THE WHITE HOUSE AT WORK
Tuesday, May 23,
2000
PRESIDENT CLINTON:
WORKING TO PROTECT THE SAFETY OF PATIENTS
PARTICIPATING IN CLINICAL TRIALS
"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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