Appeal
An MSc can refuse a clinical trial because of an opt out on the part I conclusion, a negative conclusion on part II or a negative opinion from the ethics committee*. An interested party has the right to appeal to an administrative court against this refusal pursuant to section 8:1 of the General Administrative Law Act [Algemene wet bestuursrecht]. Before lodging an appeal to the court, the interested party shall lodge an objection or an administrative appeal to CCMO.
If CCMO came to the negative decision, the interested party may lodge a notice of objection to CCMO within six weeks after the day on which the decision was reached (section 7:1 of the General Administrative Law Act).
If an accredited MREC came to the negative decision, the interested party may lodge a notice of administrative appeal to CCMO as the appeals authority within six weeks after the day on which the decision was reached (section 23 of the WMO).
See also the procedure for objection and administrative appeal.
According to national Dutch law, it would be possible to lodge an administrative appeal or objection against a negative decision based on a negative conclusion of part I by the rMS. However, this appeal or objection will be declared inadmissible, because this decision is taken at international level. Resubmission of the clinical trial as a new clinical trial with adjustments is possible.
* In the Netherlands the opinion from an ethics committee is captured in the part I and part II assessment.