The course follows requirements in the Norwegian regulation on animal experimentation (FOR-2015-06-18-761) §25 and annex E. Additionally, the course aims to follow the Education and Training Framework by the European Commission to fulfill requirements for functions (a) (persons who carry out procedures on animals) and (b) (persons who design procedures and projects). 

The course covers the following modules: 1) Legislation, 2) Ethics, animal welfare and The three R¿s, 3) Basic and appropriate biology (rodents, swine, zebrafish) 4) Animal care, health and management, 5) Recognition of pain, suffering and distress, 6) Human methods of killing, 7) Minimally invasive procedures without anesthesia, 8) Design of procedures and projects, 9) Anesthesia for minor procedures and advanced anesthesia for surgical prolonged procedures, 10) Principles of surgery.

After the course is completed the students should be able to transfer their acquired knowledge into practical activities with research animals. Working with research animals must take place under supervision until the candidate can demonstrate the requisite competence.

Description of modules

Module 1 - National legislation

The module contains presentations and written material covering national and European legislation within the area of handling, care and use of experimental animals. The Norwegian Animal Welfare Act and the EU Directive on the protection of animals used for scientific purposes are central documents in this module together with EU Commission guidance documents covering various aspects, such as severity assessment, organization of animal welfare bodies, project evaluation and inspection and enforcement.

Module 2 - Ethics, animal welfare and the 3 R¿s

The use of animals in research raise ethical questions and there are different opinions in the public whether use of animals can be justified. Even though there are strict regulation for animal there are situations that can be addressed by regulatory compliance, and compliance with the regulations does not assure ethical behaviour. The module contains video presentations and additional literature which presents basic principles within animal ethics, including the 3 R¿s, ethical positions, animal welfare vs. animal rights, how ethical framework is reflected in laws and regulations, the five freedoms, re-use of animals, the concept of harm to animals.

Module 3 - Basic and appropriate biology

This course module provides an introduction to the basic principles of animal behaviour, care, biology and husbandry. The course material is presented in different video presentations covering basic anatomy, physiology, reproduction, behaviour, husbandry and enrichment practices of different animal species (mouse, rat, pig and zebrafish). Some of the videos are recordings of healthy animals showing normal behaviour in a laboratory animal facility. Added to the presentations there is written material to read that covers the topic of this module.

Module 4 - Animal care, health and management

This module provides video presentations and added written information on various aspects of animal care and management including environment, husbandry, diet and prevention of disease. Environmental factors important for the wellbeing of laboratory animals, and how these factors are monitored and controlled are described. Consequences of inappropriate environmental conditions on animal welfare and research results are highlighted as well as measures that can be taken to minimize such effects.

Module 5 - Recognition of pain, suffering and distress

This module provides presentations and literature on how to identify signs of abnormal behaviour, signs of discomfort, pain, suffering, or distress and how to distinguish them from each other and from normal behaviour. The concepts of humane endpoints and severity classification are defined and put in context of animal experimentation in order to avoid unnecessary suffering and for implementation in a 3 R strategy.  

Module 6 - Humane methods of killing

This module describes the principles of and legislative requirements related to humane killing methods, including requirements for availability of competent personnel and which methods are allowed to use on different animal species, including a discussion of how to select the most appropriate method. Finally, the criteria of death and how death is confirmed is described. Presentations are provided with additional literature.

Module 7 - Minimally invasive procedures without anaesthesia

This module presents videos and descriptions from the literature of relevant minimally invasive procedures that can be performed without anaesthesia, such as restraint of animals, administration of compounds, injections, blood sampling, oral gavage, tissue biopsies and marking of individual animals.

Module 8 - Design of procedures and projects.

This module has presentations and background literature on the basic principles of design of animal experiments and statistical analysis of results of generated data. Special emphasis is given to explain principles of hypothesis testing in statistical analysis and the importance of power estimation in the planning of animal experiments.  

