Kuali Coeus: Conflict of Interest Module Eric D. Swank, Executive Director, Research Compliance Stephanie R. Roberts, Research Compliance Advisor Carey L. Conover, Project Analyst, Research Administrative Systems and Decision Support Indiana University

KC: COI Module Mission of the KC COI Module: “To capture reports of outside financial interests and outside activities allowing universities to fulfill regulatory requirements set forth in NIH/NSF rules Responsibility of Applicants for Promoting Objectivity in Research.”

KC: COI Module Flexibility is a Defining Principle: Coeus baseline Institutions developing their own “conflict of interest” questions, reports, and processesto satisfy: Current and future federal regulations State statutes University policies Sponsor specific requirements

KC: COI Module Key Module Features: 1.Design of COI Questions and Questionnaire  COI Module permits flexible structure for questions Customizable question text Questions that “branch”  Answer parameters defined by administrators Ability to specify multiple answers Ability to specify whether numbers or text are expected Ability to build your own dropdown menus “Tie in” to information from other KC Modules

KC: COI Module  Accommodates different reporting triggers Annual financial interest reporting requirements Event based triggers (e.g., submission of a proposal or IRB protocol) 2. Financial Interest Reports  Questions presented to investigators and others required to report interests  System will prompt user to complete mandatory questions not completed at submission

KC: COI Module

3. If the Response Leads to a Reportable Interest  System triggers the user to provide additional information – as currently collected in Coeus Lite  Institutions may customize these fields to address different state laws and institutional requirements

KC: COI Module

4. Certification of Responses  When response is submitted it will be ‘certified’ by the reporter  Institutions may customize these fields to address different state laws and institutional requirements  Certification language should be version controlled and auditable

KC: COI Module 5. Audit Tracking  Versions of the questions will be tracked  Answers and questions will be fixed once they are completed by a Reporter  Version tracked even if an administrative user makes future changes to questions or the questionnaire

KC: COI Module 6. Connection to Other Modules  Connections across: Awards and Proposals Module IACUC Module IRB Module  Other Modules will have a specific area indicating Reporter status of COI report  Security and privacy are important: access to details of reportable interest will be limited  Specified administrators will have access to Management Plan

KC: COI Module 7. “Routing” to Reviewers or Approvers  Once completed the report ‘routes’  Each institution may customize routing within the confines of their workflow requirements  Possible actions include: Return to Reporter for additional information Approve and route further Finalize Pend for additional follow-up

KC: COI Module 8. COI Administrators  Permissions based access to information Central University COI Administrator Departmental COI Administrator  Distinct access, routing, and approval roles and responsibilities between COI Administrators set by the institution

KC: COI Module

10. Committee Activity  Use of the COI Module to help administer and manage the COI Committee Use of common KC “Committee Infrastructure” elements Meeting Minutes Meeting Agenda Delivery of materials consistent with functionality in other Modules

KC: COI Module

Questions? Comments?