Conflict of Interest
Frequently Asked Questions Regarding the Disclosure Process
Who must disclose?
- Who must disclose?
Pursuant to USF System Policy 0-309, Investigators, regardless of funding source, who have a conflict of interest with a USF System Research Project must access the eCOI disclosure system and complete a Project Specific Disclosure to disclose the Investigator's interests, and/or those of the Investigator's immediate family.
Pursuant to USF System Policy 0-309, all Investigators must submit an Interest Inventory prior to proposal submission to a federal agency. Interest Inventories are submitted through the eCOI disclosure system.
In addition, an Interest Inventory is required prior to proposal submission for all Investigators submitting to an Other Agency that has adopted the U.S. Public Health Service regulation for objectivity in research. For a list of agencies that have adopted the regulation, visit the COI Terms and Conditions page on our website.
- I have submitted a proposal for federally funded research, have read through USF's
Conflict of Interest Policy 0-309 and don't think I have any Significant Financial
Interests to disclose. Do I still need to complete an Interest Inventory?
Yes. Even if you don't have any Significant Financial Interests to disclose, you must still log in to ARC, complete the required training and check the box next to the statement that reads "Neither I nor any of my Immediate Family Members have had any Significant Financial Interests Related to my Institutional Responsibilities within the previous 12 months." Please remember that you must update your Interest Inventory within 30 days of acquiring or discovering a new Significant Financial Interest, at Notice of Award from a federal agency, and annually.
- Who is an Investigator?
Investigator means the project director or Principal Investigator and any other person (faculty, staff, students and collaborators or consultants outside of the USF System), regardless of title or position, who is responsible for the design, conduct or reporting of a USF System Research Project.
"Design, conduct or reporting" includes but is not limited to:
- Designing, conducting, and/or directing a USF System Research Project.
- Applying, on behalf of the USF System, for grants or awards to perform the USF System Research Project.
- Serving as the principal investigator/program director, co-investigator, or sub-investigator.
- Enrolling research subjects (including obtaining informed consent, if applicable) or making decisions related to eligibility for enrollment.
- Analyzing, reporting, presenting, or publishing research data.
All key personnel listed on a submission for the USF System Research Project to the USF Institutional Research Board (IRB) or any other institutional review board, the USF Institutional Animal Care and Use Committee (IACUC), or the applicable Sponsored Research office are Investigators.
Also, any Investigator working on a USF System Research Project as a sub-grantee, contractor, or collaborator via a subcontract, sub-award, or other agreement is an Investigator for purposes of this definition. Note: USF System Policy No. 0-309 requires disclosures from sub-grantees, contractors, or collaborators for projects funded by the National Science Foundation, U.S. Public Health Service and Other Agencies that have adopted the PHS Objectivity in Research Regulation (For a list of agencies that have adopted the regulation, visit the COI Terms and Conditions page on our website.
- Do graduate students and post-docs need to disclose?
Yes. If a graduate student or post-doc meets the definition of an Investigator (see Question 2, above), then they must disclose.
- Do I need to disclose my spouse/domestic partner's financial interests?
To comply with both USF policy and federal regulation, limited information about financial interests of Immediate Family members, including an investigator's spouse or domestic partner, must be disclosed. For more information please see USF System Policy 0-309, Individual Conflicts of Interest in USF System Research Projects and USF System Financial Conflicts of Interest (FCOI).
What must be disclosed?
- I have submitted a proposal to a federal agency. How do I know whether my Significant
Financial Interests are related to my Institutional Responsibilities?
Investigators must disclose those Significant Financial Interests that "reasonably appear to be related" to the Investigator's institutional responsibilities. Each Investigator must make a good-faith determination about whether a particular Significant Financial Interest is related to his/her institutional responsibilities. To do so, it may be helpful to ask whether, to the best of your knowledge, the research or institutional responsibilities you have may affect the value of your financial interest or could have a financial impact on the entity in which you hold the financial interest. Generally speaking, income received from consulting or speaking on behalf of an entity is always related to your institutional responsibilities, because you have most likely been retained as a result of your expertise on a particular subject matter.
- Does salary support or travel on a sponsored award need to be disclosed?
No, such funding supports your position at the University and is not considered an outside financial interest.
- Do I need to disclose payments or honoraria received from another U.S. university?
No. Income from U.S. institutions of higher education, academic teaching hospitals, medical centers or research institutes affiliated with an institution of higher education is excluded from the definition of Significant Financial Interest and does not need to be disclosed. Please note, however, that income received from a foreign university, institute of higher education or medical center is included in the definition of Significant Financial Interest and thus must be disclosed.
- I receive royalties from a patent or other intellectual property that is assigned
to the University. Do I have to disclose?
Yes. USF System Policy 0-309 requires the disclosure of intellectual property and related remuneration, even if the intellectual property is assigned to USF.
- Do I need to disclose mutual funds or other investments?
It depends. Income from mutual funds or other retirement accounts in which the Investigator does not control the investment decisions is excluded from the definition of Significant Financial Interest and does not need to be disclosed. If you own other investments, however, you will need to evaluate them to determine whether they are reasonably related to your Institutional Responsibilities. If so, then you must disclose.
