Individual Conflict of Interest

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:

coistaff@psu.edu
814.865.1775
 

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.