FAQs
- Who has to file a Conflict of Interest (COI) Disclosure form?
- How do I file my COI Disclosure?
- When do I have to file my new COI Disclosure?
- When do I have to update my COI Disclosure?
- How do I update my COI Disclosure?
- What types of activities do I have to report?
- What is meant by "financial interest" and "Significant financial interest"?
- Are there financial interests that I don't have to disclose?
- Who determines if I have a conflict of interest?
- What happens if I do have a conflict of interest?
- Are there university policies that address the types of outside activities that OSU faculty/staff can participate in?
- Does the Conflict of Interest Policy interact with the Health System's new Vendor Interaction Policy?
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. Therefore university policy and procedures require that the following individuals complete an annual COI disclosure:
- All regular faculty engaged in teaching and/or any research activities;
- All part-time, clinical, research, auxiliary or emeritus faculty who have a role in the design, conduct, or reporting of research - including research with animals, human subjects, recombinant DNA molecules, stem cells, or pathogenic microorganisms;
- Clinical and research staff members and students who have a role in the design, conduct, or reporting of research - including research with animals, human subjects, recombinant DNA molecules, stem cells or pathogenic microorganisms. Examples of such roles include the following:
- Staff or students who are formally listed on, or their salary or effort is associated with, a specific sponsored project or award;
- Staff and students who are included as a co-investigator or key personnel on an institutional review board (IRB), institutional animal care and use committee (IACUC) or institutional biosafety committee (IBC) protocol;
- Clinical or research staff or students who collect or analyze data, or consent research subjects; and
- Staff or students who plan to participate as authors on publications or presentations resulting from research.
- Principal Administrative Officials designated by the Vice President of Research as having a significant role in the supervision of research.
If you have questions as to whether you are required to file an annual COI disclosure, please contact the Office of Research Compliance at ConflictInfo@osu.edu.
How do I file my COI Disclosure?
The university utilizes an electronic COI screening and disclosure form (eCOI). The eCOI 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 eCOI application. For technical assistance with accessing the eCOI application or if you are not affiliated with OSU please contact the Office of Research Help Desk at 688-8288 or orhelpdesk@osu.edu. For regulatory or procedural questions please contact ConflictInfo@osu.edu.
When do I have to file my new COI Disclosure?
University policy requires that your eCOI disclosure be filed each year. The current 2008/2009 eCOI disclosures expire on 10/31/2009. The new eCOI disclosure year (2009/2010) is available as of 9/15/2009 and once completed, the 2009/2010 eCOI disclosure will be effective through 10/31/2010.
When do I have to update my COI Disclosure?
Your eCOI disclosure needs to be updated whenever there are any changes to report, for example, after entering into a new consulting or financial relationship or after receiving additional income from an existing relationship. Updating your COI disclosure is especially important when the change results in the creation of a new "significant" financial interest (e.g., greater than or equal to 5% stock ownership or $10,000 per year in personal income from consulting, speaking fees or honoraria).
How do I update my COI Disclosure?
Instructions for updating a currently approved eCOI disclosure are provided below and can also be accessed by clicking the "Instructions" button on the eCOI form page.
- Faculty/Staff/Students that need to update their eCOI disclosure form should send an email to ConflictInfo@osu.edu and simply place in the subject line "Reopen eCOI disclosure". You will receive an email confirmation that your eCOI disclosure form has been reopened (this may take a few hours).
- Once you have received email confirmation, log in to the eCOI application using your OSU Name.## and password.
- Revise your disclosure as needed.
- Click the "Submit" button and your revised eCOI disclosure will be routed to the appropriate parties for review and approval.
What types of activities do I have to report?
You must report any activities or financial interests that might reasonably appear to affect or to be affected by any of the research that you are doing. This would include any interests in any company or business that:
- funds your research through sponsored research agreements, gifts, or any other funding arrangement;
- provides materials or other in kind support (e.g., drugs, devices, other tangible items) for your research;
- holds an Investigation New Drug application (IND) or Investigation Device Exemption (IDE) for the research being performed;
- owns, licenses, or has any financial interest in your research; or
- acts for on behalf of another company. This may include some medical education companies or other similar entities.
