Financial Conflicts of Interest in Research

Scope

This Policy applies to all persons at IU who are “Investigators” on University research projects or sponsored programs, as defined below (see Definitions).

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Policy Statement

The University is required to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research, including research funded under Public Health Service grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. Investigators are required to annually disclose Significant Financial Interests for evaluation by the University’s Conflict of Interest Program, and to update this disclosure as interests change to comply with federal regulations designed to protect the objectivity of federally funded research and sponsored programs.  The University Conflict of Interest Committee and Conflict of Interest Program shall be responsible for identifying Conflicts of Interest and determining appropriate steps to reduce, manage, or eliminate the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.  The Conflict of Interest Program shall develop separate procedures to administer this program.  Those procedures should also ensure that, to the extent required by federal law and regulation, the Conflict of Interest Program fulfills federal public disclosure requirements of managed Conflicts of Interest and provides training to Investigators (see, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)).

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Reason for Policy

To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct and reporting of research, including research funded under Public Health Service grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest .

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Procedures

See Compliance Services: Conflict of Interest on the website of the Office of Research Compliance: researchcompliance.iu.edu/coi/index.html   

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Definitions

“Conflict of Interest” means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research or a Sponsored Program.

Conflict of Interest Program means the University Conflict of Interest Committee and the Office of Research Compliance staff supporting the administration of this Policy.

“Family Members” are defined as the Investigator’s spouse and dependent children.

“Financial Interest” is defined as anything of monetary value, whether or not the value is readily ascertainable, including, but not limited to, salary, commissions, consulting fees, honoraria, equity interests, interests in real or personal property, dividends, royalties, rent, capital gains, intellectual property rights, and forgiveness of debt, other than:

• compensation from Indiana University;
• income from seminars, lectures, or other educational activities sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
• income from service on advisory committees, or review panels for a public federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
• an interest arising solely by means of investment in a mutual, pension, or other institutional investment fund where the Investigator does not exercise control over the management and investments of such fund.

“Indiana University” or the “University” shall refer to Indiana University.

“Investigator” means University faculty, staff, and students who have responsibility for designing research, collecting research data, performing other substantive research activities, or reporting research. Investigator also includes the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of Research.

“Research” means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development.

“Significant Financial Interest” means one or more of the following Financial Interests of the Investigator (and those of the Investigator’s Family Members) that reasonably appear to be related to the Investigator’s University Responsibilities:

• With regard to any publicly traded entity, it is the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000 from one enterprise or entity;
• With regard to any non-publicly traded entity, it is the value of remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest;
• Intellectual property rights and interests, upon receipt of income of $5,000 or more from such rights and interests, other than rights assigned by the Investigator to the University and associated royalty sharing agreements,
• Salary, remuneration, or similar payments which exceed, or are expected to exceed, $5,000 within any one-year period, when aggregated for the Investigator and her/his Family Members; or,
• Any reimbursed or sponsored travel, related to an Investigator’s University Responsibilities subject to the de minimis thresholds set by the federal regulations and guidance; provided, however, that Investigators need not disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C 1001(a), an academic teaching hospital, a medical center, or a research institution that is affiliated with an Institution of higher education.

“Sponsored Program” means projects or activities, other than Research, undertaken within the University pursuant to funding from an external source.

“University Conflict of Interest Committee” consists of University faculty and administrators, appointed by the Vice President for Research, who are responsible for evaluating disclosures from Investigators and ensuring compliance with this Policy.

“University Responsibilities” are defined as the responsibilities of an Investigator to perform University activities as defined by University or unit policy, contract, or collective bargaining agreement and, are defined as activities that are undertaken directly to fulfill one’s research, teaching, or service responsibilities within the University.

“University Official” is the Vice President for Research who provides oversight of the Conflict of Interest Program and is the institutional official for purposes of administering the duties outlined in applicable federal regulations.

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Sanctions

Violations of university policies, including the failure to avoid a prohibited activity or disclose a conflict of interest in a timely manner, will be dealt with in accordance with applicable university policies and procedures, and may include sanctions related to participation in research as well as disciplinary actions up to and including termination from the university.  University faculty, staff, and students that are found to be in violation of this policy may be subject to sanctions relating to their participation in research.

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Additional Contacts

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History

This policy was updated in October 2012 to comply with federal regulations and guidance regarding "significant financial interest" (see Definitions). These changes were approved by the University Faculty Council on October 30, 2012 and went into effect, by approval of the Board of Trustees, on December 6, 2012. 

University Faculty Council previously approved this policy on the following dates: 9/12/00, 3/9/04, 4/24/04, 11/24/09, 4/24/2012

The Indiana University Board of Trustees previously approved this policy on the following dates: 9/15/00, 3/3/06, 5/4/2012, 8/17/2012

Previous Versions:

Effective Dates: 10/30/2012 - 03/20/2018

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