    [Public Papers of the Presidents of the United States: WILLIAM J. CLINTON (2000, Book I)]
    [May 23, 2000]
    [Pages 1008-1009]
    [From the U.S. Government Publishing Office www.gpo.gov]

    Statement on Steps To Enhance the Safety of Clinical Trials
    May 23, 2000

        This is a moment of remarkable promise for our country. Not only are
    we in the midst of the longest economic expansion ever, but thanks to
    the brilliant, persistent work of scientists all over the world, we are
    also in the midst of a remarkable revolution that is allowing us to live
    longer, healthier lives.
        In December I asked the Department of Health and Human Services to
    develop a plan to ensure that mandatory safeguards for individuals
    participating in clinical trials are upheld. Public uncertainty about
    the safety of clinical trials could discourage participation in these
    critical studies and undermine the critical progress science has made
    towards developing new methods to detect, treat, and prevent diseases
    once thought to be deadly.
        To that end, I am pleased to announce that the Department is taking
    new steps to enhance the safety of clinical trials. These include: new
    actions designed to ensure that individuals are adequately informed
    about the potential risks and benefits of participating in research; new
    training requirements to ensure that researchers are familiar with
    ethical issues related to human subject research; and steps designed to
    address the potential financial conflicts of interest faced by
    researchers. We are also sending the Congress a new legislative proposal
    to authorize civil monetary penalties for researchers and institutions
    found to be in violation of regulations governing human clinical trials.
        We are on the brink of discoveries that are astonishing in their
    complexity and implications for human life in the decades ahead. But as
    committed as we are to further progress, we must be as committed to
    ensuring that we enter

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    this new age of discovery in a manner that protects the safety of those
    making these new discoveries possible. These new actions are a critical
    first step towards meeting that goal.