This application is in response to PAR-13-027, International Research Ethics Education and Curriculum Development Award. The proposed project builds on an existing relationship in biomedical research capacity- building and training between the University of Pennsylvania (Penn) and two Guatemalan universities, the Universidad de San Carlos de Guatemala (USAC), the country's premier public university, and the Universidad Francisco Marroquin (UFM).
We aim to contribute substantively to this endeavor by creating learning and practice opportunities in research ethics and the responsible conduct of research (RCR) for researchers as well as reviewers of research. Based in a new Ethics Support Center in the medical school at USAC, our two-pronged approach will develop a research ethics knowledge base in the Universities, and professionalize and enhance Institutional Review Board (IRB) capacities. The first activity comprises a faculty development and certification program designed to build in-country teaching capacity in research ethics and responsible conduct of research (RCR) we will also initiate an annual RCR training program for Guatemalan researchers, current and prospective IRB members, staff, and medical and other graduate students. Faculty trained as certified RCR teachers will join in the RCR training activities by year 3 of the grant, and take over the project courses to create a self-sustaining educational program at USAC. In parallel, we will enhance the capacity of IRBs at USAC and UFM in anticipation of and to facilitate the growing body of research expected of faculty and graduate students at these institutions. We will identify candidates who seek professional careers in IRB administration, provide English language and basic RCR training in Guatemala, followed by a 6-month fellowship training at the Human Research Protections Program at Penn that includes special training in medical English, followed by a field practicum at an IRB upon their return to Guatemala.
The aims of this project are to: 1) train a cadre of faculty in RCR and research ethics topics, curriculum design, teaching, and evaluation who are able to build sustainable research ethics education and training programs at USAC and UFM~ 2) develop and present a series of annual workshops on RCR and research ethics topics that will enhance ethics skills of USAC and UFM faculty, graduate students, staff, and IRB members who are engaged in research while providing hands-on teaching experience for Guatemalan faculty seeking certification as trainers in these subject areas~ and 3) train a staff of Guatemalan professionals to assume positions of administrative responsibility for IRBs in order to enhance and expand their capacities to review, monitor, and facilitate research at USAC and UFM.
The volume of biomedical and health-related research in Guatemala is growing rapidly, and it is critical that knowledge about how to do research well be matched by the knowledge of how to do it ethically, and that ethics review systems are in place to ensure human subjects protections are adequate. This project addresses these needs by developing a sustainable research ethics teaching base for research ethics in two universities, the Universidad de San Carlos de Guatemala and Universidad Francisco Marroquin, and by training a cadre of professional administrators to enhance capacity of their Institutional Review Boards.
