Conflict of Interest

The COI Management Plan should contain the following:

1. A list of the players and their relationships
2. A description of the activity that creates a COI between the players
3. The plan to manage the COI

For example:

1. Professor X is the parent of student Y.
2. Professor X wishes to appoint student Y to his grant.
3. Dept Chair Professor Z will review the appointment to determine whether student Y is qualified to serve the role on the grant, will establish the stipend for the student, and will conduct normal performance evaluations and approve reappointments, etc. (but Professor X will direct student Y’s work on the research project).

Example 2:

1. Professor X is a co-founder and co-owner of Company Y and is also Department Chair.
2. Company Y wishes to subcontract a grant to Professor X as PI and to rent university space under an FUA.

Associate Dean Z will review and approve the subcontract statement of work and budget and will have signature authority for expenditures on the award for any salary or travel support of Professor X. Associate Dean Z will also review and approve the FUA terms, in collaboration with the Office of Research Services.

Conflicts of interest in research may occur when outside financial interests or commitments/relationships compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting, or reporting research. If an investigator believes a financial or commitment conflict of interest exists with a proposed project for themselves or a member of their team then they are required to disclose the conflict and follow the guidance below. Even if there is no identified PHS FCOI, the Investigator should ensure compliance with the University Conflict of Interest Policy (https://apps.hr.ou.edu/FacultyHandbook/#5.10).

In 2011, the Public Health Service (PHS) released revised financial conflict of interest (FCOI) regulations (42 CFR 50) that apply to any institution receiving funds from a PHS entity. The University’s PHS FCOI policy and the implementation plan correspond with the mandate of this new regulation.  Note that these requirements affect not only National Institute of Health (NIH) proposals/awards but other agencies (listed below) who have adopted this guidance.

Disclosure Requirement

Disclosure of PHS FCOI (and FCOI) is done by the Primary Investigator (PI) (see definition below) at submission of the information sheet prior to proposal submission. According to the federal reporting requirements, the project director or investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research must submit a FCOI disclosure form at the time of application, within 30 days of acquiring or discovering a new Significant Financial Interest (SFI), and annually after the Notice of Award. If there is insufficient space to include all your SFIs in one report, submit a second report with those relationships that did not fit in the first submission.

Submit a PHS-FCOI Disclosure Form

Training Requirement

According to the federal requirements, all PHS-funded 'Investigators' at the University must complete the online FCOI training available here: https://www.citiprogram.org/. Successful completion of the training is required prior to the expenditure of funds on any newly funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Current PHS awards are not subject to these new requirements until the noncompeting continuation is awarded.  

New users to the CITI program must create an account. The same CITI account can be used for both the FCOI requirement and the University's IRB training requirement.

In addition, training is required immediately when:

•  Financial conflict of interest policies are revised in a manner that changes researcher requirements,
•  A researcher is new to the University, or
•  A researcher is non-compliant with financial conflict of interest policies and procedures.

Definitions and PHS Agencies/Delegations

Investigator, for the purposes of this policy, means the Principal Investigator and any person listed by the Principal Investigator as responsible for the design, conduct, or reporting of their sponsored program(s). These individuals are listed at the time of proposal submission.

Normally, all senior research personnel should be listed as Investigators. All of the following should be considered, to the extent they are responsible for the design, conduct, or reporting of the sponsored program: professorial faculty, research associates, emeritus faculty, research collaborators, visiting scientists, postdocs, GRAs, or students.

Significant Financial Interest (SFI)

SFI means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator's University responsibilities:

·       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.

• 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
• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that are not paid through the University

A FCOI means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

[1] The requirements regarding Investigator financial conflicts of interest in research funded under PHS grants or cooperative agreements can be found at http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf, pp 53283-53288.