Module 9 - Anaesthesia for minor procedures and advanced anaesthesia for surgical prolonged procedures

This module provides information on the use of anaesthesia and analgesia in experimental animals for minor procedures and surgical or prolonged procedures. There are presentations on physiology, recognition, assessment and management of pain, which provide a basis for choosing and applying analgesia and anaesthesia in different animal models and for different purposes. This includes suggestions to pharmacological pain management according to prospective severity assessment, the concept and requirements for balanced anaesthesia, the assessment of anaesthesia depth, planning and surveillance of anaesthesia, characteristics of different anaesthetic and analgesic agents and specific anaesthesia protocols, and the normal pulmonary function and how anaesthesia will affect pulmonary physiology.

Module 10 - Principles of surgery

This module is divided in two parts covering surgical principles. The first part provides presentations on surgical site infections, including classification and risk factors and aseptic preparation of animals, surgeon and supporting staff. The second section address basic surgical techniques.

After completing the course, the student should be able to:  - Identify and describe the national and European legislation which regulate the scientific use of animals  - Describe the differing views within society concerning the scientific use of animals.  - Demonstrate a comprehensive understanding of the principle of the 3Rs. - Describe the principle and consequences of implementing early humane endpoints in animal experimentation.  - Describe the basic biology of the relevant animal species and recognise how this impact animal experiments .

- Describe the relationship between environmental factors and animal health.  - Be aware of potential human health hazards associated with contact with laboratory animals and how these can be prevented  - Describe the principles of humane killing and list appropriate euthanasia methods for the relevant animal species. Recognise that the choice of a euthanasia method may influence the scientific outcome  - Describe appropriate methods and principles for handling of animals, and describe common techniques / procedures, including administration and sampling techniques  - List the different types of formal experimental designs and describe variables affecting reliability of outcome variables in animal experiments.   - Describe how to monitor the microbiological health of laboratory animals  - Describe the components of pain physiology and list the types of analgesic drugs that are effective at the different components  - Describe how to do pre-operative, intraoperative and post-operative evaluation of research animals  - Indicate some of the problems associated with pain recognition and pain management in animals 

The course is divided in modules and based on e-learning tools, study groups, quiz and individual assignments. Each module has  a theoretical framework defined by video presentations some of which ends with a multiple choice test which has to be passed before the student can go on to the next module. Each module also contains additional material for in depth studies and/or group work.

Course participants will have to take part in group work covering topics relevant to the theoretical part of the course. In addition, each participant has to submit a course assignment which involves design of an animal experiment and application for animal experimentation through the national application portal (FOTS).

The practical training must be supervised by a person who has appropriate and up to date knowledge and is skilled and competent in the procedures. The practical training must be documented. A course program is available for documentation of the practical training, covering 21 hours of mandatory sessions. Course participants should select their specialization on basis of the animal species they will work with after the course. The student has to arrange the practical training themselves.

A course certificate will be issued when the following has been completed: Attendance at the theoretical lectures, completion of the e-learning modules, passed the home assignment and passed the written exam. This diploma is valid together with a practical training document. 

The exam is web based multiple choice in Canvas, 50 questions, 50 minutes.

In addition there is a mandatory oral group assignment, a mandatory written individual assignment and a mandatory practical training. 

If the written exam is evaluated as "failed" the written exam must be repeated. If the home assignment is evaluated as "failed" a new home assignment must be submitted.

It is difficult to estimate the exact time used in this course. E-learning is condensed and demanding in the sense that additional time has to be spent in order to absorb and understand the theoretical content of the course. The syllabus also includes a considerable amount of legislative text, which is demanding for unexperienced readers. Parts of the course also requires considerable time for reflection, in depth studies and maturation.  It is essential that the estimated time use must secure a maximal learning outcome from the course, which in this case will include a minimum of 310 hours including all modules, assignments, practicals and exam.

Module

Estimated time use

Module 1: Preparation, time used ca. 30

Module 2: Preparation, time used ca. 50

Module 3: Preparation, time used ca. 10

Module 4: Preparation, time used ca. 10

Module 5: Preparation, time used ca. 20

Module 6: Preparation, time used ca. 10

Module 7: Preparation, time used ca. 25

Module 8: Preparation, time used ca. 15

Module 9: Preparation, time used ca. 50

Module 10: Preparation, time used ca. 10

Practicals: Preparation, time used  21

Final exam: Preparation, time used Ca. 50

Total: Preparation, time used Ca.  301