Dutch ‘EthischeCommissieDierproeven’, hereinafter named ‘ECD’)has the following assignment:
3. The evaluation of the planned and executed animal experiments.
4. Formulate criteria for the ethical use of laboratory animals.
5. Provide the labs with advice concerning the ethical aspects of animal experiments and concerning the supervising government.
6. The ECD also takes into account thescientific value and relevance of the animal experiments.
7. The application should be completed by the responsible experiment manager. S/he will also be the contact person for the ECD for all communication concerning the project.
8. Complete this form concisely but as thoroughly as possible. It is of the utmost importance that you DO NOT use technical jargonand that the application is written in a clear and plain language. This is NOTa scientific project application or a scientific discussion of your work. Your application will also be evaluated by specialists not familiar with animal experiments. Forms that, according to the members of the ECD do not comply with the above will be returned for clarification (vulgarization) and reapplication for evaluation at a later date.
9. A separate form has to be submitted for every project.
10. If the application is admissible aproject number will be assigned to the project. When ordering animals this number has to be mentioned each timeon the order form, next to the animal species. Order forms should be sent to theAnimalarium ().
11. The application is not complete without the non-technical summary (NTS). The NTS has to be written in one of the official languages (Dutch, French or German); English is not accepted.
12. Please submit a signed paper version of the application form and the NTS to the ECD secretariat (in person or through internal mail)AND the digital Word-version of the application form and the Excel-version of the non-technical summary, by e-mail to
    

Ethical Committee for Animal Experiments

Vrije Universiteit Brussel - Laarbeeklaan 103 - 1090 Brussels

Building D - room D.327 – 02/477.48.08 -

1. General PROJECT information

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1. USERS

2.1. Coordinates of themain user

2.2.Coordinates of the partner(s)

If part of the animal experiments is carried out under the responsibility of another LA number (within or without the main institution), indicate where these experiments take place.

1. STAFF

3.1. Responsible Project Manager

The project manager(“proefleider”) is responsible for the design of the experiments, its implementation and the good use of the animals in accordance with the project license. S/he is furthermore the contact person for the ECD for all communication regarding the project.

3.2.Personnel actively participating in the experiments (incl. responsible project manager)

3.3.Follow-up of animal wellbeing during the experiments

State the name, function and contact details of the person/s that is/are taking care of the regular follow-up of the animals during the experiments.

The responsibility for the animals’ wellbeing lies with the responsible project manager.

1. PROJECT

4.1. General project description, purpose and justification. (What, why, how).

Describe in max. 300 words (excl. references) the general scientific aspects, relevance of the project and the final objectives, without the description of the individual experiments, which are to be mentioned in chapter 6. The project must be described in such a way that it is understandable to all members of the Ethical Committee.

It is essential to specify:

(i) The bibliographical references (specifying their date) that contribute to the accountability of the proposed research.

(ii)The current state-of-the-art with regard to the project and

(iii) The scientific, ethical and social considerations that allow to assess the expected benefit of the project. The scientific questions or scientific or clinical necessities that justify the project should be mentioned).

4.2.Purpose of the project

Select the purpose(s) of the research project and complete. Multiple choices are possible.

Fundamental research:

Specify in which field of research this project is situated? How will the obtained knowledge be distributed? Please specify whether the project was evaluated by other agencies/committees and if so, specify:

Translational or applied research

Please specify what benefits are achieved from this research and how and within what period it will contribute to the wellbeing of humans or animals).

Regulatory test

Select the appropriate legislation:

legislation fulfilling the requirements of the European Union

legislation fulfilling the requirements of the national regulations (in the European Union)

legislation fulfilling requirements that are not part of the regulations of the European Union

When a test is required by law, specify the legal basis or the regulatory guidelines.

