News Release
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FOR IMMEDIATE RELEASE
Wednesday, May 12, 2004 |
Contact: HHS Press Office
(202) 690-6343 |
HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects
HHS Secretary Tommy G. Thompson today released new guidance for
protecting research subjects from possible harm caused by financial
conflicts of interest that may arise in research studies.
The guidance, “Financial Relationships and Interests in
Research Involving Human Subjects: Guidance for Human Subject
Protection,” applies to all human subjects research conducted
or supported by HHS agencies or regulated by the Food and Drug
Administration.
“All who take part in research deserve the strongest possible
protection,” Secretary Thompson said. “Openness
and honesty help promote ethical research and can only strengthen
the research process.”
Institutions, institutional review boards (IRBs), researchers and
other responsible parties are encouraged to use this guidance to
help ensure that any potential conflicts of interest stemming from
financial relationships are identified and eliminated or managed
with the subject’s best interests in mind. The guidance
presents a series of points to consider in determining if and how
specific financial interests in research can affect the rights and
welfare of human subjects, and if so, what actions can be
considered to protect those subjects.
As institutions, IRBs and researchers consider potential financial
conflicts of interest, they can refer to the guidance for possible
mechanisms to manage such conflicts. These mechanisms
include:
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Separating institutional responsibility for research activities
from management of the institution’s financial interests;
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Establishing conflict of interest committees (COICs) or identifying
other bodies or persons and procedures to address financial
interests in research;
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Using independent organizations to hold or administer the
institution's financial interest;
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Determining whether current methods for managing conflicts of
interest are adequate for protecting the rights and welfare of
human subjects and whether other actions are needed to minimize
risks to subjects;
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Determining the kind, amount, and level of detail of information to
be provided to research subjects regarding funding and financial
interests; and
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Using special measures to modify the informed consent process when
a potential or actual financial conflict exists.
In preparing this guidance, the Department considered public
comments on an earlier draft guidance published in March
2003. The guidance is available at
http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf.
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Last Revised: July 26, 2004
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