According to Danish law, all research projects in Denmark involving human beings or any kind of human tissue, cells, blood, etc. must have permission from a regional ethics committee. In the case of multi-centre trials, the investigator shall only apply for permission from the regional committee where the principal investigator carries out the research project. However, in the case of multi-national trial projects, permission from a Danish committee is always required.
If material or information from a biobank (i.e. ‘a structured collection of human biological material which is accessible under certain criteria, and where information contained in the biological material can be traced back to individuals’) is used in a research project, the additional approval of the Danish Data Protection Agency is required.
The principal investigator is responsible for ensuring confidential, secure and appropriate storage of the tissue, ethical use of the tissue, respect for donor confidentiality and appropriate disposal of the tissue. It is recommended that you do not work with your own biological material due to the risk of transformation and lack of antigenicity.
Collection of specimens/samples from living individuals: Only registered physicians, nurses or certified technicians who are trained to withdraw human biological material for scientific or medical purposes, and who obtain specimens/samples while working under protocols and procedures approved by the relevant regional ethics committee, are authorised to extract human biological material. This regulation does not apply for the non-invasive collection of biological fluids such as semen, saliva, milk, etc.
Storage: All human specimens/samples must be stored in a secure location, which is clearly labelled on the outside with the universal biohazard symbol. You must place samples in secure, leak-proof containers and store them in a manner that will prevent decomposition or deterioration during storage. Each container must also be labelled with the name of the biological material, the user’s name and contact information. Containers used for specimen/sample storage must be discarded as biohazardous waste after removal of the sample.
Handling: All human specimens/samples should be handled as potentially hazardous as regards contamination and infection. Adequate personal protective equipment for handling potentially contaminating agents should therefore be chosen according to the risk of exposure. Personal protective equipment includes gloves, protective eyewear, masks, aprons, shoe covers and cap/hair covers, etc.
All work with human specimens/samples MUST be carried out in areas that have been classified as class I.
Disposal: Human specimens/samples should be disposed of in closed, non-leaking containers and put in the yellow bags or autoclaved. Blood sampling equipment, scalpels and other equipment that can damage the skin should be disposed of in specified yellow needle boxes.
Transport: To avoid spill, human specimens/samples should be transported in unbreakable closed containers marked as biohazardous material.
Biological spills on non-working areas such as the floor should be removed immediately and cleaned normally. You should also remove large spills immediately and disinfect the affected area with an appropriate agent (1% Diversol or 70% ethanol in water, possibly supplemented with UV light for 30 minutes).
If you injure yourself or others with equipment that has been contaminated with either blood or tissue fluids:
– let the wound bleed
– wash carefully with water and soap
– brush the wound with 70% ethanol or 2.5% iodine ethanol
If you become contaminated with biological material in your mouth or a wound, you should carefully rinse the area with saline or normal tap water.
If you get biological material in your eyes, rinse them carefully using the eye rinsing bottles available in all laboratories.
You should contact the emergency room at the local hospital (Aarhus University Hospital, Nørrebrogade) immediately or within two hours of the accident for a risk assessment of infection with HIV, hepatitis B or hepatitis C. There is normally no treatment 24 hours after the accident.
Contact your local safety officer at MBG to make a claim report of the accident. It is important that you contact the safety officer no matter how minor the accident.