Extract from the Statutes on Committee
(approved by the Meeting of members under Agreement on 7.12.2000, supplemented on May 31st, 2010, amended on June 10, 2011, amended on February 14, 2014)
The Committee is independent from political, administrative-and-managerial, official, collegial, financial and economic impacts. The main objective of the Committee`s activity will be contribution to compliance with rights and interests of the participants of clinical trials, and code of ethics at the stage of their bringing to correspondence with the Good Clinical Practice (GCP).
The Committee shall perform its activity pursuant to the standards and requirements formulated in the following documents:
- World Medical Association`s Declaration of Helsinki (amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013),
- Recommendations to be given to the Ethics Committees which carry out expertise of biological and medical investigations of World Health Organization and EFGCP,
- Consolidated Guideline for good clinical practice (ICH E6)
- Federal Drugs Circulation Act, No. 61-FL, 12.04.2010,
- National Standard of the RF GOST-P 52379-2005 «Good Clinical Practice» (ICH E6 GCP), approved by the order of the Federal Technical Regulation and Metrology Agency, 27.09.2005, No. 232-ñò,
- Order of the Ministry of Health of the Russian Federation, June 19th, 2003, No. 266 «Adoption of regulations related to clinical practice in the Russian Federation»,
- any other current international statutory regulations and acts of the Russian Federation related to activities of ethics committees and carrying of clinical trials, as well as by virtue of these Statutes and standard operating procedures (SOPs), being the annex to these Statutes.
In the course of its activity, the Committee shall take into consideration the following statutory regulations:
- Directive 2001/20/EC of the European Parliament and of the Council of April 4th, 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in carrying out of clinical studies on pharmaceutical products for human use,
- «Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use» (ENTR/CT 2, 2006),
- ISO 14155:2011, Clinical investigation of medical devices for human subjects – Good clinical practice,
- «Ethical considerations for clinical trials on medicinal products conducted with the pediatric population» (2008),
- «Clinical Safety Data Management: Definitions and Standards for Expedited Reporting» (ICH E2A),
- Good epidemiological practice – GEP.
The Committee has proper authorities in order to approve or to waive such approval as to:
- review of clinical trials, non-interventional studies and other scientific medical studies at the stage of their scheduling;
- introduction of amendments and additions into the study protocol as well as any other files associated with current research;
- continuation of study in case of unwanted, negative consequences associated with the use of given medications.
The Committee shall have the right to direct inquires in relation to observance of corresponding rights of the participants in studies and the ethics to applicants, to monitor a clinical study from the perspective of ethics and law, to inform investigators, medical organizations, on the base of which the studies are being implemented, regulatory agencies, corporate sponsorship and other engaged organizations in connection with any breach of the rules for carrying out of clinical trials. Moreover, the Committee shall notify the same organizations and agencies in case of commencement of a study without the Committee`s approval.
The Committee shall not have any rights to prohibit any clinical trials or to give publicity to information which related studies and their participants without the agreement of the trials participants and sponsors.
The Committee will be obliged:
- to accept, for ethical expertise, any documents and files from all applicants notwithstanding their departmental and/or national identity, to examine them and to render decision in accordance with the established procedure;
- to guarantee to the applicant confidentiality in the relation a material of trials;
- to hold Committee`s meetings at least monthly;
- before commencement of studies to implement intensive review of submitted documents, to evaluate risks and benefits ratio for patient-participant of study, considering the fact that certain rights, safety and interests of such patient-participant of study shall prevail the interests of science and State;
- to publish annual report related to its achievements.