Disclosing a Financial Conflict of Interest in Research

Overview

The mission of Alameda Health System (AHS) is Caring, Healing, Teaching, Serving All. Our mission conveys our vital role, and our heartfelt responsibility to promote wellness, eliminate disparities and optimize the health of our communities by providing the best care to every patient through integrated clinical practice, education and research.

Individual Conflict of Interest and Conflict of Commitment in Research

A conflict of interest may arise when a covered individual’s relationship with an outside entity might appear to influence that individual’s judgment in performing their professional responsibilities at the Alameda Health System (AHS) and could or may appear to directly and significantly affect the design, conduct, or reporting of research.

A conflict of commitment may arise when a medical staff member engages in external activities or assumes external commitments that might appear to compromise their ability to fulfill the responsibilities of their obligations to Alameda Health System (AHS).

The management and/or elimination of conflicts of interest and conflicts of commitment allows the Alameda Health System (AHS) to maintain the integrity of the institution, its personnel, and the public’s interest.

Individuals Subject to this Policy

This policy applies individuals who are required to disclose their institutional responsibility to conduct research and the financial interests Related to the Research:

  • On submission of an initial review.
  • At least annually on submission of continuing review.
  • Within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest.

Disclosure Requirement

Investigators who engage in sponsored research (regardless of funding type) at AHS are required to disclose all Significant Financial Interests (SFIs) related to their Institutional Responsibilities.

Significant 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 any dependent children for the following categories:

  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 salary are consulting fees, honoraria, and the equity interest value at the date of disclosure as determined by public prices or other reasonable measure 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 (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
  3. Receipt of income from intellectual property rights and interests exceeding $5,000 during the twelve months preceding disclosure. However, Significant Financial Interests do not include royalties received from AHS.

The term “Significant Financial Interest” does not include the following types of financial interests:

  1. Mutual funds or other investment vehicles such as retirement funds as long as the Investigator does not directly control the investment decisions made for these investment vehicles;
  2. Salary, stipends, royalties, honoraria, reimbursement of expenses, or any other payments made by AHS to an Investigator as determined by AHS policy; or
  3. Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored 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;

Travel Disclosures

Travel reimbursements are made for the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration. Only the Investigator’s travel reimbursements are included in the definition of Significant Financial Interest. Therefore, the Investigator’s spouse or registered domestic partner, or dependent children’s travel reimbursements are not considered to be a Significant Financial Interest.

Travel that is reimbursed or sponsored by federal, state or local governments, a US institution of higher education, or a research institute, academic medical center or hospital that is affiliated with an institution of higher education.

Applicable AHS Policy

The revised AHS Financial Conflict of Interest in Research Policy will be posted here once the review process is complete.