Individual Conflict of Interest
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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 RP06 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.;
- Any equity interest (e.g., stock, ownership rights) in a non-publicly traded entity regardless of amount (i.e., there is no de minimis);
- Equity interest (e.g., stock, ownership rights) in a publicly-traded entity exceeding $5,000 (or, if the value of any equity interest plus any compensation from the same entity exceeds $5,000);
- Intellectual property rights (e.g., patents, copyrights) upon receipt of income related to such rights and interests that exceeds $5,000 in the previous 12 month period; or
- Reimbursed or sponsored travel paid by an entity other than the University 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 RP06 for a detailed explanation of what constitutes an SFI.
If you are unsure about whether a financial interest needs to be disclosed or whether it is related to your institutional responsibilities, please contact email@example.com to discuss the matter, or call 814.865.1775 and ask to speak with a member of the COI team.
Review of Disclosures
Not all financial interests give rise to a real or perceived conflict of interest; thus, pursuant to Policy RP06 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 RP06 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 acquisition of a new SFI.
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.
Federal policies related to individual conflict of interest
Standard Operating Procedures
Administrative Review and Processing of COI Disclosures
Last update July 23, 2015
Handling of Noncompliance
Last updated December 16, 2016
Handling of Disclosures of SFI and COI Related to PHS-Sponsored Research
Last updated July 23, 2015
Resources for Individuals with Management Plans
Resources for Students
- Guidelines for Students and Post Docs involved in Faculty Related Significant Financial Interests (pdf)
- Principles for Student and Post Doc Engagement in Faculty Enterprises (pdf)
Resources for Entrepreneurs
- Quick Reference for Entrepreneurs (pdf)
- Subcontracting & Conflicts of Interest: For Entrepreneurs (pdf)
Resources for Hershey/College of Medicine
An Individual Conflict of Interest Committee (COIC), appointed by the Provost, will review all individual disclosures, develop COI management plans, and provide oversight as needed. The Director of the Office for Research Protections serves as the Conflict of Interest Official for the University. Committee membership will be comprised of:
Faculty representation from a minimum of two (2) of the following disciplines:
Earth and Mineral Sciences
Health and Human Development
One (1) faculty representation from the social sciences/humanities
One (1) active human participants investigator
Please see the Hershey College of Medicine ("COM") website for more information regarding the Conflict of Interest Review Committee, which meets at the COM campus to review all disclosures made by COM and Hershey Medical Center investigators, students and staff.
2017 Individual Conflict of Interest Meeting Schedule
Meetings are called to order at 9:30 a.m.
Disclosure Forms must be
submitted by 4:00 pm on:
|June 7||June 16|
|July 12||July 21|
|August 9||August 18|
|September 6||September 15|
|October 11||October 20|
|November 8||November 17|
|December 6||December 15|
PLEASE NOTE: Due to the confidential nature of the information discussed, Committee meetings are not open to the public. Meetings may be canceled if there is not a quorum or if no new disclosures were received.
Institutions receiving financial assistance for research from federal agencies are required to have COI policies. This is intended to protect against bias, or perceptions of bias, in research, as well as protecting human subjects and students. With increasing numbers of researchers interacting with industry, by consulting, forming companies, and other avenues, there is a need to promote transparency among such relationships. Not only is it required by regulations and policies – it is a national best practice among research institutions, and serves to protect researchers and the University.
All University employees, regardless of title or position, who conduct research at the University and who meet the definition of “Investigator” must submit an annual Significant Financial Disclosure in COINS.
An Investigator is any University employee, regardless of title or position, who has the ability to make independent decisions related to the design, conduct or reporting of University research, but not including individuals who perform only incidental or isolated tasks related to a University research project.
Additionally, the IAF system requires a current COINS disclosure for all named personnel in order to process proposals.
Investigators must disclose Significant Financial Interests (“SFI”) that reasonably appear to be related to the Investigator’s Institutional Responsibilities.
An SFI is anything of monetary value (whether that value can be easily determined or not), that belongs to the Investigator, or the Investigator’s spouse or partner, or dependent children and meets ANY of the following definitions:
• You received income from a publicly-traded entity during the 12 months prior to disclosure that (in combination with the value of any equity interest in the entity) exceeds $5,000.
• You hold ANY equity interest in a non-publicly traded entity, OR you received more than $5,000 income from a non-publicly traded entity during the 12 months prior to disclosure.
• You received income from intellectual property rights and interests (such as patents, copyrights, royalties, licensing fees) exceeding $5,000 during the 12 months prior to disclosure.
• You received reimbursed or sponsored travel exceeding $5,000 from an entity during the 12 months prior to disclosure.
Disclosures of Significant Financial Interests are submitted through COINS, Penn State’s Conflict of Interest Disclosure System. The site is accessed at https://coins.psu.edu. You will log in with your Penn State access credentials, using Two Factor Authentication.
Once logged in to COINS, you will complete your Researcher Disclosure.
User Guides are available on the COINS login page. Additionally, COI Staff in the Office for Research Protections are available by phone or email to assist and answer questions:
Investigators are required to disclose new financial interests within 30 days of the new interests being acquired. Additionally, all Investigators must submit an annual financial disclosure, even if they do not have any Significant Financial Interests.
It is important to note that funds for sponsored research projects which are related to your Significant Financial Interests cannot be released until all compliance reviews, including the conflict of interest review, are complete. Keeping your Disclosure up to date will help limit delays in receiving funds.
If you submit your disclosure past a deadline, your funding may be delayed, as the Office of Sponsored Programs will not release funds for a project until any required COI review has been completed. In addition, noncompliance procedures may need to be followed at the University, and if you have PHS funding, your project may be subject to a retrospective review to determine if any actual bias has occurred.
When you submit your Disclosure in COINS, one of two things will happen. If you did not disclose any Significant Financial Interests, your Disclosure will not require any further review and the process is complete.
If you do disclose a Significant Financial Interest, your Disclosure is routed to your department head for review and then to COI Staff in the Office for Research Protections. COI Staff will review your Disclosure to determine whether it can be processed administratively or if it will require review by the Conflict of Interest Committee.
Information provided in your Disclosure will be kept confidential and will only be shared to the extent necessary to manage any identified conflicts of interest.
The COI Committee’s goal is to promote transparency and objectivity in research, protect study participants and students from undue risk or influence, as well as protect Investigators and the University from undue criticism. If it is determined that you have an FCOI, the Committee will work with you to develop a Management Plan. Your Management Plan will address the concerns of the Committee while providing you with guidance on how to best move forward in addressing the relationship between your University research and external financial interests.
A Management Plan is a set of requirements outlined by the Conflict of Interest Committee, and agreed to by the Investigator, which are aimed at promoting transparency in financial relationships, objectivity in research, and protecting human research participants and students.
The Management Plan can include, but is not limited to, such things as: a requirement to disclose one’s Significant Financial Interests in related publications; disclosure in consent forms when human subjects are involved; appointment of a student monitor or research monitor to ensure that work which could be affected, or perceived to be affected, by the Significant Financial Interest is proceeding without any concerns; formal notification sent to the sponsor outlining the potential conflict and the management plan which addresses it; or disclosure to students and colleagues working on related projects.
Investigators have the opportunity to provide feedback and request changes to the plan before agreeing to abide by it.
COI Staff members in the Office for Research Protections are available by phone, email and in person, to assist you with COINS and address any questions you may have about financial disclosures and conflicts of interests.