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Background information about the Committee

The Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies (hereinafter referred to as the ''Committee'') is the independent local research ethic committee. It was established in 2000 by Moscow State University of Medicine and Dentistry, Russian Academy of Medical Sciences, Society for Pharmacoeconomics and Outcomes Research, League to support clinical studies and Scientific Center for medical information ''Universimed'', have made, executed and signed corresponding Agreement.

The status of the Committee corresponds to the non-profit-making organization without establishing a legal person. It is not a constituent element of regulatory approval system that governs the pursuance of clinical studies of the Ministry of Health and Social Development of the Russian Federation. Carrying out by the Committee of expertise shall be implemented on the initiative of applicants only and by virtue and according to their voluntary appeal.

The Committee's activity shall be regulated pursuant to standard operating procedures (SOPs) being integral appendices to Statutes on Committee.

The multidisciplinary nature of the Committee shall be considered as its key feature. The differently-skilled experts from various areas of medicine and public health experienced in ethical review of clinical studies and possessing expert knowledge in the issues related to security of rights and interests of participants in clinical trials as well as some persons without medical education are the members of the Committee.

The Committee holds meetings where they examine materials of proposed and current clinical trials at least monthly.

In a decade the Committee gathered considerable experience in the area of ethical review of clinical trials. The Committee's members improve their proficiency in the area of ethics on a regular basis, they participate in Russian and international conferences and workshops.

The Committee entered into the Agreement on cooperation with Freiburger Ethik-Kommission International – feki (www.ethicscommission.com), one of the oldest European ethics committee (founded in 1980) for the purposes related to high quality assurance in the activities of research and ethics committees in Russia and Germany. Regular meetings, exchange of information in the area of ethical review and exchange of experience on issues relating to ethical solutions and etc. contribute to improvement of the Committee's activity.

The Scientific Center for medical information ''Universimed'', acting in capacity of administration and secretary of the Committee, implements managerial and engineering support of the Committee's activity.

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