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 CCMO Central Committee on Research involving Human Subjects  (Central Committee on Research involving Human Subjects)
  • A declaration of no objection from the Minister of VWS Ministry of Health, Welfare and Sport  (Health, Welfare and Sport)
  • A permit from the Ministry of IenW Ministry 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

Submission of the official application

What must I submit for the official application?

Can information be kept confidential?

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