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Human Resources

Human Resources

Policies and Procedures

Principal Investigator Conflict of Interest Policy (faculty)

Effective 10/19/13
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Table of Contents

  1. Introduction
  2. Purpose
  3. Financial Disclosure
  4. Significant Financial Interest
  5. Exclusions to Significant Financial Interest
  6. If There is a Potential Conflict of Interest
  7. Definitions
  8. Record Retention
  9. Other Related Policies, Documents and Resources
  10. Appendix

1. Introduction

The National Institute of Health (NIH) revisions to the Conflict of Interest in Research (CoIR) regulations went into effect August 24, 2012. As a result, Eckerd College has established standards and procedures to be followed by investigators applying for federal funding to ensure that the design, conduct, or reporting of research; educational activities; and cooperative agreements or contracts will not be influenced by any conflicting financial interest of those investigators responsible for the proposed activity.  The rationale for establishing policies to manage conflict of interest in research is to protect employees and the College from potential accusations of malfeasance.
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2. Purpose

The purpose of this policy is to guide faculty involved in research projects about the procedures required when seeking funding from external resources to comply with federal regulations.
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3. Financial Disclosure

Principal investigators must complete the Conflict of Interest Disclosure Form and submit it to the Vice President for Academic Affairs (VPAA) or designee as outlined in this paragraph.  The purpose of the Form is to disclose whether or not the Principal Investigator has a direct or indirect financial interest in the sponsor of research which is funded or supported in whole or in part (a) through a contract or grant with a non-governmental entity or (b) by a gift from a non-governmental entity which is earmarked by the donor for a specific research project or a specific principal investigator. Disclosure statements must be filed (a) before final acceptance of such a contract, grant, or gift; and (b) when funding is renewed.  When disclosure indicates that a financial interest exists, an independent substantive review of the disclosure statement and of the research project must take place prior to acceptance of the contract, grant, or gift. Department chairs must disqualify themselves from approving a research proposal for a project which is funded in whole or in part by a non-governmental entity in which they have a significant financial interest.
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4. Significant Financial Interest

A conflict of interest may occur when an investigator's affiliation with an external organization meets any one of the following criteria:

  1. Compensation: i.e., anything of monetary value including, but not limited to, salary, gifts, consulting fees, honoraria or other payments for services that is more than five thousand US dollars ($5,000) in the aggregate over the last twelve (12) months;
  2. Equity interests: e.g. stocks, stock options, warrants, contractual rights to acquire or receive ownership interests, or other ownership interests in a publicly-traded company that is more than five thousand US dollars ($5,000) or any amount in a non-publicly-traded company;
  3. With respect to a publicly-traded company, the aggregated value of compensation, as defined above, over the last twelve (12) months and equity interest that is more than five thousand US dollars ($5,000);
  4. Intellectual property rights: e.g. patents, copyrights and royalty income or the right to receive future royalties under a patent license or copyright;
  5. Non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of the research (e.g. bonus or milestone payments to the investigators in excess of reasonable costs incurred);
  6. Service as an officer, director, or in any other executive position in an outside business, whether or not remuneration is received for such service; and
  7. Reimbursed or sponsored travel (only applies to investigators involved in Public Health Service funded research and their spouses, registered domestic partners or dependent children) that exceeds $5,000 when aggregated per entity over the last twelve (12) months. Disclosures shall include the purpose of the travel, the identity of the sponsor/organizer, the destination and the duration of the travel, and any other information as requested by the disclosure form or designated official
See exemptions below.

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5. Exclusions to Significant Financial Interest

  1. Interests of any amount in, or income from, investment vehicles, such as mutual funds or retirement accounts so long as the investigator does not directly control the investment decisions made in these vehicles.
  2. Salary and other compensation from Eckerd,
  3. Income from seminars, lectures or teaching engagements 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; or
  4. Income from service on advisory committees or review panels for 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.
  5. Reimbursed or sponsored travel that is reimbursed or sponsored by a federal, state or local government agency, an Institution of higher education, an academic teaching hospital, or a research institute that is affiliated with an Institution of higher education.

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6. If There is a Potential Conflict of Interest

The Vice President for Academic Affairs or designee will review any potential conflicts and determine which disclosed interests could affect the design, conduct or reporting of the research or educational activity. If the Vice President determines that a potential conflict exists, the following may occur:

  1. Request a reformulation of the work plan to eliminate the conflict(s).
  2. Request monitoring of research or educational activity by independent reviewers.
  3. Divestiture of relevant personal interests.
  4. Consider a disqualification from participation in the portion of the project that would be affected by the significant financial interests.
  5. Request severance of outside relationships posing a conflict of interest.
  6. Other appropriate disclosures or activities.

If the Vice President for Academic Affairs determines that imposing the above or other conditions or restrictions would be inequitable, or that the potential negative impact that may arise from a significant financial interest is outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Vice President may recommend that, to the extent permitted by federal regulations, the research go forward without imposing such conditions or restrictions.  The latter decision must be made within the context of the principle of "Academic Freedom."

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7. Definitions

College means Eckerd College

Conflict of Interest means the real or apparent interference of one person’s outside interests with the interests of another person where potential bias may occur due to prior or existing personal or professional relationships.  This definition seems broader than the definition represented in the policy.

Disclosure – For purposes of this policy, disclosure of outside interests and commitments or of anything else that may have the appearance of a conflict of interest by investigators must be made to the Vice President for Academic Affairs and Dean of Faculty (or designee) with each application for funding. This is accomplished by completing the attached Conflict of Interest Disclosure Form. The disclosure must be updated during the period of the award, annually or as new significant financial interests are obtained, as applies.

Investigator means the principal investigator, project director or any other person at Eckerd College responsible for the design, conduct, or reporting of a research project, proposed or funded.

Immediate Family means the employee’s spouse or domestic partner and dependent children.

Significant financial interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights (see 42 CFR 50.603 and 45 CFR 604.3).

Only those outside interests related to College activities need to be reported. Not all outside interests and financial relationships place the investigator in conflict with his or her obligations to the College and/or his or her profession. As explained in this policy, not all conflicting interests are necessarily impermissible. Timely and complete disclosures of potential conflicts of interest protect the investigator and are in the best interests of all concerned.  Collaborators at other institutions and sub-contractors must either comply with this policy or certify to Eckerd College that their portion of the project has been reviewed according to their own institutional policies.

Vice President for purposes of this policy, Vice President refers to the Vice President for Academic Affairs and Dean of Faculty or designee.<
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8. Record Retention

After completion of an inquiry or investigation and all ensuing related actions, the Vice President for Academic Affairs or designee will prepare a complete file, including the records of any inquiry and copies of all documents and other materials related to the inquiry. The file will be kept in a confidential folder for seven years.
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9. Other Related Policies, Documents and Resources

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