NIH Conflict of Interest

Updated: 8/16/22
Contact: Procurement Office

CONFLICT OF INTEREST POLICY APPLICABLE TO A SUBAWARD ISSUED UNDER A PUBLIC HEALTH SERVICES PRIME AWARD

The federal Public Health Service has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take in order to promote objectivity in research. The regulations apply to all Public Health Service funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is Public Health Service. The regulations require that investigators submitting applications for funding on behalf of a subrecipient, where the prime sponsor is Public Health Service (e.g., funding from the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control), prior to the submission of the subaward application to the Public Health Service Grantee organization1, disclose to William Jewell College any significant financial interests related to their institutional responsibilities at William Jewell College.

Definitions

Institutional responsibilities mean an Investigator’s professional activities on behalf of William Jewell College (e.g., teaching, administration, research or clinical care). Specifically, these include:

Externally sponsored research or scholarly activities (includes activities such as proposing, conducting, and analyzing research and disseminating results)
Research (includes participation in study sections, peer review of manuscripts, or effort on non-sponsored research)
Instruction/University Supported Academic activities (including preparation for and presentations of formal and informal courses to students/trainee groups, mentoring students and trainees, and participation in resident training)
Clinical Service activities such as performing services for the College’s Faculty Practice Plan and affiliated hospitals
Administrative activities including serving as Department Chair, Program Director, or service on institutional committees, participation in department activities or faculty advisory boards, etc.
Special Service activities on behalf of William Jewell College including institutional community service.

Investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by a subaward, or proposed for such funding, which may include, for example, collaborators or consultants. William Jewell College’s Principal Investigator or Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

Significant Financial Interest means:

A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities on behalf of William Jewell College.

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 disclosure, when aggregated for the investigator, investigator’s spouse and dependent children, 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); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
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 when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest)
With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests.

Third party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children) of greater than $5,000 that is related to the Investigator’s institutional responsibilities (i.e., administrative, teaching, research, or clinical activities) must be disclosed to William Jewell College. The details of this disclosure will include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. This disclosure requirement excludes travel paid for by William Jewell College and does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, an U.S. 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.

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

Salary, royalties, or other remuneration paid by William Jewell College to the Investigator if the Investigator is currently employed or otherwise appointed by William Jewell College, including intellectual property rights assigned to William Jewell College 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
Income from seminars, lectures, or teaching engagements sponsored by a U.S. 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
Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, institution of higher education as defined at 20 U.S.C. 1001(a), academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education.

Disclosure

Prior to the submission of an application to the Public Health Service Grantee for funding, the Principal Investigator and all other Investigators at William Jewell College must have disclosed to William Jewell College’s Conflict of Interest Committee or designated official an up-to-date listing of their Significant Financial Interests (and those of their spouse and dependent children), as defined above. Any new Investigator, who, subsequent to the submission of an application to the Public Health Service Grantee for funding from the Public Health Service Grantee, or during the course of the research project, plans to participate in the project, must similarly disclose their Significant Financial Interests to the College’s Conflict of Interest Committee or designated official promptly and prior to participation in the project.

Each Investigator who is participating in research under a subaward where the prime award originates from Public Health Service must submit an updated disclosure of Significant Financial Interest at least annually during the period of the award. Such disclosure must include any information that was not disclosed initially to William Jewell College, pursuant to this Policy, or in a subsequent disclosure of Significant Financial Interest (e.g., any financial conflict of interest identified on a Public Health Service- funded project directly as a Public Health Service Grantee and/or indirectly through a subaward that was transferred from another institution) and must include updated information regarding any previously disclosed Significant Financial Interest (e.g., the updated value of a previously disclosed equity interest).

Each Investigator who is participating in research under a subaward where the prime award originates from Public Health Service must submit an updated disclosure of Significant Financial Interest (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest.

Review by William Jewell College’s Conflict of Interest Committee or/Designated Official

The Conflict of Interest Committee or designated official will conduct reviews of disclosures. The Conflict of Interest Committee or designated official will review any Significant Financial Interest that has been identified in a disclosure; these interests will be compared to each research subaward funded under a Public Health Service prime award on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the Significant Financial Interest is related to the award and, if so, whether the Significant Financial Interest creates a Financial Conflict of Interest related to that research subaward.

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The Conflict of Interest Committee or designated official will determine whether an Investigator’s Significant Financial Interest is related to the research under a subaward supported by a Public Health Service prime award and, if so, whether the Significant Financial Interest is a financial conflict of interest. An Investigator’s Significant Financial Interest is related to the research under the subaward when the Conflict of Interest Committee or designated official reasonably determines that the Significant Financial Interest: (1) could be affected by the research conducted under the subaward; or (2) is in an entity whose financial interest could be affected by the research. The Conflict of Interest Committee or designated official may involve the Investigator in the determination of whether a Significant Financial Interest is related to the research supported by the subaward.

