Enhancements to KUMC Human Research Protections

University Of Kansas Medical Center, Kansas City KS

Investigators

Abstract

Funding of this proposal will enable the University of Kansas Medical Center to enhance an already strong human subjects protection program by utilizing new technologies, improving information management, and expanding assessment and educational efforts. A cornerstone for these enhancements is a new database, which will be designed in consultation with KUMC staff by a private software firm. The database will replace two existing stand-alone systems, generate required reports, automate the continuing review process (including email notifications to investigators and progress report tracking), capture multiple compliance elements, and be automatically populated by web-based forms (including a new IRB application and a continuing review progress report). The detailed information obtained by the new forms will facilitate a more thorough initial IRB evaluation of compliance and ethical issues, and ensure that continuing review is both timely and meaningful. The web-based format will enable research personnel to access instructions, review IRB criteria, and link to federal guidance while completing the forms. A quality assurance program (comprised of policies and procedures, assessment tools and regular monitoring) will be developed and implemented to promote responsible conduct of clinical research. In addition to providing the framework for mandatory, voluntary and random assessments, the program will incorporate feedback from human research participants through the use of surveys, focus group discussions and an advisory committee. Finally, institutional policies and additional educational modules for all system users will be established to ensure that the new systems are effectively implemented. Achievement of the specific aims described above will provide a lasting improvement to the research enterprise at KUMC and strengthen its oversight of human subjects protection.