An essential element in assuring that the safety, rights, and well being of human research subjects are well protected is the effective and comprehensive education of all individuals participating in and overseeing the research enterprise in the ethical implications of human subjects research as well as policies and """"""""best practices"""""""" relating to human subjects protections (HSP). As underscored in numerous reports from funding and oversight agencies, the need for a well-educated, """"""""ethically literate"""""""" research community becomes even more critical to HSP efforts as the scope and volume of human subjects research initiatives continue to grow at research institutions such as Yale University. The broad objectives of this proposal are to strengthen the ethical foundations of institutional review board (IRB) deliberations, to deepen the knowledge of investigators and key research personnel regarding ethical and HSP issues relating to their research activities, and to ensure high and consistent standards for human subjects protections throughout Yale's expanded research enterprise.
Specific aims relating to these objectives include: 1) the comprehensive review, revision, and expansion of Yale's HSP educational materials and associated instructional technology, with a special emphasis on enriching the research ethics core of the HSP curriculum; 2) the development of educational materials, templates, and model procedures to assist non-Yale entities that rely on Yale IRB review in meeting the ethical and regulatory obligations associated with their participation in human subjects research; and 3) a review of the feasibility of extending Yale's Comprehensive IRB and Training Management Systems to non-Yale entities engaged in human subjects research reviewed by Yale IRBs (Research Affiliates). In pursuing these specific aims, Yale's project team will engage, solicit input from, and share products and findings with a number of non-Yale, Connecticut IRBs and Yale's Research Affiliates. The project team will also take advantage of the expertise and unique resources of a number of Yale initiatives, including the Donaghue Initiative in Biomedical and Behavioral Research Ethics, the Yale Training Management System, and the Yale Organizational Development and Learning Center. Realization of the aims presented in this proposal will ensure that educational efforts have a significant and enduring impact on HSP at Yale, its IRB colleagues, and its Research Affiliates.
