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US Department of Health and Human Services, Office of the Inspector General Report: “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health” (OEI-03-07-00700, November 2009, .pdf format, 37p.).

Abstract:

We found that a number of vulnerabilities exist in National Institutes of Health (NIH) grantee institutions’ identification, management, and oversight of financial conflicts of interest. For example, 90 percent of the grantee institutions rely solely on the researchers’ discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported. We found that because nearly half of the grantee institutions do not require researchers to provide specific amounts of equity or compensation on their financial disclosure forms, specific financial interests of NIH-funded researchers are often unknown. In addition, when researchers submit information regarding their financial interests, grantee institutions do not routinely verify it.

Pursuant to Federal regulation, each grantee institution receiving NIH funds must have a written policy for identifying financial conflicts of interest and ensuring that these conflicts are managed, reduced, or eliminated. Grantee institutions must certify that they have written and enforced administrative processes to identify and manage, reduce, or eliminate financial conflicts of interest. They must also certify that existing conflicts (but not the nature of the interest or other details) will be reported to NIH before the expenditure of any funds under that award; that these conflicts have been managed, reduced, or eliminated; and that any subsequently identified conflicts will be reported and will be managed, reduced, or eliminated, at least on an interim basis, within 60 days of identification.

Other vulnerabilities include the following: (1) some grantee institutions lack documentation to support their oversight of financial conflicts of interest, (2) the majority of grantee institutions do not have policies and procedures that address subgrantee compliance with Federal regulations regarding financial conflicts of interest, (3) conflicts were not reported by grantee institutions to NIH in a consistent format, and (4) grantee institutions are not required to report to NIH any financial interests that they have with outside companies.

We focused our review on all 41 grantee institutions that submitted financial conflict-of-interest reports to NIH in fiscal year (FY) 2006. We also requested supporting documentation, including researchers’ financial disclosure forms, conflict management plans, and conflict-of-interest committee meeting notes related to 184 financial conflicts of interest reported to NIH in FY 2006.

The most common type of financial conflict of interest among researchers is equity ownership (including stock and stock options) in companies in which the researchers’ financial interests could significantly affect the grant research. Other financial conflicts of interest among researchers involved inventing technology, consulting, or holding positions with outside companies. To manage financial conflicts of interest, grantee institutions often require researchers to disclose conflicts in research publications; however, grantee institutions rarely reduce or eliminate financial conflicts of interest.

As in a prior OIG report, we recommended that NIH request grantee institutions to provide it with details regarding the nature of all reported financial conflicts of interest and how they are managed, reduced, or eliminated. In addition, we also recommended in this report that NIH (1) require grantee institutions to collect all information on significant financial interests held by researchers and not just those deemed by researchers to be reasonably affected by the research, (2) require grantee institutions to collect information on specific amounts of equity and compensation from researchers, (3) develop and disseminate guidance on methods to verify researchers’ financial interests, (4) ensure that grantee institutions are providing adequate oversight of subgrantee compliance with the Federal financial conflict-of-interest regulations, (5) ensure that grantee institutions are maintaining proper documentation as outlined in the Federal financial conflict-of-interest regulations, (6) ensure that grantee institutions are taking appropriate actions against researchers who do not follow grantee institutions’ financial conflict-of-interest policies and procedures, (7) increase oversight of grantee institutions to ensure that financial conflicts of interest are reported and managed appropriately, and (8) develop regulations that address institutional financial conflicts of interest.

Overall, NIH did not state whether it concurs or does not concur with our recommendations. NIH stated that many of OIG’s recommendations are not within the current scope of Federal regulation and are included in the May 8, 2009, Advanced Notice of Proposed Rulemaking, which invited public comment on possible revisions to financial conflict-of-interest regulations. Therefore, OIG’s recommendations will be considered by NIH and the Department of Health & Human Services during the formal rulemaking process.

NIH highlighted a number of initiatives designed to enhance NIH oversight of and promote grantee compliance with Federal regulation. OIG recognizes NIH’s continued efforts in increasing oversight of grantee institutions. However, despite these efforts, vulnerabilities continue to exist at grantee institutions in their identification, management, and oversight of financial conflicts of interest. Therefore, OIG maintains its position that increased oversight of grantee institutions is needed to ensure that financial conflicts of interest are reported and managed appropriately.

www.oig.hhs.gov…