August 25, 2011 - HHS Financial Conflict of Interest Rules for Researcher
The Department of Health and Human Services August 25 issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing, and ultimately avoiding investigators' financial conflicts of interest The Final Rule updates the 1995 regulations on conflict of interest 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. 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 are available by clicking here.
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)."
ASM Statements and Testimony
March 28, 2005 - ASM Comments on Interim Final HHS Supplemental Ethics Rule
The ASM submitted comments to the Department of Health and Human Services regarding the Interim Final HHS Supplemental Ethics Rule which was published in the February 3, 2005 Federal Register.
June 15, 2004 - ASM Comments on Public Health Service Policies on Research Misconduct
The ASM submitted comments in response to the April 16, 2004 Federal Register proposed rule from the Department of Health and Human Services, "Public Health Service Policies on Research Misconduct."
April 10, 2000 - Promoting Research Integrity at the American Society for Microbiology
Dr. Julius Youngner, Chair of the ASM's Public and Scientific Affairs Board's Committee on Ethics, presented remarks at a conference convened by the Office of Research and Integrity in the Department of Health and Human Services and the American Association for the Advancement of Sciences (AAAS) on the "Role and Activities of Scientific Societies in Promoting Research Integrity."
December 2, 1999 - Proposed Federal Policy on Research Misconduct to Protect the Integrity of the Research Record
The ASM submitted written comments to the Office of Science and Technology Policy regarding the proposed federal policy on research misconduct.