Since the Medical Research Involving Human Subjects Act (WMOMedical Research Involving Human Subjects Act ) came into effect, all gene therapy research involving human subjects must be assessed by the CCMOCentral Committee on Research involving Human Subjects (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.