FAQs

Who has to file a Conflict of Interest (COI) Disclosure form?

Federal regulations require that all persons who are involved in the design, conduct, or reporting of research must complete an annual COI disclosure.   Federal regulations, State of Ohio laws, OSU policies, and accreditation requirements also mandate that faculty, staff and students who are key personnel on research protocols involving the use of human subjects, animals, or biohazardous materials in research also be screened for potential COIs.  Finally, Ohio State Faculty Group Practice (FGP) policy requires that members of the FGP file an annual COI disclosure.  Therefore university policy and procedures require that the following individuals complete an annual COI disclosure:

Faculty:

  • who have been identified as a project director, principal investigator, or senior/key personnel (including non-university employee consultants) on sponsored projects during the past 12 months;
  • who are investigators, senior, or key personnel on current Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), or Institutional Biosafety Committee (IBC) protocols during the past 12 months;
  • who received salary support during the past 12 months from specific federal grants or industry-sponsored projects, which require coi reporting;
  • who have fiduciary and financial responsibility for their units, college, or the university; and
  • Member physicians of The Ohio State University Faculty Group Practice.

Staff members, Administrators, and Students;

  • who participated as investigators, senior or key personnel on sponsored projects during the past 12 months;
  • who are investigators, senior or key personnel on current IRB, IACUC, or IBC protocols during the past 12 months;
  • who received salary support during the past 12 months from specific federal grants or industry-sponsored projects, which require coi reporting;
  • who have fiduciary and financial responsibility for their units, college, or the university; and
  • Select Staff from the OSU Wexner Medical Center.

If you have questions as to whether you are required to file an annual research-related COI disclosure, please contact the Office of Research Compliance at ConflictInfo@osu.edu. If you have questions as to whether you are required to file an annual COI disclosure for OSUMC purposes, please contact the OSUMC Compliance Office at Compliance@osumc.edu. If you have questions as to whether you are required to file an annual COI disclosure for University fiduciary or financial responsibilities, please contact the Office of University Compliance and Integrity at Compliance-Integrity@osu.edu.

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I am new to Ohio State.  Do I need to disclose financial interests I acquired before joining the University?

Yes, federal research regulations require the disclosure of any financial interests (e.g., employment or consulting payments) from the previous 12 months that could be related to your institutional responsibilities.

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How do I file my COI Disclosure?

The university utilizes an electronic COI screening and disclosure form (e-COI). The e-COI application makes the process of submitting, updating, and managing potential financial conflicts of interest simple and efficient. Additional information is available from the Office of Research Compliance website along with access to the e-COI disclosure website at http://go.osu.edu/coi.

For technical assistance with accessing the e-COI application or if you are not affiliated with The Ohio State University, please contact the ORIS Help Desk.

For regulatory or procedural questions please contact ConflictInfo@osu.edu.

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When do I have to file my new COI Disclosure?

The 2016 e-COI disclosure process begins April 25, 2016. Faculty, staff, and students should file their 2016 e-COI disclosures before May 23, 2016. OSUWMC staff should file their 2016 e-COI disclosures before June 30, 2016.

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When do I have to update my COI Disclosure?

The federal COI regulations and university policy require faculty, staff, and students to update their e-COI disclosure within 30 days of receiving any new financial interest with an outside entity, or within 30 days of any changes to a currently-disclosed financial interest.   See the FAQ “How do I update my COI Disclosure?” below for more information.

Also, faculty, staff, and students must report any reimbursed or sponsored travel that is not paid for or reimbursed with The Ohio State University funds or sponsored project funds within 30 days.  See the FAQ “Does sponsored or reimbursed travel need to be disclosed?” below for more information.

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How do I update my COI Disclosure?

Instructions for updating a currently approved e-COI disclosure are provided below and can also be accessed by clicking the “Help” button on the e-COI form page. Additional information can also be found in the Step by Step Instruction Guide for using eCOI application.

  • Log in to http://go.osu.edu/coi using your OSU Internet username (name.#) and password.
  • Once signed-in, click the “Re-open Disclosure” button to re-open and update your information.
  • Click the “Submit for Approval” button and your revised COI disclosure will be routed to the appropriate parties for review and approval.

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How do I get a copy of previous years disclosure forms?

  • Log in to http://go.osu.edu/coi using your OSU Internet username (name.#) and password.
  • Once signed-in, click the “Re-winding Clock” icon on the top left-side of the screen.
  • You will be able to download a PDF copy of all forms that were successfully submitted from 2012 thru current reporting year.

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What types of financial interests do I have to report?

You must report all personal financial interests from external sources, including travel. This would include any interest in a company, business, foundation or other organization that:

  • Provides products or services in your academic, clinical, or research discipline or area of study. An example would be a manufacturer that has products in your  professional discipline, clinical practice area, or area of research;
  • Will likely make use of your scholarly work or research – either directly or indirectly.  For example, could the company, foundation or organization use your scholarly work or research in its own product line, or could it be used by a competitor?;
  • Is a member of an industry, trade, advocacy group or professional association that funds scholarly work, research or is an advocate for funding in your professional discipline or area of study or expertise;
  • Has some other relationship not described above that could reasonably appear to impact your research or other obligations to the University;
  • You receive royalties directly from intellectual property that you have licensed to an external entity.

Note: For all of the above financial interests, including traveling on behalf of an external entity to an industry meeting, professional society, to testify to the FDA, etc., you need to execute a consulting agreement and to disclose this activity and any monies paid to support the activity on your eCOI disclosure.

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Am I required to disclose passive investments (e.g., retirement accounts, mutual funds)?

Maybe, but only if you have direct control over the investment decisions made in these vehicles.

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For research purposes, what is meant by “financial interest” and “significant financial interest”?

A “financial interest” is any monetary value that belongs to you, your spouse or partner, or your dependent children. The financial interest becomes “significant” if it meets ANY of the following conditions:

  • All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $10,000 or represents more than 5% ownership interest in any single entity. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
  • ANY equity interest held in a non-publicly traded entity, or more than $10,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
  • Income from intellectual property rights and interests received from an entity other than The Ohio State University that exceeds $10,000 during the 12 months prior to disclosure.

Please note that the U.S. Public Health Service (PHS) and its agencies define a “significant” financial interest (SFI) at a lower level than do other federal agencies, such as the National Science Foundation, and the university’s longstanding level of $10,000 described above.

Specifically, if you have worked on PHS funded research in the past year, or expect to work on PHS-funded projects this year, a financial interest becomes “significant” if it meets ANY of the following conditions:

  • All income from a publicly-traded entity received during the 12 months prior to disclosure plus the value of any equity interest in the entity as of the date of an annual disclosure, when combined, exceeds $5,000. Examples of income include consulting fees, honoraria, or paid authorship. Equity interest includes any stock, stock option, or other ownership interest;
  • ANY equity interest held in a non-publicly traded entity, or more than $5,000 in income from a non-publicly traded entity received during the 12 months prior to disclosure; or
  • Income from intellectual property rights and interests received from an entity other than The Ohio State University that exceeded $5,000 during the 12 months prior to disclosure.

PHS agencies include the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services (CMS), Administration for Children and Families (ACF), or Administration on Aging (AOA).

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Are there financial interests that I don’t have to disclose?

Federal regulations and university policy do not require you to disclose the following types of financial interests:

  • Reimbursement or payment of travel paid by The Ohio State University, or covered by a sponsored program agreement managed through the Office of Sponsored Programs;
  • Royalties received from The Ohio State University for intellectual property owned by the university;
  • Royalties resulting from traditional academic publishing activities such as the publication of text books or other educational materials;
  • Any salary or other remuneration paid to you by The Ohio State University or an Ohio State physician or dental practice group.

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Do I need to disclose my service as National PI of a clinical trial?

If you serve as National PI in your personal capacity (i.e., not as an Ohio State researcher), then you must disclose the personal compensation you receive for these activities.

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Does sponsored or reimbursed travel need to be disclosed?

