# NIH Oversight of Extramural Financial Conflicts of Interest

## Background

The topic of investigator financial conflicts of interest (FCOI) has
been much in the news lately. NIH believes that it is vital to maintain
objectivity in research and that all research must be conducted with the
highest scientific and ethical standards and in a manner that assures
the integrity of the scientific record. NIH is fully committed to these
principles.

The Public Health Service (PHS) regulation at [42 CFR Part 50, Subpart
F](http://grants.nih.gov/grants/guide/notice-files/not95-179.html) is
designed to promote objectivity in PHS-funded research by establishing
standards to ensure that the design, conduct, and reporting of research
funded under PHS grant awards is not biased by any conflicting financial
interests. The regulation places the responsibility for the
identification and management of investigators' FCOI with the
institution, which oversees the investigator's activities. The NIH, as
the grantor agency, has primary responsibility for overseeing
institutional compliance with these requirements. The keystones of this
process are: (1) the prompt and full disclosure by investigators of
financial interests that may be impacted by their NIH-supported
research, and (2) sound institutional management of any conflicting
interests, including reporting those interests to the NIH. Ensuring
objectivity in research requires the full commitment of investigators,
institutions, and the NIH.

Reports of an investigator\'s failure to fully disclose their financial
interests are very serious and NIH vigorously addresses these concerns
both internally and with the recipient institutions.

In general, when a concern is raised that investigator financial
interests may compromise the objectivity of NIH-funded research, NIH
carefully considers the issues in the context of the investigator's
projects supported with NIH funds. Such concerns could arise during the
normal course of oversight or may be brought to the attention of the NIH
by external sources.

## Taking Action

FCOI issues are considered by program staff in the Institute or Center
that funds the research together with staff in the Office of Extramural
Research (OER) in the NIH Office of the Director. The program staff has
an in-depth understanding of the science itself and the risks involved
with the particular research project(s), while the OER staff oversees
institutional compliance with the regulation.

The protocol followed by the NIH in these cases involves a careful
review of all the information pertaining to that investigator's research
obtained through, among others, NIH applications; progress reports
and/or other information submitted to the NIH; any FCOI reports received
from the recipient institution; and from publically available
information on the investigators.

The NIH may then follow-up with the recipient institution to determine
the extent of compliance with the regulation and the adequacy of any
actions that the institution has taken to assure that the NIH-supported
research is not biased by the financial interests of the investigators.

In all cases, the NIH has the authority to take appropriate action to
protect the safety of any research participants and safeguard the
integrity of the research. These actions are determined on a
case-by-case basis and are dictated by the specific status and
circumstances of the project and the risks associated with a failure to
manage the financial interests effectively. The NIH works with the
recipient institution to resolve these issues quickly and
comprehensively.

## The FCOI Regulation

Under the FCOI regulation, NIH may at any time inquire into the
Institutional procedures and actions regarding conflicting financial
interests in the NIH-funded research, and may require the submission of,
or review on site, all records pertinent to compliance with the
regulation. On the basis of its review of such records and/or other
available information, the NIH may decide that a particular conflict of
interest will bias the objectivity of the NIH-funded research to such an
extent that further corrective action is needed or that the Institution
has not managed, reduced, or eliminated the conflict of interest in
accordance with the regulations. NIH may also determine that suspension
of funding is necessary until the matter is resolved or that termination
of a project is necessary

## Frequently Asked Questions (FAQ)

As requested by Congress, NIH is currently developing an Advance Notice
of Proposed Rulemaking to gather public comment on possible revisions to
the FCOI regulation.

For more information on the regulation governing FCOI see the FAQ on the
NIH Web site (<http://grants.nih.gov/grants/policy/coifaq.htm>) or
contact <FCOICompliance@mail.nih.gov>.

Updated: August 1, 2008