Bioethical chairs and courses | Ethical committees | Nongovernmental organizations | All centers
Название: Forum for Ethics Committees in the Commonwealth of Independent States
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:
· Exchange of CIS historical, cultural experience in bioethics and research ethics;
· Review of educational and ethics review system;
· Distribution and implementation of international documents and guidelines on bioethics and research ethics (through translation on local languages and round-table discussion);
· Review the value of the implementations the SOP in process of ethical review biomedical research;
· Identification the value of the implementations the SOP in achieving independence and competence in ethical review;
· Appreciation the role of ethics review system in following the standards of GCP and regulation in research;
· Ongoing implementation of the ethical review of biomedical research in the CIS;
· Increasing the role of education and training for members of EC;
· Appreciation the role of education and training for preparation EC for audits, inspection, registration and accreditation;
· Appreciation the role of EC for contribution to the development of international human subjects protection standards;
· Contribution to the development of states-members and country-participants National Ethical Committees Forums;
· Review of the current legal framework & practical considerations regarding human rights in biomedical research and health practices in CIS Member States;
· Review of proposals CIS model regulation on Ethics in Biomedical researches;
· Promotion of the approaches to implementing the Model Law ‘On the Protection of Human Rights and Dignity in Biomedical Research in the Member States of the Confederation of Independent States’ into Legislation and Practice in states-members and country-participants;
· Appreciation the equity and responsibilities in providing access to medicines and the role of Physicians, Researchers, Manufacturers, and Governments;
· Identification and establishing principles for access to medicines in CIS;
· Creation the network for discovering, developing, and providing medicines across the Public-Private demarcation line;
· Developing an CIS awareness and a Global Vision on access to medicines;
· Preparation ethics review committees for their role in regarding access to medicines before and after research;
· Training states-members and country-participants experts in ethical review procedures in order to build in-country capacity according to shared standards.
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:
· Development of competent in-country ethical review systems (manual of the model SOPs for EC in the CIS & Model CIS Law on Bioethics);
· Development of the Resolution on the Protection of Human Rights and Access to Medicines in Biomedical Research Conducted in CIS Countries;
· Development of Educational Tools for EC members and for Investigators (website www// feccis.net); manage data and information on ethical review, education and training programs in bioethics, legal questions in bioethics, international cooperation, and etc in 11 CIS states);
· Fellowship programs;
· Networking with other international organizations involved in protection human rights in biomedical research (EC, CE, WMA, UNESCO and etc.);
· Participation in several international Grunts for Education (f.ex. ”E-Education in Research Ethics: Central and Eastern Europe - Albany Medical College-Graduate College of Union University Bioethics Program (Schenectady, New York) in partnership with the Department of Medical History and Ethics of Vilnius University) and international scientific program on bioethics;
· Including in the SIDCER IEC/IRB Recognition Program «Human Subject Protection Course in Research”;
· Summarizing experience in the development of ethical expertise of biomedical research in the region with respect to their cultural and historical specifics;
· Producing a program template for data management of Ethics Committees’ tasks.
In general the ethical aspects of CT in the CIS are based on the development of systematic ethical review and ethical insight and responsibility on the part of researchers, sponsors, and government agencies and society. This process in connection with science and law needs to be translated into policy-level practice within government, research and education enterprises, and accepted by society. The approach should be global, across the CIS, throughout the world and focus on independence in ethical decision-making.
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