Public Health Service (PHS) means the Public Health Service of the U.S. Department of Health and Human Services and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS 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 Global Affairs (OG)
• 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)
• Office of Public Health and Science
• Substance Abuse and Mental Health Services Administration (SAMHSA)

Other agencies following PHS regulations include (but aren’t limited to):

Alliance for Lupus Research, Alpha-1 Foundation, American Asthma Foundations, American Cancer Society, American Heart Association, American Lung Association, Arthritis Foundation, CurePSP, JDRF - Juvenile Diabetes Research Foundation, Lupus Foundation of America, Patient-Centered Outcomes Research Institute (PCORI), and Susan G. Komen Foundation

Institutional Responsibility to Review Disclosures

Upon receipt of the Information Sheet (where SFI/FCOI is identified) and/or when the official disclosure process detailed above is initiated and prior to award, the internal process for PHS FCOI/COI begins (see above). Upon receipt of award from the Public Health Service and prior to expenditure of any funds, as well as within 60 days for any interest that the University identifies as conflicting subsequent to the University’s initial report under the award, or at the time of an NIH award extension, the University must determine:

• If the SFI is related to the Investigator’s research responsibilities and to the specific research award in question
• If the SFI creates an FCOI
• If an FCOI is determined to exist, then a Management Plan detailing how the conflict will be managed, reduced, or eliminated must be developed and implemented

As part of the University’s responsibilities, the Office of Research Services coordinates with designated officials to ensure the certification documents, management plan, and any required training is completed prior to finalizing award processing and within regulation time requirements for FCOI disclosed after initial award set up.

Reporting FCOI

The University will monitor investigator compliance and report identified FCOI to the NIH via eRA Commons FCOI Module per the regulation.  Any investigator who has knowledge or suspicion of an FCOI that has not been reported should contact the chair of the Conflict of Interest committee or email VPRFCOI@ou.edu

Designation of Institutional Official and Requirements

The Provost has established a Conflict of Interest committee.  The Conflict of Interest committee will handle review of the Investigators’ FCOI Disclosure forms as required by this policy and pursuant to the faculty handbook and/or as required by the Board of Regents policy.

Subrecipient Requirements

If sub-awardees/subrecipients, contractors, or collaborators carry out agency funded research, the University will take reasonable steps, via written agreement, to ensure that the collaborating entity has its own policies in place that meet the requirements of the PHS policy or that investigators working for such entities follow the policies of the University.

Situations of Noncompliance

In the event the University identifies a significant financial interest that was not disclosed in a timely fashion by the Investigator or was not previously reviewed by the University during an on-going PHS funded research project, the University will, within 60 days, determine whether a financial conflict of interest exists and will implement a management plan.

In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, the University will, within 120 days of its determination of non-compliance, complete a retrospective review of the investigator’s activities and the PHS funded research project. The purpose of the review is to determine whether any PHS research conducted during the period of non-compliance was biased in its design, conduct, or reporting.

The documentation of the retrospective review will include all the elements of a regular review (Proposal/Project number, Title, PD/PI name [or contact if multiple PI/PD model used], name of investigator with conflict; name of entity with which the Investigator has an FCOI), and the reasons for the retrospective review.  The methodology of the review and findings/conclusions of the review will also be documented.

Based on the retrospective review, if appropriate, the University will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI and monitor Investigator compliance with the plan.  If bias is found, the University will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include the key elements documented in the retrospective review, the impact of the bias on the research project and University’s plan of action or actions to eliminate or mitigate the effect of the bias.

In any case in which Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness or 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 as required by PHS regulations, the University will 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 Accessibility

Prior to the expenditure of funds, the University will make certain that information concerning FCOI held by Senior/Key personnel is publicly accessible by a written response to any requester within five business days of a request or as required by law. This response will provide current information (subject to annual updates and within 60 days of identification of a new FCOI) and will include:  the Investigator’s name, title, and role with respect to the research project; the name of the entity in which significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (in pre-specified dollar ranges), or a statement that a value cannot be readily determined.

If the University responds to written requests for the purposes of this subsection, the University will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the University's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

Maintenance of Records

The University will maintain records relating to all Investigator disclosures of financial interests and the University’s review of and actions taken related to such disclosures for at least three years from the date the final expenditures report is submitted to the sponsor, or where applicable, from other dates specified in PHS regulations.  Primary repository of records is the Cayuse system.

