Med. pravo., 2015; 2(16): 41-51
LLM Law, PhD student of Kyiv University of Law of National Academy of Sciences of Ukraine
The legal category of biomedical researches on human beings: an essay
In Ukrainian legal science biomedical researches are not almost characterized as an independent concept and it has not received adequate differentiation from other related concepts of experiments. Such situation led to certain scientific gaps as in applied science of determination of biomedical researches and in the theoretical and legal terms this phenomenon hardly studied at the level of an independent legal category.
Hence there is the fact of advancing the practice of biomedical researches before it legal regulation.It is necessary to stress that the concept of biomedical researches has not received proper legal consolidation within international law and national legislation. The lack of a clear understanding of the concept of "biomedical researches" in legal terms leads to ambiguity of legal practice in the field of implementation of medical and biological research.
Analysis of the legal nature of the "biomedical researches" will provide an opportunity not only to unify the understanding of these concepts, as well dissociate it from other related legal conceptsthat will provide further methodological basis for the determination of biomedical researches as a clearly defined legal phenomenon, provide an opportunity to study the legal and practical aspects of the medical and biological experiments.A biomedical experiment includes for itself all descriptions of biomedical research, at the same time has own descriptions that does not conflict with descriptions of biomedicalresearch.
Except that, a scientist distinguishes the concept of clinical tests of medicinal facilities thaton his persuasion, comes true within the limits of realization of biomedical experiment. Investigating the range of problems of realization of biomedicalexperiments in public, to that, as we marked, the clinical tests of medicinal facilities belong, a scientist follows the criterion of "principle of interferences" :-an achievement publicly of useful aim on condition of their scientific validity;-a presence of advantage of possible success above the risk of infliction of heavy consequences for a health or life-publicity of application of experiment;-informative and voluntarily of consent of adult capable physical person, that is subject to the experiment, in relation to the requirements of his application;-inhibition in the necessary cases of medical secret. Thus we are divide position, that biomedical research is the special variety of biomedicalresearch, as aimed at the study of the biomedicalphenomena and processes, features of their motion.In medicine of concept a medical experiment in public opens up scientists as active (pharmacological, surgical, radial and other) influence on a man that changes motion of physiology and pathological processes with the aim of achievement whole to the experiment. By means of experiment the means of treatment are investigated in default of complete guarantees of safe result.
Except that, specified scientists on that a medical experiment always has scientific character, to him the row of requirements is pulled out, including possibility of reiteration of experiments, their variation and others like that.From the point of view of medicine characteristic for a biomedical experiment is:object of experiment -living organisms, as a rule, in the cut of their co-operating with the complex of various factors of environment, part from that behaves to morbific;an aim of experiment is establishment of conformities to law of origin of different illnesses, mechanisms of their development, development and verification of efficiency of new methods of prophylaxis and treatment;functions of experiment: а) comes forward as means of receipt of new scientific data; б) is the method of selection general in the series of the similar phenomena, ground of conformities to law, forming of hypotheses; в) comes forward as means of verification of hypotheses and theories, is the criterion of their truth, by basis for advancement of new hypotheses; г) is a relative guarantor before application of new methods of diagnostics and treatment of illnesses in clinical practice;There are the following types of experiment :sharp experiment (for example,recreation of sharp, ambustial trauma, poisoning carbon monoxide et cetera); chronic experiment.Analysing legal nature of biomedical experiment we take into account his understanding in science to ethics that has or not decision influence on a law draftingprocess. Thus in sign of ethics of concept of biomedicalexperiment is the article of the special scientific interest. So ethics determines a biomedicalexperiment as method of cognition of secrets of living nature that will be realized in medical and biological sciences, stopped up in the wild of individual. Realization of biomedical experiment conditioned by instinct of survival, self-preservation of individual, aspiring to healthy and safe existence of individual.Marking independence of concept "biomedical experiment", that includes for itself the "requirements of practical medicine and biology, from one side, and socialhumanistic expectations of society, from other", his further description comes true through the analysis of ethic principles on the base of that bioethics is produce the certain moral codes of conduct of doctor and physician-researcher.
To such principles belong: principle of respect of autonomy of personality, autonomy of personality, dignity, principle of the informed consent, voluntarily, integrity, vulnerability, justice, and principleof carefulness. Such scientific going near description of biomedical experiment is base on principles of bioethics, what formulations inlaid in basis and concept. However, to our opinion, the indicated ideas are characteristic for understanding of biomedical experiment as element of concept-category vehicle of science of ethics, however fully go near description of biomedical experiment as legalcategory.
Thus to our opinion a biomedical experiment is a variety of biomedical research of the phenomena and processes of human organism, maintenance of that is active influence on the organism of man as application of diagnostic, curative, prophylactic methodologies, medicinal preparations, related to interference with the personal human rights, has scientifically reasonable, the system, judicial character predefined publicly by an useful aim is base on system of principles, aimed at establishment of conformities to law of originof different illnesses, mechanism their development, development and verification efficiency new method prophylaxis and treatment.
