Office of Research Conflicts of Interest - Office of Research

Conflicts of Interest

Requirements

Researchers engaged in human subjects research are required to report any related financial interest (RFI) to the IRB. Click here for the UC Davis IRB’s definition of “related financial interest.” Click here for UC Davis IRB’s policy on reporting of a related financial interest. In some instances, investigators must also report an RFI to the Conflict of Interest Committee (COIC).  Click here for information on the RFIs that need to be reported to the COIC, how to report them, and when to report them. Click here for the UCOP policies related to conflicts of interest (COIs).

The IRB has created this presentation to help researchers understand the requirements for reporting financial interests to the IRB and COIC at UC Davis.

Reporting to the IRB

At UC Davis, the IRB is charged with oversight of COIs in human subjects research as part of its mandate to protect the rights and welfare of human subjects and the integrity of the research data. Oversight of conflicts promotes transparency with research subjects (typically through disclosure in consent documents); supports the principle of equipoise among investigators and staff; avoids bias in subject recruitment and contributes to good study design.

Investigator Responsibilities

Investigators and research staff must report RFIs to the IRB at initial review and within 30 days of acquiring a new RFI or receipt of additional unreported income from the same entity. A complete description of the RFI must be provided. The description must include:

  • The nature of the RFI;
  • The relationship of the RFI to the study;
  • The amount of income (including travel expenses) received, if any;
  • A description of the services performed, if any;
  • The value of any equity interest in the sponsor or sponsor competitor;
  • The position title, if the RFI involves employment;

Investigators may satisfy this requirement by uploading a narrative description of the RFI or submitting the COIC Forms 700-U, 800 and the Supplemental Form.

If additional, related income is expected before the study expires, Investigators may report the amount of the expected income in the description to avoid having to submit additional modifications when the additional income is received.  However, if the income exceeds the amount included in the report, investigators must submit a modification and report the additional income.

RFI Disclosures 

If a member of the research team has a financial interest in the research, the financial interest should be disclosed in the consent form. A disclosure statement should include each of the four elements below. Example language in bold is provided for your use.

  1. Name and role: Provide the name of the person with the financial interest and describe his/her connection to the study.
    • Dr. Jane Doe, a researcher on the study team,
  2. Interest in an entity or in the product: Define the type of interest.
    • If the interest is in an entity such as the sponsor, manufacturer, licensee, or performer, e.g., subcontractor, language such as the following should be included: has a financial interest in [name of company], the company paying for this study; or the company  that  will manufacture the drug; or the company that will sell the drug; or a company conducting part of this study.
    • If the interest is other than a financial interest in an entity, e.g., in the product being tested, language such as the following should be included: has a financial interest in the [product, drug, device] being studied.
  3. Description: Describe the interest.
    • Income: [name of company and relevance of company to study, e.g., sponsor] is paying Dr. Doe a [describe payment, e.g., consulting fee, salary].
    • Scientific Advisor: Dr. Doe is being paid to be a scientific advisor to [name of company, relevance of company to study, e.g., manufacturer of the drug]
    • Member of the Board: Dr. Doe is on the board of [name of company, relevance of company to study]
    • Officer: Dr. Doe is the [president, chief executive officer, etc.] of [name of company, relevance of company to study]
    • For significant stock ownership in a publicly traded company: Dr. Doe owns stock in [name of company, relevance of company to study]
    • For stock ownership in a non-publicly traded company: Dr. Doe is a [founder or majority or minority shareholder] of [name of company, relevance of company to study]
    • For stock option: Dr. Doe has a stock option from [name of company, relevance of company to study] and may get income in the future.
    • Inventor: Dr. Doe invented the [drug, device] being studied and may benefit financially if it is marketed.
  4. Elaborate: If possible, elaborate on the information provided.
    •  The consulting income Dr. Doe receives is in addition to her salary from the University of California.

 

Below is an example of a disclosure statement

Dr. Jane Doe, a researcher on the study team, has a financial interest in Sponsor Inc., the company paying for this study. The company is paying Dr. Doe for consulting. The consulting income Dr. Doe receives is in addition to her salary from the University of California.

 

Policy Information

The following are links to IRB Administration policies associated with RFIs:

HRP-054 – SOP – Institutional Conflicts of Interests

HRP-055 – SOP – Financial Conflicts of Interests

HRP-056 – SOP – PPM 230-05 Public Health Service Regulations on Objectivity in Research

HRP-057 – SOP – University of California Policy on Financial Conflicts of Interests

NOTE: A conflict of interest routinely requires disclosure in subject facing documents, especially informed consent forms, as well as public documents such as publications of study outcomes.  COIs may also require individuals to be removed from certain research activities such as subject recruitment, data collection, and independent data analysis. It may be advisable to incorporate anticipated requirements in study documents so as to avoid a halt of enrollment or required study modifications following conflict of interest determinations in either the COIC or the IRB.
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