Animal experiment timeline

Animal Welfare Body (AWB)

The Animal Welfare Body (AWB) (Instantie voor Dierenwelzijn IvD) helps to ensure a responsible animal experimentation policy within Radboud University and Radboudumc. The AWB acts on behalf of  the Radboud University to oversee legal supervision of the performance of animal experiments and the welfare of laboratory animals, in accordance with the Animal Experimentation Act.

Organizationally, the AWB falls under the Animal Research Facility (CDL). The AWB is composed of animal welfare officers, bio-technicians, and one or more scientists. If necessary, the group is supplemented by a veterinarian, statistician, or other specialists.

Additional information can be found below the contact information.

Contact

Email
instantievoordierenwelzijn@radboudumc.nl
Secretary AWB
Janny Verstegen-Gröning: +31 (0)24 361 35 00
Contact persons
Jeannette Lorteije: +31 (0)24 309 74 95
Miriam Kool: +31 (0)24 309 23 64
Alinde Wallinga: +31 (0)24 304 1059
Anke Schoenmakers: +31 (0)24 309 89 37

Additional information

Any institution that performs experiments on animals, or breeds or supplies animals for experiments, is required by the provisions of the 'Wet op de dierproeven' to set up such a body. We conduct our TASKS primarily for Radboud University and Radboudumc, and also for a few other educational and research institutions.

Optimal welfare for animals 
Our goal is to ensure that the optimal welfare of laboratory animals is an integral part of the structure of the Radboud University and Radboudumc. Of key importance is the optimal use of alternatives and proper and responsible research within the legal frameworks and with extra attention paid to replacement, reduction and refinement (3Rs).

Collaboration at all levels
In order to achieve these goals, we work closely together with researchers, research technicians, animal caretakers, managers and directors of Radboud University and Radboudumc. Together we maintain a ‘culture of care’.

Tasks
The Animal Welfare Body has a large number of tasks that we conduct on behalf of Radboud University and Radboudumc. These tasks are largely prescribed by law in accordance with the provisions of the Experiments on Animals Act. These tasks deal with issues such as animal welfare, alternatives to animal experiments, procedures, registration, supervision and communication with the Central Authority for Scientific Procedures on Animals (CCD). The most important of these tasks include:
Animal welfare and alternatives

• offering advice on animal welfare during acquisition, accommodation, care and utilisation of animals
• offering advice on replacement, reduction and refinement (3Rs)
• providing information about technical and scientific developments
• establishing and testing procedures for monitoring and reporting on animal welfare
• providing information and advice on the rehousing scheme and the appropriate socialisation of the animals

Procedures

• discussing a project proposal with the applicant prior to applying for a project licence from the Central Authority for Scientific Procedures on Animals (CCD)
• consulting with the researcher prior to the conduct of an animal experiment
• working with the researcher to determine whether changes in the project must be submitted to the CCD

Registration and supervision

• collecting registration data on animals and experiments
• monitoring the welfare of laboratory animals
• supervising the registration and evaluation of authorizations, expertise and skills of those working with laboratory animals

Central Authority for Scientific Procedures on Animals (CCD)

• providing information for retrospective evaluation
• reporting cases when a project is conducted differently than specified in the licence
• reviewing the non-technical summary
• all other correspondence with the CCD

And more…

• developing internal policy
• communicating about animal experiments (policy)
• contributing to training and education
• acting as the first point of contact in the event of problems or potential problems pertaining to animal welfare 
• encourage cooperation and collaboration between researchers and animal caretakers
• acting as the first point of contact for inspectors from the Netherlands Food and Consumer Product Safety Authority (NVWA)

Certification

The law requires that those involved in experiments on animals must be qualified. The successful candidate of the LAS course will get a FELASA accredited certificate of the Radboud University and will be registered in the European FELASA database.

The LAS course has been accredited by the Federation of European Laboratory Animal Science Associations (FELASA). FELASA represents common interests in the furtherance of all aspects of laboratory animal science (LAS) in Europe and beyond. The FELASA accreditation program follows the requirements stated in article 23 of the EU Directive 2010/63  and the EC Guidelines (European Commission, 2014) and is recognized as the premier accreditation scheme in Europe for LAS courses.

Access to the CDL

To gain access to the CDL, all registered students, art. 9 persons, art. 13f2 persons and guest researchers must follow the online 'Welcome to the CDL' workshop. In this workshop, you get to know about routing and procedures for animal experiments, the digital welfare logbook and the CDL house rules. The workshop is concluded with an assignment, to be handed in with, and checked by, the AWB. After passing the workshop assignment, you may make an appointment to visit the CDL unit at which you will work. After the tour your personal access badge will be activated.

