|Public Comments Sought on Regulations for Financial Conflicts of Interest in Federally-Funded Research
The National Institutes of Health is seeking comments from the public on possible changes to the federal regulations regarding Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding Is Sought(42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). The existing regulations issued in 1995 were designed to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest on the part of the researcher.
Since the publication of the current regulations, the NIH has launched many
initiatives to enhance effective oversight and regulatory compliance. The Advance
Notice of Proposed Rule Making (ANPRM) (http://edocket.access.gpo.gov/2009/pdf/E9-10666.pdf)(PDF
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was motivated by NIH’s ongoing commitment to that end. Through the ANPRM,
NIH invites public comment on all aspects of the regulation, with particular
interest in potential for expanding the scope of the regulation and disclosure
interests; the definition of "Significant Financial Interest" identification
and management of conflicts by institutions; assuring institutional compliance;
requiring institutions to provide additional information to the PHS; and broadening
the regulations to address institutional conflicts of interest.
"Both the public and the private sectors are deeply involved in collaborative
research efforts to meet public health needs," said NIH Acting Director
Raynard Kington, MD, Ph.D, "These collaborations are increasingly complex
and it is important to consider if changes are needed to the regulation to
ensure the integrity of the science. The public comments we are inviting through
the ANPRM can help us understand if changes are needed, as well as suggest
strategies that may be beneficial."
The comment period for the ANPM is open until July 7, 2009. Comments may be submitted online, by fax, or by mail. To submit electronically, please follow the instructions at the Regulations.gov portal [to be linked]. Written submissions may be faxed to the attention of Jerry Moore, NIH Regulations Officer, NIH Office of Management Assessment, at 301-402-0169 or mailed to him at 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669.
The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
Addendum: On May 13,
a link was added to "Advance Notice of Proposed Rule Making (ANPRM)" (http://edocket.access.gpo.gov/2009/pdf/E9-10666.pdf)(PDF
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in the second paragraph of this release, included in the text