This project has two specific aims: (i) to develop training materials and conduct training sessions for Institutional Review Board (IRB) members and staff in order to establish a second Weill Medical College (WMC) IRB and facilitate effective and consistent review of research; and (ii) to implement a web-based, electronic submission and IRB protocol tracking system that will result in increased efficiency and effectiveness of protocol submission; initial and continuing IRB review and oversight; IRB administration; and monitoring of adverse events. Training materials will be developed by PricewaterhouseCoopers consultants Michele RusselI-Einhorn and Tom Puglisi. The product resulting from this effort will be a manual for IRB members that includes (i) basic and advanced information related to the ethical and regulatory review of research, and (ii) a series of 10-12 case studies that illustrate challenging IRB review issues. An instructor's manual will also be created to assist instructors in leading the discussion of the case studies. Creation of these materials will extend the benefits of the project well beyond the one-year project period. New IRB members will receive a minimum of six hours of introductory training, and continuing IRB members will receive three hours of refresher training during the one-year project period. Comparable training sessions will also be conducted for IRB members at the Cornell University Ithaca Campus. Implementation of a sophisticated electronic submission and IRB protocol tracking system will result in at least five enhancements to the WMC human subject protection program that will extend the benefits of this project well beyond the one-year project period: Increased efficiency and effectiveness in comprehensive monitoring of adverse events: (i) decreased administrative and clerical burden for IRB members, resulting in more substantive review of protocols; (ii) decreased administrative and clerical burden for IRB staff, resulting in increased time for educating research investigators and study coordinators and for monitoring approved protocols; (iii) decreased administrative and clerical burden for research investigators and study coordinators, resulting increased attention to ethical and scientific concerns related to human subject protection; (iv) ready access by IRB members to the entire IRB history of any protocol, resulting in more effective continuing review of research; and (v) linkage of IRB records with the results of the recently launched clinical research quality assessment and audit program, resulting in more extensive monitoring of clinical research. Once implemented at WMC, the electronic submission and IRB tracking system will be extended to the Cornell University Ithaca Campus, with comparable benefits for the IRB located there. Effectiveness of the project activities will be evaluated primarily through self-report user surveys with indicators in a Likert-scale format, as well as open-ended questions designed to probe respondents' perceptions and experiences.
