Studies using existing data
No permission is required from those involved if the study is totally anonymous. In principle, individuals involved in studies need to provide explicit consent if the details involved are directly or indirectly identifiable. There are a number of exceptions, however. Coded data that can indirectly lead back to participants may be used without consent in scientific research if the individuals concerned have not objected to this and the study involves such large groups that the research could not reasonably be carried out by asking each individual for their consent. Data leading directly to participants may only be used without consent if the individuals concerned have not objected to this and if it is impossible to request such consent due to various cases described in the code of conduct: Use of Data in Health Research .
Keep in mind that for these kinds of studies you do have to get a judgement by the Medical Ethics Review Committee to obtain a decleration that your study does not fall under the remit of the WMO. More information about this process can be found here .
Laboratory studies involving human material
Studies involving human material are conducted by culturing existing cell lines. This is regulated by the procedures of the laboratory in question. Studies are also conducted on human tissue obtained from patients in the course of normal medical treatment. Material is taken for diagnosis and is later made available for research. Some human tissue is taken especially for research purposes. These last two cases are regulated by the code of conduct for responsible use. More information about the code, and about the handling, and storing of human materials can be found at the VUmc Biobank site , and on the website of the Medical Ethics Review Committee.
If you want to use patient data or other personal data in combination with human materials, first check for privacy issues!
Laboratory Studies with potentially hazardous substances
Contact your local quality officer for details of safe working procedures when working with potentially hazardous substances.
General instructions for working with genetically modified agents can be found in the Genetically modified organisms handbook . The handling of such GMOs is supervised by specialized officials or the BSO (Biological Safety Officer).
The handling of radioactive materials (Radioactive Substances Handbook; Orange Book) is only permitted in special laboratories and must be supervised by a local radiation expert, referred to as a C-deskundige (C expert). If you have any general questions or need to locate such an expert, please contact the AMD .
Studies involving animal models
Studies involving animal models are regulated by the Experiments on Animals Act (Wet op de dierproeven). Your study must be approved by a special committee known as the DEC (dierexperiment commissie). Only qualified personnel ( artikel 9 functionaris ) are allowed to perform animal experiments. Animal experiments can be performed in the controlled environment of the UPC .