In 1966, prior to conducting the first clinical research at the Institute for Cancer Research (precursor to Fox Chase Cancer Center [FCCC]) an Institutional Review Board (IRB) was established. The IRB has functioned ever since to protect human research subjects. Fifteen years ago FCCC started a voluntary network of community hospitals in Pennsylvania and New Jersey (the Fox Chase Network, FCN) to provide better cancer care in the community and to make clinical cancer research available to a larger patient population. In this proposal, we plan to enhance protection of human research subjects by amplifying mechanisms for oversight, to improve education of investigators with respect to human subject's protection and bioethics, promote patient's rights, and improve human subjects protection in the community.
Our specific aims are as follows:
Aim 1 : Provide access to policies, procedures and programs for oversight of human subjects research developed by FCCC to the IRBs of the 25 FCN member hospitals. Create a """"""""Users Group"""""""" of IRB staff for FCN hospitals and other regional hospitals to share approaches to consent monitoring, protocol auditing, preparation of federal assurances, and conduct of protocol reviews.
Aim 2 : Develop a fully integrated system for the new Phase I - II Committee (established as part of the FCCC Data Safety and Monitoring Plan) to signal fulfillment of safety and efficacy milestones.
Aim 3 : Link the databases of the IRB, the Protocol Information Management System, and Grants Office to facilitate uniformity of shared information on human research subjects. Expand the Protocol Information Management System to include the 180 - 200 non-clinical (population and behavioral science) studies not currently included in the database.
Aim 4 : Evaluate, implement and expand mechanisms for monitoring the consent process and auditing of research involving human subjects. Use information collected from monitoring programs to enhance education of investigators.
Aim 5 : Develop a new IRB web page for FCCC, FCN and other outside users that will contain IRB policies, procedures, forms, contact information, and certification status of investigators and staff Aim 6: Enhance the operational efficiency of the IRB office and staff by increasing automation and simplifying workflow. These initiatives will accelerate creation of additional levels of protection and education for investigators and staff. Our objective has been and will continue to be to ensure the highest level of human subject's protection possible.
