On January 10, 2011, the OIG released a report on institutional conflicts of interest at NIH grantees. Grantee institutions include universities, medical schools, and other research institutions (e.g. private or nonprofit research organizations) that receive research grants from NIH. The OIG recommended that NIH promulgate regulations that address institutional financial conflicts of interest. Section 493A of the Public Health Service (PHS) Act directed the Secretary of HHS to establish regulations that would protect PHS funded research, of which NIH grants are a significant part, from bias resulting from conflicts of both researchers and entities (i.e. grantee institutions). Accordingly, Federal regulations were implemented that require these institutions to have a written policy for (1) identifying investigators/researchers’ conflicts of interest; and (2) ensuring that conflicts are managed, reduced, or eliminated. In promulgating the relevant Federal regulations, NIH stated in the July 1995 final rule that institutional conflicts would be treated separately from investigators/researchers’ conflicts. Since then neither HHS nor NIH have promulgated Federal regulations for defining, identifying, reporting, or managing institutional conflicts of interest. A copy of the complete Client Alert is available by clicking here.