Downstate Medical Center has and continues to take seriously its commitment to properly inform and protect participants in all of its research activities. Downstate also recognizes that this commitment extends to a regular, ongoing review of not only it policies and procedures but also to an assessment of the effectiveness of the application of these policies and procedures. Based on recommendations from a consultant review of the Center's oversight process and recent FDA and OHRP site visits, Downstate plans to undertake an improvement program, funded in part by NIH, that will include the following elements: ? Development and implementation of a Quality Assurance/Quality Improvement Program; ? Enhancement of the IRB Investigator Education Program; and ? Enhancement of the IRB Data Management and Protocol Preparation/Review Process. In addition, other aspects of Downstate's human subjects protection program that are currently being addressed include: ? Foreign language translations of informed consent materials; ? Fuller integration of the campus conflict of interest policy and procedure into the IRB review process; and ? Revisions to the IRB Principal Investigator's Procedures Manual for the Use of Human Subjects. Through these efforts, we are working to improve the protection of human subjects while minimizing the bureaucratic aspects of IRB review and oversight. With these two goads, we hope to create an institutional culture in which the protection of research participants is a high priority and the IRB is seen as a resource rather than a needless impediment.
