The SIDCER-FERCAP Foundation

In an effort to address the fundamental ethical gaps and challenges encountered in global health research, the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) was founded in 2001 by the World Health Organization under the Special Programme for Research and Training in Tropical Diseases (WHO-TDR). Focusing on grass-root initiatives, SIDCER was formed as a network of independently established regional fora for ethical review committees, health researchers and invited partner organizations from the Asia and Western Pacific region (FERCAP), former Russian states (FECCIS), Latin America (FLACEIS), Africa (PABIN) and North America (FOCUS) with one shared goal: to contribute to the global protection of human subjects by developing the local capacity for ethical review and raising understanding of ethics in health research.

In honor of SIDCER's founding, WHO-TDR published the Operational Guidelines for Ethics Committees that Review Biomedical Research as a contribution towards the development of an international standard for quality ethical review. The Guidelines take into consideration the established international guidelines on ethical review requirements as well as existing practices of ethical review from countries around the world and serve as a basis upon which ethics committees can develop their own Standard Operating Procedures (SOP) for ethical reviews of biomedical research. Riding on the tail of this success, WHO-TDR also developed and published the Surveying and Evaluating Ethical Review Practices Operational Guidelines in 2002. This set of Guidelines, published in complementary to the first set of Operational Guidelines, were developed as a tool to facilitate and support the development of an international framework for surveying and evaluating ethical review practices to ensure transparency in the work of the ECs. These two Guidelines, together with the existing international ethical and regulatory guidance, are the guiding principals in SIDCER's endeavors to guide and support the development of regional and national capacity for ethical review.

As an initiative of the organization, SIDCER collaborated with many institutions worldwide to hold activities which provided SIDCER's members and other independent ECs the opportunity to open up dialogue, exchange ideas, and challenge as well as help each other in developing their own capacity for ethical review. These activities included training workshops on Human Subject Protection and SOP development, international conferences on emerging ethical issues in biomedical research, as well as a 6-month fellowship program in collaboration with WIRB that provided advance training for EC members.

After 2004, SIDCER broadened its focus to also include the development of the capacities of individual researchers in addition to the development of the ECs as a whole. This decision was made out of SIDCER's ambition that individuals should have the capacity to recognize as well as practice ethical research and thereby also be able to evaluate the quality of the ECs in their respective countries. In conjunction to this endeavor, SIDCER also began to lay the ground works for the development of a new program specifically aimed towards the monitoring and evaluation of ethical review systems for the continuous quality improvement of ECs worldwide. Launched in 2005 as the SIDCER Recognition Program, the program assesses the quality of ECs through the evaluation of 5 criteria: (1) the structure and composition of the EC; (2)adherence to specific policies for ethical review, (3) the completeness of its review process, (4) the after review process, and (5) documentation. This methodological approach has received endorsement from WHO-TDR and has led the program to its growth over the years. Since its conception, the program has become internationally acknowledged with over 200 recognized ECs from over 12 countries around the world.

In 2012, due to the rising focus on Asia and Africa as the centers for clinical trials, in conjunction with the urgent need for the rapid development of a competent ethics review system in these 2 regions, SIDCER resolved to focus its resources and attention on its members that were experiencing the greatest difficulties: FERCAP (Asia and Western region) and PABIN (Africa). In the same year, SIDCER moved its office to Thailand due to the support its received from the National Research Council of Thailand and the Office of Human Research Protection of Thailand, leading to its closer working relationship with FERCAP's on-going local initiatives.

While in Thailand, SIDCER also worked together with the Middleton Foundation for Ethical Studies to develop the Middleton Foundation for Ethical Studies Global Fellowship Program - an 18-week international course whose aim is to train and guide young researchers in building their individual capacities in ethical review to better protect human subjects in biomedical research. Through the exchange of ideas and experiences, the fellows are encouraged to broaden their perspectives and challenged to critically approach current practices of ethical review of ethics committees around the world. From the knowledge they have gain from the program, it is hoped that both new and established members of ethics committees will be inspired to promote ethical research in their various research fields. Since the Fellowship Program welcomed its first class in 2015, over 30 fellows have already graduated from the program and return to make an impact on the ethical review practices in their institutions.

Due to SIDCER's and FERCAP's beneficial collaboration over the years, initiatives began in 2015 for a long term collaboration that could pave the way towards aiding other grass-roots initiatives to work closely with their respective national system in developing a national accreditation system. On September 25, 2017, after 2 years of preparation and planning, the SIDCER-FERCAP Foundation for Promoting the Development of Human Research Ethics was successfully established.

The Vision of the SIDCER-FERCAP Foundation is globalizing Ethics in health research, fostering quality improvement and sustaining international standards for the enrichment of human subject protection.

The Mission of the SIDCER-FERCAP Foundation lies in the fostering of competent, independent, in-country decision making in order to promote responsible conduct of human research and to monitor the quality and effectiveness of ethics review worldwide, with mutual understanding and respect for cultural, regional and national differences.

The Objectives of the SIDCER-FERCAP Foundation are as follows:

• To promote the development of Research Ethics in health research and to ensure that research is conducted in compliance with the principles of international research ethics;

• To promote the survey and evaluation system of Ethics Committees for continuous quality improvement;

• To collaborate with public educational institutions , governmental agencies and private organization in holding activities that strengthen the capacity for ethics review in research;

• To promote the conduct of research ethics and disseminate the results to address the ethical issues in health research;

• To act as the interdisciplinary research and development information center for printed and digital media as well as data from the internet;

• To collaborate with research institutions and human research ethics committees, both domestically and internationally, to promote and develop ethics in research;

• To promote the training of human resources related to human research; and

• To not be involved in any political agenda.

• The SIDCER Recognition Programme

• Facilitating the establishment of National Accreditation systems

• Mentoring EC/IRB members regarding international ethical review standards

• Capacity-building of EC/IRB members

• Networking with international research institutions