1. Financial Conflict of Interest
A Quick Review for Investigators Supported by Federal Funds
Updated September 2016
Research Integrity & Compliance

2. Topics Covered Understanding of Financial Conflicts of Interest (FCOI)
Definition of an Investigator
Responsibilities of an Investigator
Definition of a Financial Interest that Must be Disclosed
How to Disclose Financial Interests
Managing an FCOI
Things to Remember 2

3. What is a financial conflict of interest?
An FCOI in research is a significant financial interest (SFI) that could directly or indirectly affect the design, management (conducting) or reporting of research 3

4. Who reviews potential conflicts?
Significant financial interest must be disclosed by investigators working on research projects. These are reviewed by the NDSU designated officials.
NDSU designated officials (Policy 823, “Financial Conflict of Interest”) are the Administrative Heads (e.g., Department Chairs, Deans). 4

5. How do I know if I am an investigator?
For any research project, you are considered an investigator (regardless of your title, position or employment) if you are responsible for one of the following research elements:
Design
Management (conducting)
Reporting
For FCOI, research is defined as a “systematic investigation, study or experiment designed to develop or contribute generaliz-able knowledge relating broadly to public health, including behavioral and social-sciences research.” 5

6. How do I know if I am an investigator?
The principal investigator (PI) is always an investigator. An investigator is also anyone named on the grant or contract as key and anyone working on the research project whom the PI determines meets the definition of “responsible.”
The PI determines who else on the
research project is considered “responsible” and, therefore, an investigator.
Investigators may also be referred to as “key” or “responsible” personnel. 6

7. How do I know who is “responsible”?
Design-The planning of the scientific strategy to test a research proposal
Management (conducting)-The supervision or management of a study’s execution. This is typically done by the principal investigator (PI) and co-investigators, but may also be performed by other project personnel, such as postdoctoral fellows, graduate students, or other technicians.
Reporting-The authorship of publications or reports to the sponsor related to the research. This includes anyone who will likely present the data at national/international meetings. 7

8. “Responsible” always includes…..
For studies involving human subjects, anyone who is responsible for explaining the risks, benefits and/or alternatives to potential subjects
Anyone listed on the FDA Form 1572 or device agreement (not common at NDSU) 8

9. Apply Your Knowledge: Question 1
Sally is a project coordinator supporting research work led by a principal investigator. In her staff role she will be:
Monitoring tasks & timelines
Submitting administrative paperwork
Documenting progress
Scheduling meetings
Is Sally an investigator for the purpose of considering financial conflicts of interest with this project? 9

10. Answer: Question 1
No, Sally is not an “investigator” because she is not responsible for
Design
Management (conducting) or
Reporting of research
Although she will be fulfilling duties that support the responsibilities of the PI, she has no opportunity to control or influence the research herself. 10

11. Apply Your Knowledge: Question 2
John is a data analyst for the Pharmacy Department. He is assisting the PI. In his role, he will provide identifiable data to the PI listing patients being treated for high blood pressure.
Ann is a pharmacy student. The PI provides Ann the data from John. In her role she:
Reviews each person’s pharmacy records against the inclusion/exclusion criteria to determine if they are possible candidates for the study.
If yes, she contacts them to explain the potential risks and benefits of the study.
Are John and Ann investigators for the purposes of considering financial conflicts of interest with this project? 11

12. Answer: Question 2 John is not an investigator.
Although he will be fulfilling duties that support the responsibilities of the PI, he has no opportunity to control or influence the research himself.
Therefore, FCOI requirements do not apply to his activities; although, other requirements (e.g., privacy) may apply.
Ann is an investigator for purposes of considering financial conflicts of interest with this project because:
The study involves human subjects, and
She is responsible for explaining to potential participants the study, risk-benefits, and/or alternatives. 12

13. What do investigators have to do?
Investigators must
Follow regulations and NDSU policy
Complete a training course (CITI Conflict of Interest and/or take refresher training every 4 years
Disclose all significant financial interests related to your responsibilities at NDSU ( including familial relationships within the research project team
These requirements apply immediately to investigators as they are added to the project. 13

14. What financial interests do investigators need to disclose?
As an investigator you must disclose:
Any financial interest related to your responsibilities at NDSU that:
You
Your Spouse or Domestic Partner
Your Dependents
Received or owned/held in the previous 12 months from:
Any entity, whether or not that entity is publicly traded,
That meets the threshold for disclosure (see slide 19) 14

15. What is a financial interest?
A financial interest is anything of monetary value:
Whether or not the value is readily ascertainable
Related to your NDSU responsibilities
That is not held in an investment vehicle in which you do not directly control investment decisions, such as a mutual fund or retirement account 15

16. What are some examples of financial interests?
Salary and payment for services not otherwise identified as NDSU salary (eg. consulting fees, honoraria, paid authorship)
Ownership of stock, shares, or other types of equity interests
Options to acquire stock, shares, or other types of equity interests
Income arising from stock shares, and other types of equity interests
Royalty payments
Licensed, optioned, or revenue- generating intellectual property
Sponsored or reimbursed travel
See slides for exceptions 16

