Public Health Service (PHS)

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.

At the proposal stage the Principal Investigator (PI) must fill out the Conflict of Interest screening questions in SPO's Proposal Submission Request webform on behalf of all investigators that will be involved in the project.

If any investigator prompts the PI to respond “yes” to any of the screening questions, the investigator will be required to complete and submit the PHS Financial Disclosure Form to the COI Office at coi@ucmerced.edu for review prior to the award being released.

To Whom does the Public Health Service (PHS) Conflict of Interest (COI) policy apply?

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.” Investigators must disclose all significant financial interests related to their institutional responsibilities and 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.

What must be reported under the PSH COI policy?

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

All investigators must disclose:

• With regard to any publicly-tradedentity: 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.

When are disclosures required?

Disclosures are 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.

DOE Financial Disclosure Training Requirement

All Investigators are required to take PHS-compliant training prior to engaging in research projects wholly or in part funded under PHS financial assistance awards for all new awards and at least every four years while engaging in PHS-funded research. The training requirement must be met as follows:

UC Ethics and Compliance Briefing for Researchers (ECBR) is available for UC Merced researchers with a UCM ID through the UC Learning Center.

Go to the UC Learning Center, login with your UCM ID, and search for UC Ethics and Compliance Briefing for Researchers.

Go through the training slides to complete the course.

After you have completed the training, you will receive a certification email. Keep this email for your records.