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Working To Protect The Safety Of Patients Participating In Clinical Trials

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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:

  • Oversight responsibilities are too often ignored, resulting in trials operating outside of their approved protocols;
  • Patients are often inadequately informed about the risks associated with participation;
  • Investigators and Institutional Review Board members are often not trained to uphold human subject protections;
  • Financial conflicts of interest may interfere with the safety of clinical trial participants; and
  • Lack of public confidence in clinical trial safety threatens participation in medical research, thereby undermining progress in detecting, treating, and preventing diseases.

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:

  • Explicitly requiring investigators to obtain new informed consent from participants after any unexpected death or serious adverse health event occurs related to their clinical trial that may affect their willingness to participate;
  • Issuing new guidelines stating that Institutional Review Boards are expected to conduct an annual audit of safety protocols to ensure that informed consent has been obtained and is being maintained appropriately;
  • Initiating a broad public review of the informed consent process to ensure that it protects the rights of trial participants;
  • Proposing new penalties of up to $250,000 per individual and $1 million per institution for failure to comply with federal regulations;
  • Expanding human safety training requirements for researchers;
  • Improving the ability of Institutional Review Boards to monitor ongoing clinical trials. and
  • Addressing issues related to financial conflict of interest.

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