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IU's Kuali Coeus system ensures protections for human research subjects

IU is the largest university to implement the open source software, Kuali Coeus Institutional Review Board, an online system for human subjects research.

BLOOMINGTON, Ind. -- Indiana University has implemented the Kuali Coeus Institutional Review Board, a comprehensive online system for the submission, review and approval of human subjects research. With seven Institutional Review Boards and more than 4,800 approved active research studies, IU is the largest university to implement this community-developed open source software.

Human subjects are key to IU research in fields such as medicine, psychology, sociology and anthropology. This research includes field surveys, focus groups, biological specimens and behavioral studies, all requiring both trust and accountability. With that in mind, IU Institutional Review Boards exist to ensure the physical and mental well-being of research participants. KC-IRB adds another level of protection -- ensuring not only compliance with laws and regulations, but also adherence to the highest ethical standards for research involving human subjects.

"This has been an ambitious and successful effort to improve the service we offer to human subject researchers," said Jorge José, IU vice president for research. "When all components are rolled out this academic year, the KC-IRB system will provide researchers, staff and IRB reviewers a single online portal to submit, track, review, manage and approve studies."

KC-IRB is a joint effort of the IU Office of the Vice President for Research and the Office of the Vice President for Information Technology.

"By partnering with other leading universities, IU has been able to share the software and support costs of critical research administration systems," said Brad Wheeler, IU vice president for information technology and chief information officer. "We've saved millions -- $20 million in the case of the recently implemented companion Kuali Financial System -- by implementing community-developed software that draws on expertise from many leading universities. The previously implemented Kuali Research Contracts and Grants and now KC-IRB continue that cost-efficient strategy."

As with other Kuali Coeus modules, KC-IRB streamlines processes by rationalizing and simplifying the workflow of creating, approving and monitoring human subjects research. The integrated system eliminates reliance on email, multiple databases and paper files.

"The new system even allows multiple users to work on the same submission concurrently, so a researcher and a designated reviewer can have a convenient give-and-take about research protocol," said John Baumann, executive director of human research protection programs.

The scale of KC-IRB necessitates a phased rollout. As of Aug. 3, all administrative management of human subjects research protocol submission, review and approval will occur within KC-IRB. This will be followed by a phased rollout culminating in total system implementation by July 2014.

IU's projected KC-IRB timeline:

  • Aug. 19, 2013: Researchers submit all new studies through KC-IRB.
  • November 2013: Researchers submit all actions (e.g., amendments, continuing review and general information) through KC-IRB.
  • February 2014: Human Research Protection Program staff use KC-IRB to manage workflow, and researchers and staff channel all study-specific information through KC-IRB.
  • Spring 2014: IRB members review and approve studies through KC-IRB.
  • Summer 2014: Web-based questionnaire replaces all forms; KC-IRB fully implemented and functional.

"Implementing KC-IRB is an important step in our plan to bring all of our research administration and compliance systems into the KC system," José said, "which will help IU's researchers focus more of their efforts on research."

About Kuali Coeus Institutional Review Board

KC-IRB is based on the Coeus research system created at MIT and refined by the Coeus Consortium. It is a product of the Kuali Foundation, a nonprofit community of more than 70 college, university and commercial members who support the development of open source administrative software for the higher education community. IU is a founding member of the foundation.


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About Indiana University

Digital textbooks, virtual software delivery, and flexible learning environments support IU's mobile community and place the university at the cutting edge of IT for higher education. As part of this culture of innovation, Indiana University manages the nation's leading research networks, heads research initiatives supported by the National Science Foundation, partners with other universities on open source software development, and provides leadership in cybersecurity. These distinctions have earned IU a place in Computerworld's 100 Best Places to Work in IT.