The main reasons of the setting up the Ethics Committees in the CIS is the reflex of the global dialogue on the Best Practice in Health Research. This process grows out of the international partnerships developed by the TDR/WHO project “Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)”. On the platform of the SIDCER vision – to promote the dignity and rights of all human participants in health research globally, and SIDCER mission – to built competent, independent, in-country decision-making for promoting responsible conduct of human research through its international network of Fora, the regional Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) was established in 2001 in the international conference of the representatives from CIS countries involved in ethical evaluation of biomedical research and education on bioethics.  

 

 Sharing the SIDCER idea to promote the quality of ethics review worldwide, with mutual understanding and respect for cultural, religion, and national differences, setting up the Ethics Committees in the CIS should be significantly different in various nations, but at the same time needs collaboration and could be harmonized because of common background, such as: interest and ability of the health-care system in the CIS to participate in international CT and interest and motivation of pharmaceutical industry to involve the CIS's health-care system in multi-central CT. Besides this in the begging of FECCIS’ activity there were the communication problems partly due to lack of appropriate regulations, information and resources, and such reality as absence of ethical review system in some CIS, or even ECs in some institutions conducting research; heterogeneity in EC systems and procedures, no monitoring/follow-up and archiving system, problems with informed consent process and inadequate training of EC members.

 

In compliance with these base features the performance measures of FECCIS started in the following directions as the development of competent in-country ethical review systems - through establishment system of EC, education and training for EC's members and legal issues: assisting national health authorities with the development of national guidelines - through presentation and adaptation of international guidelines, creating the competent in-country ethical educational programs that are integrated into university curricula - through creation of courses in bioethics in medical universities, developing human subjects protection programs of which ethical review is a part - through discussion in IPA of the CIS and including model laws and contributing to the international discussions on ethics in health research - through publications,  participations in international meetings and projects.

 

So the main purpose of FECCIS establishment and activities is the integration of CIS into the world system of biomedical research with regard to safeguarding ethical standards of human rights protection and harmonization of regulative and methodological space to safeguard protection of human rights and dignity of biomedical research participants in CIS.

 

For achieving this purpose FECCIS activity is focused on legislative, methodological, educational and informational initiatives.

 

FECCIS legislative initiative was realized through the creation on Model Law ‘On the Protection of Human Rights and Dignity in Biomedical Research in the Member States of the Commonwealth of Independent States’ in the frame of Permanent commission IPA CIS on the social policy and human rights. This Law is intended to ensure the protection of honor and dignity, of rights for safety and health and also of interests of research participants. It is also intended to ensure credibility and reliability of research results and to create single lawful space inside and outside CIS’s region. The Model Law regards ethical review and scientific review of biomedical research to be the basic measure for protection of each individual and communities participating in the research.

 

Methodological, educational and informational FECCIS  initiatives includes the organization the series of conferences and workshops in the different CIS states, creation the text book for Standard Operational Procedures (SOP) for Ethics Committees in the CIS and the setting up the FECCIS web site.

 

The main objectives of the series of conferences and workshops, which took place in 2001 - 2005 years (Saint-Petersburg, Russia, 2001, 2003, 2005; Kiev, Ukraine, 2001, 2004; Almata, Kazakhstan, 2002, 2005; Baku, Republic of Azerbaijan, 2004; Minsk, Byelorussia, 2005; Tashkent, Uzbekistan, 2005 and Yerevan, Armenia, 2005) were the creation of a single legislative and normative basis for the protection of human rights and dignity in biomedical research conducted in CIS countries, to contribute the development of legal consideration for ethical review in the CIS to clarify the responsibility of ECs to ensure access to medicines in research through wide international discussion. Within this framework, the following specific objectives have been achieved in each of the workshop:

 

 

One of the most important opportunity in these meetings was the evaluating by the WHO, EC, CE, UNESCO, WMA, EFGCP, DHHS, USA, National Ethics Committees from different countries (Baltic States, Belgium, Canada, Germany, Spain, Italy, Netherlands, etc) rapporteurs on different aspects of the international fundamental guidelines such as Nuremberg Code, International Code of Medical Ethics of WMA, The Declaration of Helsinki, EC Convention on Human Rights in Biomedicine, The CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, WHO and ICH Guidelines for Good Clinical Practice, and the WHO Operational Guidelines for Ethics Committees That Review Biomedical research and etc.

The FECCIS activities current outcomes are covered the following areas in complains with Strategic Plan of SIDCER: