Jessica L. O'Hara
The US Department of Health and Human Services (HHS) issued a notice of proposed rulemaking (NPR) Friday, May 21, 2010, that recommends significant changes to how institutions and investigators receiving funding from public health service (PHS) agencies—including the National Institutes of Health (NIH)—disclose, report, and manage financial conflicts of interest (FCOI). The revised regulations aim to enhance regulatory compliance, strengthen NIH and institutional oversight, and expand FCOI transparency.
The current notice reflects public comments submitted in response to an advanced notice issued by HHS in May 2009. The proposed regulations would:
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Require that PHS-funded investigators disclose to their institutions all significant financial interests related to their institutional responsibilities.
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Lower the monetary threshold at which interests require disclosure, generally from $10,000 to $5,000.
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Require institutions to develop a management plan for every identified FCOI. The institution would be required to provide to the appropriate PHS agency significant additional information on identified FCOI and their oversight and management.
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Require every PHS-funded institution to post, on a publicly available website, information on certain significant financial interests the institution has determined are related to PHS-funded research and constitute FCOI.
In a commentary published in the Journal of the American Medical Association Monday, May 24, NIH Director Francis S. Collins, MD, PhD, and NIH Acting Deputy Director for Extramural Research Sally J. Rockey, PhD, affirmed NIH’s commitment to providing greater transparency and accountability in matters of FCOI. According to Dr. Collins and Dr. Rockey, “without such changes, even more instances of real or perceived FCOI will likely be encountered in the future” and “for the good of the research enterprise and for our nation… it is imperative to take collective steps now to usher in a new era of clarity and transparency in the management of FCOI.”
The proposed rule has a 60-day comment period. Comments may be submitted electronically through the
Federal eRulemaking Portal at http://www.regulations.gov. Dr. Collins said in a recent interview that the final rule will be released in late 2010.