Approval and monitoring

The authority responsible for these matters in Berlin is the Berlin State Office for Health and Social Affairs (LaGeSo). Its decisions are supported by an animal experimentation committee which at all times includes representatives of animal welfare organizations (one third of the members), scientists, and an ethics commissioner.

Every experiment must be justified, precisely described, and then authorized by the animal welfare authorities before any animals become involved in a scientific project. The expected scientific and medical benefits of every animal experiment must be weighed against the estimated degree of suffering that the animals will experience. A comprehensive literature review must make sure the experiment has not already been conducted elsewhere and would therefore be unnecessary. In short, the 3R principles must be adhered to. 

During experiments, our animal protection officers check compliance with the standards and advise researchers when necessary. The Max Delbrück Center currently employs six such officers. The responsible authorities can check compliance with the standards at any time. All experiments are logged, and the number of animals used is reported annually to the LaGeSo.

The most important questions and answers

Who regulates, approves and monitors animal research?

In Germany, animals are protected by the constitution. This national objective is regulated in the German Animal Welfare Act. The authority responsible for approval and monitoring in Berlin is the State Office for Health and Social Affairs (LaGeSo).

In Germany, animals are protected by the constitution. Article 20a of the Basic Law protects “the natural foundations of life and animals.” This national objective is regulated in detail in the German Animal Welfare Act. Section 1 of this Act states that no one may cause pain, suffering or harm to an animal without reasonable cause, and the conducting of research on animals for scientific purposes is considered to be one such reasonable cause. But the law obliges scientists to always weigh up the pain and distress to which animals are exposed against the expected benefit to medicine and science.

Sections 7 to 9 of the Animal Welfare Act specifically regulate the protection of laboratory animals. Both the number of animals and the pain and suffering inflicted on them are to be kept to a minimum, taking into account that the perception of pain varies from species to species. The last amendment to the Animal Welfare Act in 2013 incorporated the EU Directive on the protection of animals used for scientific purposes. This resulted in stricter rules governing the reporting and documentation of animal experiments. The legal regulations reflect the 3R principles (replace, reduce, refine), which were formulated by UK researchers back in 1959 as ethical guidelines for animal research.

Any study that involves animal experiments must receive prior approval. This means that researchers must first submit an application to the regulatory authority, which in Berlin is the State Office for Health and Social Affairs (LaGeSo). The procedure for gaining approval – as well as for keeping laboratory animals and conducting animal research – is laid out in detail in the German Regulations on the Welfare of Animals Used for Experiments or for Other Scientific Purposes. Animal welfare officers at the Max Delbrück Center, for example, must submit an opinion together with every application for approval or for the extension of an experiment and/or series of experiments. Once the application has been submitted to the authority, it is forwarded to the members of the animal welfare committee appointed by LaGeSo, who also comment on and review the aspects requiring approval. LaGeSo officials forward the committee’s comments – including any requests for clarification – to the applicants, and only make a decision once open issues are resolved. This application process can take two to three months. LaGeSo representatives visit the Max Delbrück Center several times a year to inspect the animal keeping conditions and observe experiments.

Is every animal experiment and every application approved?

No. Some applications are rejected. An approved animal testing application is always the result of an extensive process of review, improvement and discussion.

No. The authorities do reject applications, which must then be revised and resubmitted. Even if an application is not rejected, it is usually returned to the applicants with additional questions. An approved animal testing application is always the result of an extensive and sometimes lengthy process of review, improvement and discussion involving many parties. Before the application is even submitted to Berlin’s responsible animal welfare authority, the State Office for Health and Social Affairs (LaGeSo), it is first examined internally by our animal welfare officers. They discuss any concerns with the researchers and work to develop improvements. The application is then supplemented by an independent, written opinion of the animal welfare officer – whose assessment can also be negative.

How many animal welfare officers does the Max Delbrück Center have and what are their roles and responsibilities?

Six animal welfare officers work at the Max Delbrück Center. In addition to providing guidance and advice, their main roles are to ensure compliance with and internal monitoring of legal regulations, and to further develop our animal welfare policies.

The six animal welfare officers at the Max Delbrück Center are all veterinarians with research experience – almost all with additional qualifications in laboratory animal science. The officers’ key roles and responsibilities include ensuring that scientists comply with legal regulations, monitoring experiments and further developing animal welfare measures. They operate independently and are not subject to the directive authority of the scientific staff.

They advise the scientists even during the application process. This involves checking whether the number of and burden on the animals is reasonable in proportion to the expected gain in knowledge. They also make sure that the application can be understood by non-scientific professionals. In order to limit the number of animals used in the experiment, they may, for example, indicate that existing animals are being used in an experiment rather than animals that must be newly bred or obtained from the breeder. They also attend experiments at random to check compliance with the regulations or to make sure surgical procedures are being carried out properly. In addition, they examine the records that researchers are required to keep during the course of an experiment to ensure that, for example, the number of animals and the procedure and duration of the experiment are in keeping with what has been approved.

Another important task of the animal welfare officers is to advise and train the scientific staff and animal keepers on issues that affect the animal at all stages of research: from the submission of applications to the design of experiments and their implementation. This involves the choice of animal species, the age groups or sex of the animals, the animal-friendly implementation of procedures, and the appropriate use of painkillers and anesthetics. Knowledge of statistics or existing literature can also help to reduce the number of animals used in experiments. Thorough research of the scientific literature, for example, can make an animal experiment superfluous if the results of an experiment have already been published, while statistical considerations in the design and planning of an experiment ensure the quality of the results – and a meaningful result prevents the need to repeat the experiment with additional animals. Publication of negative results – results that do not confirm the scientific hypotheses – can also help to avoid the unnecessary repetition of experiments and thus the suffering of animals. Further training courses teach scientists how to use procedures that minimize pain and distress or how to recognize suffering in animals. Pain is expressed differently depending on the species: mice display a particular body posture and facial expression, while zebrafish change their swimming motion.

Our laboratory animals

Good science and good animal welfare practices go hand in hand