All biomedical and behavioral research protocols are reviewed and approved by the ChristianaCare Institutional Review Board in accordance with 21 CFR 50 and 45 CFR 46. The ChristianaCare IRB has been granted a Federalwide Assurance by the Office for Human Research Subject Protection (OHRP) approved through the Department of Health and Human Services (Federalwide Assurance Number FWA00006557). The IRB meets biweekly. ChristianaCare is frequently recognized by auditors for high quality IRB processes.
In compliance with federal regulations, ChristianaCare IRB conducts reviews of all protocols at least annually and sometimes, depending on the relative risk of the protocol, more frequently. This assures that all protocols are reviewed at least annually. The final continuing review occurs at the time of a closure of a protocol when there are no longer any patients being followed.
The ChristianaCare Office of Sponsored Programs (OSP) is the central administrative office responsible for assisting with the processing and submission of sponsored programs at ChristianaCare. This includes grant proposal review and submissions as well as contract and budget processing with pharmaceutical, federal and private foundation sponsors on behalf of ChristianaCare. OSP is responsible for overseeing that all research proposals, contracts and other agreements abide by ChristianaCare and external sponsors research policies and guidelines. Furthermore, the OSP serves to advise and educate the administration and staff on matters of regulatory compliance, federal and internal policies on research, and other research-related issues.