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®: CRE Regulatory Action of the Week

HHS Responds to Industry Funding of Research By Changing Rules on Research Objectivity
The Department of Health and Human Services has published final rules changing HHS' 1995 regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought. According to HHS:

    "The purpose of the 1995 regulations was to ensure that there is no reasonable expectation that the design, conduct, or reporting of PHS-funded research will be biased by any Investigator [financial conflict of interest]."
    "Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators' disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators' financial conflicts of interests, as well as increase the Department of Health and Human Services' compliance oversight."
HHS' Federal Register notice of the new rules states some remarkable facts. For example,
    "an analysis of financial support of biomedical research from 1994 to 2004…showed that funding increased from $37.1 billion in 1994 to $94.3 billion in 2003. Fifty seven percent of the funding in 2003 came from industry sources. At the same time, relationships between individual academic researchers and industry have also increased from 28% in a 1996 survey…to 52.8% in a survey conducted in 2007…."
HHS received "136 unique comments" on the proposed rules. In its Federal Register notice of the final rules, HHS responds to these public comments.

Any Institution applying for or receiving PHS funding from a grant, cooperative agreement, or contract that is covered by this rule must be in full compliance with all of the rules' requirements no later than August 24, 2012; and immediately upon making its institutional Financial Conflict of Interest policy publicly accessible as described in the final rules.
  • Click here to read HHS' Federal Register notice of final rules