[Weekly Compilation of Presidential Documents Volume 36, Number 21 (Monday, May 29, 2000)]
[Page 1195]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
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 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.