Several regulations apply to working with Biological agents, especially for working with Genetically Notified Organisms (GMOs). In the campus-wide BioRisk Management system, all decisions and regulation on working safely with Biological agents, GMOs and related activities have been converted into a set of clear procedures and related documents.
Go to the BioRisk Management system
Terminology is used, which are explained below, with additional links to specific documentation where appropriate.
Biological agents
Biological agents are genetically modified micro-organisms, cell cultures and human endoparasites that can cause infection, allergy or toxicity. If you work with these, it is important to follow the guidelines for working safely with biological agents.
Contained use
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.
BioRisk Professionals
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. There are 6 BioRisk Professionals working within the Radboud campus, including 5 biological safety officers, 2 environmental safety officers and 2 Occupational Hygienists, together they occupy a broad area of expertise.
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.
Occupational hygienist
The occupational hygienist, part of Radboudumc's Occupational Health & Safety and Environmental Service department (AMD), deals with working conditions in the working environment. The occupational hygienist helps you identify whether employees face health risks due to their working conditions and advises how to carry out work in a healthy environment.
Decentralised responsibility
Each department or research group has its own responsible staff member ('Responsible employee'), 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.
Incidents
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.
More information
Voor meer informatie kun je de handboeken biologische agentia, genetisch gemodificeerde organismen ingeperkt gebruik, genetisch gemodificeerde organismen introductie in milieu en BioRisk-related raadplegen.
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.
The BioRisk Prevention Team
Do you have questions about the day-to-day running of activities with genetically modified organisms and for carrying out risk assessment or preparing a permit application? If so, please contact the employee responsible in your department.