For all questions regarding the workshop, contact the AWB at contact the AWB via e-mail.

Important information for researchers that do not have a Radboudumc Z-number
If you are not a Radboudumc employee or student (no Z-number), a PNIL contract needs to be made for you before you can receive your access badge. Please contact the CDL front office to take care of this, simultaneously with your registration with the AWB.

Summary of the steps to be taken to gain access to the CDL

Workshop Welcome to the CDL

Invitation to the workshop

After registration with the AWB, all students, art. 9 persons, art. 13f2 persons and guest researchers will receive an invitation to the online 'Welcome to the CDL' workshop with login data and instructions. The workshop can be followed at your own time of choice, either from home or from work. Following the workshop and passing the assignment is obligatory to gain access to the CDL. Only after passing the workshop assignment, your personal access badge will be activated.

Contents of the workshop

The workshop is organized by the AWB and contains:

1. Information on all process steps involved in setting up and performing an animal experiments at the CDL
2. Video instructions on how to work with our online laboratory execution system iVentionLES
3. A case study in which an animal experiment is followed from writing a project license proposal to the welfare evaluation after the experiment. This case study will be concluded with an assignment, including actions to be performed in iVentionLES, questions about the process and exemplary situations in which to decide the best course of action. The assignment is to be handed in to the AWB. All the information you need for passing the assignment is contained in the online study materials.
4. Information about the CDL house rules.

Tour of the CDL unit and activation of access badge

After passing the workshop assignment, you may make an appointment with the CDL coordinator of the unit where you will perform your experiments. They will give you a short tour of the unit. During the tour any unit-specific house rules will be explained to you and you can make an appointment to work with the animal caretakers for one morning or afternoon. During this session, you can get familiar with the way animals and cages are handled in the CDL. At the end of the tour, your personal access badge will be activated, allowing you access to the unit.

For all questions regarding the workshop, contact the AWB via e-mail.

iVentionLES

iVentionLES is the laboratory execution system (LES) for animal experimentation used at Radboudumc and Radboud University. The system supports the entire cycle of a research project: from the research question involving animal experiments to the implementation of these experiments and the registration of the research results. In addition, financial data, invoicing information and management data is generated as output.
 
iVentionLES is a modular system. Each module is released separately.

Authorization

Every researcher registered at the Animal Welfare Body of the Radboudumc can get access to iVentionLES. Please send the request for an account to the helpdesk of the Radboud Animal Research Facility (in Dutch: Centrale Dierenlab).

Log in

> go to log in IVentionLES

Contact

Helpdesk
Email: helpdesk.cdl@radboudumc.nl
T: +31 (0)24 361 35 00
Contact persons
Dorien van de Pol: +31 (0)24 361 93 80            
Christien Frederiks: +31 (0)24 36 13500

It's all about competency

Persons working with laboratory animals should always be trained and competent in order to ensure animal welfare, optimal implementation of the 3R’s and scientific quality of animal experiments.

Until they have demonstrated the required competency, they can only perform these tasks under supervision of a competent person.

The Animal Welfare Body (AWB) of the Animal Research Facility (in Dutch: Centraal Dierenlaboratorium (CDL)) of Radboudumc has developed a system that governs training in and assessment of competency in execution of animal procedures, and includes the concept of Continuing Professional Development (CPD). The system is in line with the EU directive and guidance documents on CPD.

Applying for a project licence

• General information

  Researchers who wish to begin a research or education project that involves experiments on animals are required to apply for a license from the Central Authority for Scientific Procedures on Animals (CCD). All license proposals are first reviewed by the AWB. Once the AWB and the researcher are satisfied with the content, the license holder submits the project to the CCD; our license holder has delegated this responsibility to the AWB who will send the documents to the CCD via a secure connection (Net FTP) The CCD will send the project to the Animal Ethics Committee (DEC) for ethical evaluation. The advice from the DEC serves as a basis for the decision of the CCD to grant or reject the project license.

• Infographic

  Before reading further, please download our elaborate infographic (pdf). The infographic schematically depicts the process for project license application. It consists of the following distinct phases:

  1. Preparation by researcher
  2. Review phase 1: AWB
  3. Review phase 2: DEC
  4. Review phase 3: CCD

• 1. Preparation by researcher

  In this first phase, the researcher creates and writes the project in iVentionLES. A project license proposal consists of 3 separate forms:

  1. Project Proposal (PP)
  In the project proposal, the project is embedded in the field of research, generally describing scientific background, aims and hypothesis, structure and coherence of the project. 

