Executive summary and introduction

Executive Summary

The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of independently established regional fora for ethical review committees, health researchers and invited partner organizations with an interest in the development of ethical review. The regional fora are composed of Asia and Western Pacific (FERCAP), former Russian states (FECCIS), Latin America (FLACEIS), Africa (PABIN) and North America (FOCUS). SIDCER formally began through the formation of these fora.

SIDCER was established to address the fundamental ethical gaps and challenges encountered in health research globally. As an international partnership, SIDCER focuses its activities on developing global capacity in ethical review and Good Research Practices. It has developed out of the capacity-building activities of WHO/TDR in cooperation with the national and international research organizations. For the first few years of its existence, SIDCER will be a WHO/TDR collaborative initiative, and will become independent when it can sustain itself. The primary objective of SIDCER is to contribute to human subject protections globally by developing capacity in ethical review and the ethics of health research

The SIDCER vision is to ensure protection for all human participants in health research globally. The SIDCER mission lies in fostering competent, independent, in-country decision making for promoting responsible conduct of human research through its international network of For a, and to monitor the quality and effectiveness of ethical review worldwide, with mutual understanding and respect for cultural, regional and national differences.

This international network provides a voice for human subjects research issues in national, regional, and international healthcare settings. The strength of the SIDCER Project lies in its partnership model that fosters a grassroots (bottoms-up) approach placing primary responsibility and decision-making authority in the hands of the Fora that operate at the local, national, and regional levels. The dedication and commitment of the regional Fora is the primary factor driving the project. The emphasis on valuing local knowledge and cultural understanding contributes critically to the Project's evolution and success. Information gathering, knowledge sharing, and capacity-building across organizations, sectors, and regions create the required conditions to achieve the SIDCER mission.

This Project Plan follows from two years of experience, research and discussion of concerned individuals from around the world. The primary goals of this Initiative include: development of regional and local Fora for ethical review; establishment of national, regional, and international partnerships with organizations that can provide support and guidance; ongoing improvement in the quality of ethical review processes; expansion of health research ethics education and training; development and dissemination of best practices for ethical review; provision of venue for regional input into international discussions of research ethics; assurance of subjects, researchers and their institutions, and the public that human subjects protection is adequately addressed; mobilization of resources to ensure the sustainability of local, national and regional Fora. This Project Plan covers the formation and implementation phases of the SIDCER initiative with regard to establishing a Secretariat, Steering Committee, Advisory Board, developing Standard Operating Procedures (SOP's), hiring/training staff, and developing fund-raising capacity in order to establish a framework of financial sustainability and effective project implementation. The Plan reviews the initiative's strengths and weaknesses, challenges and benefits, setting out the objectives, vision, and guiding principles needed to achieve the SIDCER mission The plan establishes realizable goals supported by a strategic approach to funding and execution over a two to five year period.

Introduction

The increasing globalization of health research has led to new opportunities for fighting disease and improving healthcare around the world, particularly in resource poor countries. Global awareness has been raised on the importance of human subject protections and ethics related to health research. Every research project should be required to undergo proper scientific and ethical review, particularly within the country where the research is to be undertaken. However, in many countries in the world today where important research needs to be conducted, insufficient procedures, knowledge, and understanding exists regarding proper ethical review and oversight. An improved structure for approaching and debating health research ethics is required. A renewed focus has recently been placed on the importance of independent and competent ethical review being established in all countries where research is carried out.

The need to foster independent and competent ethical review as an integral part of the research process has been well recognized in recent years. However, there has been no entity to ensure that ethical review and protection of human research subjects is provided throughout the world. SIDCER was founded as a project within WHO/TDR in 2001to address the fundamental ethical gaps and challenges encountered in global health research. The SIDCER network of regional fora creates unique opportunities for professional development and learning while fostering innovative approaches to cross-cultural, cross-national, and cross-regional understanding and mutual support. SIDCER has created a unique partnership model which brings together under one roof the following equals:

  • the individuals who have created the most up-to-date international expertise in human research protections in the West;
  • the most concerned and capable individuals of the developing world;
  • several key scientists from WHO/TDR, with the trust, leadership, and resources to make the partnership work for all parties.

Assuring subjects, researchers and their institutions, as well as the public that human subjects protection is adequately developed, implemented and funded is a foremost concern of the Project. SIDCER will address the critical concern for national and international assurances based on the quality improvement of ethics committees and research sites. The Project is committed to assisting with the implementation of regulatory standards and to support regulatory authorities and governments in the promulgation and enforcement of regulations.

This Plan is based on two years of research and discussion by the Project Development Team under the leadership of WHO/TDR, involving the leading research and ethics organizations, as well as governmental and intergovernmental organizations. The plan presents a strategic approach based on a careful and disciplined analysis of the complex cultural, social, economic, and political realities of defining global health research today. It establishes an initiative modeled on the ongoing development of partnerships and continuing innovation that permits a stabilizing approach to the dynamics of global developments in science and ethics as well as the ever-shifting organizational, economic, and political exigencies of today's societies.

The planning process has involved a careful analytic approach to the needs of the initiative from a variety of perspectives, including those of various cultures and research communities, the varieties of kinds and approaches to health research, the challenges and controversies in contemporary research ethics, and the needs and interests of researchers and their organizations.

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