Questions

Inquiries about the NIH FCOI regulation for grants and cooperative agreements may be directed to: VPRFCOI@ou.edu.

1.     Purpose

This University of Oklahoma (“OU”) Department of Energy (“DOE”) Conflict of Interest (“COI”) and Conflict of Commitment (“COC”) Policy (hereinafter referred to as the “Policy”) establishes standards and requirements to provide a reasonable expectation that the design, conduct, and reporting of projects wholly or in part funded under DOE financial assistance awards (e.g., grants, cooperative agreements, or technology investment agreements) are conducted free from actual, apparent, or potential bias resulting from financial conflicts of interest or conflicts of commitment.

2.     Applicability

This Policy applies to any covered individual at OU who is planning to participate in or is participating in the project funded wholly or in part under the DOE financial assistance award. This Policy establishes requirements for the disclosure, review, and management of actual, apparent, and potential COI and COC. Covered individuals must disclose applicable financial interests, outside commitments, and other relationships to OU in accordance with this Policy.  This Policy does not apply to Office of Indian Energy applications and awards. References to DOE include both DOE and the National Nuclear Security Administration (NNSA).

3.     Definitions

Award, financial assistance award, or Federal award means the same as the definition provided in 2 CFR 200.1 for Federal award.

Conflict of Commitment (COC) means a situation in which an individual accepts or incurs conflicting obligations, whether foreign or domestic, between or among multiple employers or other entities. This may include conflicting commitments of time and effort, including obligations to dedicate time in excess of institutional or DOE policies or commitments. Other types of conflicting obligations, including but not limited to, obligations to improperly share information with, or to withhold information from, an employer or DOE, can also threaten research, technology or economic security and integrity. Examples of situations that may give rise to conflicts of commitment include, but are not limited to, current or pending employment; positions, appointments, or affiliations such as titled academic, professional, or institutional appointments, whether remuneration is received and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary positions); and participation in or applications to foreign government-sponsored talent recruitment or similar programs.

Conflict of Interest (COI) means a situation in which a covered individual or the spouse or a child of the covered individual has a significant financial interest or financial relationship, whether with a domestic or foreign entity, that could directly and significantly affect the design, conduct, reporting or funding of a project or other Federal financial assistance award-related activities. Examples of situations that may give rise to a COI include, but are not limited to, holding an Executive position, director position, or equity over a certain dollar amount in a company that stands to benefit from Federal financial assistance award-related activities, receiving financial compensation in the form of consulting payments or payment for services from a company that stands to benefit from Federal financial assistance award-related activities, or intellectual property rights or royalties from such rights whose value may be affected by the outcome of Federal financial assistance award-related activities.

Covered Individual means any individual, regardless of title or position, who:

(1) Contributes in a substantive, meaningful way to the development or execution of the scope of work of a project funded by DOE or proposed for funding by DOE; and,

(2) Is designated as a covered individual by DOE.

(3) DOE designates as covered individuals any principal investigator (PI), project director (PD), co-principal investigator (Co-PI), co-project director (Co-PD), project manager, and any individual regardless of title that is functionally performing as a PI, PD, Co-PI, Co-PD, or project manager; and persons designated in the applicable Notice of Funding Opportunity (NOFO) or terms and conditions of the Federal financial assistance award. Submission of a current and pending support disclosure and/or biosketch/resume for a particular person serves as an acknowledgement that DOE designates that person as a covered individual.

DOE means the U.S. Department of Energy and the National Nuclear Security Administration (NNSA).

Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

Other Support means all resources made available to a covered individual in support of and/or related to all of their professional research (including basic and fundamental research), development, demonstration, and/or deployment efforts, including resources provided directly to the covered individual rather than through the research organization, and regardless of whether or not they have monetary value ( e.g., even if the support received is only in-kind, such as office/laboratory space, equipment, supplies, or employees). This includes resource and/or financial support from all foreign and domestic entities, including, but not limited to, gifts provided with terms or conditions, gifts provided without terms or conditions, financial support for laboratory personnel, and participation of student and visiting researchers and visiting scholars supported by other sources of funding.

