Direct Sponsor

Direct provider of funds to the institution. Example: Genentech receives funds from the Public Health Service for a study, and provides some of those funds to Berkeley Lab to conduct a specific part of the study. Genentech is the Direct Sponsor.

Prime Sponsor

Originating source of funds provided to the institution. Example: Genentech receives funds from the Public Health Service for a study, and provides some of those funds to Berkeley Lab to conduct a specific part of the study. The Public Health Service is the Prime Sponsor.

Substantial Role

Any individual responsible (including in an advisory role) for the negotiation, approval, execution, or performance of work conducted or to be conducted under an CRADA or non-federal SPP. This typically includes the principal investigator, co-investigators, any other research personnel considered essential to performance of the work, the division director, the contracting officer, SPO manager, and any other individual who is responsible for negotiating, approving, executing, or performing research under a CRADA or non-federal SPP.

Significant Financial Interest

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 dependent children for the following categories, except in the case of travel:

1. With regard to any 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. Included are consulting fees, honoraria, gifts, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measures of fair market value.
2. With regard to any non-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, when aggregated, exceeds $5,000, or when the investigator holds any equity interest.
3. Intellectual property rights and interests, upon receipt of income, exceeding $5,000 during the twelve months preceding disclosure from such rights and interests. However, significant financial interests do not include royalties received from the University of California Regents.
4. In the case of travel, sponsored travel or reimbursements made to or on behalf of the investigator, regardless of the amount, by a for-profit or non-profit entity related to the investigator's institutional responsibilities. However, significant financial interests do not include travel reimbursed or paid 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.¹
   
   *The inclusion of "registered domestic partner" is consistent with California State law (Family Code, section 297 et seq.).

The term "significant financial interest" does not include the following types of financial interests:

• • Salary, royalties, or other payments paid by the University of California Regents to a University or Laboratory investigator who is currently employed or otherwise appointed by the Laboratory or University.
  • Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by a federal, state, or local government; an agency; a U.S. institution of higher education; or a research institute, academic medical center, or hospital affiliated with an institution of higher education.²
  • Income from investment vehicles, such as mutual funds and retirement funds, in which the investigator does not directly control investment decisions.
    
    ^1,2 These references refer to a U.S. institution of higher education or a federal, state, or local government agency within the United States. Therefore, Investigators, including subrecipient Investigators, must disclose all financial interests received from a foreign institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country). 

Financial Conflict of Interest

A situation in which an Investigator or the Investigator’s spouse or dependent children has a significant financial interest or financial relationship that could directly and significantly affect the design, conduct, reporting or funding of a project.

Date

Revision

By Whom

Revision Description

Section(s) Affected

Change Type

1/2/2012

0

M. Stoufer

Rewrite for wiki (brief)

All

Minor

9/25/2012

1

M. Stoufer

Rewrite for wiki (policy)

All

Minor

Periodic review: updated to combine CRADA, SPP and 700-U requirements based on C31 Mod 1155 update to clause I.138. Merged with the Conflict of Interest in Research – Private Sponsors policy. Policy name changed from COI - CRADAs to COI - CRADAs and non Federal SPPs.

All

Major