Conflict of Interest in Human Research

Conflicts of Interest

Federal regulations, state laws and University policies recognize that researchers may have financial interests in research sponsors and/or in entities with business interests closely related to their research.

The term “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise or have the appearance of compromising a researcher’s professional judgment in conducting or reporting research.

When conducting research involving human subjects, researchers should submit financial disclosures prior to or concurrent with their application for IRB approval of a new project and at the time of continuing review.

In This Section


 

What is the Requirement?

All Investigators responsible for the design, conduct or reporting of the research must submit required disclosures to the Institution via the eCOI system. Required disclosures are described in HRP-055.

For New Projects, disclosure is required if:

  • The study is PHS-funded
  • The study is privately funded or supported
  • The study is FDA-regulated
  • Any Investigator has a significant financial interest when the research is unfunded and not FDA-regulated

At Containing Review, an updated Form 800 is required for non-PHS studies that have an active management plan. A Form 800 submitted within 90 days of study expiration will be accepted.  This ongoing reporting ensures that any changes in the financial relationship are appropriately managed by the existing management plan. Review the Human Subjects Research Annual Disclosure Guide for more information.


 

How do I Comply with the Requirement?

When applying for initial review of a new project, Investigators should notify the IRB of any required disclosures that have been submitted to the Institution. When completing the Related Financial Interest page of the Initial Review Application you will be asked if any personnel involved in the design, conduct or reporting of the protocol have a positive financial disclosure.  Select “yes” if any personnel have a positive disclosure. Complete the appropriate disclosures in eCOI.

When an Investigator has a significant financial interest in unfunded research, follow the eCOI Guide for Unfunded Studies when completing required disclosures.

When applying for continuing review, an updated Form 800 will be required for non-PHS funded studies with an active management plan. Indicate if there are any changes to the disclosures in the Post Approval Submission Form.


Linking Disclosures in eCOI and IRBNet

When completing disclosures in eCOI, you will be asked if the project involves human subjects. Mark “yes” only if the project is a human subject research project. If you mark “yes” eCOI will require an IRBNet ID. You must create a new project in IRBNet to generate an IRBNet ID. Follow the steps below:

  1. Log into IRBNet.org
  2. Create a New Project
  3. Enter Title and PI name
  4. Click Continue
  5. Find IRBNet ID in the top left corner
  6. Enter the IRBNet ID in eCOI

The IRBNet application does not need to be submitted at the same time as the eCOI disclosure. The IRBNet application must be submitted before beginning any human research activities. The IRBNet application may be deleted without being submitted if the project is never initiated.

Review Linking Projects in IRBNet and eCOI for additional information.


Review of Disclosures

The Conflict of Interest Committee shall review all positive disclosures of financial interests to determine if a conflict of interest exists, and if so, how to manage, reduce, or eliminate the conflict. The IRB participates in COIC deliberations by having an IRB representative at the COIC meetings. When a financial conflict of interest exists, the Conflict of Interest Committee will issue a management plan. The Conflict of Interest Committee will communicate the management plan to the IRB. The IRB will determine if the research complies with the management plan and if the research and management plan can be approved.

The IRB has discretion, if it deems appropriate, to revise or modify the management plan terms. If the IRB does not agree that the management plan issued by the COIC is adequate to protect human subjects, the Conflict of Interest Committee will be notified and a revised management plan will be issued by the COIC.

Upon receipt of the management plan, the IRB will review the research to determine if complies with the requirements. If the IRB determines that the research does not comply with the management plan, the IRB will notify the Investigator that a modification must be submitted to the IRB. For example, if the management plan requires a disclosure statement in the consent document, the IRB will review the consent document for the required language. If the required language is not present in the consent document, the IRB will notify the PI of the need to submit a modification. No new subjects may be enrolled until the research is brought into compliance with the management plan.


 

Disclosures of Conflicts of Interests

If the COIC determines that a member of the research team has a financial conflict of interest (FCOI), 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.
    • 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:  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:  Doe is on the board of[name of company, relevance of company to study]
    • Officer:  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:  Doe owns stock in[name of company, relevance of company to study]
    • For stock ownership in a non-publicly traded company:  Doe is a[founder or majority or minority shareholder] of [name of company, relevance of company to study]
    • For stock option:  Doe has a stock option from[name of company, relevance of company to study] and may get income in the future.
    • Inventor:  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.


 

Definitions

Significant financial interest—anything of significant monetary value, including but not limited to salary or other payments for services; equity interests (e.g., stocks, stock options or other ownership interests); intellectual property rights (e.g., patents, copyrights and royalties from such rights); or holding a position as an officer, director, agent, or employee of a business entity. “Significant financial interest” includes such interests held by a Principal Investigator or other Investigators and by their spouses, domestic partners and/or dependent children.

For non-PHS funded Investigators, significant financial interest does NOT include:

  1. Salary, royalties, or other remuneration from the University.
  2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities. 3. Income from service on advisory committees or review panels for public or nonprofit entities.
  3. An equity interest in a public company that represents less than a 5% ownership interest and less than $10,000 in value as determined through reference to public prices.
  4. Annual salary, royalties or other payments from any source other than those referenced in subparagraphs (1) and (2) above that individually or when aggregated do not exceed $10,000 over the next twelve months.
  5. Income from mutual funds and/or pension funds;
  6. A percentage of income received from the Veteran’s Administration Medical Center as part of physician reimbursement for University faculty;
  7. Interest in a business entity if the business entity is an applicant for Phase I support under the Small Business Innovation Research (SBIR) Program.

 

Resources

HRP-054 – SOP – Institutional Conflicts of Interests

HRP-055 – SOP – Financial Conflicts of Interests

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

PPM 230-05 UC Davis Policy on Individual and Institutional Conflicts of Interest involving Research

PPM 230-07 UC Davis Policy on Public Health Service Regulations on Objectivity in Research