Routine production:

The routine production (blood products, diagnostic kits, ...) is purposed to address certain needs. Explain which needs and specify the period in which these needs exist:

Protection of the natural environment in the interests of the health or welfare of humans or animals:

Indicate how this research will contribute to the welfare or health of humans or animals

Preservation of species:

These tests usually fit within large scientific and multidisciplinary programs. All information motivating these programs should be mentioned:

Forensic research:

The reference to this research should be mentioned with respect for the confidentiality of this research

Higher education or training:

Please specify what purpose you want to achieve and why this can not be reached by alternative methods. It should be demonstrated that the use of animals is unavoidable in order to achieve the objectives in the field of training and competence development. The use of alternative methods or available cadavers (not specifically killed for this purpose) are encouraged

Preservation of genetically modified colonies that are not used in other animal experiments (e.g. routine production).

Explain the needs as well as the period in which these needs exist.

1. ANIMALS

5.1. Summarizing table: species and number of animals

*Genetic status

A : non-GMO

B** :GMO without harmful phenotype

C** : GMO with harmful phenotype

5.2.Provenance of the animals

5.2.1. Provider

Specify the provenance of the animals described in table 5.1.

To add more providers copy the table below.

5.2.2. Exemption

An exemption from the Governmental Department for Animal Wellfare (“DienstDierenwelzijn”) is needed when it comes to the use of

(i)animals that were not specifically bred to be used in animal experiments and yet belong to a species of animal that is found in annex 1 of the Royal Decree of 29 May 2013,

(ii)protected animals,

(iii)animals caught in the wild and

(iv)stray animals or wild animals.

Are any of the animals mentioned above part of this project?

No

Yes. In this case, please add a copy of the exemption.

6. Synthesis of the experiments and procedures

Definitions:

• Experiment: carefully designed sequence of procedures that can be performed in order to answer a research question.
• Procedure: any act that may cause an animal a level of pain, suffering or distress equivalent to or greater than the introduction of a hypodermic needle. A procedure can be as mild as an injection, or as severe as an organ transplant. Breeding a genetically modified animal is also classed as a procedure, if genetic changes to the normal appearance or ‘phenotype’ of an animal may cause suffering. All experiments involve procedures, but not all procedures are experiments.
• Project: work package or programme with a documented scientific objective involving one or more procedures.

6.1. Describe the experiments performed that will answer the hypothesis of the project submitted.

Give a general overview of the experiments. Adding a timeline or diagram (such as the example below) may help to clarify the overview. The details of the proceduresper experiments will be outlined in section 6.2.

Example of a diagram

6.2. Experiments that are performed to complete the project

Answer questions a. through d. for each experiment separately. Copy the questions and mention in question a) the correct number of the experiment that will be described (experiment nr.1, experiment nr.2…)

1. Title of experiment nr .1

1. Description of the experiment

1. State the relevance and justification of the experiment

1. Number of experimental groups and animals per group

Clearly indicate the number of animals per condition, the number of repetitions of the experiment and the total number of animal.

1. Justification of the number of animals.

Show that the number of animals used in the experiment corresponds to the required number to obtain statistically relevant results. Which statistical resources where consulted (statistical model, expertise.) Explain the statistical model chosen. If no statistical method was chosen, motivate why and elaborate on the alternative method.

1. Describe in detail all the procedures/actions; e.g. volume and frequency of sampling, etc.. In order to understand the chronology of the operations an illustrative timeline should be added:

1. Degree of severity and animal wellbeing

1. Classification of the animal test in accordance with the severity (highest degree for the chosen procedures).

Specify how that severity and the duration was assessed. It is recommended to consult the "document on a severity assessment framework available on the website of the European Commission: _en.htm.

Severity:

Non-recovery

Mild

Moderate

Severe

Duration:

Less than 1 day

Between 1 and 7 days

Between 7 and 30 days

Longer than 30 days

1. Exceptions

No trial that leads to a serious degree of pain, suffering or fear that probably will last long and that cannot be reduced, is allowed.

If it is necessary for the objective of the test that a severe degree of pain, suffering or fear cannot be reduced, please describe here the scientific reasons that justify an application for exemption.

