Regulations

The U.S. Department of Health and Human Services (HHS) “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought” (42 C.F.R., Part 50, Subpart F) covers the requirements for disclosure, review, management and reporting of financial interest in PHS-funded research (see Financial Conflict of Interest from the National Institutes of Health). This policy requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or by subaward. Other agencies have also adopted these PHS requirements.

What does this mean?

Per these PHS regulations, principal investigators and all other investigators responsible for the “design, conduct or reporting” of the PHS-funded research project are required to disclose all significant financial interests related to their institutional responsibilities. Investigators must also disclose the financial interests of their spouses/registered domestic partners and/or dependent children.

What is “Institutional Responsibility”?

Institutional Responsibility is defined as teaching/education, research, outreach, clinical service, training, University and public service done on behalf of UC and directly related to those credentials, expertise and achievements upon which the Investigator’s UC position is based. This will generally include consulting, expert witness testimony, and the like.

Examples of of disclosable information related to the Investigator’s institutional 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?

These regulations apply to any research and any activity for which research funding is available from PHS via grant or cooperative agreement, including career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program project awards, research resource awards, conference grants, Phase II SBIR or STTR awards (but excluding Phase I SBIR/STTR).


Who/What/When

Who files?

All principal investigators, project directors, senior/key personnel, and any others, e.g. postdocs, who are responsible for the design, conduct or reporting of PHS-funded research in a substantive, measurable way, whether or not they receive salary or other remuneration. Under the regulation, these individuals are defined as “Investigator.”

When are disclosures filed?

A PHS 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:

  • With regard to any publicly-traded entity: the value of any remuneration received from the entity in the 12 months preceding financial disclosure and any equity interest owned or acquired as of the date of financial disclosure, which exceeds $5,000 when aggregated for an Investigator, spouse, registered domestic partner and dependent children. Included are salary, consulting fees, honoraria and the value of equity interest (stock, stock options or other ownership interest) as determined by public prices or other reasonable measure of market value as of the date of disclosure.
  • With regard to any non publicly-traded entity: the value of any remuneration received in the 12 months prior to the date of the disclosure, which when aggregated exceeds $5,000 or any equity interest (includes stock, stock option or other ownership interest) held by the Investigator (or their spouse, registered domestic partner or dependent children) regardless of value.
  • Any payments exceeding $5,000 received within the past 12 months for any intellectual property rights and interests assigned or licensed to a party other than the University of California.
  • Any travel reimbursement or payment in excess of $5,000 per entity made by any entity (profit or non-profit) other than those listed below within the past 12 months, regardless of value made to or on behalf of the Investigator related to their Institutional Responsibilities.

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

  • Payments (salary, royalties, honoraria, expense reimbursement or other remuneration) made by the University of California to a University of California Investigator who is currently employed or otherwise appointed by the University of California.
  • Income from seminars, lectures, teaching engagements or service on advisory committees or review panels, e.g., NIH peer review, 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 affiliated with an institution of higher education.
  • Income from investment vehicles, such as mutual or pension funds or other investment over which the Investigator does not exercise investment decisions.
  • Travel reimbursed or sponsored by U.S. federal, state, or local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or research institute affiliated with a U.S. 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 PHS 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, generally when a Just-in-Time (JIT) or similar request is received 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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