This project will build capacity in international research ethics in China. The primary focus will be a 2-year program of Master's level training focused on international research ethics to at least 30 Fellows from China, with the objective of preparing them to establish or significantly enhance research ethics training programs, Institutional Review Boards (IRBs), and/or compliance offices at their local institution. In this way, the impact of the training of these 30 Fellows will be greatly amplified in the years to come. The instructional program provided to the fellows will be tailored to each individual needs, based on their prior knowledge and experience, their specific interests, and their specific local environment. The curriculum will include (a) instruction in research ethics provided through workshops, seminars, and coursework taken primarily in China and at the University of Pittsburgh, (b) training in professional development (e.g., publishing research articles, preparing proposals, project management, and evaluation) and the aspects of responsible conduct associated with those skills, (c) instruction and involvement in the design, development, and management of research programs, (d) attendance at selected meetings of IRBs at the University of Pittsburgh, as well as discussions with the administrators of those units that will focus on preparing the participants to establish and direct such programs in China, (e) visits to IRBs at additional institutions, (f) a visit the NIH, the American Association for the Advancement of Science (AAAS), the Office of Research Integrity (ORI), and Johns Hopkins University to discuss critical issues in research ethics and science policy, and (g) instruction in pedagogy and distance learning provided in China by the PIs and other US- and China-based experts in the field of education. In the second year, the Fellows will be expected in initiate or significantly improve a course on research ethics with input from a mentoring committee consisting of one of the PIs and US- and China-based consultants. Fellows will also be encouraged to become engaged on relevant research and start up grants will be available on a competitive basis. In addition, we will develop a locally sustainable conference on research ethics for researchers, administrators, and policy makers in China to be held in the fifth year of the project. The PIs and their co-investigators and consultants will be involved in the planning and implementation of the first conference. However, the major responsibility will be that of the Fellows themselves, and a mechanism will be put in place to ensure that future conferences of this sort will be held regularly and be organized entirely by program alumni and those their trainees. A rigorous evaluation of the program will occur at all phases, and both the curriculum and the outcome of the program will be disseminated at professional meetings, on the web, and in peer-reviewed publications. The program will be overseen by an External Advisory Committee made up of individuals with relevant expertise, most of whom will not be directly affiliated with the training program except that they will assist in participant selection and the evaluation of the curriculum and its effectiveness.
Our training program is designed to develop expertise in international research ethics in China. The ethical conduct of research in China is a matter of importance for the US, as the NIH funds health related research there, and US scientists make us of the results published by Chinese scientists. In addition, nearly half of the applications for advanced biomedical research training in the US are submitted by individuals who received their initial training in China, and thus they may not be familiar with the ethical standards of international research. This may lead to problems with the research they conduct as part of their training in the US.