UNIVERSITY OF SOUTH FLORIDA

Conflicts of Interests in Research

Vinita Witanachchi, J.D.Division of Research Integrity &

ComplianceAssistant Director, HIPAA & COI

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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:

Disclosure Review Management Plan

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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

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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

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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

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“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

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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

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Federal Regulations

The federal regulations only address one type of “self-interests:”

FINANCIAL INTERESTSOther Types:

•Enhanced reputation•Personal relationships•Professional relationships•Political, religious…….

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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

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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

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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!

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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)

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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

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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

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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.

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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

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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

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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.

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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

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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

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COI Committee Review

●MotivationHow much incentive does the INV have to bias the design, conduct or reporting of the research?

●OpportunityIs the INV in a position to bias the design, conduct or reporting of the research?

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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)

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New Online COI Process

How to access the online site? Applications for Research Compliance (ARC)

sitehttps://arc.research.usf.edu/prod

Help Desk at 813-974-2880 or email at eCOI@research.usf.edu

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To learn more about the institutional COI process, please visit the following:

Conflict of Interests Administrators

Contact Person: Camille McWhirter, J.D. 813-974-6676

http://www.health.usf.edu/research/compliance/ coiusfpolicy.htm

Contact person: Vinita Witanachchi, J.D. 813-974-5478

http://www.research.usf.edu/cs/coi.htm