17. Financial Interests DO NOT include
Salary royalties, or other remuneration paid by NDSU to the investigator if the investigator is currently employed or otherwise appointed by NDSU
Intellectual property rights assigned to NDSU and agreements to share in royalties related to such rights. 17

18. Financial Interests DO NOT include
Travel
Seminars, lectures, or teaching engagements
Service on advisory committees or review panels
IF paid for, sponsored, or reimbursed by:
A federal, state or local government agency
An US institution of higher education
An academic teaching hospital
A medical center
A research institution that is affiliated with a US institute of higher education 18

19. What is the threshold for disclosure?
The disclosure threshold is reached if within the past 12 months For a publicly traded entity, If the aggregate of any remuneration and any equity (ownership) interest you, your spouse, domestic partner, or your dependents held or received exceeds $5000. For a privately held entity, If the aggregate of any remuneration you, your spouse, your domestic partner, or your dependents held, or received exceeds $5000 OR You, your spouse, your domestic partner, or your dependents held or received any equity (ownership) interests. For intellectual property and interest (e.g., patents, copyrights) When such are licensed, optioned, or generate income For sponsored or reimbursed travel when it is not exempt from disclosure as previously described 19

20. Apply Your Knowledge: Question 3
Which of the listed financial interests does Dr. Smith need to disclose?
Dr. Smith is the PI of an award to NDSU to evaluate the efficacy of a feed supplement produced by XYZ Inc. XYZ is publicly traded.
Dr. Smith’s financial interests for the past 12 months:
Consulting activities for XYZ Inc. totaling $4500
XYZ speaker’s bureau stipend totaling $1000
His wife’s ownership interest in ABC Inc. a privately held company developing a feed supplement similar to the XYZ supplement being tested
His Society of Crop Science board membership for which he received an honorarium of $6000
Free travel for his service as a grant reviewer for the USDA
Royalties of $100,000 from licensed intellectual property involving a computer program to manage animal health records. 20

21. Answer: Question 3
Dr. Smith should disclose the following financial interests because they 1) are related to the research he is working on for NDSU and 2) they meet the threshold for disclosure:
His consulting activities for XYZ Inc. totaling $4500
His activities with XYZ Inc. speaker’s bureau for which he received $1000
His wife’s ownership interest in ABC Inc. a privately held company that is developing a supplement similar to the XYZ supplement being tested
The activities (consulting and speaker’s bureau) for XYZ Inc., when aggregated for the past 12 months, exceed $ Because ABC Inc. is a potential competitor of XYZ Inc., the interest in ABC Inc. needs to be disclosed. Any ownership in a privately held company reaches the disclosure threshold. 21

22. Answer: Question 3 continued
These financial interests are not related to the research for NDSU and do not need to be disclosed:
Dr. Smith’s Society of Crop Science board membership
Free travel for his service as a grant reviewer for USDA
Royalties from licensed intellectual property involving a computer program to manage animal health records (assuming an IP agreement with NDSU; otherwise, it would need to be disclosed). 22

23. When must I disclose my financial interest?
Before submitting a new research proposal for federally funded studies, everyone named on the proposal must submit a Significant Financial Interests (SFI) Disclosure form
When funded, all investigators—as determined by the PI—must submit a SFI disclosure form
If your financial interests change during the course of an award a new Significant Financial Interests Disclosure form must be submitted 23

24. When must I disclose my financial interest? (continued)
Before serving as an investigator on behalf of NDSU, you must report whether you have held any financial interests in the previous 12 months related to the NDSU research project on which you will be working
In addition, as long as you are an investigator for NDSU, you must also:
Disclose newly discovered or acquired financial interests within 30 days
Update the disclosure annually by January 15 24

25. How do I disclose my financial interests?
Forms are available on the Research Integrity & Compliance (RIC) website
Complete the necessary form, sign the attestation, obtain signatures if necessary and submit to RIC
Electronic signatures are acceptable
Electronic versions of the form are preferred
All forms are submitted as described in the instructions on the form
Please check the RIC website for the most recent version of forms! 25

26. What happens after I submit my disclosure?
The FCOI committee/officer will review it, and if necessary will confer with you to determine if a conflict exists.
If a financial conflict of interest is present, the FCOI officer/committee will work with you to reduce, manage or eliminate the conflict. 26

27. How are FCOIs managed or eliminated?
Management plans may include one or more of the following elements:
Public disclosure of significant financial interest
Monitoring by independent reviewers
Modification of the research plan
Disqualification from participation in the portion of the funded research that could be affected by the significant financial interests
Divesture of significant financial interests
Severance of relationships that create actual or potential conflicts 27

28. What do I need to remember?
You and NDSU are responsible for promoting and maintaining objectivity in research
You are responsible for:
Being familiar with disclosure processes
Disclosing family relationships within a project
Making sure you have disclosed the required financial information on time
Adhering to the condition of the management plan if one is required 28

29. Forms and Resources All forms are available on the RIC FCOI website
NIH Guidelines
NSF Guidelines
USDA Guidelines
Please contact with any questions
Thank you! 29