700-12: Disclosure of Financial Interests & Management of Conflicts of Interests, Non-Public Health Service (Non-PHS) Research Awards

Questions? Contact Campus Administrative Policies

Overview

Describes the conditions under which certain financial interests should be disclosed by all Investigators.

Purpose

Federal regulations require Investigators to disclose certain financial interests (defined below) to ensure that the design, conduct or reporting of federally-funded projects will not be biased. The financial interests disclosed by UCSF Investigators are preliminarily reviewed by the Designated Official (or designee) and may be reviewed by the UCSF Conflict of Interest Advisory Committee (COIAC).

This policy describes the conditions under which these financial interests should be disclosed by all Investigators. The procedure is applicable to all research and educational activities supported by sponsors and programs, including the National Science Foundation, who continue to follow the 1995 regulations on Objectivity in Research [See 60 F.R. 35810 (July 11, 1995), 42 C.F.R. Part 50, Subpart F, (application/pdf, 40.1 kB, info)45 C.F.R. Part 94, and (application/pdf, 40.1 kB, info)60 F.R. 35820 (July 11, 1995 (application/pdf, 40.1 kB, info))]. The University of California and UCSF maintain a separate conflict of interest policy applicable to Public Health Service (PHS) and other non-federal sponsors that adopt the PHS policy.

Definitions

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.

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.

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.

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.

Consistent with the University of California’s definition (See University of California Policy On Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects) Significant Financial Interest means anything of monetary value including, but not limiting to:
A. Income or other payment for services including: salary, consulting payments, honoraria, reimbursement of expenses, royalty payments, dividends, loans from the entity, or any other payments or consideration with value, including payments made to the Health Sciences Compensation Plans, during the prior twelve months, of $10,000 or more when aggregated for an Investigator and the Investigator’s spouse or registered domestic partner, and dependent children;
B. Equity in the form of stock, stock options, real estate, warrants, or any other investment or ownership interest exceeding either $10,000 (current market value if publicly traded; internal estimate of value if not publicly traded; otherwise, amount of investment) or a 5% ownership interest, for any one enterprise when aggregated form an Investigator and the Investigator’s spouse or registered domestic partner and dependent children;
C. A management position, whether paid or unpaid, such as a board member, director, officer, partner, or trustee, held by the Investigator; or
D. Intellectual property interest in the form of a patent, patent application or copyright held by the Investigator, or the Investigator’s spouse or registered domestic partner, or dependent children on a patent, patent application, assigned or to be assigned to a party other than The Regents.
Specifically excluded from the definition of Significant Financial Interest are payments made by The Regents, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration from the University. Also excluded is income from public or nonprofit entities for seminars, lectures, teaching engagements, or service on advisory committees or review panels.

Policy

A. Disclosure

  1. In accordance with University policies and federal regulations, Investigators are required to disclose all Significant Financial Interests that would reasonably appear to be related to the sponsored project to COIAC.
  2. In all cases, reporting is required for the individual, his/her spouse or registered domestic partner, and any dependent children.
  3. Additionally, investigators are required to update their financial disclosure form(s) either annually or as new Significant Financial Interests that are related to the sponsored project are obtained through the period of the award.
  4. Significant Financial Interests that are not related to the sponsored project do not need to be disclosed.

B. Review of Disclosures

  1. Prior to expenditure of funds, the disclosure of Significant Financial Interests related to the sponsored project will be evaluated by the Designated Official and/or the Conflict of Interest Advisory Committee (COIAC) to determine whether they may directly and significantly affect the design, conduct or reporting of projects and thereby constitute a financial conflict of interest that may need to be managed, reduced or eliminated. Upon completion of the review, recommendations are forwarded to the Executive Vice Chancellor and Provost who makes the final decision regarding the conditions for acceptance.

C. Reporting Financial Conflicts of Interest

  1. UCSF will follow all reporting requirements set forth in the 1995 federal regulations on Objectivity in Research and as described under Responsibilities and Procedures. See 60 F.R. 35810 (July 11, 1995), 42 C.F.R. Part 50, Subpart F, 45 C.F.R. Part 94, and 60 F.R. 35820 (July 11, 1995).

Responsibilities

References

Subject area

Ethics & Compliance

Policy number

700-12

Responsible office

Office of Ethics and Compliance, Office of the Executive Vice Chancellor and Provost

Primary content owner

Conflict of Interest, Office of Faculty and Academic Affairs

Effective

Reviewed