The SIDCER activities are carried out by the regional fora, individually or collectively. The activities may be carried out in collaboration with organizations or individuals from the SIDCER Advisory Board or others. The focus of the activities is on developing ethics in health research within the context of local values and international standards. SIDCER develops regional and national capacity for ethical review based on the WHO/TDR Operational Guidelines for Ethics Committees That Review Biomedical Research and taking into account international ethical and regulatory guidance. SIDCER also promotes the development of quality assurance and quality improvement processes for ethics in health research, focused primarily on ethical review practices. Reference is made here to the companion guidance to the Operational Guidelines entitled Surveying and Evaluating Ethical Review Practices.
The activities of SIDCER are determined according to major goals (quantifiable key targets achievable over the next 2 to 5 years) and major strategic action items to plan, pursue, fund, and implement the activities required to achieve the mission. As an integral part of its growth and development as an initiative, SIDCER undertakes continual review of its operational and economic health, including analyses of the initiative's challenges/risks, opportunities/benefits to others, strengths, and weaknesses. The needs and requirements of the activities designed to achieve its mission are also continually reviewed. The initiative's mission, guiding principles, objectives, and vision are integral to the assessment of operations and activities.
The evolution of the SIDCER initiative is planned within carefully designed structure to achieve measurable aims and accommodate growth. This allows for orderly planning with appropriate separation and integration of operational activities. The definition of goals is followed by the designing of strategic actions that, step-by-step, achieve demonstrably the desired outcomes. Challenges are met by maximising resource usage through partnership, minimising risks to outcomes through rational planning, and maximizing benefits through careful research and consultation as well as consistent follow-up. The incremental approach to capacity-building in ethical review through the development and implementation of guidelines, education tools and programs, and pilot projects alongside the development of national fora allows the Project to address the potential weaknesses and limiting factors.
A. The Need
The need to foster independent and competent ethical review as an integral part of the research process has been well documented in recent years in all significant guidelines and reports addressing human subjects protections in national and international research. The development of goals (projected outcomes) and key strategic action items for SIDCER need to take into consideration this growing need the Project is designed to address. SIDCER targets the best of international expertise together with the required financial resources toward developing in-country and regional capacity. The unique partnership model based on ethical principles permits the development of public assurances that ethical review contributes responsibly to human subjects protection locally, nationally, and internationally. Assuring subjects, researchers and their institutions, as well as the public that human subjects protection is adequately developed and funded is a foremost concern of the Project. Potential or actual research participants and their communities require assurances that research has been properly reviewed by independent and competent committees and that researchers and their organizations are working according to the highest scientific and ethical principles. SIDCER also presents the most advanced model for addressing the growing concern for national and international assurances based on the quality improvement programme of ethics committees and research sites.
B. The Challenges
The primary challenge faced by the Project lies in addressing the need for the highest level of human subjects protection against the following background:
- the increased concern regarding the vulnerabilities of persons and societies in health research;
- the increasing awareness of the value of specific cultural manifestations in a world of increasing globalization, especially in the areas of economics and communication;
- the widening gap in healthcare between the wealthier and poorer segments of our societies;
- the increasing impact of scientific advancement on societies.
C. The Benefits
SIDCER provides a unique state-of-the-art approach toward advancing assurances for human subjects protections in health research in accordance with local values and international standards. Research participants, their communities, and the public at large are the direct beneficiaries of the SIDCER Project.
Ethics committees will benefit from the Project's development of operations and oversight responsibilities, including Standard Operating Procedures and accreditation processes. The promotion of local capacity and international dialogue by the Project will have a positive impact on ethics committees as well as researchers and their organizations.
The scientific community benefits from the Project's emphasis on education and awareness in ethics while taking into account scientific developments and the evolution of societal values. Funders benefit by having a direct avenue to the promotion of responsibility and social engagement in the ethics of health research.
The Project's commitment to assisting with the implementation of regulatory standards in an ethically sound research environment will benefit regulatory authorities and governments in the promulgation and enforcement of regulations.
D. The Strengths
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 at the local, national, and regional levels. The dedication and commitment of the regional fora to the advancement of their situation is the primary factor driving the project. The emphasis on developing independent and competent in-country ethical review committees and systems based upon local knowledge and cultural understanding contributes positively to the Project's development. Information gathering, knowledge sharing, and capacity-building across organizations, sectors, and regions create the required conditions to achieve the SIDCER mission.
The initiative's structural strength alongside its commitment to the expansion of partnerships provides the most innovative and sound approach to capacity building. The partnership of the fora for ethical review under WHO/TDR joined with leading international research organizations having shared values and commitments to the ethical conduct of research creates ground-breaking opportunities for the exchange of values, knowledge, financial support, and processes that combine these resources into a unique strength while avoiding the duplication of effort and investment.
E. The Weaknesses
A major area of concern is the need to establish long-term and sustained development in human resources and funding for local, national, and regional capacity-building in research ethics. The rapidly changing scientific, social, and political environments need to be monitored and taken into consideration at all times in the process of implementing effective development. In some locations, the lack of developed infrastructure has to receive direct and consistent support in order to achieve the Project's goals.
F. The Limiting Factors
The extent of knowledge, training, and resources at the regional fora level is a factor that could constrain the Project's development. Similarly, there is an ongoing need to develop the commitment and expertise of the international community with regard to the needs of human subjects protections. Most importantly, political will needs to be created and fostered at the national and international levels that will put health, health research, and human subjects protections at the top of the political agenda. Strong institutional support across sectors needs to be cultivated and sustained.