Helsinkio deklaracija ir jos nuostatų implementavimas į Lietuvos Respublikos teisės aktus

• Balsienė, Janina
• Maksvytienė, Daiva

LTPagrindinis dokumentas, sukūręs pagrindus žmonių, dalyvaujančių biomedicininiuose turimuose, etinei ir teisinei apsaugai, yra tarptautiniu mastu pripažinta Helsinkio deklaracija, kurią pirmą kartą priėmė Pasaulinė medikų organizacija 1964 m. Helsinkyje. Nacių nusikaltimai Antrojo pasaulinio karo metu paskatino pasaulio visuomenę įsigilinti į tyrimų su žmonėmis etinį ir teisinį reglamentavimą. Deklaracija vėliau buvo nuolat pildoma kaip atsakas į aktualius klausimus, iškylančius biomedicininių tyrimų srityje. Helsinkio deklaracija turėjo ir šiuo metu turi įtakos pasaulio valstybių teisinei bazei, reglamentuojančiai biomedicininius tyrimus. Straipsnyje nagrinėjami Helsinkio deklaracijos istoriniai aspektai, 2000 m. Helsinkio deklaracijos nuostatų atitiktis Lietuvos Respublikos teisės aktams, kuriais remiantis vykdomi biomedicininiai tyrimai Lietuvoje. Pastebėta Lietuvos Respublikos teisės aktų neatitiktis ir kai kurioms Helsinkio deklaracijos nuostatoms. [Iš leidinio]Reikšminiai žodžiai: Helsinio deklaracija; Biomedicininiai tyrimai; Asmens sutikimas; Declaration of Helsinki; Biomedical research; The subject consent.

ENBiomedical researches with humans are performed in order to improve the diagnostics of disease, to gain better treatment results, to discover better means of prophylactics and to deepen the knowledge about the genesis and course of the disease. The majority of diagnostic, prophylactic and therapeutic procedures in medical practice and especially in the clinical researches are related with risk for human health impairment. Ethical and legal framework of scientific biomedical researches becomes a part of modern science. Helsinki Declaration (HD) -- the document that is considered to be the main source for establishing the basis of legal and ethical protection for participants of biomedical research. This important international document was passed by the World Medical Organisation in 1964 in Helsinki and is recognised to be the continuation of the Nuremberg Code which induced the world society to deepen their knowledge in ethical and legal regulation of human research. The importance of the Helsinki Declaration on the ethical considerations and legal regulation of biomedical research is confirmed by its periodically renewed editions (1975, 1983, 1989 ir 1996) and the discussions that they provoke. The Helsinki Declaration adopted in 2000 in Edinburgh constitutes an ethical standard applicable to the biomedical research and recognized by the world medical society. This HD edition differs from the earlier editions because it reemphasises the rights and freedoms of the person who takes part in the research, the integrity and moral responsibility of the researcher. The article analyses how the Lithuanian legislation on biomedical research reflects the HD of 2000.The majority of the HD principles correlates with legal acts of the Republic of Lithuania, but some of them are presented even more accurately: proffesional responsibilities of physicians, protection and medical care of the participants of biomedical research, disposal of the research waste, maintainance of the laboratory animals and protection of the research participants' privacy. The Law on Ethics of Biomedical research of the Republic of Lituania does not mention the role of the HD in the administration of biomedical research. Article 3 of this law specifies that non-clinical and clinical research should be performed in accordance with the Guidelines for good clinical practice, approved by the Ministry of Health. Instead of a generally used term "Placebo" (imitation of treatment) this law uses an expression "non-administration of the usual treatment" (Art. 6(4)). The law should be amended as these two terms are not equivalent and could lead to numerous misinterpretations. The Lithuanian legislation does not regulate how the medical care and medical research should be coordinated. It also fails to identify the rights of the patients after termination of the medical research and does not regulate disclosure of information on the results of medical research which does not comply with the Guidelines for good clinical practice. The informed consent form, when the patient takes part in the investigation which is performed by his physician needs to be more accurately regulated. [From the publication]