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CCMO

Since the Medical Research Involving Human Subjects Act (WMO) came into effect, all gene therapy research involving human subjects must be assessed by the CCMO (Central Committee on Research involving Human Subjects) in accordance with the Central Review of Medical Research Involving Human Subjects Decree.

The reason that gene therapy research is assessed by the CCMO – and not by (local) medical research ethics committees – is that the developments in the field of gene therapy are so new that there is little relevant expertise.

The CCMO assesses the research proposal according to the criteria of the WMO. For gene therapy research the assessment focuses primarily on the risks involved in the treatment, both for the human subject and for society. Should the CCMO conclude that it does not have the necessary expertise to complete the assessment, it can seek advice from external experts for those aspects where its expertise is lacking.

Definition of parties associated with the clinical research

  • Sponsor: an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial.
  • Investigator: a person responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator.

Details and contact person

Name

Central Committee on Research involving Human Subjects

Postal address

PO Box 16302, 2500 BH The Hague, The Netherlands

Visiting address

Rijnstraat 50, The Hague, The Netherlands

Telephone no.

+31 (0)70 340 6700

Website

http://www.ccmo.nl/

Contact person

Dr. K.R.J. (Kaate) Vanmolkot (ccmo@ccmo.nl)

Contact Information

Gene Therapy Office
Coordinator: Dr. D.A. Bleijs

PO Box:
PO Box 1
Intern Postvak 1
3720 BA Bilthoven
The Netherlands

Address:
Intern Postvak 1
Antonie van Leeuwenhoeklaan 9
3721 MA Bilthoven
The Netherlands

Tel: +31 30 274 7569
Fax: +31 30 274 4401
Internet: www.loketgentherapie.nl
Email: contact@loketgentherapie.nl

GMO Office, Dr. D.A. Bleijs
+31 30 274 2793
CCMO, Dr K.R.J. Vanmolkot
+31 70 340 6700

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