Keywords:biomedical research, medical research, biological experiment, experiment, researc.
1. Chernysheva Yu. A. (2011) Poniatye, sushchnost, problemy byomedytsynskykh eksperymentalnykh issledovanyi s uchastyem cheloveka v RF. Ystorycheskye, fylosofskye, polytycheskye y yurydycheskye nauky, kulturolohyia y yskusstvovedenye. Voprosy teoryy y praktyky, 5 (11) v 4kh ch. Tambov. Hramota. Ch. III, p. 190.
2. Shylovskyi L. Pravovye aspekty provedenyia klynycheskykh yspytanyi v Ukrayne. L. Shylovskyi. Retrieved from the-medical-practice.com/articles/la1
3. Dzvoniv H.R., Makhonko N.I. Medychne pravo navchalnyi posibnyk. H.R. Dzvoniv, N.I. Makhonko. Retrieved from 2009http://yport.inf.ua/meditsinskoe-pravo-uchebnoe.html
4. Muraveva E.V. (2012) Zashchyta prav patsyenta pry provedenyy medytsynskoho eksperymenta. Nauka y obrazovanye khoziaistvo y ekonomyka, predprynymatelstvo, pravo y upravlenye. No 8. Retrieved from http://www.journal-nio.com/index.php?Itemid=108&id=1292&option=com_content&view=article
5. Novykov D.A. (2005) Statystycheskye metody v medyko byolohycheskom eksperymente. Volhohrad. VolHMU. Retrieved from www.anomaliya.3nx.ru/viewtopic.php
6. Bioetyka medyko biolohichnykh eksperymentiv. Moralni pryntsypy provedennia eksperymentiv na tvarynakh. Retrieved from intranet.tdmu.edu.ua/data/kafedra/internal/deontologi/lectures_stud/uk/med/biol/ptn
7. Konechnyi R., Boukhal M. (1983) Psykholohyia v medytsyne. Praha Avytsenum.
8. Abramova H.S., Yudkevych Yu.A. (1998) Psykholohyia v medytsyne. M., p. 87.
9. Chystov V.V. (2005) Medytsynskaia psykholohyia. Uchebnoe posobye dlia studentov psykholohycheskykh otdelenyi.
10. Hottsdanker R. (1982) Osnovy psykholohycheskoho eksperymenta. Ucheb. posobye. Per. s anhl. R. Hottsdanker. M. Yzd. Mosk. Un., 464 s., p. 209.
11. Helsinska deklaratsiia 1964 r. Vsesvitnoi medychnoi asamblei Etychni pryntsypy provedennia medychnykh doslidzhen za uchastiu liudei yak subiektiv doslidzhennia, 1964 r. iz zminamy i dopovnenniamy. Retrieved from knigi-uchebniki.com/mejdunarodnoe-pravo_696/eticheskie-printsipyi-provedeniya-meditsinskih.html
12. Belousov Yu.B., Moyseev V.S., Lepakhyn V.K. (1997) Klynycheskaia farmakolohyia y farmakoterapiia. Moskva, Unyversum Pablyshynh.
13. Kashyntseva O.Iu. (2010) Pravovyi status liudyny v biomedychnomu eksperymenti. liudyna chy animal of necessity. Pravo Ukrainy, 2, p. 114.
14. Konventsiia pro zakhyst prav i hidnosti liudyny shchodo zastosuvannia biolohii ta medytsyny. Konventsiia pro prava liudyny ta biomedytsyny vid 1997 roku. Retrieved from http://zakon2.rada.gov.ua/laws/show/994_33
15. Proekt Zakonu Ukrainy Pro vnesennia zmin do statti 45 Zakonu Ukrainy Osnovy zakonodavstva Ukrainy pro okhoronu zdorovia, shchodo zberezhennia likarskoi taiemnytsi, No 3058 vid 06.08.2013 roku. Retrieved from http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=48005
16. Proekt Zakonu Ukrainy Pro zakhyst prav patsiientiv 1132 vid 06.12.2007 roku. Retrieved from http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=30982
17. Proekt Zakonu Ukrainy Pro prava patsiientiv v Ukraini 2649-1 vid 21.02.2005 roku.Retrieved fromhttp://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=23677
18. Proekt Zakonu Ukrainy Pro zakhyst prav patsiientiv. Retrieved from http://www.psoriasis.in.ua/law.php
19. Senyuta I. (2007) Zakonodavche zabezpechennia provedennia medyko biolohichnykh eksperymentiv, mizhnarodni standarty i natsionalnyi dosvid. Apteka.UA No 618 (47) vid 03.12.2007 r. Retrieved from http://www.apteka.ua/article/5829