Working To Protect The Safety Of Patients Participating In Clinical Trials


Tuesday, May 23, 2000


"We must be committed to ensuring that we enter this new age of discovery in a manner that protects the safety of those making new discoveries possible. These new actions are a critical first step towards meeting that goal."

President Bill Clinton
Tuesday, May 23, 2000

Today, at the White House, President Clinton unveiled strong new steps by the Department of Health and Human Services to protect the safety of individuals participating in clinical trials. They include new actions to ensure that participants are adequately informed about the potential risks and benefits of trials; new training requirements to ensure that researchers are familiar with ethical issues related to human subject research; and steps to address the potential financial conflicts of interest faced by researchers. The President also announced a new legislative proposal to authorize monetary penalties for researchers and institutions who violate regulations governing human clinical trials. These new measures will help protect the safety of participants, increase public confidence in clinical trials, and enhance likely participation in these critical studies.

Additional Oversight of Clinical Trials is Needed. Although recent public attention has been focused on gene therapy trials, evidence indicates that safety concerns exist in all types of clinical trials. Stronger federal oversight and increased accountability of researchers conducting clinical trials with humans are necessary because:

New Steps to Ensure the Safety of Clinical Trial Participants. In December, President Clinton 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. In response to the President's request, HHS is taking the following actions:

May 2000

May 31, 2000

May 25, 2000

May 23, 2000

May 23, 2000

May 18, 2000

May 16, 2000

May 15, 2000

May 12, 2000

May 11, 2000

May 4, 2000

May 3, 2000

May 2, 2000

President and First Lady | Vice President and Mrs. Gore
Record of Progress | The Briefing Room
Gateway to Government | Contacting the White House | White House for Kids
White House History | White House Tours | Help
Privacy Statement


Site Map

Graphic Version

T H E   W H I T E   H O U S E