Principal Investigator (PI) means an individual identified to direct a project by an applicant to or recipient of a DOE Federal financial assistance award.

Project means the interdependent activities funded wholly or in part under the DOE Federal financial assistance award. A project has a defined start and end point with objectives described in an application or in an approved scope that, when attained, signify completion and achievement of a specific goal, and creation of a unique product, service, or result. For Federal financial assistance awards that include recipient cost share as part of the approved budget, activities funded with that recipient cost share are included.

Significant Financial Interest means:

(1) A financial interest consisting of one or more of the following interests of the covered individual (and those of the covered individual's spouse and dependent children) that reasonably appears to be related to the covered individual's non-Federal entity responsibilities:

(i) With regard to any foreign or domestic 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, 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;

(ii) With regard to any foreign or domestic non-publicly traded entity, a significant financial interest exists if the value of any remuneration, not otherwise disclosed as current, pending, or other support, received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the covered individual (or the covered individual's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); and

(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(2) Any reimbursed or sponsored travel (i.e., that which is paid on behalf of the covered individual and not reimbursed to the covered individual so that the exact monetary value may not be readily available) related to their institutional responsibilities that is not otherwise disclosed in current and pending or other support disclosures, but does not include travel that is reimbursed or sponsored by a Federal, State, or local government agency of the United States; a domestic Institution of Higher Education; or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

(3) The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the non-Federal entity to the covered individual if the covered individual is currently employed or otherwise appointed by the non-Federal entity, including intellectual property rights assigned to the non-Federal entity and agreements to share in royalties related to such rights; any ownership interest in the non-Federal entity held by the covered individual, if the non-Federal entity is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the covered individual does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, State, or local government agency of the United States, a domestic Institution of Higher Education, or a domestic research institute that is affiliated with a domestic Institution of Higher Education; or income from service on advisory committees or review panels for a Federal, State, or local government agency of the United States, a domestic Institution of Higher Education, or a domestic research institute that is affiliated with a domestic Institution of Higher Education.

4.     Requirements

(a) If a covered individual indicates on the ORS Information Sheet that a proposal is being submitted to DOE, they (as well as all other covered individuals listed on the ORS Information Sheet) will be directed to complete a COI and COC Disclosure form.

Each covered individual who is planning to participate in the DOE award shall disclose to the non-Federal designated official(s) all information required under this Policy regarding actual, apparent, or potential Conflicts of Interest (COI) and Conflicts of Commitment (COC), including applicable significant financial interests, no later than the time the DOE application is submitted.  In the event a non-Federal entity seeks to add a covered individual after the time of application, the non-Federal entity must require the individual make such disclosures prior to participating in a project funded under a DOE award.

(b) Each Investigator who is participating in the DOE award shall submit an updated COI/COC disclosure at least annually and as soon as practicable, but no later than 15 days after any new actual, apparent, or potential COI or COC arises.

(d) Each disclosure and updated disclosure must be signed and dated by the covered individual and include a certification statement that reads:

  “I understand that this Disclosure is required to obtain funding from the U.S. Government. I, [Full Name and Title], certify to the best of my knowledge and belief that the information contained in this Disclosure Statement is true, complete, and accurate. I understand that any false, fictitious, or fraudulent information, misrepresentations, half-truths, or omissions of any material fact, may subject me to criminal, civil or administrative penalties for fraud, false statements, false claims, or otherwise. (18 U.S.C. §§ 1001 and 287, and 31 U.S.C. §§ 3729–3730 and 3801–3812). I further understand and agree that (1) the statements and representations made herein are material to the U.S. Government’s funding decision, and (2) I have a responsibility to update the disclosures during the period of performance of the award should circumstances change which impact the responses provided above.”

(e)  Each covered individual is required to take University’s COI/COC training through OnPoint prior to engaging in research projects wholly or in part funded under DOE financial assistance awards for all new awards and repeat training every year on or before the renewal date while engaging in DOE-funded research.