A financial conflict of interest exists when the Conflict of Interest Committee or designated official reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Public Health Service-funded research.

In determining if an Investigator’s Significant Financial Interest is related to the research under a subaward supported by a Public Health Service prime award, and if so, whether the relationship creates a financial conflict of interest, the Conflict of Interest Committee or designated official considers the role of the Investigator and the opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the Significant Financial Interest in relation to the size and value of the entity. In addition, the Conflict of Interest Committee or designated official may also consider the following factors:

Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes
Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely
Whether the goal of the research is to evaluate an invention linked to the Significant Financial Interest (such as where the Significant Financial Interest is a patent, or an interest in a company that has licensed the invention)
Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board
Where the Significant Financial Interest is in a privately held company, whether the researcher’s Significant Financial Interest could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs)
The magnitude of the Significant Financial Interests (e.g., the amount of consulting or the percentage or value of equity)
Where the Significant Financial Interest is in the sponsor of the research and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future
The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts
Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the Significant Financial Interest
Whether other scientific groups are independently pursuing similar questions
Whether sufficient external review of the research conducted and the reporting of research results exist to mitigate undue bias
Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has a Significant Financial Interest
Whether the project involves a subaward to an entity in which the Investigator has a Significant Financial Interest

Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest

If a conflict of interest exists, the Conflict of Interest Committee or designated official will determine by what means – such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the Conflict of Interest Committee or designated official will be guided by the principles discussed in this Policy the Conflict of Interest Committee or designated official will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to:

Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research)
For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants
Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest
Modification of the research plan
Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
Reduction or elimination of the financial interest (e.g., sale of an equity interest)
Severance of relationships that create financial conflicts
For research projects involving human subjects research, use of a data and safety monitoring board
Double-blind conditions
Provisions to conduct the work simultaneously at multiple sites
Written disclosure of the conflict to all individuals working on the research project
Annual reports on the research progress to the Conflict of Interest Committee or designated official

If the Conflict of Interest Committee or designated official determines that a conflict exists, it will communicate its determination and the means it has identified for eliminating or managing the conflict, in writing, to the individual, to the relevant Principal Investigator or Project Director, and the appropriate direct supervisor. The Conflict of Interest Committee or designated official will keep a record of the disclosure and other relevant information for at least three years. If the Conflict of Interest Committee or designated official prescribes monitoring of the activity, it will describe what monitoring shall be performed and what records are to be kept.

No expenditures on a subaward supported by a Public Health Service prime award will be permitted until the Investigator has complied with the disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the Conflict of Interest Committee or designated official necessary to manage the Conflict of Interest. The Conflict of Interest Committee or designated official will communicate, in writing, with the Public Health Service Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until the Public Health Service Grantee has reported the financial conflict of interest to Public Health Service. The Public Health Service Grantee will notify William Jewell College when it may incur expenditures.

The Conflict of Interest Committee or designated official will keep a record of Investigator disclosures of financial interests and the Conflict of Interest Committee or designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant Public Health Service Regulations.

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under a subaward funded by a Public Health Service prime award, William Jewell College will ensure public accessibility, via a publicly accessible website or by written response to any requestor within five business days of a request, of information concerning any Significant Financial Interest disclosed that meets the following three criteria:

The Significant Financial Interest was disclosed and is still held by the senior and key personnel. Senior and key personnel are the Program Director or Principal Investigator and any other person identified as senior key personnel by William Jewell College in the subaward application to the Public Health Service Grantee, progress report or any other report submitted to the Public Health Service Grantee;
William Jewell College has determined that the Significant Financial Interest is related to the research funded through a subaward; and
William Jewell College has determined that the Significant Financial Interest is a financial conflict of interest.

The information that William Jewell College will make available via a publicly accessible website or in a written response to any requestor within five days of request will include, at a minimum, the following:

The Investigator’s name
The Investigator’s title and role with respect to the research project
The name of the entity in which the Significant Financial Interest is held
The nature of the Significant Financial Interest
The approximate dollar value of the Significant Financial Interest in the following ranges: $0-$4,999; $5,000-9,999; $10,000 - $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

If William Jewell College uses a publicly accessible website to comply with the public disclosure requirements of the Public Health Service regulations, the information posted will be updated at least annually and within sixty days of receipt or identification of information concerning any additional Significant Financial Interest of the senior or key personnel for the Public Health Service-funded research project that had not been previously disclosed, or upon the disclosure of a Significant Financial Interest of senior and key personnel new to the Public Health Service-funded research project, if it is determined by the Conflict of Interest Committee or designated official that the Significant Financial Interest is related to the research and is a financial conflict of interest.

