Nothing in  these statutes appears to prohibit either agency from entering into research  arrangements with nonprofit organizations such as ACC. NIEHS used the authorities granted to NIH’s institutes and centers under  sections of the Public Health Service Act, as amended, to enter into its  arrangement with ACC (sections 301 and 405). Similarly, ORD relied on broad authorities granted to EPA under sections of  the Clean Air Act, as amended; the Clean Water Act, as amended; and the  Solid Waste Disposal Act, as amended, to enter into its research  arrangement with ACC (sections 103, 104, and 8001, respectively). However, officials at both agencies took steps to manage  potential conflicts that might arise during implementation of the  arrangements. NIEHS and ORD Did Not Formally Evaluate Potential Conflicts of Interest that Could Result from Research Arrangements with ACC

In 2001 and 2003, when they entered into arrangements with ACC, neither  NIH nor EPA had specific policies requiring officials to formally evaluate  potential conflicts of interest that could result from entering into such  collaborative arrangements. Because the research  conducted under these arrangements supported the agencies’ existing  research agendas, officials believe that the ACC arrangements helped  them effectively leverage federal research dollars. NIEHS Generally Complied with NIH’s Gift Acceptance Policy, but the Policy Cannot Provide Assurance that Conflicts of Interest Are Evaluated and Managed

When accepting funds from ACC under the research arrangement, NIEHS  officials complied with those sections of NIH’s policy that guide the  acknowledgement and administration of gifts. However, the policy’s  guidance on evaluating and managing potential conflicts is extremely  broad, lacking clarity and consistency. Further, the policy does not require officials to  document the basis of their decisions. As a result, the gift policy does not  provide the public sufficient assurance that potential conflicts of interest  between NIH and donor organizations will be appropriately considered. None of  the nonprofit partners in the nine research arrangements we found at NIH  represents industry in the same direct manner that ACC represents the  chemical industry. In addition, we did not identify any partnerships similar to  the ACC research arrangement at FDA or at FAA. While these  processes were appropriate for managing the arrangements, they were not  specifically designed to address conflict-of-interest concerns and therefore  cannot be considered adequate substitutes for formal conflict-of-interest  evaluations. Consequently, without policies requiring officials at NIH and  EPA to formally evaluate and manage potential conflicts of interest when  they enter into collaborative arrangements such as those with ACC, neither  agency can ensure that similar arrangements in the future will be  systematically evaluated and managed for potential conflicts of interest. Objectives, Scope, and Methodology

As requested by the Ranking Member of the Subcommittee on  Environment, Technology and Standards, House Committee on Science,  and the Ranking Member of the Subcommittee on Research, House  Committee on Science, we determined the (1) legal authority the National  Institutes of Health’s (NIH) National Institute of Environmental Health  Sciences (NIEHS) and the Environmental Protection Agency’s (EPA) Office  of Research and Development (ORD) used to enter into arrangements with  the American Chemistry Council (ACC); (2) extent to which NIEHS and  ORD evaluated and managed the possibility that conflicts of interest could  result from their arrangements; (3) extent to which NIEHS complied with  NIH’s gift acceptance policy when accepting ACC’s funds; and (4) extent to  which similar research arrangements exist within other offices and  programs within NIH and EPA, as well as other regulatory agencies. The two agencies selected were the  Food and Drug Administration (FDA) and the Federal Aviation  Administration (FAA) because each agency had a research component to  its mission, a corresponding research budget, and a regulatory role.
Why GAO Did This Study

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.

What GAO Found

NIH's National Institute of Environmental Health Sciences (NIEHS) used the authorities granted to NIH's institutes and centers under sections of the Public Health Service Act to enter into its arrangement with ACC. Similarly, EPA's Office of Research and Development (ORD) relied on authorities granted to EPA under sections of the Clean Air Act, the Clean Water Act, and the Solid Waste Disposal Act to enter into its research arrangement. Nothing in these statutes appears to prohibit either agency from entering into research arrangements with nonprofit organizations such as ACC. NIEHS and ORD did not formally evaluate the potential for conflicts of interest with ACC before they entered into the arrangements, but both agencies took steps to manage the potential as the arrangements were implemented. NIH and EPA had no specific policies requiring officials to evaluate or manage potential conflicts of interest when they entered into the ACC arrangements, nor do they currently have such policies. Although no formal evaluation occurred, agency officials managed the arrangements through their existing research management processes. Both agencies believe these actions helped mitigate the potential for undue influence by ACC and adequately protected the integrity of the scientific research conducted under the arrangements. Because the agencies' research management processes were not designed to address conflict of interest issues they are not a substitute for a formal evaluation of such conflicts. Without policies requiring a formal evaluation and management of conflicts, there is no assurance that similar arrangements will be appropriately evaluated and managed for such conflicts in the future. NIEHS officials complied with portions of NIH's gift acceptance policy that guide the acknowledgement and administration of gifts. However, the policy's guidance on evaluating and managing potential conflicts is extremely broad, and it lacks clarity and consistency. As a result, the policy gives officials wide discretion in this area. In addition, the policy does not require the agency to document the basis for its decisions. Consequently, the policy does not provide sufficient assurance that potential conflicts of interest between NIH and donor organizations will be appropriately considered. While some institutes and centers at NIH had arrangements somewhat similar to the ACC arrangements, GAO did not find any similar arrangements at other program offices at EPA or at the Food and Drug Administration and the Federal Aviation Administration--two other agencies with significant research budgets. None of the nine research arrangements GAO found at NIH institutes and centers involve organizations that represent industry in the same direct manner that ACC represents the chemical industry.