  2. Description Animal Procedures (DAP)
  In this section the proposed animal procedures are described in more detail, providing information and justification for experimental procedures, species, number of animals, replacement, reduction and refinement, discomfort and humane endpoints. Each type of animal procedure requires a separate appendix DAP.

  3. Non Technical Summary (NTS)
  In the NTS a short Dutch lay language summary of the entire project is given. This is the only document (of the three) that is not integrated in iVentionLES; due to European agreements it needs to be submitted as a separate excel file.

  The CCD has provided elaborate instructions for writing a project licence proposal. Carefully following these instructions is crucial for rapid progression and a positive outcome in the review and authorization phase.

  Additionally, the AWB has created a document with tips and tricks for writing a good project proposal, based on our experience with project license applications. Please use this document when checking whether your project is ready for submission.

• 2. Review phase 1: AWB

  After finalizing the first version, the project license application is submitted to the AWB. Within 15 workdays, the AWB reviews the proposal, paying special attention to all aspects of reduction, replacement and refinement, but also coherence and clarity of the provided information. Based on the questions and comments of the AWB, the researcher revises the proposal in iVentionLES. The application is only submitted to the CCD after both researcher and AWB are satisfied that it is ready for ethical evaluation.

  It is important to realize that an evaluation of ‘the science’  in your project should be done by peers; the AWB can help when they happen to have a background in your research field, but it is not their job to verify the scientific value and content. 

• 3. Review phase 2: DEC

  After the AWB review, the project is submitted to the CCD (via the AWB). The CCD sends the project to a local DEC for an elaborate and independent advice within 20 working days. The DEC will review the proposal and discuss it during their meeting. There are 2 scenario’s for the procedure that follows:

  • If the DEC has questions about the project, but ethical assessment is not hampered, the DEC is allowed to ask questions directly to the applicant. In principle, one round of questions should suffice.
  • When the DEC has fundamental questions about an application that hamper the ethical assessment, the assignment (to give an advice) is given back to the CCD, along with a letter explaining why ethical evaluation is not possible. The CCD communicates this with the applicant, thereby giving her/him the opportunity to reconsider the application and react to the issues raised in the letter of the DEC.  The revised application is sent to the CCD (again via the AWB, using the secure connection), who will transfer it to the DEC along with a new request to give an advice.

  In principle, only one round of correspondence between DEC and researcher is allowed, with the exception of resolving minor unclarities remaining. When the instructions in the CCD guidelines are carefully followed, this should be sufficient for the DEC to answer all questions in the format DEC advice and make an ethical assessment. However, sometimes the DEC has to conclude that crucial information is missing. If after the first revision the DEC is still unable to make an ethical assessment, the project will be rejected by the CCD.

  Based on the questions and comments from the DEC, the researcher revises the proposal in iVentionLES and writes a point-by-point rebuttal letter addressing all concerns. The AWB reviews the answers and rebuttal before submitting the revised documents to the DEC. When all questions have been resolved, the revised version of the project, along with the DEC-advice is sent to the CCD (by the DEC secretariat, using a secure connection). 

• 4. Review phase 3: CCD

  In the final phase of the review process, the CCD will review the project license application. Based on their questions and comments, the researcher revises the proposal in iVentionLES and writes a point-by-point rebuttal letter addressing all concerns. The AWB reviews the answers and rebuttal before submitting all documents to the CCD (using the secure connection).

  Based on the advice from the DEC and - if applicable - the revisions and rebuttal by the researcher, the CCD will come to a decision to either grant or reject the project license.  When the license is granted, the project is authorized in iVentionLES, enabling the researcher to initiate the first experimental protocols. If the project is rejected, none of the procedures described in the project can be executed. The researcher can contact the AWB for advice on how to proceed.

Advice

The Animal Welfare Body offers advice and support during the entire process of drafting and writing of a project in iVentionLES and applying for the project licence at the Central Authority for Scientific Procedures on Animals (CCD).

Contact

Email
instantievoordierenwelzijn@radboudumc.nl
Secretary AWB
Janny Verstegen-Gröning
Contact persons
Pieter Verbost (Mo., Tu. & We.): +31 (0)24 309 23 69
Roel Sneepers (Th. & Fr.): +31 (0)24 309 23 68
Miriam Kool (Mo., Tu. & Th.): +31 (0)24 309 23 64

Process flow

Process flow

Animal Welfare Body (AWB)

The Animal Welfare Body (AWB) (Instantie voor Dierenwelzijn IvD) helps to ensure a responsible animal experimentation policy within Radboud University and Radboudumc. The AWB acts on behalf of  the Radboud University to oversee legal supervision of the performance of animal experiments and the welfare of laboratory animals, in accordance with the Animal Experimentation Act.

Organizationally, the AWB falls under the Animal Research Facility (CDL). The AWB is composed of animal welfare officers, bio-technicians, and one or more scientists. If necessary, the group is supplemented by a veterinarian, statistician, or other specialists.

Additional information can be found below the contact information.

Contact

Email
instantievoordierenwelzijn@radboudumc.nl
Secretary AWB
Janny Verstegen-Gröning: +31 (0)24 361 35 00
Contact persons
Jeannette Lorteije: +31 (0)24 309 74 95
Miriam Kool: +31 (0)24 309 23 64
Alinde Wallinga: +31 (0)24 304 1059
Anke Schoenmakers: +31 (0)24 309 89 37

Additional information

Any institution that performs experiments on animals, or breeds or supplies animals for experiments, is required by the provisions of the 'Wet op de dierproeven' to set up such a body. We conduct our TASKS primarily for Radboud University and Radboudumc, and also for a few other educational and research institutions.

Optimal welfare for animals 
Our goal is to ensure that the optimal welfare of laboratory animals is an integral part of the structure of the Radboud University and Radboudumc. Of key importance is the optimal use of alternatives and proper and responsible research within the legal frameworks and with extra attention paid to replacement, reduction and refinement (3Rs).

Collaboration at all levels
In order to achieve these goals, we work closely together with researchers, research technicians, animal caretakers, managers and directors of Radboud University and Radboudumc. Together we maintain a ‘culture of care’.

Tasks
The Animal Welfare Body has a large number of tasks that we conduct on behalf of Radboud University and Radboudumc. These tasks are largely prescribed by law in accordance with the provisions of the Experiments on Animals Act. These tasks deal with issues such as animal welfare, alternatives to animal experiments, procedures, registration, supervision and communication with the Central Authority for Scientific Procedures on Animals (CCD). The most important of these tasks include:
Animal welfare and alternatives

• offering advice on animal welfare during acquisition, accommodation, care and utilisation of animals
• offering advice on replacement, reduction and refinement (3Rs)
• providing information about technical and scientific developments
• establishing and testing procedures for monitoring and reporting on animal welfare
• providing information and advice on the rehousing scheme and the appropriate socialisation of the animals

Procedures

• discussing a project proposal with the applicant prior to applying for a project licence from the Central Authority for Scientific Procedures on Animals (CCD)
• consulting with the researcher prior to the conduct of an animal experiment
• working with the researcher to determine whether changes in the project must be submitted to the CCD

Registration and supervision

• collecting registration data on animals and experiments
• monitoring the welfare of laboratory animals
• supervising the registration and evaluation of authorizations, expertise and skills of those working with laboratory animals

Central Authority for Scientific Procedures on Animals (CCD)

• providing information for retrospective evaluation
• reporting cases when a project is conducted differently than specified in the licence
• reviewing the non-technical summary
• all other correspondence with the CCD

And more…

• developing internal policy
• communicating about animal experiments (policy)
• contributing to training and education
• acting as the first point of contact in the event of problems or potential problems pertaining to animal welfare 
• encourage cooperation and collaboration between researchers and animal caretakers
• acting as the first point of contact for inspectors from the Netherlands Food and Consumer Product Safety Authority (NVWA)

Process flow

Procedure after the study

If you have completed an animal experiment or a series of animal experiments, your work is not yet done.

Welfare Evaluation

After finishing each Work Protocol, you, being the researcher, fill in an evaluation form in iVentionLES.

ARRIVE

You may be working on a publication. To make animal experiments understandable for others on a detailed level, it is best to use the ARRIVE-guidelines when writing your article. 

Statement

Do you need a statement for your article, stating that the animal experiments have been issued a licence and were conducted in accordance with legal standards, then we can provide it. Let us know (instantievoordierenwelzijn@radboudumc.nl) 

Publication bias

To prevent publication bias, it is important that you make any results public, even if they are disappointing. Even if your experiment has failed, others can learn from your description of what went wrong, which will prevent them from making the same mistake. This is important in any research, but even more in animal experiments. If you haven't registered your research yet on www.preclinicaltrials.eu, you can still do so.