Office of Research, UC Riverside
Office of Research Integrity

Disclosure of Financial Interests

Office of Research

RIVERSIDE, CALIFORNIA 92521

July 24, 1998

 

DISCLOSURE OF FINANCIAL INTERESTS

RELATED TO SPONSORED PROJECTS

REVISED UCR IMPLEMENTING GUIDELINES

UC POLICY

On October 15, 1997, the University of California issued the final "Policy on Disclosure of Financial Interests Related to Sponsored Projects" to comply with federal policies requiring investigators to disclose whether they or their immediate family members have any significant personal financial interests related to sponsored projects. It replaced the Interim Policy, which became effective October 1, 1995. The Policy applies automatically only to NSF and PHS sponsored research projects. The University may elect to apply the disclosure requirements of this Policy to certain University-managed programs. However, application of this Policy will be expanded to other extramural sponsors only if necessary to comply with official requirements subsequently imposed by those sponsors.

This Policy supplements, but does not supplant, the University Policy on Disclosure of Financial Interest in Private Sponsors of Research (issued April 26, 1984) and the Guidelines for Disclosure and Review of Principal Investigator's Financial Interest in Private Sponsors of Research (issued April 27, 1984).

UCR issued its original implementation of the Interim Policy on September 20, 1995. In light of the issuance of the final Policy and drawing on the experience of the initial implementation on this campus and other UC campuses, we issue these revised UCR Implementation Guidelines. We hope this revised approach will provide a clearer and less burdensome means of complying with the requirements of disclosure of financial interests related to sponsored projects.

WHO IS COVERED BY THIS POLICY?

Any individual responsible for the design, conduct, or reporting of the results of work performed under the sponsored project. This includes the Principal Investigator, Co-Investigators, and any other individual who has independent responsibility for designing, conducting, or reporting the results of the sponsored project (hereby referred to as "investigator/s").

Please note that under the UCR implementation of the final policy, the lead Principal Investigator (listed in No. 1 on the Proposal Approval Form) must ascertain whether any personnel as described above, their respective spouses or dependent children, have a significant personal financial interest related to the work to be conducted under this project.

What is a "Related" Financial Interest

When the work to be performed under the sponsored project and the results of the undertaking would reasonably appear to affect the Investigator's significant financial interest, the interest is regarded as related to the sponsored project and must be disclosed. The designation of an Investigator's financial interest as being related to the sponsored project, under the terms of this Policy, does not in and of itself imply the existence of an actual or potential conflict of interest. The existence of a conflict of interest is determined subsequently by the Vice Chancellor for Research. If a conflict is identified, the Vice Chancellor may require additional steps to manage or eliminate the conflict.

Consistent with current federal regulations, the following are significant financial interests which are considered "related" to a sponsored project:

1. The Investigator is carrying out a project and the results of that project would be relevant to the development, manufacturing, or improvement of the products or services of the entity in which there is a financial interest;

2. The Investigator has a financial interest in an entity which might manufacture or commercialize a drug, device, procedure, or any other product used in the project, or that will predictably result from the project;

3. The Investigator has consulting income from a single entity that exceeded $10,000 during the prior twelve months, and the financial interests of that entity, or the Investigator's financial interests related to consulting for that entity, would reasonably appear to be affected by the research.

4. The Investigator has a financial interest in an entity and the sponsored project proposes to subcontract a portion of the work, or lease property, or to make referral of participants to, or make purchases from the entity; or

5. The Investigator has a financial interest in an entity that is part of a consortium or that will otherwise participate in the sponsored project.

Financial interests which are not related to the sponsored project do not need to be disclosed.

WHEN MUST DISCLOSURE INITIALLY TAKE PLACE?

The Proposal Approval Form that accompanies every proposal submitted to the ORA, contains a section entitled "Federal Disclosure of Financial Interest for NSF & NIH." When submitting a proposal to either agency, the Principal Investigator must ascertain whether any personnel as described above, their respective spouses or dependent children, have a significant personal financial interest related to the work to be conducted under this project and check the appropriate box within this section.

If the answer is "No" for ALL investigators, no other paperwork needs to be filed UNLESS a change occurs in the financial status of anyone designated as having independent responsibility for designing, conducting, or reporting the results of the sponsored project.

