According to a recently released report by the Department of Health and Human Services, Office of Inspector General (OIG), the NIH lacks critical information on the conflicts of interest that exist among its grantee institutions. In its report, "Institutional Conflicts of Interest at NIH Grantees," OIG highlights the findings from a survey of 250 research institutions that received NIH grants in fiscal year (FY) 2008. Through this survey, the OIG determined the number of NIH grantee institutions with written policies and procedures to address institutional conflicts and financial interests, as well as the extent to which these grantee institutions had financial conflicts of interest that could have affected the NIH-sponsored research.
Although Federal regulations require NIH grantee institutions to have a written policy for identifying and managing investigators' financial conflicts of interest, there currently are no Federal requirements in place that apply to the grantee institutions, themselves. Still, long after the Public Health Service (PHS) Act's directive to protect publicly funded research from bias from both investigators and institutions, little has been done to ensure that an institution's own financial interests, such as royalties for helping a pharmaceutical company invent a drug, do not improperly influence decisions involving the institution's NIH-sponsored research.
On the surface, some of the findings noted in the OIG report look rather positive. Although not required by the NIH, nearly half of the respondents indicated that they have policies and procedures that specifically address institutional conflicts and financial interests. Moreover, these institutions were more than five times as likely to identify institutional conflicts than grantee institutions without policies and procedures. However, the definitions of "institutional conflict" and "financial interest" that were used varied to a certain degree among institutions.
The release of the OIG report comes on the heels of two important regulatory actions targeting conflicts of interest in the clinical research community. The first was the passing of the Patient Protection and Affordable Care Act ("Affordable Care Act") in March of 2010, which included "physician sunshine" provisions requiring drug manufacturers to report any payment or transfer of value to providers of $10 or more, and any ownership or investment interest held by a physician or an immediate family member. The second was the NIH issuance of a Notice of Proposed Rulemaking in May of 2010, which would significantly revise and expand the scope of the current conflicts of interest regulations for all grant applicants, and facilitate the full disclosure by investigators of their significant financial interests and the appropriate review and management by their institutions. (We understand that the final rules are in clearance and are due to be published soon.)
Although the OIG took note of NIH's proposed rule on applicants' financial conflicts of interest, it commented that the proposed regulatory changes focus only on investigators' conflicts, and fail to take into account potential institutional conflicts of interest. Therefore, the OIG recommends that the NIH issue regulations that specifically address institutional conflicts of interest.
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