Here are some tips to streamline to different assessment procedures.

The assessment of gene therapy research involves various combinations of legislation and regulations as well as a number of different bodies. An applicant is therefore required to obtain one or more of the following authorisations in order to start clinical gene therapy research:

  • A positive decision from the CCMOCentral Committee on Research involving Human Subjects  (Central Committee on Research involving Human Subjects)
  • A declaration of no objection from the Minister of VWSMinistry of Health, Welfare and Sport  (Health, Welfare and Sport)
  • A permit from the Ministry of IenWMinistry of Infrastructure and Water Management  (Infrastructure and Watermanagement).

These are, in a formal sense, three separate procedures. However, the aim is to keep things as easy as possible for the investigator, as demonstrated by the organising of a joint preliminary meeting and the combining of the different application forms. Nevertheless, smooth procedures will, to a considerable extent, depend on the investigators themselves and this chapter contains a number of tips.

Tips for the applicant:

Engage in preliminary discussions

Engage in preliminary discussions

Submission of the official application

Submission of the official application

What must I submit for the official application?

What must I submit for the official application?

Can information be kept confidential?

Can information be kept confidential?

Deadlines indienen aanvraag

Deadlines submission

Contact the environmental safety officer (ESO)

Contact the environmental safety officer (ESOenvironmental safety officer )