Embargoed for Release
Tuesday, August 23, 2011
11:30 a.m. EDT
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HHS Tightens Financial Conflict of Interest Rules for Researchers

Increased Reporting, Transparency to Ensure Scientific Objectivity and Integrity

The U.S. Department of Health and Human Services today issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and ultimately avoiding investigators’ financial conflicts of interest Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process.

“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” said HHS Secretary Kathleen Sebelius. “Our financial conflict of interest rules must keep up with the times if we are to maintain our leadership role in the global scientific community.”

Major changes to the regulations include the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training. For example, the revised regulations:

  • Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities.
  • Lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
  • Require institutions to report to the PHS awarding component additional information on identified financial conflicts of interest and how they are being managed.
  • Require institutions to make certain information accessible to the public concerning identified SFIs held by senior/key personnel.
  • Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.

Additional details about the major changes to the regulations can be found at: (http://grants.nih.gov/grants/policy/coi/)

“The NIH is committed to safeguarding the public’s trust in federally supported research that is conducted with the highest scientific and ethical standards,” said NIH Director Dr. Francis S. Collins. “Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds.”

The regulations will be implemented no later than 365 calendar days after publication of the final rule in the Federal Register.

The 1995 regulations were revised after a review of public comments from the advance notice of proposed rulemaking and the notice of proposed rulemaking.

The final rule amends the PHS regulations "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (42 C.F.R. Part 50, Subpart F) and "Responsible Prospective Contractors" (45 C.F.R. Part 94).

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/.

About the National Institutes of Health (NIH): 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. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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Note: On 10/05/11, the URL for FCOI Regulations in paragraph four was updated to the current link, which appears above.

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