Ethical Committee for Animal Experimentation (ECAE)

The Animal Ethics Committee (ECD) is tasked with:

• evaluating planned trials
• monitoring the required level of training and competence of persons participating in the experiments
• drawing up ethical criteria for animal experiments
• advise users, trial leaders and collaborators on the ethical aspects of animal experiments
• carry out a retrospective analysis of all projects

ECAE internal rules (pdf, 72 KB)

Internal regulation and general legislation

Procedure

1. The researcher sends the completed application form to ethischecommissiedierproeven@uhasselt.be. The researcher will take the possible meeting dates  of the ECAE into account.
2. The researcher will receive a confirmation mail from the ECAE with a reference number for the follow-up of his/her application.
   For new studies, researchers are invited to discuss their matrix during the meeting. If studies contain adjustments and/or a prolongation of existing studies, changes are examined during the meeting and feedback will be communicated to the researcher via e-mail.
3. The application will be assessed during the ECAE meeting. If necessary, the ECAE chairman will formulate comments and/or questions (during the meeting but also by e-mail). Researchers have 1 week to answer them and then they have to send the modified application form back to ethischecommissiedierproeven@uhasselt.be, with the adjustments clearly indicated
4. Answers are assessed by the ECAE. If sufficient, the researcher receives the approval certificate together with the latest version of the application.
5. The application form together with the approval certificate must be submitted in Tick@lab  so that the researchers can start their experiments with animal testing.
6. As soon as the experimental study is finished, researchers have to fill out a retrospective analysis and send it back to the ECAE.

detailed flowchart (pdf, 197 KB)

Project evaluation

The evaluation of a project is done based on national and international guidelines established by the Law of August 14, 1986, on the protection and welfare of animals, and the Royal Decree of May 29, 2013, on the protection of laboratory animals. This Royal Decree is a direct consequence of the adoption of the new European Directive 2010/63/EU on the use of animals for scientific purposes.

A project is evaluated based on a research proposal in which a model ethical matrix form should be used. A monthly meeting is scheduled by the ECD with the responsible researchers of the submitted projects, where a decision is made based on the dialogue between the researchers and the ECD members.

The project evaluation is conducted with a degree of comprehensiveness appropriate to the type of project and is specifically designed to verify that the project meets the following criteria:

• the project is justified from a scientific or educational point of view or required by law
• the purposes of the project justify the use of animals; if alternatives exist, the use of laboratory animals is prohibited
• the project is designed so that animal experiments can be carried out in the most humane and environmentally friendly way possible.

The project evaluation includes in particular:

• an assessment of the objectives of the project and the predicted scientific benefits or educational values
• an assessment of whether the project is in line with the required replacement, reduction and refinement
• an assessment of the classification of the project according to the severity of the animal tests
• a damage-benefit analysis of the project, in which it is verified whether the damage in the form of suffering, pain and fear of the animals is justified by the expected result, taking into account ethical considerations, and in the long term can yield benefits for humans, animals or environment
• an assessment of the scientific justifications
• a list of humane endpoints; these are criteria to prevent more inconvenience to an animal than is strictly necessary for the experiment (for example by killing the animal or taking other appropriate measures).

Any changes to the research proposal (e.g. the number of animals to be used, the research methods used, and the duration of the animal experiment) must be submitted to the ECD for approval before the trial can be continued. An interim evaluation of the experiments already conducted must also be added to the research protocol.

An application for approval by the ECD must also include a non-confidential non-technical summary (NTS) of the research proposal. This summary includes information on the objectives of the animal experiment and the number and types of animals used. This summary should additionally reflect an estimate of the predicted harms and benefits of the animal experiment while also demonstrating that the required replacement, reduction, and refinement of animal experiments will be met. Summaries of approved projects will be made public.

Retrospective analysis of projects

At the end of the animal experiment, a retrospective analysis should be submitted to the ECD. This should include an overview of the experiments conducted, the animals used (number, species, sex, etc.), insights into alternatives arising from the experiments conducted, and also a welfare assessment of the animal experiment in which a comparison is made between the estimated distress before the start of the experiment and the actual distress experienced by the animals during the experiment (with an explanation of any discrepancy).

All records relating to an animal experiment or research proposal shall be retained for three years after the end of the animal experiment to which the records relate.

To be accepted as an Ethics Committee, it must demonstrate to the Service that it meets the following conditions:

• the Ethics Committee is composed of at least seven members
• the expertise of the members of the Commission ensures expertise in ethics, alternative methods to animal testing, animal health and welfare as well as in research techniques, experimental design and statistical analysis
• the veterinarian or expert in charge of monitoring animal health and welfare shall be a member of the Commission
• a representative of the Animal Welfare Unit shall be a member of the Animal Experiments Ethics Committee
  in carrying out its duties, the Animal Ethics Committee shall ensure that no conflict of interest arises and that evaluations are impartial by taking into account the opinion of parties independent of the user applying for project authorization.

The Animal Welfare Cell's mission is:

• to provide advice to staff handling laboratory animals on animal welfare in relation to the acquisition, housing, care and use of the laboratory animals
• to advise personnel on the application of the replacement, reduction and refinement requirement and keep them informed of technical and scientific developments in the application of that requirement
• to ensure the establishment and review of in-house procedures on monitoring, reporting and follow-up in relation to the welfare of the laboratory animals housed or used in the establishment
• to monitor the development and outcome of projects, taking into account the effects on the laboratory animals used, identifying and advising on elements that may further contribute to replacement, reduction and refinement
• to advise on adoption schemes, including advice regarding the appropriate socialization of laboratory animals released for adoption
• to ensure that breeding, housing and care are refined to prevent or minimize any pain, suffering, distress and lasting harm that the animals may experience.

Internal regulation will be added as soon as it's approved by the Faculty Board.

This cell must include at least one representative of the persons in charge of the special care of the experimental animals and, where appropriate, a representative of the experimenters. The expert in charge of monitoring the health and welfare of the animals has a supervisory role in this cell. A person in charge of the Animal Welfare Cell is also a member of the ECD.

The animal welfare body can be contacted via dierenwelzijnscel@uhasselt.be, regarding questions/concerns about animal welfare.

Contact: ethischecommissiedierproeven@uhasselt.be

Links:

• BCLAS
• EARA
• Belgian Biosafety Server
• Public Health Agency of Canada
• VIB 
• Informatiepunt proefdieronderzoek
• BCLAS brochure
• Belgian research organisations unite in support of animal research
• RE-Place: alternatieve methoden voor dierproeven