PHS and NSF (Federal) Policies

References

NSF Investigator Financial Disclosure Policy, dated June 19, 1995
UC Policy on Disclosures of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects, revised October 15, 1997
Objectivity in Research, NIH Guide, dated July 14, 1995

Requirements

Effective October 1, 1995, in accordance with PHS, NSF, and UC policies, Investigators submitting proposals to the NSF and the PHS (including the National Institutes of Health) must disclose their project-related financial or management interests prior to any expenditure of awarded funds and as changes in the interest(s) occur, or on an annual basis, whichever comes first. "Investigators" are those individuals with responsibility for the design, conduct, or reporting of research. Disclosure is to include all Significant and Related Interests cumulative for the investigator, his/her spouse, and dependent children. Also, please note in the case of subcontractors, NSF requires each grantee institution employing more than fifty persons to maintain an appropriate written and enforced policy on conflict of interest.

As a streamlining measure implemented at UCI in May 1998, the PI is required to disclose at the time of proposal submission. Other investigators must disclose when an award is made. It is the responsibility of the PI to ensure that a review by the Conflict of Interest Oversight Committee is completed on any positive disclosures prior to the expenditure of funds.

Significant Interest

Outside income equal to or exceeding $10,000 over the preceding twelve months or anticipated during the forthcoming twelve months. Income includes salary, consultant payments, honoraria, royalty payments, dividends, loan, or any other payments or consideration with value, including payments made to the University Health Sciences Compensation Plan.
Equity in the form of stock, stock options, or any other investment or ownership interest equal to or exceeding $10,000 (current market value) or a 5% or greater ownership interest.
A management position (e.g., director, officer, partner, or trustee) with the interested entity.
An intellectual property interest, e.g., a patent (actual, planned, or applied for) or a copyright for software assigned or to be assigned to a party other than the Regents.

However, a "Significant Financial Interest" is not disclosed if it originates from the following:

Salary, royalties or remuneration from UCI.
The proposed research relates to a Phase I SBIR or STTR (although disclosure may be required under State policy requirements).
Income from public or nonprofit entities for seminars, lectures, teaching engagements, or service on advisory committees/review panels.
Interests in business entities, less than $10,000 or less than 5% ownership interest combined for investigator, spouse, dependent children.

Related Interest

A related interest occurs when the investigator has Significant Financial Interests that would reasonably appear to be affected by the federally funded research or in entities whose financial interests would reasonably appear to be affected by the research. The UC campuses have interpreted "relatedness" to be broadly defined. Thus, consulting in one's field of expertise will automatically mandate disclosure. Also, equity holdings, consulting, or management positions in any start up technology company will also trigger conflict of interest review.

Examples include situations where the investigator:

is conducting a project where the results could be relevant to the development, manufacturing or improvement of the products or services of the entity in which the investigator has a financial interest; or
has a financial interest in an entity that might manufacture or commercialize a drug, device, procedure, or any other product used in the project or that will predictably result from the project; or
has consulting income in his/her professional field where the financial interest of the entity or the investigator would reasonably appear to be affected by the project; or
has a financial interest in an entity and the project proposes to subcontract a portion of the work, or lease property, or make referral of participants to, or make purchases from the entity, or the entity is part of a consortium or will otherwise participate in the project.

COIOC Considerations for Review

The COIOC will consider the research project according to traditionally held principles of ethical conduct and academic freedom. The COIOC will evaluate whether: there is sufficient separation of University and private interests, the proposed research is appropriate to the University, the teaching and research environment is open, freedom to publish and to disseminate research results is preserved, the University's rights are protected, the University's facilities and resources are used appropriately, and that the University receives proper compensation for their use.

Considerations for Review Relating to Human Subjects

The COIOC must consider the effect of the disclosed financial interests on the rights and welfare of the participants. The COIOC must consider whether the rights of the participants would be better protected by reduction or disclosure of a financial interest, separation of responsibilities for financial and research decisions, additional oversight, elimination of a financial interest, implementation of an independent data and monitoring committee, modification of roles in research staff, or any other mechanism which would mitigate effects of the financial interest."

Final COIOC approval is conditioned upon the Institutional Review Board's review of the COIOC findings and communication from the IRB that the COIOC has adequately considered the effect of the disclosed financial interests on the rights and welfare of the participants.

For more information, visit Procedures for Federal Financial Disclosure.

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