Conflict of Interest Policy & Disclosure Process Member Overview Purpose ● Overview of the Conflict of Interest Policy ● Requirements for Disclosure ● Steps in the Disclosure Process Policy IRS Requirement: – Policy with guidelines and principles for reporting and managing actual, potential and perceived Conflicts of Interest Policy approved September, 2009 Assists faculty, staff and students in maintaining the highest level of integrity in all University endeavors Members In a position to influence or commit University resources Faculty Staff Members Post-Doctoral Scholars Students Definition An actual Conflict of Interest arises in a situation where financial or other personal or professional considerations compromise an individual’s: Objectivity Professional Judgment Professional Integrity Ability to perform responsibilities to the University Issues Gray areas: Potential or Perceived Conflicts of Interest Could appear to others to be a Conflict of Interest Individual, Individual’s family or close relation University commitment to address proactively Eliminate anyone’s integrity from being questioned Faculty Example Scenario #1 A faculty member involved in sponsored research has a significant financial interest in an entity who stands to gain from the outcome of the sponsored project ● Objectivity ● Professional Integrity Staff Example Scenario #2 A staff member is to take part in the evaluation and selection of a supplier from a number of bidders. One of the bidding companies is operated by the person’s family member. ● Objectivity ● Professional Judgment Office of General Counsel Facilitates the Conflict of Interest Disclosure and Management Process Maintains an electronic disclosure system Serves as a resource for the University community Disclosure Process Overview Individual Completes Disclosure On-line Oversight by Responsible Parties University Conflicts Committee Reviews Designated Reviewer Evaluates Disclosure Reviewer Creates Management Plan Disclosure Oversight Disclosure UCC Member Disclosure Requirements Access to Electronic Disclosure Annual E-mail Notification - 15 days to complete Link Directly in E-mail or: www.conflictpolicy.disclosure.nd.edu Update Disclosure within 15 days www.conflictpolicy.disclosure.nd.edu Review Plan To an existing actual, perceived or potential Conflict of Interest When a new interest or activity is identified that may create an actual, perceived or potential Conflict of Interest Disclosure Oversight Disclosure UCC Review Plan Update Disclosure examples: Acquiring a new financial interest in a third party entity Proposing new research where the Cayuse system identifies a need for an update Serving in a new capacity at the University where the individual’s interest and activities now may pose a Conflict of Interest Disclosure Oversight Disclosure Log-in screen: UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Disclosure UCC Review Plan Disclosure Oversight Reviewer Evaluation UCC Review Plan Reviewer Responsible for: ● Ensuring full and accurate information ● Identifying any actual, potential or perceived conflicts of interest ● Recommending a plan to the UCC to manage any conflicts When a Disclosure is from a Faculty Member, the Reviewer may elect to forward the Faculty Member’s disclosure to the Faculty Conflict Committee (FCC) for review. For additional information on the FCC, refer to the COI policy at http://policy.nd.edu Disclosure Oversight Reviewer Evaluation Member Reviewer System Disclosure Questionnaire UCC • 15 days All Negative Responses • 15 days Disclosure Process Complete Review Plan Disclosure Oversight Reviewer Evaluation Member Disclosure Questionnaire Reviewer UCC Review Plan • Up to15 days to complete Any Affirmative Responses Reviewer and Member University Conflicts Committee • Up to15 days to complete Management Plan • Typically 1 week Response • Up to 30 days Disclosure Oversight Management Plan UCC Manage, Reduce, Eliminate Scenario #1 Management Plan A faculty member involved in sponsored research has a significant financial interest in an entity who stands to gain from the outcome of the sponsored project The faculty member has parameters in the involvement of the research, additional oversight by faculty without a financial interest, or other steps to eliminate the conflict. Review Plan Disclosure Oversight Management Plan UCC Manage, Reduce, Eliminate Scenario #2 Management Plan A staff member is to take part in the evaluation and selection of a supplier from a number of bidders. One of the bidding companies is operated by the staff member’s family member The staff member does not take part in the selection and evaluation process that involves her family’s company Review Plan Disclosure Oversight Management Plan UCC Review Plan Disclosure Oversight Management Plan UCC Review Plan Disclosure Oversight Management Plan UCC Review Plan Disclosure Oversight UCC Review UCC Review Plan UCC will determine whether an actual, perceived or potential Conflict of Interest exists Executive VP; Provost; VP for Research; VP & General Counsel UCC will approve, amend or veto the proposed Management Plan within 30 days University Conflicts Committee Oversees Training, Education and Policy Modifications Request for reconsideration within 15 calendar days Ensures Proper Management of all COI’s Subsequent decision of UCC is final Disclosure Oversight Oversight UCC Reviewer Oversight Manager Member Management Plan 12 months Review Plan Integrity Disclosure Process No paper form Individual Completes Disclosure On-line E-mail notice annually Oversight by Responsible Parties Designated Reviewer Evaluates Disclosure Updates on-line Quick review Timely follow-up University Conflicts Committee Reviews Reviewer Creates Management Plan Communication Additional Resources Please contact: Office of the General Counsel 631-6411 or policy@nd.edu ● Select in top right corner or visit: http://conflictpolicy.nd.edu 1 - Power point slides with narrative comments 2 - Navigation Guide 3 - Disclosure Guide Any technical questions regarding the disclosure system may be directed to the OIT Help Desk at 631-8111 Visit http://policy.nd.edu/ to view the University Conflict of Interest Policy in its entirety