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.

Click here to determine which procedure to follow for naked DNA

Simplified procedure

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.

Advantages:

  • 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.

More information on the advantages and preconditions of the simplified procedure.

Standard procedure

If the use of the naked DNA does not meet the preconditions of the simplified procedure, the standard procedure must be followed. More information on the preconditions of the standard procedure.