Gene therapy research should be reported if any of the following occur.
Any unexpected serious adverse reaction (SUSAR (Suspected Unexpected Serious Adverse Reaction
)(Suspected Unexpected Serious Adverse Reaction ) s);
Any unforeseen circumstances that may affect the risks of the work to humans and the environment.
Unforeseen circumstances must be reported to the Environmental and Transport Inspectorate (ILT(Inspectie Leefomgeving en Transport )).