Common mistakes in FOTS applications
Overview of the most common mistakes that will delay approval of your FOTS application.
There are some common failures in FOTS application that cause delay in the process. These should be fixed before submission to FOTS.
Information lacking or inadequate
Application summary (cf regulation § 8)
Project summary should be easily understandable to the public.
Project summary shall be anonymous and do not contain names and addresses of the user or persons involved.
The project summary shall include:
1.Purpose of the study
2.Expected harm/severity for the animals
3.Expected benefit for science or society
4.How many and what kind of animals will be used (totally in this experiment)
5.How are compliance with the requirements for replacement, reduction and refinement safeguarded
Project summary shall not contain information that is subject to confidentiality obligation under the law on public administration (Forvatningsloven)
More information on https://www.uib.no/en/rg/animalfacility/89939/new-regulation-use-animals-experimentation-was-implemented-july-1-2015
The application shall also include an evaluation of severity of the experiment, see http://org.uib.no/dyreavd/Classificationseverity.pdf for more information
Documentation of training:
Theoretical and/or practical training is not documented.
See https://www.uib.no/en/rg/animalfacility/66354/practical-training-persons-performing-procedures-function for further information
Other common failures
- Anesthesia and/or analgesia is not specified, or not enough specified, as for example
- ”We will use the same anesthesia protocol as in earlier projects”.
- Lack of dosing description.
- Anesthesia protocol without analgetic effect in long lasting invasive procedures and/or surgical procedures without postoperative analgesia/pain treatment.
- Use of NSAID before opiates in larger surgery (adbomen-/thoracis cavity, bone tissue/periostium) in projects where opiates is not methodological contraindicated.
- Project participant or manager without lab animal science course.
- Lack of argumentation for the number of animals as for example:”based on prior experience” (without pilot projects)
- On Youtube you can find an animated video on bad reasoning
- Search for alternatives is lacking or too poorly done.
- Score sheetis missing/humane endpoints and measures are unclear.
- Unnessesary invasive methods
- Tumor projects where tumor exceeds 15 % of the body weight (20 % in therapy projects)
- Application should have been treated centrally at the Food Safety Authority (i.e. when weight loss > 15 %, projects involving infectuous agents with expected severe symptoms/death, pain inflicting projects, toe clipping, field experiments, straining tumor projects etc).
- Induction of colitis by use of dextran sulfate.
The EU commission has published a guide for assessment of lab animal projects which might be worth while reading for you who are to write an application to do lab animal research. You can find it here.