Kuali Coeus: Conflict of Interest Module

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

2. 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.”

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

4. 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

5. 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

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7. 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

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9. 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

10. 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

11. 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

12. 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

13. 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

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16. 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

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20. Questions? • Comments?