An ethics committee shall mean an advisory body of the healthcare service provider the task of which is to conduct surveillance over clinical investigations within the scope of protection of trial subject rights and safety with emphasis upon ethical aspects.
The members of an ethics committee are healthcare professionals and other persons; the minimum number of members is 5, of which more than fifty per cent have to be healthcare professionals. The chairperson and other members of the ethics committee are appointed and dismissed by the statutory body of the provider of healthcare services. The members of ethics committees may be only persons who have not been sentenced for a wilful offence and who have no personal relationship to the subject-matter of the clinical investigation which could cause a conflict of interest at the time of their membership in the ethics committee.
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.
The Institute registers ethics committees for clinical investigations of medical devices and for clinical trials on pharmaceuticals.
The ethics committee issues a written approval of the conduct of the clinical investigation of a medical device and supervises its course in terms of safety and compliance with the rights of trial subjects.
The sponsor of a clinical investigation shall be obliged to inform the ethics committee in writing of his intention to conduct a clinical investigation. Together with the notification, the sponsor shall submit documentation set forth by Section 21(a) except for items 5 and 6 of the Act on Medical Devices.
The ethics committee shall provide its favourable or negative opinion on the conduct of clinical investigations within 60 days of the delivery of the notification. This timeline shall not include the period from the date of request for missing source materials by the ethics committee until the date of their delivery by the sponsor.
Transitional provision pursuant to Section 97, paragraph 2 of the Act on Medical Devices:
A provider of healthcare services, for whom an ethics committee for the purposes of conduct of clinical investigations of medical devices has been established prior to the date of coming into force of this Act shall be obliged to send information about the establishment of the ethics committee and its current membership to the Institute within 30 days of the coming into force of this Act.
Clinical Evaluation of Medical Devices Department
1.7.2015
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