At the Radboudumc and Radboud University activities are carried out with various biological agents. Any work that is carried out on campus with genetically modified organisms is mainly carried out within containment, but studies on the introduction of these organisms into the environment are also carried out. These types of activities have been incorporated into the campus-wide BioRisk Management System. BioRisk Prevention-related topics such as the Nagoya protocol, invasive exotics, biosecurity, the importation of pathogens and animal by-products are also embedded in this system.
Biological agents are genetically modified micro-organisms, cell cultures, and human endoparasites that can cause infection, allergy or toxicity.
Genetically modified organisms are organisms whose genetic material has been altered in a way that is not naturally possible. This involves the use of a wide range of organisms, including bacteria, viruses, plants and animals. These activities are carried out within premises that have been designed for contained use.
Studies on the introduction of organisms into the environment and gene therapy
‘Introduction to the environment’ activities involve any activity in which genetically modified organisms are taken out of containment and introduced into the environment. These studies include clinical gene therapy research that involves the use of genetically modified organisms, such as medicines that contain these organisms or vaccination programmes that use genetically modified viruses.
The Biological Safety Officer develops policies on working with biological agents and genetically modified organisms, oversees compliance with regulations and provides researchers with information as well as advice on risk assessments and room design.
Environmental Safety Officer
The Environmental Safety Officer develops policies on how studies on the introduction of organisms into the environment should be conducted and also oversees compliance with rules and regulations. The Environmental Safety Officer also provides advice and takes part in the preliminary consultations that precede the preparation of applications.
Each department or research group has its own responsible staff member ('Responsible empoyee'), who has been specially appointed. This person is responsible for the day-to-day conduct of activities that involve genetically modified organisms, and for conducting risk assessments and preparing applications for authorisation.
Proper action must be taken in any event in which biological agents or genetically modified organisms are inadvertently released outside primary containment. For this purpose, there is a procedure that describes what needs to be done in the event of an incident, emergency or accident. For emergencies call +31 24 365 55 55.
For more information, please consult the manuals for Biological Agents, The Contained Use of Genetically Modified Organisms, The Release of Genetically Modified Organisms into the Environment and other BioRisk-related topics. Access to the BioRisk handbooks can be requested from the responsible employee of the department/research group or the BioRisk Professonal.