The non-Federal entity must require covered individual to complete COI and COC training within 30 days of any of the following circumstances:

(i) The non-Federal entity revises its COI and COC policies or procedures in any manner that affects the responsibilities of a covered individual;

(ii) A covered individual is new to a non-Federal entity; or

(iii) A non-Federal entity finds that a covered individual is not in compliance with the non-Federal entity's COI and COC policy or applicable management plan

(f) With regard to reimbursed or sponsored travel, the non-Federal entity's COI and COC policy must require, at a minimum, reporting the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the non-Federal entity's policy, the non-Federal entity official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a COI or COC with the project funded under the DOE Federal financial assistance award.

(g) Any non-Federal entity that receives a DOE Federal financial assistance award must ensure that subrecipients, if any, follow the requirements of this subpart by:

(1) Incorporating as part of a written agreement with the subrecipient terms that establish either the COI and COC policy of the recipient or that of the subrecipient will apply to the subrecipient's covered individuals.

(2) If the subrecipient's covered individuals must comply with the subrecipient's COI and COC policy, the subrecipient shall certify as part of the agreement referenced in paragraph (g)(1) of this section that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient's covered individuals are subject to the COI and COC policy of the recipient.

(3) Additionally, if the subrecipient's covered individuals must comply with the subrecipient's COI and COC policy, the agreement referenced in paragraph (g)(1) of this section shall specify time period(s) for the subrecipient to report all identified financial COI and COC to the recipient. Such time period(s) shall be sufficient to enable the recipient to provide timely COI/COC reports, as necessary, to DOE, as required by this subpart.

(4) Alternatively, if the subrecipient's covered individuals must comply with the recipient's COI and COC policy, the agreement referenced in paragraph (g)(1) of this section shall specify time period(s) for the subrecipient to submit all covered individual's disclosures to the recipient. Such time period(s) shall be sufficient to enable the recipient to comply timely with its review, management, and reporting obligations under this subpart.

 5.     Review and Management of Conflict Interest (COI) and Conflict of Commitment (COC)

(a) When a COI/COC disclosure form is submitted (as noted further below), the non-Federal designated official(s) will review the disclosure to determine whether an actual, apparent, or potential COI or COC exists in connection with a project funded or proposed for funding under a DOE financial assistance award.

The designated official(s) will determine the appropriate action to eliminate or, where appropriate, manage or reduce the conflict. The review will consider the nature of the disclosed financial interest, commitment, relationship, or other circumstance and its potential effect on the project or other DOE financial assistance award-related activities.

(b) When an actual, apparent, or potential COI or COC is identified, the non-Federal entity shall take such actions as necessary to eliminate or, where appropriate, manage or reduce the conflict. Examples of conditions or restrictions that a recipient or subrecipient might impose to manage, reduce, or eliminate a conflict include, but are not limited to:

(i) Public disclosure of the conflict (e.g., when presenting or publishing the project);

(ii) For projects involving human subjects, disclosure of the conflict directly to participants;

(iii) Appointment of an independent monitor or oversight committee capable of taking measures to protect the purpose, design, conduct, and reporting of the project against bias resulting from the conflict;

(iv) Modification of the project plan;

(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the project;

(vi) Reduction or elimination of the financial interest (e.g., sale of an equity interest) or commitment; or

(vii) Severance of relationship(s) that create the conflict;

6.     Reporting of Conflicts of Interest (COIs) and Conflicts of Commitment (COCs)

(a) Consistent with 2 CFR 200.112, A non-Federal entity that is an applicant to or recipient of DOE financial assistance must disclose to DOE in writing any actual, apparent, or potential COI or COC, including any actual, apparent, or potential COI or COC reported to the recipient by a subrecipient, if such conflict cannot be eliminated or appropriately managed or reduced in accordance with the entity's policy. In addition, such entity must disclose to DOE in writing any actual, apparent, or potential COI or COC, including any actual, apparent, or potential COI or COC reported to the recipient by a subrecipient, involving any foreign governments, their instrumentalities, or any other entities owned, funded, or otherwise controlled by a foreign government, as well as any measures the entity has taken to eliminate or, where appropriate, manage or reduce the COI or COC.

