And a host of different government agencies—primarily those housed within the Department of Health and Human Services (HHS)—financially support biomedical research. In addition to directly supporting certain biomedical research projects, the government—primarily though the Food and Drug Administration (FDA)—continually reviews the biomedical research that is used to support an application to market certain products, like drugs or medical devices. Collectively, the various federal agencies that either support or oversee biomedical research have a strong interest in ensuring that the underlying research is scientifically rigorous and free of bias. If a researcher has a conflict of interest—that is, a real or potential incompatibility between one's private interests and one's public or fiduciary duties —that conflict, including a financial conflict, can potentially undermine the research. As a result, a potential conflict may exist that could bias the research or at the very least undermine the credibility of the research. To prevent such financial conflicts of interest (FCOIs) from undermining government supported or regulated biomedical research, the relevant government agencies have established an often-complex set of regulations and policies governing the identification and management of financial conflicts as they relate to biomedical research. Nonetheless, the requirements of other federal agencies that often fund or regulate research, such as the FDA, the National Science Foundation, and the Department of Defense, are also discussed. This report concludes with an overview of the current developments with respect to the law governing FCOIs and biomedical research. The United States Public Health Service (PHS) is the primary division of the department that oversees grants for research funded by the eight primary agencies and three human services divisions of HHS. Under that authority, HHS has promulgated rules applicable to PHS divisions to ensure federally funded biomedical research is objective and serves the public welfare. Some federal agencies outside the scope of PHS, but which also fund biomedical research, voluntarily follow the PHS regulations. However, the following are not considered significant financial interests:
1. Conflicts Determination

After each Investigator has disclosed all significant financial interests to the Investigator's Institution, the designated institutional official or committee must then determine whether any of the disclosed significant financial interests is "related to" the PHS-funded research and, if so, whether the interest is a FCOI. If the first step is met, and the financial interest is "related to" the funded research, the institutional official must then determine whether the interest "could directly and significantly affect the design, conduct, or reporting of PHS-funded research." Conflict Management and Reporting

When an institutional official determines that a FCOI exists, the agency must follow five steps. The primary implementation mechanism for the Common Rule is an Institutional Review Board (IRB). When the government provides funding for research involving human subjects the IRB's written assurance must be "satisfactory to the department or agency head" that the institution will comply with the minimum safeguards set out by the HHS Common Rule. In particular, like the HHS Common Rule, the FDA regulations on human subject testing bar a member of IRB from participating in the review of a project if that member has a "conflicting interest." A financial arrangement can be any of the following:
1. NSF requires that all investigators must disclose (1) any "significant financial interest" to the responsible party with the institution if the significant interest "reasonably appear[s] to be affected by" the research, or (2) if the research could reasonably appear to affect the financial interests of the entity in which the Investigator holds a significant interest. The revisions to the PHS objectivity rules included the lowering of financial interest reporting thresholds, expanding reporting obligations, and requiring institutions receiving federal funds to develop and enforce policies on FCOIs through training and education programs.
Every year the federal government through a host of different agencies spends billions of dollars supporting biomedical research. In addition, the federal government, through the Food and Drug Administration (FDA), continually reviews the biomedical research that supports an application to market certain products, like drugs or medical devices. Collectively, the various federal agencies that either support or oversee biomedical research have a strong interest in ensuring that the underlying research is scientifically rigorous and free of bias. However, if a biomedical researcher has a conflict of interest—that is, a real or potential incompatibility between one's private interests and one's public or fiduciary duties—that conflict, including a financial conflict, could bias the research or at the very least undermine the credibility of the researcher's conclusions.
To prevent such financial conflicts of interest (FCOIs) from undermining government-supported or -regulated biomedical research, the relevant government agencies have established an often-complex set of regulations and policies governing the identification and management of financial conflicts as they relate to biomedical research. The primary federal agency that funds biomedical research is the Department of Health and Human Services (HHS). Within HHS, the Public Health Service (PHS) oversees the 11 operating divisions of HHS that provide research grants and cooperative agreements. When funding is granted to an individual, private organization, public or private university, or other institution by any of the 11 funding agencies, the grantee institution must follow the PHS rules for "objectivity" in research.
The PHS objectivity rule provides that individual researchers must disclose "significant financial interests." A financial interest is "significant" if the interest exceeds the minimum threshold outlined under federal regulations and the interest "reasonably appears to be related" to the responsibilities of the researcher as dictated by the policies of the researcher's institution. If both of those requirements are met and a researcher has a "significant financial interest," the researcher must disclose the significant financial interest to his institution's designated official. The institution, in turn, must make a determination of whether the significant financial interest amounts to a FCOI. Such a determination is made by looking to whether the disclosed interest "relate[s] to the PHS-funded research" and, if so, whether the interest "could directly and significantly" affect the design, conduct, or reporting of the PHS-funded research. If the institution determines that a potential FCOI does exist, the institution must follow federal regulations to proactively address and manage a financial conflict.
Beyond the PHS objectivity rule, other federal rules respecting FCOIs and biomedical research exist, as well. For example, the HHS Common Rule may be applicable when an institution uses federal funds to conduct biomedical research involving human subjects. The Common Rule, by mandating that research institutions employ Institutional Review Boards (IRBs) to oversee human subject testing, have provided IRBs with the potential to scrutinize the effect of FCOIs on a particular research project. Moreover, the FDA has its own version of the Common Rule and a distinct set of regulations requiring a separate review of financial interests before certain products can be marketed. Importantly, covered applicants must disclose financial interests to the FDA even when no federal funds are used in the research and development of a product. Agencies outside HHS also fund biomedical research, albeit on a somewhat smaller scale. Most, but not all, of those agencies follow rules similar to the PHS objectivity requirements and Common Rule. This report summarizes the standards for disclosing financial interests for an institution conducting research funded by the National Science Foundation and the Department of Defense. Finally, this report concludes by discussing recent administrative and legislative developments with respect to the law regarding FCOIs and biomedical research.