Healthy Skepticism Library item: 16872

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Publication type: Government Document

Levinson DR
How Grantees Manage Financial Conflicts Of Interest In Research Funded By The National Institutes Of Health
Department of Health and Human Services 2009 Nov
http://oig.hhs.gov/oei/reports/oei-03-07-00700.pdf

Abstract:

EXECUTIVE SUMMARY
OBJECTIVES
1.
To determine the nature of financial conflicts of interest reported by grantee institutions to the National Institutes of Health (NIH) in fiscal year (FY) 2006.
2.
To determine how grantee institutions managed, reduced, or eliminated these financial conflicts of interest.
3.
To determine whether vulnerabilities exist in grantee institutions’ oversight of the identification and management of financial conflicts of interest.

BACKGROUND
NIH receives billions of dollars annually to support its mission of conducting and supporting medical research. In FY 2008, the total NIH appropriation was $29.5 billion, 80 percent of which was distributed through almost 50,000 competitive grants to more than 325,000 investigators (hereinafter referred to as researchers) at over 3,000 universities, medical schools, and other research institutions across the country and around the world. Pursuant to Federal regulation, each grantee institution receiving NIH funds must have a written policy for identifying financial conflicts of interest (hereinafter referred to as conflicts) and ensuring that 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 conflicting interests. They must also certify: ï‚· that existing conflicts (but not the nature of the interest or other details) will be reported to NIH prior to the expenditure of any funds under that award; ï‚· that these conflicts have been managed, reduced, or eliminated; and ï‚· 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. We collected information from each of the 41 grantee institutions that reported conflicts to NIH in 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 conflicts reported to NIH in FY 2006.

FINDINGS
The most common type of financial conflict of interest among NIH-funded researchers is equity ownership. Financial conflicts of interest may provide researchers with incentives to improperly influence the results of grant research. The most common type of conflict among researchers (111 out of 165 researchers with reported conflicts) was equity ownership (including stock and stock options) in companies in which the researchers’ financial interests could significantly affect the grant research. Grantee institutions provided specific equity amounts for 56 researchers. Six of these researchers had equity valued at greater than $100,000, and 13 researchers had equity ownership of 50 percent or more.
Other conflicts involved researchers inventing technology, consulting, or holding positions with outside companies. For these conflicts, grantee institutions that could provide specific compensation amounts indicated that seven researchers received at least $50,000 in royalty payments or compensation for their services.
To manage financial conflicts of interest, grantee institutions often require researchers to disclose their conflicts in research publications; however, grantee institutions rarely reduce or eliminate financial conflicts of interest. Grantee institutions reported that they managed 136 researchers’ conflicts, reduced 6 researchers’ conflicts, and eliminated 6 researchers’ conflicts. Another 17 researchers’ conflicts were handled using a combination of management, reduction, and elimination.
Grantee institutions frequently used disclosure to manage researchers’ conflicts. This includes disclosing the conflict in publications and/or presentations in which research results are presented. Some of the other methods used by grantee institutions to manage conflicts did not seem to directly address the specific conflicts. Examples of these methods include researchers’ certifying that their primary commitment is to the grantee institution and agreeing to abide by institutional financial conflict-of-interest policies and procedures.
Vulnerabilities exist in grantee institutions’ identification, management, and oversight of financial conflicts of interest.
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Ninety percent of the grantee institutions rely solely on researchers’ discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported.
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Because nearly half of the grantee institutions do not require researchers to provide specific amounts of equity or compensation on their financial disclosure forms, the specific financial interests of NIH-funded researchers are often unknown.
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Grantee institutions do not routinely verify information submitted by researchers.
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Conflicts were not uniformly reported by grantee institutions.
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The majority of grantee institutions do not have policies and procedures to address subgrantee compliance with Federal regulations regarding conflicts.
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Grantee institutions lack documentation to support their oversight of conflicts.
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Grantee institutions are not required to report to NIH any financial interests that they have with outside companies.