UNIVERSITY OF SOUTH FLORIDA Conflicts of Interests in Research Vinita Witanachchi, J.D. Division of Research Integrity & Compliance Assistant Director, HIPAA & COI

Learning Objectives Generally:  Define a conflict of interest (COI)  Define a COI in research  Understand when a COI is a “COI in research”  Understand the process involved: DisclosureReview Management Plan 2

What is a conflict of interest? A conflict between a person’s private interests, and public obligations A “COI” is a situation in which someone in a position of trust has competing interests which makes it difficult to fulfill his/her duties impartially. Even if no unethical or improper act results from it, a conflict could still exist. Importantly, a COI can create an appearance of wrongness which can undermine confidence in the person or the institution at large. A conflict can be mitigated by third party evaluation Multiple interests, one of which could possible corrupt the motivation for an act in the other 3

Types of Conflicts 1. Conflicts of Interest and commitment with university employment  Time spent on external endeavors 2. General conflict of interest  Nepotism, doing business with USF in private capacity, Board memberships and purchasing decisions 3. Conflict of interest in research  Personal Financial interest that may bias the design- conduct or reporting of USF research 4

What is Conflict of Interest in Research? ●Competition between ‘Primary Interest’ vs. ‘Secondary financial interest’ ●It is a situation in which professional judgment concerning the primary interest in research is unduly influenced, compromised (or appear to influence) as a result of a competing secondary financial interests held by the investigator 5

“Working” Definitions Conflict of Interest in Research  A conflict of interest in research exists when an investigator’s self interests may compromise, or have the appearance of compromising, an investigator’s professional judgment in the design, conduct or reporting of research Investigator  Any person responsible for the design, conduct or reporting of research 6

Working Definitions (con’t) COI= Individual + Self-Interest + An Ethical or Professional Duty COI in Research= Investigator + Self-Interest + Objectivity in the Design/Conduct/ Reporting of research HINT: The management goal is to protect the integrity of the research 7

Federal Regulations The federal regulations only address one type of “self-interests:” FINANCIAL INTERESTS 8 Other Types: Enhanced reputation Personal relationships Professional relationships Political, religious…….

General Principles in Dealing with COI in Research  COI is virtually unavoidable  COI does not preclude participation of an investigator in a project  Must have a culture of honest and full disclosure so that steps can be taken to manage conflicts effectively  Not all COI can be managed 9

What are ‘secondary financial interests?’ Some examples:  Receiving payment for speaking engagements from the sponsor of the study  Holding an ownership interest in the company that manufactures the drug/devise being tested  Having intellectual property rights to the drug/device being tested, just to name a few 10

Conflicts of Interests in Research  It is illegal or unethical to have a secondary financial interest? NO!  Bayh-Dole Act of 1980 encourages entrepreneurships among private industry, institution and the researcher  Benefits to the institution? YES!  Any unintended by-product of Bayh-Dole Act? Yes, possibly conflicting interests! 11

What types of research-related conflicts exist? It is anything that could be quantified, but not limited to the following:  Payment for services, consulting fees, honoraria, reimbursements of expenses, dividends, any other payments or consideration  Equity interests (such as stocks, stock options)  Intellectual property rights (patents, copyrights, royalties) 12

How do you know you have a reportable interest?  Do you own stocks, stock options, real estate or have other ownership interests in an ‘entity related to the research?’  Do you or your domestic partner or dependant children own stock, stock options, or other ownership interest in an entity related to the research?  Did you or will you (including family members) receive salary, consulting fees, royalties, honoraria, dividends or other payments from an entity related to research?  Do you or your family members hold a management position such as director, officer, partner or trustee in an entity related to the research? Important: If the answer to any of the questions above is YES, you may have a conflict of interest in research that you must disclose to the institution for management 13

What is an ‘entity that is related to research?’ To name some: ● Sponsor or the funding source of the research ● Supplier of equipment, materials, products, or services related to research ● Holder of any ownership interest in a product/device being investigated ● Business enterprise which is commercializing a product that the research is intended to evaluate of further develop ● Anyone whose financial interests would seem to be directly and significantly affected by the proposed research 14

Exceptions to reportable interest The following financial interests and commitments are generally recognized as NOT relating to or not being impacted by the outcome of the research and therefore do NOT need to be disclosed:  Salary, royalties or other remuneration received from USF or the USFPG  Receipt of royalties for any published scholarly works and other writings  Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities. NOTE: All honoraria received from commercial entities must be disclosed. 15

Exceptions to reportable interest (con’t) Income from service on advisory committees or review panels for public or nonprofit entities. Interests in commercial enterprises on the part of an investigator which commercial enterprises are in no way related to the investigator’s professional role and/or obligations Any “arms length” financial interest (i.e., those that occur through participation in a mutual fund or employer retirement plans), where the participant has no control over the investment decision Income from speaking engagements sponsored by government or non-profit 16

Why does the university want to avoid/manage COI? ● Public Trust: To gain public trust in the research conducted at public universities ● Integrity: To maintain integrity of research process and research results 17

How might conflicts in research be avoided or mitigated? ● Disclosure! Disclosure! And Disclosure! Always remember – “Disclosure is the Golden Rule to gaining public trust!” ● What is the institutional process? Disclosure to the institution who then will conduct a thorough review of the financial relationships involved, and place management controls to thwart bias being introduced to each of the phases (design-conduct-reporting) of research. 18

Examples of some management controls Provide notice of the conflicting interest to study participants, research personnel, collaborators, editors of journals funding agencies Engage independent reviewers to monitor certain aspects of the study Specific data management strategies Additional independent studies to confirm the results Blinding the interested investigator Multiple non-interested investigators Objective end-points Divestiture of the related interest 19

When should financial interests be reported ? Upon initial submission of research proposal To DSR (for sponsored research) To the investigator’s Department Chair or Committee (for non-sponsored research) To review committees (IRB, IACUC) for approval Within 30 days from when the previously disclosed interest has changed Upon Joining a research project Must submit a disclosure within 30 days of beginning work on the research 20

COI Committee Review ● Motivation How much incentive does the INV have to bias the design, conduct or reporting of the research? ● Opportunity Is the INV in a position to bias the design, conduct or reporting of the research? 21

Review Process for Financial Interests in Research at USF (Cont’d) COI Administrator develops management plan in consultation with interested investigator COI Administrator may approve without committee review if certain conditions are met (BUT not for human subjects research) COI Committee Reviews FRDF and Management plan Notification to  Interested Person  DSR  IRB (if USF IRB is IRB of record) 22

New Online COI Process 23 How to access the online site? Applications for Research Compliance (ARC) site Help Desk at or at

To learn more about the institutional COI process, please visit the following: Conflict of Interests Administrators  Contact Person: Camille McWhirter, J.D coiusfpolicy.htm  Contact person: Vinita Witanachchi, J.D