Conflict of Interest Help for IAF Investigators Tab

Question 1 from IAF Investigators Tab

Could the proposed research reasonably appear to:

• Affect the value of any "Significant Financial Interests " held by you, your spouse, or dependent child;

AND/OR

• Have a financial impact on the company in which you, your spouse, or dependent child hold the "Significant Financial Interest"?

Question 1 HELP

What is a Significant Financial Interest ("SFI")?

A Significant Financial Interest ("SFI") is anything of monetary value 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 prior 12 months 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 in income from a non-publicly traded entity during the prior 12 months.
• You received income from intellectual property rights and interests (such as patents, copyrights, royalties, licensing fees) exceeding $5,000 during the prior 12 months.
•  You received reimbursed or sponsored travel exceeding $5,000 from an entity during the prior 12 months.

NOTE: Investigators at the College of Medicine should note that there is a $0 threshold for reporting financial interests when those interests are related to human subjects research. That means that ANY financial interest in a for profit entity or ANY intellectual property, regardless of income generated, is considered a Significant Financial Interest and must be disclosed if related to humans subjects research or purchasing authority at the College of Medicine. More information can be found at https://research.med.psu.edu/research-support/conflict-of-interest/.

How do I determine whether the proposed research could affect my interest or could have a financial impact on the entity/company that I hold an interest in?
You should consider whether there could be a perception by others that this proposed research could somehow affect your interest or the company's interest, even if only in the future. Here are a few examples of how your research could reasonably appear to affect the value of your SFI. If you can answer YES to any of these questions or if you see a connection between your SFI and this proposed research, please answer YES to the IAF question:

1. Your research directly involves your SFI. For example, you will be using your own Intellectual Property licensed to another company in the research.
2. You research is sponsored by the entity/company that you hold an SFI in. For example, you serve as a consultant for the company that is sponsoring the research.
3. The entity/company that you hold an SFI in is somehow involved in the proposal. For example, you plan to issue a subcontract to them, you are testing their products or services, or you are using one of their products as a tool in the proposed research.
4. The research results could show something positive or negative about technology, products, or services owned or sold by the company your SFI is in OR in a competitor, even if your SFI is not directly involved in the proposal.
5. The entity/company that you hold an SFI in will be interested in the results of this proposed research.

What happens if I answer YES to this question?
If you answer Yes, you may continue with submitting the other information necessary on the IAF. Your COI Program will receive a notification that you answered yes and will follow-up with you to gather more information. You may be asked to update your COINS disclosure and your disclosure may need to be reviewed by the Conflict of Interest Committee at University Park or the College of Medicine. 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 a real or perceived conflict of interest, 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.

 Who can I contact for help?
University Park and Campuses, except for the College of Medicine: email COI Staff in the Office for Research Protections at coinsadmin@psu.edu or call 814-865-1775 and ask to speak with someone in the COI Program.
College of Medicine: email COI Staff in Hershey/College of Medicine at COIProgram@pennstatehealth.psu.edu or call (717) 531-0003 ext. 283526.