Additionally, you must report any other financial interests that could reasonably appear to be affected by your research including any patents or property held by you or an immediate family member.
Example: Faculty Traveling on Behalf of Company - If traveling on behalf of a company to an industry meeting, professional society, to testify to FDA, etc., you need to execute a consulting agreement and to disclose this activity and any monies paid to support the activity (including travel reimbursement) on your eCOI disclosure.
What is meant by "financial interest" and "Significant financial interest"?
A "financial interest" is any interest or other opportunity representing a tangible personal benefit or gain that may exert or appear to exert a substantial or improper influence on a person's professional judgment when exercising any university duty or responsibility including designing, conducting, or reporting research. When disclosing financial interests you must consider any financial interests held by yourself, your spouse, and any dependent children. Examples of financial interests include but are not limited to:
- salary or other compensation for services including: consulting fees, honoraria, speaking fees, serving on advisory boards/panels, directorships, executive roles or other special relationships;
- equity interests including stocks, stock options or other ownership interests;
- intellectual property (IP) rights including patents and copyrights; or
- royalties, licensing fees, or other similar payments deriving from IP rights that are related to the research at issue.
Under the current federal regulations and university policy and procedures, a financial interest is considered Significant when it:
- equals or exceeds $10,000 in personal income in any given 12 month period;
- represents an equity interest (including stock, stock options, warrants or other ownership interest) in a publically traded company that exceeds $10,000 in value or 5% of a company's stock or other ownership interest;
- represents an equity interest of any amount in a non-publically traded company;
- represents royalty income or the right to receive future royalties from commercialization of research results;
- represents any non-royalty payments or entitlements to payments in connection with research that are not directly related to the reasonable costs of the research (as specified in the sponsored research agreement); or
- represents a proprietary interest in a patent, trademark, copyright, or licensing agreement.
These examples are provided only as samples of commonly encountered significant financial interest situations but are by no means exhaustive. For complete information on significant financial interests please consult the Office of Academic Affairs, Conflict of Interest Implementation Procedures (beginning on page 23).
Are there financial interests that I don't have to disclose?
The university does not require you to disclose the following types of financial interests:
- salary, royalties or other compensation received from Ohio State University;
- income from seminars, lectures or teaching activities sponsored by public (e.g., federal, state entities) or non-profit entities;
- income from service on advisory committees or review panels for public (e.g., federal, state entities) or non-profit entities;
- royalty income resulting from traditional academic publishing activities such as the publication of text books or other educational materials; or
- income from diversified mutual funds in which you have no control over the equities held by the fund.
Who determines if I have a conflict of interest?
Your COI disclosure is reviewed by your Department Chair in conjunction with the university's Conflict of Interest Administrator and the Conflict of Interest Advisory Committee.
What happens if I do have a conflict of interest?
If it is determined that a significant financial conflict of interest exists, a Conflict Management Plan is created in order to manage, reduce, or eliminate the conflict. All Conflict Management Plans are reviewed, approved, and annually monitored by the university's Conflict of Interest Advisory Committee as required by university policy. Conflict Management Plans are renewed annually and are effective as long as the conflict is present.
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:
- Conflict of Interest and Work Outside the University (Policy 1.30) – (University Staff)
- Financial Conflict of Interest Policy for Faculty - (Faculty)
- Faculty Paid External Consulting Policy - (Faculty)
- Conflict of Commitment Policy – (Faculty)
- OSUMC Vendor Interaction Policy – (Faculty)
- OSU Extension Conflict of Interest Policy Statement – (Faculty with Extension appointments)
For Additional Information please see the Office of Academic Affairs, Conflict of Interest Implementation Procedures (begin on page 23)
Does the Conflict of Interest Policy interact with the Health System's new Vendor Interaction Policy?
Yes, the new 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 the OSUMC Office of Legal Services at 292-5062 or the OSUMC Compliance Office at 293-7802.
