Statement on Steps To Enhance the Safety of Clinical Trials - Transcript - Brief Article

Weekly Compilation of Presidential Documents, May 29, 2000

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.