The Health Science Center recently signed a contract to implement an electronic Web-based system to manage the Institutional Review Board (IRB) process, nicknamed eIRB. This system will allow all investigators and staff to submit and track IRB submissions online.
For investigators, the eIRB will provide a mechanism for electronically submitting protocols, progress reports, adverse event reports and monitoring their progress within the IRB. Current IRB forms will be converted to user-friendly electronic ‘smart forms’ which will guide investigators through the process and include links to regulations and online help. Investigators will be able to manage their protocols and track updates.
The eIRB will streamline protocol processing and correspondence with investigators so that less time will be spent on clerical chores and more time on assuring the safety of human subjects participating in research.
“We were looking for ways to improve the process,” said Anthony Infante, M.D., Ph.D., associate dean for research. “With the increase of regulations, including HIPAA, the IRB has had a tremendous influx of paperwork.”
For the institution, the eIRB will create a database that will allow tracking, monitoring and reporting of activity by protocol type, investigator and department.
The software selected for this process is Webridge Compliance Extranet by Click Commerce. Webridge has supplied similar software for several medical schools, including the University of Washington, the University of Michigan and the University of Pittsburgh.
The project was begun in mid-June, but will not be fully running until spring 2005. After that all new protocols will need to be submitted electronically, and those coming up for continuing review will need to be converted to electronic format on their anniversary dates. By following this process, all protocols will be converted to electronic form in one year.
For questions or comments send an e-mail to Dr. Infante at
infante@uthscsa.edu or to Bryan Menn at
menn@uthscsa.edu.
