700-11: Disclosure of Financial Interests & Management of Conflicts of Interests, Public Health Service (PHS) Research Awards

Definitions

Conflict of Interest Advisory Committee (COIAC)

The UCSF faculty committee charged with determining whether Significant Financial Interests are related to the proposed research and whether they constitute Financial Conflicts of Interest. The COIAC is appointed and is advisory to the Executive Vice Chancellor and Provost. The Chancellor designated the Executive Vice Chancellor and Provost as the official who receives and approves recommendations from the COIAC regarding Financial Conflicts of Interest.

Designated Official

Campus official (or designee) designated to solicit and conduct review of disclosures of Significant Financial Interests from each Investigator who is planning to participate in, or is participating in a PHS Activity. The Designated Official at UCSF is the Associate Vice Chancellor, Ethics and Compliance.

Financial Conflict of Interest (FCOI)

A Significant Financial Interest that is related to the PHS-funded activity in which the Investigator is engaged and that could directly and significantly affect the design, conduct or reporting of PHS Activity.

Institutional Responsibilities

Teaching/education, research, outreach, clinical service, and University and public service on behalf of the University of California which are in the course and scope of the Investigator’s University of California appointment/employment.

Investigator

Any individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project. This includes the Principal Investigator, Co-Investigators, Collaborators, Consultants, and any other individual who has responsibility for designing, conducting, or reporting of funded research or proposed such funding.

Key Personnel

A PHS research Project Director, Principal Investigator and any other personnel considered essential to work performance and identified as Key Personnel in the contract proposal, grant, or contract.

PHS Activity(ies)

Any activity for which funding is available from PHS awarding agency including but not limited to research contracts, cooperative agreements, research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program projects or research resources awards, conference grants, and Phase II Small Business Innovative Research (SBIR) and Phase II Small Business Technology Transfer Research (STTR) awards. Only Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) awards programs are excluded.

Principal Investigator (PI)

The individual ultimately responsible for the appropriate scientific and financial conduct of a sponsored research project. On occasion, co-principal investigators who share responsibility for a project.

Significant Financial Interest (PHS)

Consistent with the University of California’s definition (See University of California Policy Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service Research Awards) , Significant Financial Interest means a financial interest consisting of one or more of the following interests of the Investigator or the Investigator’s spouse or registered domestic partner and any dependent children for the following categories:
A. With regard to any publicly-traded entity, a Significant Financial Interest exists if the value of any remuneration (other than remuneration described in Paragraph E, below) 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. Included are salary (other than salary described in Paragraph E, below), consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure of fair market value.
B. With regard to any non-publicly-traded entity, a Significant Financial Interest exists if the value of any remuneration (other than remuneration described in Paragraph E, below) 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, registered domestic partner, or dependent children) holds any equity interest (including stocks, options, etc.)
C. Receipt of income from intellectual property rights and interests exceeding $5,000 during the twelve months preceding disclosure. However, Significant Financial Interests do not include royalties received from the University of California Regents.
D. Travel reimbursements made to, or on behalf of, the Investigator, regardless of the amount, by a for-profit or nonprofit entity, excluding a federal, state, or local government, a U.S. institution of higher education or an affiliated medical center/hospital or research institute. Only the Investigator’s travel reimbursements are included in the definition of Significant Financial Interest. Therefore, the Investigator’s spouse or registered domestic partner, or dependent children’s travel reimbursements are not considered to be a Significant Financial Interest in this policy.
E. The term “Significant Financial Interest” does not include the following types of financial interests:
1. Mutual funds or other investment vehicles such as retirement funds as long as the Investigator does not directly control the investment decisions made for these investment vehicles;
2. Salary, stipends, royalties, honoraria, reimbursement of expenses, or any other payments made by the University of California Regents to a University of California Investigator who is currently employed or otherwise appointed by the University;
3. Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a federal, state, or local government, agency, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with an institution of higher education;
4. Travel that is reimbursed or sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with an institution of higher education.