ERI COI INFORMATION & INSTRUCTIONS
PHS Financial Conflict of Interest (FCOI) Requirements for ERI Investigators and Research Staff
Revised PHS Conflict of Interest Regulations
PHS has changed its financial conflict of interest (FCOI) rules effective August 24, 2012, and this means that ERI must correspondingly change our processes and procedures for PHS proposal and awards. (Note that many non-PHS sponsors have adopted the PHS rules as well. A current list of sponsors is available from the ERI office.) This change impacts our investigators as well as our subrecipients, and potentially our consultants or collaborators/service providers as well. The major changes from the current federal conflict of interest rules include:
- A change in the de minimis threshold that the federal government considers to be a “significant” personal financial interest form $10,000 under the old rule to $5,000 under the new rule;
- A requirement for disclosure of ALL reimbursed travel by investigators AND research staff that is not sponsored by a federal agency, state or local government, or a U.S. academic teaching hospital or university affiliated research institution;
- A requirement that each investigator and research staff complete formal conflict of interest training prior to engaging in PHS-funded research and re-training every four years; and
- A requirement that the ERI make certain conflict of interest information is publicly accessible, either by website or written response to requests.
The PHS regulations require disclosure by the Investigator of the Significant Financial Interest of the Investigator and, except for travel, the Significant Financial Interests of the Investigator’s spouse or registered domestic partner, or dependent children that:
- Meet the PHS thresholds for reporting (see below); and
- Reasonably appear to be related to or are in the same field of expertise as the Investigator’s institutional responsibilities as defined as teaching/education; research; outreach; clinical service or public service on behalf of the ERI or Los Angeles County performed in the course and scope of the Investigator’s ERI and/or Los Angeles County appointment.
What is a Significant Financial Interest (SFI)? The new requirements greatly expand what needs to be reported. Consulting income (including income earned from legal fees), honoraria and travel (with certain exclusions) must be reported. Contact the ERI if you are unsure about whether an activity is considered a significant conflict of interest.
When Needs to be Disclosed? Each investigator who is planning to participate in PHS-funded research must disclose Significant Financial Interest to the ERI no later than the time of applying for funding and/or within 30 days of identifying or acquiring a new significant financial interest. Each investigator must update the disclosure at least annually during the period covered by the grant.
What Needs To Be Disclosed? The new requirements are broader in what activities are required to be disclosed. Investigators must disclose Significant Financial Interests in any outside (non-ERI, UCLA or Los Angeles County) organizations. Such organizations may include companies, service providers, non-government organization (NGOs), foundations, and for-profit or not-for-profit organizations with which you, or except for travel, your spouse or registered domestic partner, or dependent children had a financial relationship in the previous 12 moths.
- Income in excess of $5,000 from a publicly-traded entity (a company whose stock is available for purchase by the general public) during the past 12 months.
- Stock valued in excess of $5,000 at the time of disclosures in a publicly-traded entity.
- A combination of the above two items (stock and income) that exceeds $5,000.
- Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity (such as a start-up company).
- Compensation, income or other payment for services that exceeds $5,000 from a non-publicly traded entity in the past twelve months.
- Income received from an organization, other than the ERI, Los Angeles County or UCLA for intellectual property rights and interests during the 12 months prior to disclosure which exceed $5,000. This could include such things as royalties for books or license fees for software or technology invented by the Investigator. Income is related to intellectual property rights paid by any source other than the Investigator’s current institution.
- Any reimbursed or sponsored travel paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution of higher education or a research institute affiliated with such, a medical center, or an academic teaching hospital. The specific details that must be disclosed are: the name of entity sponsoring the travel and purpose, destination, and duration of the travel.
- Examples of income or other payment for services include the following:
- Providing expert testimony or consulting services
- Serving on a board of directors, scientific advisory board, committee, panel or commission sponsored by a for-profit or non-profit organization, including professional or scholarly societies
- Acting in an editorial capacity for a professional journal
- Reviewing journal manuscripts, book manuscripts, or grant or contract proposals for a non-profit or for-profit organization
- Salary received outside of the ERI, Los Angeles County or UCLA.
- Any other interests required under ERI’s policy.
What Does Not Need to be Disclosed?
- Payments made by the ERI, UCLA or Los Angeles County for salary, stipends, royalties, honoraria, reimbursement of expenses or any other remuneration received from an employer.
- Income from investments in mutual funds or retirement accounts, as long as the Investigator does not make the investments decisions.
- Income from services (honoraria, advisory committees, review panels, etc.) and travel expenses paid by a federal, state or local government agency, a U.S. institution of higher education or a research institute affiliated with such, a medical center, or an academic teaching hospital.
What Do I Need To Do? First, Investigators must complete conflict of interest training. This training is offered through ERI’s CITI Training website. Log into your CITI account and select Add a course or update your learner groups for Olive View-UCLA Education & Research Institute and then indicate yes to Question 3 - Would you like to take the Conflicts of Interest course? This will then take you to the training module. Re-certification is required every four years and you will receive notice from CITI training.
Following this initial training, Investigators are required to report any Significant Financial Interests at least annually AND must also be reported within 30 days of acquiring or discovering a new Significant Financial interest. The ERI’s Research & Education Operations Committee (REOC) will review the disclosure(s) and determine whether a disclosed Significant Financial Interest is related to a particular proposal or award and require further review to determine whether it is a financial conflict of interest. The REOC and/or ERI staff may contact the Investigator to gather more information or clarification. If the REOC determines that the disclosures could reasonably appear to directly and significant affect the design, conduct or reporting of the research, the REOC will develop a plan designated to eliminate, reduce or manage the conflict. The Investigator may be asked to help in developing the plan and will be required to review it and confirm its acceptability. ERI staff will then provide all necessary reports to PHS and, as necessary, will respond to public request for information.
ERI Investigators have a number of responsibilities related to the disclosure of Significant Financial Interests. Investigators must know how they are defined. A financial interest is anything of monetary value, whether that value can be easily determined or not, that is held by the Investigator, his/her spouse or registered domestic partner, and dependent children. Under the PHS definitions, a financial interest becomes significant when it is could reasonably appear to be related to or is in the same field of expertise as the Investigator’s institutional responsibilities OR it meets any of the following reporting categories and thresholds as previously defined.
Failure to disclose a Significant Financial Interest, to complete training or to comply with a plan put in place to manage a conflict may result in the requirement for additional training, withholding of research funding, or implementation of other ERI or sponsor enforcement mechanisms.