Technology: 7 significant changes under the impending PHS conflict of interest rule

The rule aims to increase oversight of relationships between industry sponsors and academic researchers

In August 2011, the federal Department of Health and Human Services released a final rule that updates the regulations governing conflicts of interest in research supported by, or proposed to be supported by, the Public Health Service (PHS). The new rule updates regulations that have been in place since 1995 and covers, among other research, that funded by the National Institutes of Health. Like the Physician Payments Sunshine Act, the new PHS conflict of interest rule aims to strengthen accountability, enhance transparency and increase governmental compliance oversight in light of the growth in biomedical research and the increasingly complex nature of relationships between industry sponsors and academic researchers. Institutions must comply with the new rule by Aug. 24, 2012. 

Significant changes under the new conflict of interest rule include the following:

  1. Requiring institutions with policies that are more stringent than the PHS requirements to follow their policies and to provide reports in accordance with them

The new rule significantly expands institutions’ responsibilities with respect to reviewing significant financial interests of investigators, reporting conflicts of interest to the PHS and making information available to the public. However, whether these changes enhance the objectivity of PHS-funded research and result in increasing public trust in research and medicine, as the PHS intends, remains to be seen. In particular, the new rule raises the following questions, among others:

  • How should institutions handle institutional conflicts of interest? 

In commentary accompanying the new rule, the PHS mentions that it considered requiring institutions to adopt policies on institutional conflicts of interest. However, the PHS did not, and institutional conflicts remain unregulated. Relationships between industry sponsors and institutions have grown more common in recent years, and leaving it up to institutions themselves to handle the effects of these relationships on research could lead to significant gaps in the recognition and management of conflicts of interest.

Contributing Author

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Julie Rusczek

Julie Rusczek is an attorney in the health care group in the Milwaukee office of Drinker Biddle and Reath LLP. Her practice focuses on research compliance issues,...

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