(1) For all conflicts that require disclosure to DOE:

(i) A non-Federal entity applying for DOE funding must clearly and explicitly disclose such conflict(s) in the application.

(ii) In the event a non-Federal entity seeks to add a covered individual after the time of application, the non-Federal entity must clearly and explicitly disclose such conflict(s) in writing to DOE prior to the individual participating in the project.

(2) If specified in the applicable funding opportunity announcement and/or terms and conditions of the Federal financial assistance award, a DOE program office may require the non-Federal entity disclose to DOE in writing all covered individuals' COIs and COCs, including those COIs and COCs determined by the non-Federal entity to be appropriately managed or reduced.

(b) DOE may require the non-Federal entity to provide associated disclosures, supporting documentation to demonstrate how the COI or COC was managed or reduced; and sufficient information to enable DOE to understand the nature and extent of the COI or COC, and to assess whether the actions are sufficient to ensure the integrity of the DOE-supported project and to protect the Government's interests.

(c) For any COI or COC previously reported by the non-Federal entity regarding an ongoing project funded under a DOE Federal financial assistance award, the non-Federal entity must provide DOE with an annual COI/COC report that addresses the status of the COI or COC and, if applicable, any changes to the management plan for the duration of the DOE Federal financial assistance award. The annual COI/COC report must specify whether the conflict is still being managed or if it remains unmanaged/unmanageable. Alternatively, the annual COI/COC report must explain why the conflict no longer exists. The non-Federal entity must provide annual COI/COC reports to DOE for the duration of the project period (including extensions with or without funds) in the time and manner required by term and condition of the Federal financial assistance award.

(d) In addition to the annual COI/COC report, DOE may require a non-Federal entity to routinely, or upon request, submit all or some covered individuals' disclosures. Circumstances when DOE may require a non-Federal entity to submit all or some of such covered individual disclosures include but are not limited to:

(1) As part of monitoring the non-Federal entity's compliance with this subpart;

(2) Bankruptcy of the non-Federal entity;

(3) Other legal winding down of the non-Federal entity;

(4) Acquisition of the non-Federal entity by a foreign entity, where “acquisition” includes a foreign entity obtaining a controlling interest in the non-Federal entity; or

(5) As otherwise set forth in 2 CFR part 200 and this part.

(e) If a non-Federal entity becomes aware that a covered individual failed to comply with the non-Federal entity's COI and COC policy or a management plan, the non-Federal entity must promptly notify DOE in writing of the failure to comply and of the corrective action taken or to be taken. DOE will evaluate the situation and, as necessary, take appropriate action, which may include referring the matter to the non-Federal entity for further corrective action consistent with non-Federal entity's established COI and COC policies, DOE directing the non-Federal entity to take specific mitigation measures, or termination of the Federal financial assistance award.

7. Organizational Conflicts

(a) Consistent with 2 CFR 200.318, if a non-Federal entity has a parent, affiliate, or subsidiary organization that is not a State government, local government, or Indian Tribe, the non-Federal entity must maintain written standards of conduct covering organizational conflicts of interest (OCI) as that term is defined in 2 CFR 200.318(c)(2).

(b) If the effects of a potential or actual OCI cannot be avoided, eliminated, or mitigated, the procurement or other transaction anticipated by the non-Federal entity must not be made using DOE or cost share funds.

8. Reporting Organizational Conflicts of Interest (OCIs)

The non-Federal entity must disclose in writing any potential or actual OCI to DOE within 15 business days of learning of the conflict.

(a) The non-Federal entity must provide the disclosure to DOE in an application for financial assistance and prior to engaging in a procurement or other transaction to acquire services or property, using DOE funds with a parent, affiliate, or subsidiary organization that is not a State government, local government, or Indian Tribe.

(b) The disclosure must include, at a minimum, the following:

(1) The name, address, and website (as applicable) of the entity that presents a potential or actual OCI;

(2) The relationship between the non-Federal entity and the entity at issue;

(3) The nature of the anticipated procurement or other transaction with the parent, affiliate, or subsidiary organization; the anticipated value of the procurement or other transaction; and the basis for making the procurement or other transaction with the parent, affiliate, or subsidiary organization;

(4) The basis for the non-Federal entity's determination regarding the existence of an OCI; and

(5) How the non-Federal entity will avoid, eliminate, or mitigate the OCI.

