Biomedical Research:

HHS Direction Needed to Address Financial Conflicts of Interest

GAO-02-89: Published: Nov 26, 2001. Publicly Released: Dec 18, 2001.

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Financial relationships between individual investigators or their research institutions and private industry have yielded significant results, including treatments for such diseases as AIDS and strokes. However, some collaborations have raised concerns that the focus on financial reward might compromise the integrity of the research and the safety of human research subjects. GAO reviewed five universities with broad policies and procedures on financial conflicts of interest. All five had difficulty providing basic data on individual investigators' financial conflicts of interest in clinical research involving human subjects. The universities acknowledged a need for better coordination of information on investigators' financial relationships, and several universities were developing ways to do so. Policies and procedures at the five universities addressed financial conflicts of interest affecting institutions, including technology transfer activities and financial relationships with small start-up companies that market products developed by the universities. The Department of Health and Human Services has had limited success in promoting the integrity of biomedical research and protecting human subjects. HHS has taken steps to improve its oversight and monitoring and has drafted guidance on financial conflicts of interest, but this guidance does not provide detailed advice on how to manage institutional conflicts of interest.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: NIH, the principal federal agency that funds biomedical research, has taken several actions over the past few years to address GAO's recommendation. For example, in 2002 NIH posted a resource document on its Web site that summarized observations and comments from its compliance site visits (conducted from 2000 to 2004). The resource document contained examples of compliance in action related to financial conflicts of interest which described best practices of institutions. In 2001, NIH requested that 300 institutions provide a copy of their policy on financial conflicts of interest. A representative sample of over 100 policies was selected for more in-depth review by NIH officials. NIH subsequently published a report on its Web site containing findings and areas of concern, as well as best practices in the form of issues to consider when reviewing or revising financial conflict of interest policies and helpful suggestions. Finally, on October 25, 2007, NIH announced a pilot compliance program to assess institutional implementation and compliance with the requirements of the federal conflict of interest regulations. The pilot program will involve selecting a number of institutions and reviewing their financial conflict of interest policy and related information. NIH plans to share the results of this pilot, including information on best practices, with the NIH research community.

    Recommendation: To ensure the integrity of biomedical research and the protection of human research subjects, the Department of Health and Human Services (HHS) needs to improve the implementation of its financial interest regulations and its oversight of financial conflicts of interest. Specifically, the Secretary of Health and Human Services should develop and communicate information on best practices for institutions to consider for identifying and managing investigator and institutional financial conflicts of interest in biomedical research.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: On May 12, 2004, HHS released guidance entitled "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection." This guidance included some specific recommendations about addressing institutional financial conflicts of interest. Therefore, HHS has addressed GAO's recommendation that HHS should develop specific guidance or regulations concerning institutional financial conflicts of interest.

    Recommendation: To ensure the integrity of biomedical research and the protection of human research subjects, HHS needs to improve the implementation of its financial interest regulations and its oversight of financial conflicts of interest. Specifically, the Secretary of Health and Human Services should develop specific guidance or regulations concerning institutional financial conflicts of interest.

    Agency Affected: Department of Health and Human Services

 

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