Ustawi Research Institute
Ustawi collaborates with principal investigators in major universities and colleges for qualitative and quantitative studies. All formal research carried out in this manner must be subject to academic and institutional review boards of Ustawi and the sponsoring institution.
Through its collaboration and partnership development, Ustawi has created an arsenal of investigators from many countries around the world, and intends to continue building relationships until all countries are represented on Ustawi platform.
Ustawi will help clients seeking to conduct formal research in all academic disciplines including basic sciences of biology, physics, chemistry, geography, economics, sociology, and the like. Ustawi is also gearing up to support applied research in medicine such as clinical trials administration, architecture and design, applied engineering, law, leadership and governance.
Clinical Research Administration
Emerging and frontier countries suffer from a disproportionately high percentage of the global disease burden while possessing remarkably low investment in health research. Clinical trials and other directed research engagements are particularly important for finding new preventative measures, diagnostic and therapeutic interventions that would address prominent diseases such as HIV/AIDS, TB, malaria, sleeping sickness, and cancer, hypertension etc. Such trials have to be supported by Good Clinical Practice guidelines, informed consent, ethical review, genetics, and other areas, taking into account the specific needs of communities living in emerging economies and frontier markets.
The general problem is that preventable diseases continue to kill many people in frontier countries. High incidence of disease and death results from lack of medical products and services. Medical products include medical drugs and medical devices; medical services include health services provided by medical professionals such as doctors, clinical officers and nurses in a clinical setting.
Medical products are lacking because of absence of a thriving medical manufacturing industry. Creation of thriving pharmaceutical and medical device industry resulted in generalized improvement of health and wellbeing of people living in developed countries. The development of such an industry predicates upon a well organized human clinical research capability.
The specific problem is that organizations that could facilitate the conduct of human clinical research within the African continent are very few. Consequently, medical products manufacturers are unable to introduce medical products in Africa which are not evaluated through an African human clinical research organization. Human research professionals in the academia hardly explore research possibility in Africa in the absence of a facilitating human clinical research organization working in the continent.
The purpose of URI Clinical Research Program is to facilitate conduct human clinical research in Africa. The URI Clinical Research Program helps manufacturers to evaluate medical products and services in the African populations. In addition, the program facilitates human research possibility among the human research professionals in the academic setting in Africa, through Ustawi University Partnership program.
The vision URI Clinical Research Program is to become the foremost clinical research organizations with the most advanced clinical research capability in the frontier markets.
Mission is to establish clinical research cap work with industry and academia as a contracting research organization to conduct at least five (Phase I to IV) clinical trials in Africa by five years.
URI Clinical Research Program operates as a contract research organization facilitating conduct of clinical research in African countries. The organization has developed core competency for clinical research administration in compliance with the generally accepted code of conduct governing the ethical aspects of human research embodied In Declaration of Helsinki (World Medical Association, 1964/1975/2004/2008) and the Nuremberg Code (1947).
To ensure sustainable supply of human resource, URI Clinical Research Program trains clinical research professionals from cadres of already training health workers such as registered nurses, clinical officers, and physicians in Africa. Specific areas of training include standards of practice of clinical research, good laboratory practices (U.S. Food and Drug Administration) and good clinical practices (International Conference on Harmonization, 1996).
URI Clinical Research Program engages the local people to establish a permanent dialogue about the importance of clinical research. Such a dialogue is critical to acceptance of culture of beneficial human research by the local people. The dialogue establishes the value of informed consent in ascertaining research integrity as stipulated in the Nuremberg Code of 1947.
URI Clinical Research Program helps the industry to understand the local regulatory environments. Specifically, the organization files all regulatory documentations with relevant authorities in the country. TURI Clinical Research Program has acquired deep understanding of the terrain of drug regulation and clinical trials administration in African countries such as Nigeria, Uganda, Tanzania, Rwanda and Burudi. URI Clinical Research Program helps the industry to evaluate medical products and services in the African populations.
The cost of conduct of clinical research is a serious concern to the academic departments conducting human research in the developed countries in Europe, Japan and United States. Clinical trials procedures, ranging from initial documentation, to recruitment of human subjects, to the conduct of clinical trials, to the development of the final reports are prohibitively expensive in developed countries. These prohibitive costs leave the academic research department seeking for partners in other regions of the world where the cost of research is much lower. In the recent past, institutions in developed countries have engaged partners mainly in China and India. African countries are left unattended.
URI Clinical Research Program draws agreements with departments of human research in academic organizations such as universities and colleges. The program provides technical assistance to American, European, and Japanese academic human research departments seeking opportunity to conduct clinical trials in Africa.
URI Clinical Research Program uses the platform created for the industry described in the previous section to facilitate collaborative clinical research administration in Africa. This collaborative outsourcing of clinical research is win-win strategy for the academic human research departments in developed countries and the local people; the academic departments gain access to large and diverse target populations at a substantially lower cost.
Forward looking African leaders are encouraging their governments to shape policies that facilitate science and technology innovation aligned to the needs of the local people. URI Clinical Research Program partners with country governments in development of domestic policies that support best practices for conduct of human research. The government liaison office in Ustawi translates the prevailing knowledge in clinical science for formulation of policies that are beneficial to the nation.
International development agencies and donor organizations are stunned by lack of effectiveness of donor funded projects. Well funded projects often fail at implementation. Some projects are initially successful, but are followed later by negative side effects, following the law of unintended consequences. Failure at implementation of well funded development initiatives is a relevance paradox.
Diaspora nationals of economically disadvantaged countries make tremendous effort to assist local nationals, but generally rely on disparate and small-scale programs to assist in the development back home. Despite this fragmentary approach, some diaspora nationals have (a) built schools, hospitals, and roads; (b) run training programs; (c) supplied books and computers to deprived schools; and (d) established scholarships to assist students through school. These efforts are located outside of the sphere of mainstream national development agenda.
In the mainstream, the diaspora nationals play an important role in parent country's development on two levels:
direct investment, sharing of personal and technical skills, tourism, education, philanthropic and charitable work; and
participating in civil societies and voluntary agencies, lobbying for change, and working to develop external business and diplomatic relations in the host countries
Thus, remittances by diaspora nationals could play a powerful role in opening up financial systems mobilizing savings, and generating small business loans. Diaspora nationals of developing countries are critical to scientific innovation and invention of clinical products and services in their parent countries.
Local nationals of economically disadvantaged countries account for as much as 84% of world population, and 93% of the worldwide burden of disease. By contrast, they represent only 18% of global income and 11% of global health spending. There is a strong correlation between economic strife and burden of disease among the local nationals. The local nationals are the victims of symptomatic events based interventions with the attendant recurrent fixes-that-fail, and shifting-the-burden, inherent of the global health and human development programs. Local people benefit from products of clinical research such as new medicines, new devices, and new ways of delivery of care.