U.S. Public Health Service and conflicts of interest
- What is the PHS?
PHS is the Public Health Service of the U.S. Department of Health and Human Services. PHS agencies include:
Agency for Healthcare Research and Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Office of the Assistant Secretary for Health (OASH)
Office of the Assistant Secretary for Preparedness and Response (ASPR)
Office of Global Affairs (OGA)
Substance Abuse & Mental Health Services Administration (SAMHSA)
Additionally, several non-PHS agencies have adopted the PHS Objectivity in Research Regulation (e.g. American Cancer Society, PCORI, American Heart Association and several others). For a complete and current list, visit the COI Terms and Conditions page on our website.
- Who is covered by the PHS Objectivity in Research Regulation? Must all institutions
that receive PHS funding adhere to the Regulation?
Yes. The PHS Objectivity in Research Regulation is applicable to all institutions that apply for or receive funding from a PHS agency or other agency that has adopted the PHS Regulation, and through implementation by the institution to any Investigator planning to participate in or participating in such research (including consultants and subrecipients).
- Who must disclose reimbursed or sponsored travel?
Only Investigators who are working on research funded by a U.S. Public Health Service (PHS) agency or an agency that has adopted the PHS regulation regarding objectivity in research must disclose reimbursed or sponsored travel. Please see the COI Terms and Conditions page on our website for a list of agencies that are subject to the PHS regulation.
- When do I need to disclose my reimbursed or sponsored travel?
If you are a PHS-funded Investigator, you must disclose your reimbursed or sponsored travel within thirty days of the end of your trip.
- Is there any type of travel that I do not need to disclose?
Yes. Travel that is reimbursed or sponsored by a Federal, state or local government agency, an U.S. institution of higher education, an academic teaching hospital, medical center, or a research institution affiliated with an U.S. institution of higher education is exempt from the definition of Significant Financial Interest and does not need to be disclosed.
- What is meant by "reimbursed" and "sponsored" travel?
"Sponsored travel" is when an entity purchases your airline ticket or pays for your hotel. "Reimbursed travel" is when an entity directly reimburses you for your purchase of transportation or lodging.
- Does travel paid for by a professional society need to be disclosed?
Yes, travel paid for by a professional society must be disclosed.
- What if I don't know how much my trip cost?
The cost of a trip is not currently required information. You must only disclose the purpose of your trip, your destination, length of stay and the name of the entity that sponsored the travel or reimbursed you for the cost.
Intellectual Property-related Questions
- I receive royalties from a patent or other intellectual property that is assigned
to the University. Do I have to disclose?
Yes. USF System Policy 0-309 requires the disclosure of intellectual property related to institutional responsibilities, even if that intellectual property is assigned to the University.
- I have a patent that is unlicensed and therefore not currently generating income.
Under the USF policy, do I need to disclose?
Yes. USF System Policy 0-309 requires the disclosure of intellectual property related to institutional responsibilities.
- Will the information I submit in my disclosure be available to the public?
It depends. For PHS-funded studies, federal regulation requires that, within five days of a written request, USF will make information available to the public concerning any Significant Financial Interest (SFI) disclosed to the University that meets the following three criteria:
1. The SFI was disclosed and is still held by the Senior/key personnel as defined in the PHS Regulation;
2. The University has determined that the SFI is related to the PHS-funded research; and
3. The University has determined that the SFI is a Financial Conflict of Interest (FCOI).
Pursuant to federal regulations and USF System policy, the information that the USF Conflict of Interest Program Manager will make available to any requestor shall include, at a minimum, the following:
1. The Investigator's name;
2. The Investigator's title and role with respect to the USF System research project;
3. The name of the entity in which the SFI is held;
4. The nature of the SFI;
5. The approximate dollar value of the SFI (dollar ranges are permissible), or a statement that the interest is one whose value cannot readily be determined through reference to public prices or other reasonable measures of fair market value.
- What happens if I fail to make a disclosure or my disclosure is late?
Failure to report as required by USF System policies and federal regulation may be grounds for disciplinary action under the provisions of any applicable USF System regulation, policy, or collective bargaining agreement. Failure to comply with these disclosure requirements may also result in the termination of current awards and ineligibility of the Investigator or USF to receive future awards.
Institutional Conflict of Interest, USF Policy No. 0-317 (research-related institutional conflicts of interest)
- What is an institutional conflict of interest?
An institutional conflict of interest describes a situation in which the financial interests of an institution or institutional official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research conducted under the auspices of the institution.
An institutional conflict may arise when USF receives licensing income from a technology owned by the university and that technology is being evaluated in a study or if USF owns part of a company sponsoring a USF system research project. Also, when a senior official who has oversight of research has a financial interest that could be impacted by the research, a potential institutional conflict of interest may exist.
- How do I disclose an institutional conflict of interest?
Disclose the relationship on the Sponsored Research Internal Form and, if applicable, on your application to the IRB (human subjects research) or IACUC (animal studies). Additionally, submit a project-specific COI disclosure via ARC prior to engaging in the research.
- What if I am not sure whether my study involves an institutional conflict of interest
or have other questions?
Please contact the COI Program at 813-974-5638 or firstname.lastname@example.org for assistance.