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

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

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

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

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

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

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

“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

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

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

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

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

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

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

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

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 17-18 for exceptions 16

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

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

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

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

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 $5000. 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

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

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

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

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

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

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

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

Forms and Resources All forms are available on the RIC FCOI website www.ndsu.edu/research/integriy_compliance/fcoi NIH Guidelines www.nih.gov NSF Guidelines www.nsf.gov USDA Guidelines www.usda.gov Please contact 701-231-8908 with any questions Thank you! 29