In evaluating human research projects taking place in international settings, U.S. Institutional Review Boards (IRBs) acknowledge their limitations in the understanding of local culture and context. Yet they remain obligated to comply with the 45CFR46 regulations (Common Rule) requirements, as attested to in their Federal Wide Assurance (FWA) to the U.S. Government. Similarly, institutions in international settings that are engaged in research funded by the U.S. government must also comply with their FWA obligations. It is widely recognized, however, that international sites lack a thorough understanding of their obligations under the FWA, and the potential ramifications, both for themselves, and for the U.S. partner should they not comply with its conditions. The goals of this proposal are to deepen the knowledge of institutional leaders, IRB members, staff, investigators and key research personnel regarding ethical and human research protection issues, and to ensure high and consistent standards for human research protections when Yale researchers are involved in international research projects. The project includes two specific aims: 1) human research protection program (HRPP) capacity strengthening in Cali, Colombia through the institution of ongoing training activities and access to new resources at the international site, and 2) enrichment of Yale resources for international human research collaborations, through development of a new Yale International Human Research Protection Program Toolkit. The overall strategy proposed here is to work with two affiliated Colombian IRBs to develop a model of education and support by creating tools, informational resources and procedures to aid international institutions in understanding and complying with their human subject protection obligations encompassed within their U.S. FWA. This work will also increase understanding and capacity of the U.S. (Yale) HRPP personnel, to aid and enable improvements at international sites.
Through the creation of a plan for the education, support, informational resources and procedures based on US FWA standards geared toward this international collaboration, a model will have been developed for use for other international collaborations, thereby enhancing Human Subject protection globally.
| Alfano, Sandra L; Piedrahita, Laura E; Uscinski, Kathleen T et al. (2012) Strengthening capacity for human research protections: a joint initiative of Yale University, CIDEIM, and UniValle. IRB 34:16-20 |
