Maintaining Objectivity in Research – Know Your Disclosure Requirements

Ensuring that research is carried out with the highest standards of integrity is essential for maintaining the public trust.  All Investigators applying for or carrying out NIH-funded research must comply with the regulation that establishes standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded by the NIH will be biased by any conflicting financial interest of an Investigator. This message bears repeating to ensure that these requirements are clear.

According to the regulation (commonly called the Financial Conflict of Interest or FCOI regulation), Investigators must disclose to their Institutions all “Significant Financial Interests” (1) that would reasonably appear to be affected by the research for which funding is sought from the NIH; and (2) in entities whose financial interests would reasonably appear to be affected by the research. In addition, particular Institutional policies may have additional requirements.   Your institution could have more restrictive disclosure requirements, so it is important that you understand your institutional responsibilities with respect to FCOI.

In addition to the Institutional policies governing this issue, many investigators participate in NIH-supported clinical trial networks.  These networks may have study-wide policies for each trial that require investigators to disclose their financial interests to the network’s steering committee/operations office.  It is important to remember that disclosing to a steering committee or other entity overseeing an NIH-supported clinical trial may not fulfill your responsibilities under your Institution’s FCOI policy.  Investigators may also need to disclose their Significant Financial Interests to their Institution in accordance with its FCOI policy.  Please refer to the Institution’s policy (which may integrate network disclosures) and verify with the Institution disclosure requirements and how they apply to your research.

For more information on this important topic, consult the Frequently Asked Questions document on the OER Web site or contact FCOICompliance@mail.nih.gov.

Definitions

An “Investigator” is defined as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding.  The definition includes the Investigator’s spouse and dependent children.

A “Significant Financial Interest” is defined by the regulation as anything of monetary value, including but not limited to:

  • salary or other payments for services (e.g., consulting fees or honoraria);
  • equity interests (e.g., stocks, stock options or other ownership interests);
  • intellectual property rights (e.g., patents, copyrights and royalties from such rights).

The term does not include:

  • salary, royalties, or other remuneration from the Institution;
  • any ownership interests in the Institution, if the Institution is an applicant under Phase I of the SBIR and STTR programs;
  • income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
  • income from service on advisory committees or review panels for public or nonprofit entities;
  • an equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity;
  • salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.
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