If the answer is "Yes" for ANY member of the project who is defined by the PI to be responsible for the design, conduct, or reporting of the results of work performed under the sponsored project, a UCR Federal Financial Disclosure Form must be filed by that individual for review by the Vice Chancellor for Research and, if called for, the UCR Research Disclosure Committee. This form should accompany the proposal when it is submitted to the ORA for review. We are required to have any positive disclosure(s) in hand BEFORE the proposal may be sent.

WHAT MUST BE DISCLOSED?

Investigators must disclose "related" financial interests if they meet the thresholds described below:

1. Income from a single business, public or nonprofit entity, including salary, consulting payment in your professional field, honoraria, royalty payments, dividends, loans from the entity, or any other payments or consideration with value, including payments to the niversity Medical Compensation Plan, from a single business, public or nonprofit entity, received during the prior twelve months, exceeding $10,000 when aggregated for an investigator and investigator's spouse or dependent children. Income from seminars, lectures, teaching engagements or service on advisory committees or review panels is excluded.

2. Equity in the form of stock, stock options, loans to the entity, real estate, 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 for an investigator and the investigator's spouse and dependent children.

3. Management in the form of a position as a board member, director, officer, partner, or trustee held by the investigator or the investigator's spouse and dependent children.

4. Intellectual property interest held by the investigator, the investigator's spouse or dependent children on a patent, patent application, or a copyright of software assigned to a party other than The Regents of the University of California.

Please note: A "financial interest" does not include payments made by the Regents, including salary, stipends, royalty payments, honoraria, reimbursement of expenses, or any other remuneration.

CAMPUS PROCEDURES

As indicated above, the appropriate box in the "Federal Disclosure of Financial Interest for NSF & NIH" section of the Proposal Approval Form must be checked by the PI whenever this form is submitted with a proposal being submitted to either of the covered agencies.

UCR is required to review positive disclosures and mitigate any conflicts of interest before funds can be spent on the project including pre-award expenditures. Positive disclosures will be reviewed by the Vice Chancellor for Research to determine whether any related financial interest is one which would reasonably appear to be directly and significantly affected by the proposed sponsored project. If the Vice Chancellor for Research or investigator conclude that a potential or an actual conflict exists, the Research Disclosure Committee will review the case and make final recommendations to the Vice Chancellor for Research on appropriate steps to mitigate or eliminate the conflict.

SUBCONTRACTS AND MULTI-CAMPUS PROJECTS

If cooperating investigators are included in a UCR proposal from other UC campuses, they must submit a copy of their local disclosure forms together with their multi-campus proposals through their local campus contract and grant office. Similarly, cooperating investigators from other educational or other non-profit institutions must process disclosure forms together with their subcontract proposals through their own contract and grant office. The other UC campuses or institutions will approve the multi campus or subcontract proposals and certify to UCR that they have a policy and procedures that are in compliance with federal requirements. Each participating UC campus or other institution will maintain and handle disclosure forms for their own investigators. These forms should not be sent to UCR. Cooperating investigators employed by private for-profit entities that meet the criteria for disclosure may be required to submit their forms through the Riverside Campus before a subcontract is issued. A decision will be made on a case-by-case basis and the request will be made by the Office of Research.

UCR investigators asked to participate: 1) in a multi-campus project submitted by a lead PI from another UC campus, or 2) under a subcontract with a lead PI at another educational or non-profit institution, must indicate whether or not they have any related financial interest (as described above) on the UCR Proposal Approval Form accompanying the multi-campus or Subcontract Proposal. All UCR Proposal Approval Forms and any updates for multi-campus or subcontract projects will be processed and maintained at UCR and should not be sent to the prime campus or prime institution. The Office of Research will submit the multi-campus proposal or subcontract proposal to the prime UC campus or other institution and certify that UCR has established policies and procedures in compliance with federal policy. Updates will be processed and maintained in accordance with campus policy.

UPDATING DISCLOSURES

The federal policy requires covered investigators to submit an initial disclosure (as indicated on the Proposal Approval Form) with the proposal, and thereafter, provide updates either (1) on an annual basis or (2) when changes occur in an investigator's financial status. UCR has elected Option 2. Thus, when such a change occurs, the investigator (as described above) must file with the ORA a UCR Federal Financial Disclosure Form (checking the "Update" box) for each sponsor listed in which the investigator, his/her spouse or dependent children have a financial interest related to the current active or pending sponsored project.