Sponsor Specific Guidance

Overview

Federal agencies and other sponsors vary in their requirements for adhering to the principles and regulations associated with Conflicts of Interest and Commitment. At Wright State University, the procedures and certification forms have been developed to adhere to two of the more common sponsors: the Public Health Service and National Science Foundation. However, contracts and the requirements stemming from specific activities (e.g. clinical trials), may entail additional requirements for Certification and COI Management. It is the responsibility of the Investigator to have knowledge and comply with sponsor requirements. Non-federal sponsors that include requirements for addressing conflicts include but are not limited to: the American Heart Association, the American Cancer Society, the American Lung Association, and the Arthritis Foundation.

Examples of Relevant Federal Regulations include:

1. Public Health Service (PHS) 42 CFR, part 50, subpart F and 45 CFR part 94
2. National Science Foundation (NSF) Grantee Conflict of Interest Policies
3. Department of Energy Interim Conflict of Interest Policy Requirements for Financial Interest, FAL 2022-02
4. U.S. Food and Drug Administration (FDA) 21 CFR 54
5. Federal Office of Management & Budget publication 2 CFR Chapter I, Chapter II, Part 200, et al., "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards."
6. Securities and Exchange Commission (SEC)

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Summary Guidance for Common Sponsors

Public Health Service (PHS) and National Institutes of Health (NIH)

PHS Agencies include but are not limited to:

• 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 Planning and Evaluation
• Office of the Assistant Secretary for Preparedness and Response (ASPR)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• Administration for Community Living (ACL)
• Administration for Children & Families (ACF)
• Office of National Coordinator for Health Information Technology (ONC)

Reporting

Prior to expenditure of any funds or within 60 calendar days for any interest that the University identifies as conflicting subsequent to the University's initial report under a PHS-funded research project, the University must provide the PHS Awarding Component with a financial Conflict of Interest (FCOI) report regarding the related FCOI and implemented Management Plan. This report must include the following information:

• Grant/Contract Number
• Project Director/Principal Investigator (PD/PI) or contact PD/PI
• Name of investigator with FCOI
• Nature of the FCOI (e.g., equity, consulting fees, or honoraria)
• Entity Name
• Value of the financial interest
• Description of how FCOI relates to PHS-funded research
• Key elements of the Management Plan

Annual updates are also required for the duration of the research project. NIH requires the submission of an Original and annual FCOI report via the eRA Commons FCOI Module. The annual report is due at the same time as when the recipient is required to submit to NIH the annual progress report, multi-year progress report, if applicable, or at time of grant extension.

If a significant financial interest (SFI) was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days: review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so:

Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward, and

Whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research; and

Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward; and

If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review below and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually; and

Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.

The Institution is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:

1. Project number;
2. Project title;
3. PD/PI or contact PD/PI if a multiple PD/PI model is used;
4. Name of the Investigator with the FCOI;
5. Name of the entity with which the Investigator has a financial conflict of interest;
6. Reason(s) for the retrospective review;
7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
8. Findings of the review; and
9. Conclusions of the review.

Per 42 CFR 50.605(a)(2), whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the Institution, the designated official(s) of the Institution shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. Depending on the nature of the significant financial interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date of disclosure and the completion of the Institution's review.

In accordance with 42 CFR 50.606(c), in any case in which the HHS determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this regulation, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Public Disclosure

In accordance with PHS regulations, the University will respond to requests regarding SFIs or financial conflicts of interest by written response within five business days of a request. The response shall include, the Investigator's name, and position relative to the research project, the name of the entity in which the SFI is held, the nature of the SFI, and the approximate dollar value of the SFI, or a statement that the value cannot be readily determined.

Subrecipients

For PHS research that involves subcontractors, subgrantees or sub awardees (collectively "Subrecipients") at other institutions, the University requires written agreements from Subrecipients that they have a Conflict of Interest (COI) policy that conforms to the requirements of all applicable regulations, including time periods to meet disclosure of significant financial interests and/or financial conflict of interest (FCOI) reporting requirements

If any Subrecipient does not have an adequate COI policy, the University shall require that the Subrecipient follow the University’s (WSU’S) policy and procedures.

A Subrecipient’s failure to promptly apply an acceptable COI policy upon request from the University shall be considered to be grounds for immediate termination by the University of any applicable subcontract or subaward. Any written agreement terms required by the University shall contain the provision that Subrecipients will report to the University, as the awardee institution, any identified FCOI in sufficient time to allow the University to report the FCOI to meet sponsor reporting obligations

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Required Training for Investigators

Investigators must complete any University-required FCOI training prior to engaging in research related to the PHS-funded grant or contract and at least every four years thereafter, and immediately under the designated circumstances:

This Program changes in a manner that affects Investigator requirements;

1. An Investigator is new to the University; or
2. The University finds that an investigator is noncompliant with this Program or their University-approved Management Plan

The Universities FCOI training informs the Investigator of, but is not limited to:

1. The Institution’s FCOI policy,
2. The Investigator’s responsibility regarding disclosure of SFIs, and
3. The FCOI regulation.

“Significant Financial Interest” under PHS policy means:

1. A financial interest consisting of one or more of the following interests of the Investigator (and/or those of the Investigator's spouse, domestic partner, and/or defendant children) that reasonably appears to be related to the Investigator's institutional responsibilities:

• a. With regard to any publicly traded entity, a significant financial interest exists if 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 the disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship, travel reimbursement). Equity Interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
   
• b. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or the Investigator (or the Investigator's spouse, domestic partner, or dependent children) holds any equity interest.
   
• c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

2. For PHS-funded Investigators, any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities.

3. The term significant financial interest does not include the following types of financial interests:
 

• Salary, royalties, or other remuneration paid by the University to the investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; or
   
• Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local agency within the United States, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of higher education; or
   
• c. Income from service on advisory committees or review panels for travel that is reimbursed or sponsored by, a federal, state or local government agency within the United States, a U.S. institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a U.S. institution of high education.

The exclusions above only relate to domestic entities. Investigators must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure.

For any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator so that the exact monetary value may not be readily available) related to institutional responsibilities, the disclosure will include, at a minimum, the following:

• purpose of the trip,
• the identity of the sponsor/organizer,
• the destination, and
• the duration of travel.

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National Science Foundation and Other Federal Agencies

All Investigators must disclose any “Significant Financial Interest” (SFI) and/or “Related Financial Interest” (RFI) of themselves, spouse, registered domestic partner, and dependent child(ren) where that financial interest may be: (1) affected by the research being conducted or, (2) in any organization that would reasonably appear to be affected by or benefit from the research being conducted.

For purposes of NSF-funded and other federal government-funded research not addressed above, a Significant Financial Interest is defined as anything of monetary value including, but not limited to:

• Salary, income, honoraria, royalties, dividends, consulting, loans, or other payment or consideration with value (including payments made to the University of California Health Sciences Compensation Plans and e.g., equipment loans) from any business, public, or nonprofit entity exceeding $10,000 during the prior twelve months, aggregated for the Investigator, spouse, dependent child(ren), and registered domestic partner. Equity interest (stock, stock options, real estate, etc.) that exceeds $10,000 or 5% ownership.
   
• Equity interest (stock, stock options, real estate) that exceeds $10,000 or 5% ownership.
   
• Management position such as board member, director, officer, partner, or trustee held by the Investigator.
   
• Intellectual property interest held by the Investigator, spouse, dependent child(ren), or registered domestic partner assigned or to be assigned to a party other than the Regents.