Graduate Program in Bioethics in Research

PROYECT SUMMARY Project: Graduate Program in Bioethics in Research PD/PI Names: Montoya, Juny and Fernández Pinto, Manuela Organization: University of los Andes Project Period: 07/05/2022 - 06/30/2027 This R25 project implements and evaluates a two-year, fully online Master's program in Bioethics in Research at Universidad de los Andes (Bogotá, Colombia). The program combines an interdisciplinary, problem-based curriculum with applied, mentored experiences to build competencies in research ethics, responsible conduct of research (RCR), and the ethical analysis of health research and health systems. A defining pedagogical objective is to prepare graduates as train-the-trainer leaders who multiply high-quality research ethics instruction across institutions in Colombia and Latin America. A clear scientific rationale supports the foreign component. Colombia is an active site for NIH-funded biomedical research. A search of the NIH RePORTER database identifies multiple currently active grants in Colombia, including studies on Alzheimer's disease and related dementias (TW012455, UCSF / Universidad Javeriana, 2024-2029), zoonotic and vector-borne disease research (D43TW010331, Colombia-U.S. Fogarty program), and dengue/arboviral surveillance studies supported by NIAID. Colombia also hosts institutional ethics committees registered with the U.S. Office for Human Research Protections (OHRP) under Federal-Wide Assurances (FWAs), which are required to review and approve all NIH-funded human subjects research conducted in the country. As the number and complexity of U.S.-Colombia research collaborations grow, so do the demands on local capacity for ethical protocol review, consent quality, participant protections, data stewardship, and regulatory compliance aligned with U.S. standards. These training contexts, site needs, and trainee populations cannot be fully accessed or replicated through U.S.-based activities alone. The project has direct potential to benefit American health. When Colombian ethics committees and researchers lack the expertise to ensure rigorous consent processes, protocol review, or data security, the evidence generated at these sites is compromised, as illustrated by the well-documented case of the Caucaseco malaria research center in Cali, where NIH ultimately withdrew funding following failures in ethics oversight, including studies conducted without proper informed consent and without mandatory regulatory approval. This program is designed to prevent such failures by systematically strengthening research ethics capacity at the institutional level. By improving competence in protocol review, participant protections, data stewardship, and oversight practices (and by training graduates who can teach these practices to others) this program enhances the integrity, reliability, and operational quality of multi-site research that contributes evidence relevant to prevention, diagnosis, and treatment decisions affecting Americans. Infectious diseases studied in Colombia (including arboviruses such as dengue, Zika, and chikungunya; tuberculosis; and antimicrobial-resistant pathogens) pose growing threats to U.S. populations through globalization and population movement, making ethically sound Colombian research directly relevant to U.S. public health.