Kuali Coeus: Conflict of Interest Module
Eric D. Swank, Executive Director, Research ComplianceStephanie 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 processes to 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
QuestionnaireCOI 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 ReportsQuestions presented to investigators and others
required to report interestsSystem will prompt user to complete mandatory
questions not completed at submission
KC: COI Module
KC: COI Module
3. If the Response Leads to a Reportable InterestSystem 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
KC: COI Module
4. Certification of ResponsesWhen response is submitted it will be ‘certified’ by the
reporter Institutions may customize these fields to address
different state laws and institutional requirementsCertification 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
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