Disclosing Financial Interests: Clinical Trials

A Clinical Trial is the controlled, clinical testing or comparison in human subjects of investigational new drugs, approved drugs, devices, treatments, or diagnostics.

A Clinical Trial is conducted to assess the safety, efficacy, benefits, costs, adverse reactions, and/or outcomes of these tests or comparisons. It may be conducted under an industry-initiated protocol or an investigator-initiated protocol. In addition, a clinical trial is most often used in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration. Although some clinical trials can be designed with the sole purpose of collecting and analyzing data about an approved drug or device in order to contribute to medical knowledge about the treatment of a disease or medical conditions. An example can include:

• A pharmaceutical company provides funding and the drug(s) to a UCSD Investigator to perform a specific protocol (scope of work). The UCSD Investigator recruits, enrolls, and conducts the clinical testing in accordance with the approved protocol.

700-U Form:

The State of California's Fair Political Practices Commission requires disclosure of financial interests by using the State of California's Statement of Economic Interest for Principal Investigators, or the 700-U form. Keep in mind that all financial disclosures must also be updated during the entire period of the award, as new reportable significant financial interests occur.

The 700-U form must be filled out in its entirety by the Principal Investigator who must disclose their financial interests; as well as the financial interests of their spouse or registered domestic partner, and/or their dependent children.

Addendum:

If a positive financial interest is disclosed, meaning a conflict of interest may exist due to the information that was disclosed on the 700-U form, a conflict of interest Addendum form must also be completed by the Principal Investigator. The Addendum provides the opportunity for the Principal Investigator to more fully describe their financial interest and indicate whether that financial interest could directly and significantly affect the sponsored project.

• Salaried or unsalaried positions with the sponsor
• Scientific advisory board memberships
• Vested or non-vested stock or stock options
• Gifts
• Loans
• Travel reimbursements
• Income received through honoraria or consulting

A financial interest refers to the direct financial relationship between the principal investigator and the industry sponsor, or indirectly through their spouse, their registered domestic partner, or their dependent children. Some examples of this include:

• Equity holdings in the sponsor
• Management positions with the sponsor
• Consulting income received from the sponsor (refer to Consulting page for more information)
• Honoraria received from the sponsor
• Principal Investigator's spouse or registered domestic partner being an employee of or having a financial interest in the sponsor

The Principal Investigator at UCSD must disclose their financial interests; as well as the financial interests of their spouse or registered domestic partner, and/or their dependent children.

• For research involving human subjects; any UCSD individual on the list of OTHER PERSONS ASSOCIATED WITH THIS PROJECT (IRB Facesheet - Section 7) must disclose their financial interests; as well as the financial interests of their spouse or registered domestic partner, and/or their dependent children.

In general terms, financial interests that must be disclosed for industry sponsored research can be separated into 6 main categories, and are only for activities that took place 12 months prior to the time of financial disclosure. These categories include, but are certainly not limited to:

Positions with the sponsor:

These can include positions as founder, partner, director, manager, officer, trustee, employee, or any other position of management with the sponsor within the past 12 months.

Investments in the sponsor:

Investments in the sponsor, within the past 12 months, can include stocks, bonds, warrants, and stock options, including margin or brokerage accounts that have a value totaling $2000 or more.

Income from the sponsor:

Income received from the sponsor within the past 12 months, which can include salaries, consulting income, honoraria from speeches or other services that were performed, royalty payments, and stock dividends and/or interest earned, or the proceeds from any stock sales. In addition, income also includes compensation received by the University of California Health Sciences Compensation Plans.

Gifts from the sponsor:

Gifts from the sponsor, which includes the gift or the promise of a gift received from the sponsor of $50 or more, or multiple gifts from a single sponsor totaling $50 or more, within the past 12 months. Keep in mind that it is the acceptance of the gift, not the ultimate use of the gift, that imposes the obligation to disclose. Therefore, personal gift must be disclosed even if never used it or even if given away to another person. If the exact amount of the gift is not known, a good faith estimate of the item's fair market value must be made. Some common examples of disclosable gifts include; tickets or passes to sporting or entertainment events, or amusement parks, parking passes, transportation and lodging, and forgiveness of a loan (received from the sponsor).

Loans from the sponsor:

Loans from the sponsor require disclosure if the outstanding balance has exceeded $500 within the past 12 months. This also includes community property interest in loans received by the spouse or registered domestic partner.

Travel Reimbursements from the sponsor:

Travel reimbursement from the sponsor for travel expenses within the past 12 months, which includes per diem, payments for transportation outside California, travel advances, lodging, and meals that were received from the sponsor.