The interim Cabinet approved a decision to institute the National Committee for Ethical Examination of Clinical Research and the regulations concerning its work. The Committee will examine the documents and appraisals of clinical research involving human subjects from ethical viewpoint, IPN reports.
Under the decision, no matter whether these human subjects suffer from diseases or are healthy, the Committee will ensure the protection of their rights, their safety and state of health. The protection of the rights of human subjects involved in clinical research will be ensured by correctly choosing the examiner, the equipment and the conditions in which the clinical research is conducted and by informing the subjects about the procedures to which they are subject and the possible impact.
Acting minister of health Ruxanda Glavan said the Committee will pay special attention to clinical research involving persons who do not realize the risks of biomedical experiments and cannot defend their rights, like the minors, disabled persons and patients with particular mental disorders. The persons suffering from mental disorders can be included in clinical research only when there is a guarantee that the administered preparations will improve their state of health. The institution of this Committee will enable the health facilities to introduce advanced treatment methods, with new medicines.
The regulations provide that the introduction of a new medicine on the market must be accompanied by a file with information about the results of the clinical research and tests. There are European norms concerning the complication of the file, which must be strictly respected.
The National Committee for Ethical Examination of Clinical Research will be a nonprofit and autonomous institution, while the Ministry of Health will be considered its founder.
