This project is designed to meet the needs of Romanian institutions for expertise in research ethics. First, the project will help prepare a core group of faculty members who have already received basic training in research ethics to take the lead in establishing a Masters program in “Medical Research Ethics and Methodology” at Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca (UMF), the leading Romanian institution for biomedical research. They need to build upon their prior basic training in research ethics and develop advanced knowledge and skills in this subject matter. They also need to earn Masters degrees in research ethics to be credible leaders of the Masters degree program. To accomplish this goal, our program will provide Masters degree training and mentorship for faculty from Cluj-Napoca, Romania. With training, mentorship, and that critical credential, those faculty members will be able to provide Masters degree training for faculty from Romania and Moldova, a neighboring country where Romanian is also spoken. In turn, the UMF Masters degree training will enable others in their region to develop the requisite knowledge and skills to provide research review, education, and assure compliance with international standards for the ethical conduct animal and human subject research at their home institutions. A faculty team from Icahn School of Medicine at Mount Sinai (ISMMS), together with its partner, the University of Belgrade School of Medicine, has been conducting a Fogarty International Center NIH educational Certificate program providing basic research ethics education in the Balkans and Black Sea region for the past five years. ISMMS is a leading U.S. medical institution, currently ranked 13th in biomedical research funding. The ISMMS faculty members participating in this project have significant experience in conducting clinical research, and both empirical and theoretical ethics research. They have extensive experience in human and animal research review and oversight, leadership roles in teaching courses on the ethical conduct of research, bioethics, and research methods. The Cluj-Napoca Masters curriculum will build upon the curriculum of our successful Fogarty Certificate program. The development plan is comprised of two key elements: (1) providing advanced research ethics training for Masters program faculty and (2) supporting that faculty in their development and implementation of a Masters curriculum in research ethics. Faculty development will include: enabling faculty members to complete a Masters in Bioethics in the Clarkson-ISMMS Bioethics Program, providing skills training, co-teaching experience, practical experience with research review, consultation and guidance throughout the curriculum development and implementation process. The continuing education for faculty development will employ distance learning technology where feasible and on site education.

This project is designed to meet the needs of Romanian institutions for trained faculty members who can provide requisite expertise and assure compliance with international ethical standards for conducting animal and human subject research. To accomplish these aims, we will provide training and mentorship for faculty members from the Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, the leading Romanian institution for biomedical research, and guide them in the establishment of a Masters program in “Medical Research Ethics and Methodology.”