Individual COI Process
Increasingly, Penn State researchers have financial interests and ties outside the University, many of which have proven to be excellent partnerships for translating academic research into technologies which benefit the public. However, those ties may create a Conflict of Interest (“COI”) due to the potential for bias, or a perception of bias, in the research being conducted. The challenge for Penn State researchers today, then, is to meet increased scrutiny while balancing and managing their outside interests with their Penn State research and other scholarly activities. To that end, the University has a comprehensive COI Program, within the Office for Research Protections, to review and manage all potential financial conflicts of interest in a manner that is consistent throughout the University
Penn State’s Individual Conflict of Interest Policy RA20 requires disclosure of Significant Financial Interests (“SFI”) held by an investigator (or an investigator’s spouse, partner or dependent children) that are related to an investigator’s institutional responsibilities (e.g., teaching, research, service). Investigators can be faculty members, staff, students, administrators and other officials.
Categories of SFI include:
- • Compensation/Remuneration received from an entity other than the University exceeding $5,000 in the previous 12 month period. (Remuneration means salary and any payment for services not otherwise identified as salary, including, but not limited to, consulting fees, honoraria, and paid authorship);
• Any equity interests (e.g., stock, ownership rights) in a non-publicly traded entity regardless of amount (there is no de minimis);
• Equity interest (e.g., stock, ownership rights) in a publicly-traded entity, the value of which exceeds $5,000 in the previous 12 month period (or, if the value of any equity interest plus any compensation from the publicly-traded entity exceeds $5,000);
• Intellectual property rights (e.g., patents, copyrights) upon receipt of income related to such rights and interests (including but not limited to royalties, or licensing revenues) that exceeds $5,000 in the previous 12 month period; or
• Reimbursed or sponsored travel paid by an entity other than the University or through a University sponsored award or grant that exceeds $5,000 in the previous 12 month period. (Travel that is reimbursed or sponsored by a federal, state, or local government agency in the United States, an American Institution of Higher Education as defined at 20 U.S.C. 1001(a) , an American academic teaching hospital, an American Medical Center, or a research institute that is affiliated with an American Institution of higher education does not need to be disclosed as an SFI).
Financial Interests, even if they meet the thresholds outlined above (e.g., $5,000), that are unrelated to an investigator’s institutional responsibilities do NOT need to be disclosed. There are a number of exceptions and exclusions which apply in certain situations. Please see Policy RA20 for a detailed explanation of what constitutes an SFI. Please view or print out the COI Tip Sheet for a brief description of what an SFI is and for some brief information about the COI disclosure process.
If you are unsure about whether a financial interest needs to be disclosed or whether it is related to your institutional responsibilities, please contact the COI Program staff to discuss the matter or see our Frequently Asked Questions for more help. Please refer to the "Contact Area Staff" portion of our website for contact information.
Review of Disclosures
Not all financial interests give rise to a real or perceived conflict of interest; thus, pursuant to Policy RA20 the University has established an Individual Conflict of Interest Committee to review disclosed financial interests. The Committee is charged with reviewing all disclosed financial interests, determining if a real or perceived conflict of interest is present, and, if so, developing a plan to manage or eliminate the conflict. The COI Program is charged with maintenance and oversight of Policy RA20 and administrative support of the Committee. Not all disclosures are subject to full Committee review, and may instead be administratively processed or approved.
Procedure for Disclosure
All SFI disclosures must be made using COINS, Penn State’s web-based Conflict Of INterest System. Investigators are required to disclose all SFI prior to the submission of an application for Research funding, at least annually, and within thirty (30) days of the discovery or acquisition (e.g., through purchase, marriage, or inheritance) of a new SFI.
Pursuant to Policy RA20 (Appendix A), the University has adopted a three year implementation schedule for implementation of the annual disclosure requirement. Please see Appendix A for this detailed implementation schedule.
Disclosures are electronically routed to the Conflict of Interest Program in the Office for Research Protections. Conflict of Interest staff determine whether disclosures can be processed administratively, or if they need to be reviewed by the Conflict of Interest Committee.