LEGAL ASPECTS OF REGULATION ON BIOMEDICAL SCIENTIFIC RESEARCHES

Abstract

SUMMARY: The existence of numerous new relationships created upon the improvement of modern medico biological researches emphasized, during the last decades, the need of improvement of several normative regulators which are to assure the following of certain ethical and legal principles. Different scientific societies have been issuing ethical codes and regulations, in order to regulate their activities. The appliance of these codes is assured by certain committees and commissions, which come up with expert opinions according to the level up to which certain research complies with the ethical and legal principles prescribed in specific legal regulation on European and national level. In Bulgaria, there are created committees in ethics of scientific research in the field of medicine, among which are: National Council of Bioethics to the Ministry of Education and Science, National Ethic Committee and ethic committee of transplantations to the Ministry of Health, Bioethics Committee to the Institute of Neurobiology to the Bulgarian Academy of Sciences, Committee of ethics in scientific research activity to the Medical University in Pleven and Committee of ethic in scientific researches to the Medical University in Sofia. The activity of these committees, commissions and councils is regulated by acts such as the Universal Declaration of Human Rights, WMA Declaration of Helsinki regarding ethical principles for medical research involving human subjects, the European convention on bioethics as well as all legally binding European legal instruments related to ethics in scientific researches, as well as article 203 of the Bulgarian Healthcare Act, Regulation No 14 issued by the Ministry of Health on the terms and orders for conduct of clinical trials of drugs on humans and the regulations in other international and national documents in the field of ethics in scientific research and scientific publications. Subject of expert evaluation are clinical and nonclinical biomedical scientific researches on human beings, scientific researches using personal biomedical data, human tissue, animals particular- genetically modified animals and microorganisms. The range of interest also include all ethical problems regarding protection of public interests and the researched objects from dishonest activities of researchers in production, announcement, offering and publication of results of scientific researches.