Regulations

The U.S. Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance covers the requirements for disclosure, review, management and reporting of financial interest in DOE-funded research under financial assistance awards. This policy requires disclosure of financial and organizational conflicts of interests by investigators who participate in DOE-funded research under financial assistance awards either directly or by subaward.

What does this mean?

Per these DOE regulations, principal investigators and all other investigators responsible for the “purpose, design, conduct or reporting” of the DOE-funded research project are required to disclose all significant financial interests or financial relationships related to their non-Federal entity responsibilities. Investigators must also disclose the financial interests or financial relationships of their spouses/registered domestic partners and/or dependent children that could directly and significantly affect the design, conduct, reporting or funding of a project.

What is “Investigator’s non-Federal entity responsibilities”?

Investigator’s non-Federal entity responsibilities means an Investigator’s professional responsibilities on behalf of the non-Federal entity, and as defined by the non-Federal entity in its policy on financial conflicts of interest (FCOI), which may include: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Examples of disclosable information related to the Investigator’s non-Federal entity responsibilities may include but are not limited to: 1) income or honoraria received for activities such as providing expert testimony or consulting services, serving on a board of directors, scientific advisory board, committee, panel or commission sponsored by a for-profit or non-profit organization, including professional or scholarly societies; acting in an editorial capacity for a professional journal or reviewing journal manuscripts, book manuscripts, or grant or contract proposals for a non-profit or for-profit organization; accepting a position as a salaried employee outside the University or receiving royalty payments for intellectual property rights held by an entity other than The Regents; 2) holding stock or stock options in a company that is developing, manufacturing or selling products or providing services used in an Investigator’s clinical practice, teaching, research, administrative or committee responsibilities; or 3) travel paid for or reimbursed by an outside entity.

What is “Income”?

Income includes but is not limited to salary, consulting fees, honoraria, paid authorship, income received related to intellectual property rights and interests (not paid by or assigned to the UC Regents).

What types of research does this apply to?

This DOE Interim COI Policy is applicable to DOE financial assistance awards and to each Investigator who is planning to participate in or is participating in a project funded wholly or in part under a DOE financial assistance award, and to each non-federal entity sub-recipient under the award. The DOE Interim COI Policy does not apply to Office of Indian Energy and Phase I Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) applications and awards.


Who/What/When

Who files?

The principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct or reporting of DOE-funded research, whether or not they receive salary or other remuneration. Under the regulation, these individuals are defined as “Investigator.”

When are disclosures filed?

A DOE Financial Disclosure is required at the time a proposal is submitted to the Sponsored Projects Office, at least annually at the time of submission of the progress report/non-competing continuation, at no-cost time extensions, when new investigators are added to the project, and within 30 days of acquiring or discovering a new significant financial interest.

What must be disclosed?

All investigators must disclose any “Significant Financial Interest” (SFI).

What is a “Significant Financial Interest”?

All investigators must disclose:

  1. 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 appears to be related to the Investigator’s non-Federal entity responsibilities:

    1. 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;

    2. 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 Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);

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

  2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator 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, provided that this disclosure requirement does not apply to 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. The non-Federal entity’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the non-Federal entity’s FCOI 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 FCOI with the project funded under the DOE award.

What is excluded from disclosure/What is not a “Significant Financial Interest”?

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 Investigator if the Investigator 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 Investigator, 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 Investigator 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.

What is an “Entity”?

An Entity is any domestic or foreign, public or private organization (excluding a U.S. federal agency) from which an investigator (and their spouse, registered domestic partner or dependent children) receives compensation or in which that individual has an ownership or equity interest.

What is the process for disclosing at UC Berkeley?

For the disclosure process at award and proposal stage and during the life of the award, see DOE Financial Disclosure .

What happens after the disclosure is submitted?

If the screening questions were all “no,” then nothing more is required unless 12 months have passed or there is a change. This is referred to as a “negative” disclosure.

If an investigator provides any “yes” responses to the screening questions, then additional information is required. This is referred to as a “positive” disclosure. This disclosure will then be reviewed by the COI Coordinator and if necessary by the COI Committee. A financial interest does not necessarily mean a conflict of interest. More detailed financial information will not be collected unless and until a proposal is likely to be funded or if the Investigator requests early review.

See Review and Management for more information on positive disclosures and the review process.


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