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Federal Research: NIH and EPA Need to Improve Conflict of Interest Reviews for Research Arrangements with Private Sector Entities

GAO-05-191 Published: Feb 25, 2005. Publicly Released: Mar 31, 2005.
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Highlights

An institute at the National Institutes of Health (NIH) and an office in the Environmental Protection Agency (EPA) entered into collaborative arrangements with the American Chemistry Council (ACC) to support research on the health effects of chemical exposures. NIH accepted a gift from ACC to help fund the research. EPA and ACC funded their proposals separately. The arrangements raised concerns about the potential for ACC to influence research that could affect the chemical industry. GAO determined the agencies' legal authorities to enter into the arrangements; the extent to which the agencies evaluated and managed potential conflicts of interest resulting from these arrangements; the extent to which the NIH institute complied with NIH's gift acceptance policy; and the extent to which NIH, EPA, and other agencies have similar arrangements.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
National Institutes of Health The Director of NIH and the Administrator of EPA should develop formal policies for evaluating and managing potential conflicts of interest when entering into research arrangements with nongovernmental organizations, particularly those that represent regulated industry.
Closed – Implemented
In September 2005, NIH revised the policy manual to address our recommendations. In February 2005, we reported that NIH did not have an adequate process for identifying and managing real or potential conflicts of interest when entering into research arrangements with non-federal partners, particularly those that represent regulated industry. On the basis of our recommendation, NIH convened a high-level working group to develop a proposed policy that includes guidance on assessing conflicts before entering into an agreement. One part of the policy requires officials to identify and address possible conflicts of interest before finalizing an agreement. The policy also directs officials to document their consideration of potential conflicts and management required to mitigation conflicts. As of June 2005, the draft policy is under review.
Environmental Protection Agency The Director of NIH and the Administrator of EPA should develop formal policies for evaluating and managing potential conflicts of interest when entering into research arrangements with nongovernmental organizations, particularly those that represent regulated industry.
Closed – Implemented
In July 2006, EPA notified GAO that in February 2006, ORD had revised its Memorandum of Understanding Policy to address our recommendations. In February 2005, we reported that EPA did not have an adequate process for identifying and managing real or potential conflicts of interest when entering into research arrangements with non-federal partners.
National Institutes of Health The Director of NIH should further revise the NIH gift acceptance policy to require NIH officials to evaluate gifts, particularly from organizations that represent regulated industry, for potential conflicts of interest and to document the basis for their decisions, including what, if any, steps are needed to manage potential conflicts.
Closed – Implemented
In September 2005, NIH revised the policy manual to address our recommendations. In February 2005, we reported that NIH did not have an adequate process for identifying and managing real or potential conflicts of interest when accepting gift funds from non-federal partners, particularly those that represent regulated industry. On the basis of our recommendation, NIH has revised its Gifts Administration policy to require that officials document decisions on whether to accept gift funds and to complete an evaluation of the potential conflicts of interest.

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Topics

Chemical researchConflict of interestsGifts or gratuitiesMedical researchNonprofit organizationsPolicy evaluationResearch grantsResearch programsChemical industryPolicies and procedures