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Announcements and
Notices - View/Download |
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Protecting Human
Research Participants NIH Office of Extramural Research |
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N O T I C E |
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Beginning
on September 2, 2008, the link to the old NCI Human Participant
Protections Education for Research Teams course will automatically
redirect to the NIH Office of Extramural Research on-line tutorial
Protecting Human Research Participants (PHRP).
On March 1, 2008, the NIH Office of Extramural Research on-line
tutorial
Protecting Human Research Participants (PHRP)
replaced the NCI Human Participant Protections Education for
Research Teams course. The NCI course is no longer available. The
PHRP course updates the old course. It is an improved course that
covers the same material. The PHRP course satisfies all the
requirements met by the old course. |
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Re: NIH – Federal
Regulations on Financial Conflict of Interest (FCOI) |
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N O T I C E |
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Date Issued:
August, 28, 2008 |
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Issued by the JSU
Vice President for Research and Development |
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Dear
Principal Investigator,
I am writing to remind you of the importance of financial conflict
of interest (FCOI) requirements applicable to all Institutions that
apply for NIH research funding. Proper stewardship of Federal funds
includes ensuring objectivity of results by protecting
Federally-funded research from compromise by FCOI. It is essential
that all NIH-funded Institutions and Investigators are fully aware
of their obligations under the FCOI regulation (42 CFR Part 50,
Subpart F). To this end, NIH developed a Web-based tutorial which
reviews the requirements of, and the Institutional and Investigator
responsibilities for compliance with the regulation. The tutorial is
designed for use by Institutional officials responsible for managing
NIH funded projects and for individuals who are responsible for the
design, conduct or reporting of NIH-supported research.
View the Tutorial.
As you know, the Public Health Service (PHS) regulation at 42 CFR
Part 50, Subpart F 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 of an Investigator
(defined under the regulation as the principal investigator and any
other person who is responsible for the design, conduct, or
reporting of research funded by PHS, or proposed for such funding;
for purposes of the regulatory requirement relating to financial
interests, the definition includes the Investigator’s spouse and
dependent children). 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.
Essential to the compliance process are: (1) Investigators’ prompt
and full disclosure 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 (specifically, to the appropriate Chief Grants Management
Officer of the funding Institute/Center).
At NIH, program staff in the Institute or Center that funds the
research, together with staff in the Office of Extramural Research (OER),
address FCOI issues. 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 that NIH follows when
addressing FCOI issues involves a careful review of all relevant
information obtained through, among other sources, applications for
NIH funding, progress reports and/or other information submitted to
the NIH, and FCOI reports received from the recipient institution,
as well as a review of any publicly available information. 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
Investigator(s).
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.
I am confident that by working together we can continue to uphold
the highest standards of conduct in our extramural activities.
Sincerely yours,
Felix A. Okojie Ed.D., MPH, CRA
Vice President for Research and Development
cc:
JSU Conflict of Interest Policy Pertaining to
Sponsored Projects
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