On September 26, 2011, the U.S. Department of Health and Human Services ("HHS") issued new regulations governing the disclosure by faculty members and research staff of significant financial interests related to certain federal grants, and the reporting of "financial conflicts of interest" to certain federal agencies by colleges and universities that receive funding for Public Health Service ("PHS")-sponsored research. See 42 C.F.R. § 50.601 et seq.
Colleges and universities that receive research funding from a PHS "Awarding Component," including the National Institutes of Health ("NIH"), must be in compliance with the new regulations by no later than August 24, 2012.
The new regulations significantly expand the coverage of 1995 HHS regulations on the same subject. Significant changes to the regulations include: expanding the definition of “significant financial interest”; lowering the threshold for financial disclosure; requiring the disclosure of sponsored and reimbursed travel; expanding institutional responsibilities, including training requirements, reporting requirements, and retrospective review; requiring the inclusion of subrecipient institutions; and increasing public disclosure requirements.
For a more detailed analysis, please click here to read the issued Client Alert.