The emergence of biotechnological techniques with huge potential for
commercial applications has caused concern about researchers' objectivity
when their own financial interests may be at stake. As of October 1, 1995,
all institutions receiving research funds from the Department
of Health and Human Services or the National
Science Foundation must have policy and procedures to insure that research
is not biased by financial conflicts. The following is a summary of the
regulation:
All Investigators Must Disclose Significant Financial Interests
An "Investigator" means the principal investigator and any other person
who is responsible for the design, conduct, or reporting of research.
For purposes of determining financial interests, the Investigator's interests
include those of his/her spouse and dependent children.
What Constitutes a Significant Financial Interest?
Significant Financial Interest means 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); and intellectual property rights (e.g., patents,
copyrights and royalties from such rights).
Financial interests which are subject to reporting for any given research
proposal include those which would reasonably appear to be affected by
the specific research proposed; and/or are interests in entities whose
financial interests would reasonably appear to be affected by the research.
The term "Significant Financial Interest" does NOT include:
-
Salary, royalties, or other remuneration from the applicant institution;
-
Any ownership interests in the institution, if the institution is an applicant
under the Small
Business Innovation Research Program;
-
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, meets both of the following
tests:
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.
If a Significant Financial Interest Exists, What Actions
Must be Taken?
Investigators are required to report any significant financial interests
at the time of applying for institutional approval of a research proposal.
Officials appointed by the institution (in the Bureau these are the Scientific
Committee or the Institutional Animal Care and Use Committee as applicable)
will consider any reported interests, determine if there is a potential
conflict of interest, and, if so, will determine how to manage, reduce
or eliminate the conflict.
Examples of conditions or restrictions that might be imposed to manage
conflicts of interest include, but are not limited to:
-
Public disclosure of significant financial interests;
-
Monitoring of research by independent reviewers;
-
Modification of the research plan;
-
Disqualification from participation in all or a portion of the research
funded;
-
Divestiture of significant financial interests; or
-
Severance of relationships that create actual or potential conflicts.
See also:
NIH/PHS
Policy on Objectivity in Research
NIH FAQ About
Financial Conflict of Interest
Bureau Financial Interest
Disclosure Form
Bureau Policy on Financial Conflict of Interest
in Research
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