New Steps To Protect The Safety Of Patients Participating In Clinical Trials May 23, 2000


THE WHITE HOUSE
Office of the Press Secretary


For Immediate Release May 23, 2000



PRESIDENT CLINTON ANNOUNCES STRONG NEW STEPS TO PROTECT THE SAFETY OF PATIENTS PARTICIPATING IN CLINICAL TRIALS
May 23, 2000

Today, President Clinton will announce that the Department of Health and Human Services is taking new steps to strengthen Federal oversight and increase the accountability of researchers conducting clinical trials with human subjects in order to protect the safety of individuals participating in all clinical trials. New actions include: (1) issuing new guidelines stating that investigators must obtain new informed consent from participants after any unexpected death or serious adverse health event related to their clinical trial that may affect their willingness to participate; 2) 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; 3) beginning a systematic evaluation of the informed consent process to ensure that it safeguards the rights of trial participants; 4) proposing new civil monetary penalties of up to $250,000 per individual and $1 million per institution to promote compliance with current regulations; 5) expanding human safety training requirements for researchers; and 6) taking initial steps to address potential financial conflict of interest issues. These new actions, which respond to a Presidential request made in December, are necessary to strengthen requirements designed to protect the safety of participants, increase public confidence in clinical trials, and in so doing, enhance likely participation in these critical trials.

ADDITIONAL OVERSIGHT OF CLINICAL TRIALS IS NECESSARY TO ENSURE THE SAFETY OF CLINICAL TRIAL PARTICIPANTS. Public attention has been primarily focused on the shortcomings of gene therapy clinical trials, recent evidence indicates that safety concerns exist in all types of clinical trials. Although HHS has acted to suspend Federally funded research when trials operate out of compliance with current regulations, additional action and more stringent oversight is necessary to ensure patient safety.

PRESIDENT CLINTON ANNOUNCES NEW STEPS TO PROTECT PARTICIPANTS IN CLINICAL TRIALS. Today, President Clinton will announce new action to:




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