9. Remedies, Penalties, and Enforcement

(a)(1) If a non-Federal entity fails to disclose a conflict of interest (COI) or conflict of commitment (COC) as required under this subpart, or fails to sufficiently manage or mitigate a COI or COC to ensure the integrity of the DOE-supported project or to protect the Government's interests, DOE may:

(i) Require the non-Federal entity to take action to eliminate or mitigate the conflict to a risk level acceptable to DOE. In the event the non-Federal entity does not eliminate or mitigate the conflict to a risk level acceptable to DOE, DOE may determine the Federal financial assistance award no longer effectuates the program goals or agency priorities and terminate the Federal financial assistance award;

(ii) Determine the circumstances disqualify an entity or individual from participating in all or a portion of a Federal financial assistance award; or

(iii) Reject an application.

(2) DOE may inquire, at any time before, during, or after a Federal financial assistance award, into any covered individual's disclosures and the non-Federal entity's review (including any retrospective review) of and response to such disclosure, regardless of whether the disclosure resulted in the non-Federal entity's determination of a COI or COC. A non-Federal entity is required to submit or permit on-site review of all records pertinent to compliance with this subpart. To the extent permitted by law, DOE will maintain the confidentiality of all records of financial interests. Based on its review of records or other information that may be available, DOE may determine that a particular COI or COC will bias the objectivity of or adversely impact the project funded under the DOE Federal financial assistance award to such an extent that further corrective action is needed or that the non-Federal entity has not managed the COI or COC in accordance with this subpart. DOE may determine that the imposition of specific award conditions under 2 CFR 200.208 is necessary. DOE may also take one or more the actions specified under 2 CFR 200.339, as appropriate in such circumstances.

(b) If a non-Federal entity fails to disclose an OCI to DOE prior to engaging in a procurement or other transaction to acquire services or property, using DOE funds with a parent, affiliate, or subsidiary organization that is not a State, local government, or Indian Tribe, the costs of such procurement or transaction may be disallowed. If a non-Federal entity fails to disclose an OCI to DOE that is not avoided, eliminated, or mitigated or fails to avoid, eliminate, or mitigate a disclosed OCI, prior to engaging in a procurement or other transaction using DOE funds with a parent, affiliate, or subsidiary organization that is not a State, local government, or Indian Tribe, DOE may determine that imposition of specific award conditions under 2 CFR 200.208 is necessary. DOE may also take one or more actions specified under 2 CFR 200.339, as appropriate in the circumstances.

(c) Any false, fictitious, or fraudulent information, or the omission of any material fact, on a disclosure, report, or other record required under this subpart may be subject to criminal, civil, or administrative penalties for fraud, false statements, false claims or otherwise. (18 U.S.C. 287 and 1001 and 31 U.S.C. 3729-3733 and 3801-3812)

(d) If fraud, misrepresentation, or related misconduct is suspected in relation to any disclosure submitted to DOE, then the cognizant contracting officer and/or program official should coordinate with appropriate counsel and thereafter, as appropriate, refer the matter to the DOE Office of Inspector General (OIG).

(e) If a covered individual knowingly fails to disclose required information, DOE may take one or more of the following enforcement or other actions:

(1) Reject an application;

(2) Suspend or terminate a Federal financial assistance award;

(3) Temporarily or permanently discontinue or de-obligate any or all funding for the covered individual or non-Federal entity;

(4) Refer recipients for consideration of suspension or debarment proceedings;

(5) Refer the failure to disclose to the DOE OIG for further investigation or to Federal law enforcement authorities to determine whether any criminal or civil laws were violated;

(6) Report the entity in the Federal Awardee Performance and Integrity Information System (FAPIIS) to alert other Federal agencies to the noncompliance;

(7) Take one or more of the actions described in 2 CFR 200.339; or

(8) Take such other actions against the covered individual or non-Federal entity as authorized under applicable law or regulations.