Sixteen years ago Fox Chase started a voluntary network of community hospitals in Pennsylvania and New Jersey (the Fox Chase Network, {Network}) to improve cancer care in the community and to make clinical and behavioral cancer research available to a larger patient population. Using resources provided by the initial HSRE Program award, the Fox Chase IRB began providing support for Network IRB staff, training of their investigators and staff, coordinating education activities, and created the Delaware Valley IRB Consortium (DVIC). With this award, we will enhance protection of research subjects at Fox Chase by refining mechanisms for oversight, improving education of investigators regarding human subject's protection and bioethics, and promoting patients rights. At the 28 hospitals in the Network, as well as other regional institutions not currently affiliated with Fox Chase, we will improve human subjects protection by making available the programs, procedures and policies developed for this purpose at Fox Chase. The proposal has 6 aims: 1) (a) Provide access to education, new initiatives, policies and standard operating procedures for human subjects research protection developed by Fox Chase to IRBs of the 28 Network hospitals and community IRBs not affiliated with Fox Chase. (b) Exploit DVIC to improve regional IRB education programs and share best practices. 2) Include new course on research ethics in Human Subjects Protection Education Certification. Make all Fox Chase certification programs in Human Subjects Protection Education available to Network. 3) Expand activities of the Phase I / II Data Safety and Monitoring Committee (DSMC) to serve as the DSMC for Phase I/II protocols at Network institutions. 4) Link databases of the IRB, Protocol Information Management System, and Grants Office to integrate shared information on human research subjects. 5) Evaluate mechanisms for monitoring consent process auditing human subjects research protocols; reviewing serious adverse events. Use results to educate !investigators, improve practices. Provide these programs to Network IRBs. Appraise performance of IRB website. 6) Enhance efficiency of Fox Chase IRB office and staff to handle expanded responsibilities.