Faculty, staff, and students are required to disclose the occurrence of any reimbursed or sponsored travel paid for directly or reimbursed by an external entity.  However, this disclosure requirement does not apply to:

  • Any travel reimbursed, sponsored or paid for by a U.S. government agency, a U.S. higher education institution, a U.S. academic teaching hospital, medical center, or a U.S. research institute affiliated with a U.S. higher education institution; and
  • Any travel reimbursement or payment of travel made by The Ohio State University, a university college, department or unit, or travel covered by a sponsored program agreement managed through the Office of Sponsored Programs.

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Who determines if I have a conflict of interest?

For research purposes, if you disclose a “significant” financial interest with an outside entity, your e-COI disclosure is reviewed by your department chair or college dean, who determines if the significant financial interest may be related to your institutional responsibilities.  If s/he determines that the interest may be related, your e-COI disclosure is then routed to the Conflict of Interest Administrator and The Ohio State University Conflict of Interest Advisory Committee (COIAC) for review.  The COIAC determines whether a significant financial interest is related to a specific research project or protocol and, if so, whether the interest could directly and significantly affect the design, conduct or reporting of the research.

For OSU and Medical Center faculty and staff who do not participate in research, any financial interest with an outside entity that is disclosed will be reviewed by compliance representatives from the respective business units for compliance with OSU policies and procedures and the Ohio Ethics Laws.

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What happens if I do have a conflict of interest?

For research purposes, if it is determined that a significant financial conflict of interest exists that may directly and significantly affect the design, conduct or reporting of a specific  research project, then a formal Conflict Management Plan (CMP) is created by The Ohio State University Conflict of Interest Advisory Committee (COIAC) to manage, reduce, or eliminate the conflict.  All Conflict Management Plans are reviewed, approved, and annually monitored by the COIAC pursuant to university policy and federal regulations. CMPs are renewed annually and are effective as long as the conflict is present.

For OSU and Medical Center faculty and staff who do not participate in research, if it is determined that a potential financial conflict exists, the faculty or staff member will be contacted by their Senior Fiscal Officer or Compliance representative for further review. After a review, if it is determined that a potential financial conflict exists, actions such as management plans may be implemented to control, limit or eliminate the potential financial conflict.

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Are there university policies that address the types of outside activities that OSU faculty/staff can participate in?

Yes, the following policies govern outside activities that OSU faculty/staff can participate in:

For additional information please see the Office of Academic Affairs OAA Policies and Procedures Handbook.

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Does the Conflict of Interest Policy interact with the Medical Center’s Vendor Interaction Policy?

Yes, the Ohio State University Medical Center (OSUMC) Vendor Interaction Policy and the university’s Financial Conflict of Interest Policy, Conflict of Commitment Policy, and the Faculty Policy on Paid External Consulting overlap when a faculty member engages in personal activities for Medical Center vendors or research sponsors, or a faculty member provides continuing medical education (CME) activities outside of the Medical Center’s CME program. For additional information, please consult the Vendor Interaction Policy or contact OSUMC Compliance Office at Compliance@osumc.edu.

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Who is required to complete a disclosure for the Wexner Medical Center?

  • Health System Leaders
  • College of Medicine leaders
  • Purchasing Personnel
  • eMaterials Requisition Entry and Approvers
  • eMaterials Purchase Order Approvers
  • FSOU Health System voucher Approvers
  • Cost Center Authorization List Designees
  • Health System Authorization List Designees
  • Health System Personnel Directors, and
  • Revenue Cycle/Finance managers.

Medical Center faculty and staff who also are members of the above group will only be required to complete a single coi disclosure this year. For additional information, contact Medical Center Compliance at 614-293-7802 or Compliance@osumc.edu.

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What is an Organizational Financial Conflict of Interest?

Organizational Financial Conflicts of Interest (OCOI) may emerge when the university (or its key leaders) have financial or proprietary interests in a company sponsoring human subject research. As necessary, The Ohio State University Conflict of Interest Advisory Committee (COIAC) will develop a formal Conflict Management Plan designed to manage, reduce, or eliminate the OCOI. These recommended plans will be provided to the Institutional Review Board for final approval.

For more information on OCOI (also known as Institutional COI, or ICOI), please see the Human Research Protection Program’s policy on Organizational Financial Conflicts of Interest.

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