Operating Procedures for Institutional Conflicts of Interest
These procedures support the policy on Institutional Conflicts of Interest (III.B.6), herein referred to as the “Policy.” Please refer to the Policy for contact information and applicable definitions.
Effective date: July 1, 2019
All University Officials, as defined in the Policy, must submit a financial disclosure statement upon appointment and annually thereafter using the form designated by the Vice President for Ethics and Compliance (VPEC). The disclosure must include all interests held by the University Official or their immediate family members that meet the definition of an Institutional Financial Interest.
Upon request, the units listed below must provide to the Offices of the VPEC and the Executive Vice President for Research and Partnerships (EVPRP) institutional information pertinent to evaluating whether an Institutional Conflict of Interest exists and, if so, determining whether it can be managed, mitigated or eliminated.
- Office of the Comptroller
- Office of Treasury Operations
- Office of Financial Planning and Analysis
- Procurement and purchasing departments
- Purdue Research Foundation
- Sponsored Program Services
Review of Disclosures
The VPEC will convene a meeting no less frequently than twice per year (every six months) that will include appropriate representation from the Offices of the VPEC and of the EVPRP. The purpose of the meeting will be to review the submitted disclosures noted above and identify any Institutional Conflicts of Interest. Additionally, the meeting participants will determine whether each identified conflict can be managed, mitigated or eliminated, and will develop management plans for that purpose where appropriate. Meeting participants who are associated with an Institutional Conflict of Interest will recuse themselves from the relevant review process.
Consideration during IRB Review
No less than twice per year (every six months), a list of Institutional Conflicts of Interest will be provided to the Human Research Protection Program (HRPP). When Institutional Research Board (IRB) protocols are submitted to the IRB for review, responsible staff will identify whether an Institutional Conflict of Interest appears within the supplied list.
In the event that an actual or perceived conflict is identified, the HRPP will confirm that the interest is managed, mitigated or eliminated through an approved management plan. The results of the evaluation of the actual or perceived conflict will be provided to the IRB reviewer(s) during the IRB review process. The IRB has the final authority to decide whether the conflict is appropriately managed in relation to the proposed research and whether to allow the proposed research to be conducted as described in the associated protocol. An Institutional Conflict of Interest that may impact research involving human subjects or the integrity of the HRPP must be eliminated.
For a conflict that is unmanageable or inappropriate to manage, either the protocol will be reviewed by an appropriately qualified external and independent IRB (i.e., a third-party IRB) or the associated research will be conducted at another institution, therefore eliminating any real or perceived Institutional Conflict of Interest. In cases where an IRB Chair, IRB Reviewer, or HRPP/IRB staff member is associated with an Institutional Conflict of Interest, they will recuse themselves from the IRB review process. In cases where an HRPP/IRB staff member and/or a University Official is required to recuse themselves from relevant decision-making, supervision and review processes, the management plan will describe the conflict and how it may impact the integrity of research with human subjects, and will designate an oversight manager for the segregation and recusal processes.
Only those records used for the purposes of determining, managing, mitigating or eliminating an Institutional Conflict of Interest will be retained. Records related to disclosures associated with IRB protocols will be maintained with the IRB protocol record for at least three years from completion of the research. All other records will be maintained in accordance with the University’s records retention schedule.
Requests for records associated with Indiana’s Access to Public Records Act or the federal Freedom of Information Act will be referred to the University’s public records officer in accordance with established University procedures.