Introduction of ethical standards in practice of clinical researches in the Russian Federation through system of ethical committees (summary)

© 2011 М.Е. Gurylyova, F.Т. Nezhmetdinova

2011 – № 2 (2)

Key words: bioethics, ethics committee, biomedical research, clinical trials, patient rights, standard operating procedures, safety of life and health, ethical expertise

Abstract: The article advocates the necessity of the protection of rights of the participants to biomedical researches. In 1998 an ethical committee of Kazan state medical university was created. The committee has got the republic-wide jurisdiction in 2003. Through the example of the work of the Ethical committee of Tatarstan Republic principles and standard operational procedures of ethical expertise are analyzed by the authors.

The article shows that in modern conditions of society democratization carrying out of biomedical researches and clinical tests of medical products put a problem of safety of life and health of the person. Health of the person is considered as set of physical, mental and social well-being and is social value. The international experience shows that for maintenance of guarantees of social protection and safety of health of the population at rendering of the medical and pharmaceutical help, working off of the special mechanisms providing this protection by means of special bodies – ethical committees is necessary. In Republic Tatarstan the ethical committee has been created in 1998 at the Kazan state medical university, in 2003 to it the status of the republican has been betrayed.

Maintenance of effective protection of the rights, safety, well-being and advantage of the person and separate groups of the population in the field of health protection, at use of modern achievements of biology, medicine, in system of practical public health services, in the conditions of obligatory medical insurance and presence of the market of private medical services became the purpose of creation of such committee.

The committee has done a big job, training researchers and members of committees on ethics in the territory, has introduced standards of ethical examination recommended a CART, the first in territory of the Eastern Europe has received certification the CART and the document, testifying that it carries out the work with quality at level of the international standards. Its forces in republic started the project – the Russia conferences on ethics and the medical right. The first has taken place in 2009, the second is planned in June, 2011

In 2009 in connection with great volume of loading on supervision over research activity at the Kazan in Kazan state medical university was created local ethical committee which is coordinating scientific researches in the field of bioethics and perfection of teaching of bioethics and the medical right.

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