If William Jewell College responds to written requests for the purposes of public accessibility, it will ascertain from the Investigator that the information provided is current as of the date of the correspondence and will note in its written response that the information is subject to updates on at least an annual basis and within 60 days of the William Jewell College’s identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

Information concerning the Significant Financial Interests of an individual, as limited by this Policy, will remain available, for responses to written requests or for posting via William Jewel College’s publicly accessible website for at least three years from the date that the information was most recently updated.

Reporting of Financial Conflicts of Interest

Prior to the expenditure of any funds under a subaward funded by a Public Health Service prime award, William Jewell College will provide to the Public Health Service Grantee a financial conflict of interest report compliant with Public Health Service regulations regarding any Investigator’s Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan. William Jewell College cannot incur expenditures until it has received notification to do so from the Public Health Service Grantee.

While the subaward is ongoing (including any extensions with or without funds), William Jewell College will provide to the Public Health Service Grantee an annual financial conflict of interest report that addresses the status of the financial conflict of interest and any changes in the management plan. A financial conflict of interest report will be submitted within 60 days of a newly participating Investigator in the project.

For any Significant Financial Interest that is identified as conflicting subsequent to an initial financial conflict of interest report during an ongoing Public Health Service-funded research project (e.g., upon the participation of an Investigator who is new to the research project), William Jewell College will provide to the Public Health Service Grantee, within forty five days, a financial conflict of interest report regarding the financial conflict of interest and ensure that William Jewell College has implemented a management plan and the Investigator has agreed to the relevant management plan.

Training Requirements

Each Investigator must complete training on William Jewell College’s Conflict of Interest Policy Applicable to A Subaward Issued Under A Public Health Services Prime Award prior to engaging in research related to any Public Health Service-funded subaward and at least every four years and immediately (as defined below) when any of the following circumstances apply:

William Jewell College revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators (training is to be completed within the timeframe specified in communications announcing such changes)
An Investigator is new to William Jewell College’s research under a subaward issued under a Public Health Service prime award (training is to be completed prior to his/her participation in the research)
William Jewell College finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the Conflict of Interest Committee or designated official)

In fulfillment of the training requirement, William Jewell College requires its investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this Policy. All investigators must print a certification of completion at the end of training and retain it for audit purposes.

Failure to Comply with William Jewell College’s Conflict of Interest Policy Applicable to Public Health Service Funded Subaward

When a financial conflict of interest is not identified or managed in a timely manner, including, for example, because the underlying Significant Financial Interest is not disclosed timely by an Investigator or, because a financial conflict of interest was not timely reviewed or reported by a second tier subrecipient or by William Jewell College; or because an investigator failed to comply with a management plan; then William Jewell College will within 90 days:

Complete a retrospective review of the Investigator’s activities and the research project to determine any bias in the design, conduct or reporting of research
Document the retrospective review consistent with the regulation
Document William Jewell College’s determination as to whether any research, or portion thereof, conducted during the period of time of the Investigator’s non-compliance with this Policy or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research
Notify the Public Health Service Grantee in writing

If bias is found, William Jewell College shall notify the Public Health Service Grantee promptly and submit a mitigation report to the Public Health Service Grantee that shall address the following:

Impact of the bias on the research project
William Jewell College’s plan of action or actions taken to eliminate or mitigate the effect of the bias.

Thereafter, William Jewell College shall submit financial conflict of interest reports annually to the Public Health Service Grantee, in accordance with the regulation and terms and conditions of the subaward agreement. Depending on the nature of the Financial Conflict of Interest, William Jewell College may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the Financial Conflict of Interest is identified and the completion of William Jewell College’s independent retrospective review.

Clinical Research

If the Public Health Service Grantee determines that one of its funded clinical research projects 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 William Jewell College, the Public Health Service Grantee 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.

Failure to Comply with This Policy

No expenditures of funds on a subaward supported by a Public Health Service prime award will be permitted unless the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any Conflict of Interest Committee or designated official-approved financial conflict of interest management plan.

Any failure by an individual to adhere to this Policy may be cause for disciplinary action, including, in severe cases, termination, and termination of the subaward by the Public Health Service Grantee.

1For purposes of this Policy Public Health Service Grantee is the organization that receives a prime award directly from Public Health Service and under that prime award the Public Health Service Grantee issues a subaward to a subrecipient. This policy may also be used for those subawards under a non-Public Health Service sponsor adopting the Public Health Service Promoting Objectivity in Research regulations.