Taking an active approach to ensuring ethical practices in research

Highlights

  • CHDR provides all of the services needed to optimise development and streamline approval of a new protocol.
  • If desired by the sponsor, CHDR can also serve as a legal representative within the EU.
  • In the Netherlands, clinical studies using medicinal products must be approved by a certified ethics committee that reviews the ethical considerations as well as the underlying science.
  • CHDR has an established working relationship with several ethics committees.
  • In most cases, approval can be obtained within four weeks of submitting the application.
  • Clinical studies using specialised medicinal products such as nucleotides or stem cells must also be approved by the Dutch competent authority.
  • A number of CHDR’s board members have served — or currently serve — as board members on the Dutch competent authority

Summary

In the Netherlands, a balanced system is used for regulating clinical research, thereby ensuring that subjects are fully protected and minimising the need for overregulation. When the protocol itself is clear and to the point, the regulatory procedures can actually be both fast and efficient.
CHDR’s project leaders develop the protocol, submit the protocol to a certified ethics committee and the competent authority, and communicate with the Dutch regulatory bodies.

Timelines

Dutch law has established limits regarding how long the ethics committee and competent authority can take to review a clinical trial application (CTA). 

− The competent authority has two weeks to complete review and issue a ‘statement of no objection’; in the case of specialised medicinal products, an additional 30 days is allowed.

 − Approval by the ethics committee should occur within 60 days of receiving the CTA, during which the ethics committee can request additional information.

− If the CCMO conducts the review, an additional 30 days is allowed.

 − With protocols involving xenogenic cell therapy, no time limit is applied to the review process. 

The clinical trial application (dossier) is intensively reviewed by the Ethics Committee, which can legally take up to 60 days to complete their review. In most cases, however, CHDR receives full approval within 14 days from the time of Ethics Committee meeting. In parallel, the Competent Authority also performs a marginal review, where the statement-of-no-objection is usually issued within 10 days.

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