New provisions for the 2011 Financial Conflicts of Interest Regulations

Source: HHS.GOV

After 15+ years, The U.S. Department of Health and Human Services has published its final rule governing financial conflicts of interest involving investigators conducting Public Health Service (PHS)-supported research. In the 2011 FCOI Regulation are several modifications that will have an impact on the conflict of interest compliance programs at grantee organizations.

Please see the key provisions below.

• • Amended definition of "Investigator” covers who must disclose.
• • New definitions of “Key Personnel” and “Senior/Key Personnel” for whom disclosed information must be made publicly available.
• • Lower monetary threshold for mandated disclosures.
• • Broader mandated disclosures captured in the revised definition of “Significant Financial Interest” (SFI).
• • Fewer excluded interests from definition of SFI.
• • Mandatory disclosure of policies and certain SFIs on a publicly available website.
• • Implications for institutions with more stringent policies.

For a description of each point above, please visit this webpage.

Conflict of interest (COI) compliance is a complex discipline with many moving parts. In large healthcare organizations with many projects and research professionals, the process can be daunting. When addressing conflicts, a company must have data that is easy to mine and use to support their financial disclosure efforts and reduce risk. To streamline this process, Osprey Software Solutions introduced Osprey COI RiskManager™, an enterprise-class compliance management system with the guidance and support of a major healthcare provider.

About Osprey Software Solutions Osprey Software Solutions, Inc. is a premier team of experts in the design and development of complex business applications. Osprey has assembled one of the most highly regarded teams of architects, engineers, and consultants in the software development business. The Osprey team has an outstanding track record in the design and delivery of large scale, advanced business systems in a variety of industries, including: Financial Services, Lending, Energy, Healthcare, and Defense. For more information about Osprey’s COI RiskManager please contact Michael Vidoni, author of this article, email or by phone 888.677.7394, ext.1004