For applications regarding studies involving naked DNA, there are two procedures for permits issued by the Ministry of Infrastructure and Watermanagement (IenWMinistry of Infrastructure and Water Management ): the simplified procedure and the standard procedure.
By answering the five questions below, you will be able to determine which procedure you are required to follow.
Clinical research using naked DNA qualifies for the simplified procedure if the research meets certain preconditions. Among other things, this must concern plasmid DNA without viral sequences, with the exception of a number of frequently used viral sequences.
- short and simple application form, Part A;
- a standard environmental risk assessment drawn up by the Minister;
- a simpler course of the procedure (the statutory periods of deposit for inspection still apply);
- various adjustments to the work can be implemented quickly, merely by reporting them, and do not need to be deposited for inspection, provided that these adjustments remain within the framework of the simplified procedure.