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

• Questions? • Comments?