Abstract: The growth in research activity projected for the next decade by the Mozambican government and multiple international agencies highlights the continued need for capacity building in research ethics well into the future. With the groundwork laid for systems of basic, translational, clinical and public health research, parallel capacity development in research ethics will be essential to address critical locally relevant research questions in an ethically-consistent way. The four most evident areas in which attention is needed are: 1) ethics education, review and oversight of graduate and professional student researchers and their thesis research projects; 2) the burgeoning growth of research using biological specimens and clinical and epidemiologic data, including the development of biobanks and a national data warehouse; 3) research on the prevention and treatment of infectious and non-communicable diseases; and 4) international collaborative research that requires dual review and agreement on the authority of the potentially different regulatory requirements of partner countries. A team of experienced research ethics educators from UEM, UTSW, and VIGH, in collaboration with the National Bioethics Committee for Health (CNBS) seeks to renew the Formação Colaborativa em Etíca na Pesquisa, FoCEP (Collaborative Research Ethics Education-Mozambique). We propose a series of interrelated educational aims and activities intended to build capacity for ethical design, review, and conduct of biomedical research in Mozambique. The specific aims of this study are to 1) expand the cadre of Mozambican leaders in biomedical research with in-depth knowledge and practical skills in both research design and the ethical conduct of clinical and epidemiologic research through a tailored MPH program and masters-level curriculum enhancements at UEM; 2) enhance the knowledge and practical skills of Mozambican REC members and research educators in research ethics, RCR, and research integrity; and 3) further create, evaluate, and distribute curricular materials on research ethics and the responsible conduct of research tailored to Portuguese speaking Africa. After 5 years of collaborative engagement in phase one of FoCEP activities, the program implementation team is uniquely familiar with the country's challenges and are well positioned to further develop Mozambique's capacity in research ethics, ethical review of research protocols, and the provision of research ethics and integrity education to the country's next generation of health researchers. The team has comprehensive knowledge of research ethics and the responsible conduct of research; skill in health sciences education; and fluency in Portuguese that, together with its established relationships within the National and Institutional Bioethics Committees, Ministry of Health, and research-oriented universities, make it well suited to carry out this renewal program proposed here.

Project Narrative: The project Formação Colaborativa em Etíca na Pesquisa, FoCEP (Collaborative Research Ethics Education-Mozambique) will build upon successes of its first five-year period and continue to nurture a new generation of global health researchers from Mozambique in the ethical review of human participant research and the responsible conduct of research (RCR). This program will continue to strengthen the development and institutionalization of a system for ethical review of human research protocols in Mozambique's biomedical research institutions and newly developed Research Ethics Committees (REC). The present proposal has been developed in response to focused and carefully considered requests from the leadership of UEM and the Mozambican National Bioethics Committee for Health (Comité Nacional de Bioética para Saúde, CNBS) for VUMC's assistance in developing national capacity for ethical review of human studies protocols and teaching research ethics to biomedical and public health investigators.