AdditionalTabText object

An ethics committee may be established by a provider of healthcare services from whom the sponsor of the clinical investigation has ordered its conduct. On the basis of a written contract concluded with a provider of healthcare services who has not established it, any ethics committee may act also as the ethics committee for this provider of healthcare services. The conditions for the operation of the ethics committee shall be safeguarded by the provider of healthcare services who has established the committee.

The provider of healthcare services shall notify the Institute of the establishment of an ethics committee, including its membership, within the timeline of 30 days of its establishment. Dissolution of an ethics committee shall be notified to the Institute by the provider of healthcare services without any delay. (Section 16 of Act No 268/2014 on Medical Device)