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: