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Report (OEI-03-09-00480)

01-10-2011
Institutional Conflicts of Interest at NIH Grantees

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Summary

There are no Federal requirements that grantee institutions identify, report, and manage actual or potential institutional conflicts. An institutional conflict may arise when an institution's own financial interests (e.g., royalties, equity, stockholdings, and gifts) or those of its senior officials pose risks of undue influence on decisions involving the institution's research.

We surveyed 250 grantee institutions to determine whether they have developed any policies and procedures regarding institutional financial interests and conflicts. We requested information on any institutional financial interests related to NIH grants awarded in fiscal year (FY) 2008. A total of 156 institutions responded, for a response rate of 62 percent.

We found that although not required for institutional financial interests, 70 of 156 responding NIH grantee institutions have written policies and procedures addressing these interests. Fifty-nine of the seventy institutions with written policies and procedures regarding institutional financial interests have defined, in writing, what constitutes an institutional financial interest. The three most common definitions are: (1) institutional officials' individual financial interests, (2) equity held by the institution in publicly held entities, and (3) equity held by the institution in nonpublicly held entities.

We also found that although not required for institutional conflicts, 69 of 156 responding NIH grantee institutions have written policies and procedures addressing these conflicts. Fifty-nine of these institutions have defined, in writing, what constitutes an institutional conflict. These institutions typically defined institutional conflicts as financial interests that could affect the research, decisionmaking, loyalty, or objectivity of either the institution or individuals.

Grantee institutions that have written polices and procedures were more likely to identify conflicts (15 of 69 institutions) compared to those that do not (3 of 87 institutions). Eighteen institutions identified at least 38 institutional conflicts related to NIH research grants in FY 2008. The most common type of conflict was institutions' holding equity in nonpublicly held companies. For institutions that identified institutional conflicts, the strategy most often used to address them was disclosure.

NIH should require grantee institutions to identify, report, and address institutional conflicts in a consistent and uniform manner. It is important that NIH know of the existence of such conflicts so it can ensure that the related research is free from any intended or unintended bias.

Therefore, we recommend that NIH promulgate regulations that address institutional financial conflicts of interest. Until regulations are promulgated, NIH should encourage grantee institutions to develop policies and procedures regarding institutional financial interests and conflicts. In response to our report, NIH stated that it is reviewing public comments to finalize regulations regarding financial conflicts of interest and, therefore, it neither concurs nor nonconcurs with our recommendation. However, in the May 21, 2010, Notice of Proposed Rulemaking regarding financial conflicts of interest, NIH proposed regulatory changes that focus only on researchers' conflicts. The proposed regulations do not address institutional conflicts. Therefore, OIG continues to recommend that NIH include institutional conflicts in regulations addressing financial conflicts of interest.

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