1. Re-use

Does this experiment include animals that have been used in previous experiments?

No

Yes

If yes, the final decision to keep an animal alive after its use in an experiment can only be taken by the expert who is responsible for the well-being and health status of the animals. Re-use is only possible if the actual severity was mild or moderate.

What was the severity of the previous experiment?

Mild

Moderate

1. How is the follow-up of the animal welfare during the animal experiment guaranteed: indicate the criteria for the evaluation of animal welfare. If a "score" table is used, this should be attached.

1. Specify which methods (e.g. analgesics, anesthesia, conditioning, training, ...) are used to reduce the inconvenience (pain, suffering, anxiety) the animals experience

1. If analgesics / anesthetics / antibiotics / anti-inflammatory drugs are used: enter the list of medication, as well as the dose, route of administration, duration and frequency. Please specify also which references were consulted to choose the most appropriate method of analgesia / anesthesia (bibliographic reference, name and position of the consulted person)

1. Specify the refinement of animal housing and care conditions during the experiment (for example, adaptation of housing, nutrition, environmental enrichment, ..):

1. Ending the experiment and disposal of the animals

i.End-points

Specify the human end-points for the animals.

To determine the end-points one has to rely on the criteria for the evaluation of animal welfare.

If a pilot study is carried out to determine the end-points of the project, please describe this pilot study.

ii.Killing of the animals

Only the procedures set out in annex 7 of the Royal Decree of 29 May 2013 are permitted to kill laboratory animals.

Specify the animals involved and clearly describe the method(s) used to kill the animal and confirm is death:

1. Animals that are not killed at the end of an experiment

The final decision to keep an animal alive after its use in an experiment can only be taken by the expert who is responsible for the well-being and health status of the animals.

Will animals be kept alive after use in an experiment?

No (all animals used in this experiment will be killed).

Yes

If yes, and if it is already known, specify the animals and their destination:

1. IMPLEMENTATION OF THE 3 R’s: REPLACE, REDUCE, REFINE

The principle of the 3 R's should always be applied.

7.1.Replace

7.1.1.Alternative methods

Which alternative method can be chosen where no animals are used to realize the objective of the project, which are the alternative methods that you have analyzed and describe why it is not in the project:

7.1.2. Which sources did you consult and at which date?

Examples

Regulatory testing

-

-

-

Research:

- Databases of ECVAM or FRAME

- Invittox

- SIS (http:/ihcp.jrc.ec.europa.eu/)

- Go3Rs ()

Education:

- Norina ()

- NCA ()

-Interniche ()

7.2.ReduceandRefine

7.2.1.Species

Why did you choose these species? Show the relevance of the chosen animal species. Pay attention to the requirement for animal species that experience less pain, less suffering or undergo less permanent damage with the same experiment reliability.

7.2.2.Collaborationwithotherresearchers

Is a collaboration with another (internal or external) laboratory possible to reduce the number of animals (e.g. common use of the animals, several laboratories using the same organs)?

7.2.3. Avoiding duplication of the same experiments

Does the project include duplicates of previous experiments?

No.

Yes

If so, motivate why

8. SAFETY OF THE RESEARCHERS AND/OR ENVIRONMENT

8.1. Could the project cause health risks for the researchers and/or the environment?

No
Yes

8.2.If yes, specify the type of risk:

Biosafety (genetically modified material, pathogens…)
Radiation

Other, specify

Please contact the biosafety coordinator (Walter Kempenaers, 02/629.15.25, ) for an approval, and specify the number of the file if it already exists:

Date, name and signature of the responsible experiment manager and laboratory director, preceded by ‘read and approved’:

We declare that the experiments shall be performed in according to the provisions of the Royal Decree of 29 May 2013 concerning the protection of animals used for scientific purposes and the Regulations of the Ethical Committee for Animal Experiments.

Responsible experiment manager:

Date:

Laboratory Director:

Date:

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