Creation and approval of NTPs - Non-Technical Project Summary (NTS) of animal experiments in Germany

Since the third amendment of the Animal Welfare Act and the Animal Laboratory Animal Ordinance came into force in 2013, a non-technical project summary (NTS) must be included with every application for approval of a project involving an animal experiment. The BfRshort forGerman Federal Institute for Risk Assessment publishes the NTS online in the AnimalTestInfo database to keep the general public informed about animal experiments.

NTS inform about the purposes of animal experiments, about the intended benefits, and about the harms that might be expected for the animals. NTS contain information on the number and species of animals (mice, rats, etc.) intended to be used, as well as all measures adopted to avoid the use of animals in advance (Replacement), or to reduce their numbers in the experiment (Reduction), or to improve their well-being (Refinement).

After approval of a project involving animal experiments, the competent authority designates the associated NTS for publication. The BfRshort forGerman Federal Institute for Risk Assessment publishes these NTS online in AnimalTestInfo within twelve months. As a general rule, NTS are published three months after receipt.

Since every application for approval of an animal testing project must be accompanied by a generally understandable, non-technical project summary (NTP), the Bf3R has compiled information on the content of the NTPs for animal testing projects in the “Guidelines for the preparation of the non-technical project summary (NTP) for animal testing projects”.

NTS for approved projects can be managed and designated for publication by the respective authority in the password-protected area of AnimalTestInfo i.e. the “AnimalTestInfo Competent Authority” web application. This requires successful registration and login.

Information on the content of the NTS for projects involving animal testing can be found in the “Guidelines for preparing the Non-Technical Project Summary for animal testing projects” below.

In AnimalTestInfo, data on projects involving animal experiments are listed in a structured way within the data fields of the NTS. This structure enables targeted searches for data as well as systematic retrieval of the NTS contents.

For this purpose, scientists at the BfRshort forGerman Federal Institute for Risk Assessment have classified NTS contents in a pilot project using data from the years 2014 and 2015. The intended benefits of projects were classified with the code of the International Classification of Diseases (ICD). The ICD is a classification system for human medical diagnoses and is acknowledged worldwide. The assignment of NTS to ICD codes enables a very precise analysis of scientific objectives of projects.

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