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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,
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.
Oversight responsibilities are too often ignored. The Office
of the Inspector General (OIG) recently testified before Congress that
Institutional Review Boards (IRBs) conduct minimal continuing review of
approved research as required by Federal regulations. As a result, clinical
trials are operating outside of their approved protocols by: enrolling people
in trials even though they did not meet the operational protocol; using medical
devices as part of a study without IRB approval; and failing to obtain informed
consent from patients participating in the trial.
Patients are often inadequately informed about the risks
associated with participation in a clinical trial. Recent reports indicate
that trial subjects are often not informed of events in other studies, either
on animals or on people, that have significant implications for the safety of
human studies, and researchers often fail to communicate information clearly or
correctly to participants.
Investigators and IRB members are often not trained to uphold
human subject protections. Although the IRB system depends on
researchers' commitment to uphold human-subject protections, a recent OIG
report stated that IRBs offer only limited opportunities for continuing
education for IRB members and investigators to ensure that they are sensitized
to the importance of these protections. Investigators that are not adequately
trained often fail to realize the ramifications -- for both the integrity of
the research and the health of the trial participants -- of ignoring patient
Financial conflicts of interest may interfere with the safety of
clinical trial participants. Recent reports indicate that researchers --
even in academic settings are now involved in commercial ventures that
create new ethical and conflict-of-interest considerations. For example,
investigators leading clinical trials often have a significant financial
interest in the product being tested. This month's edition of the New
England Journal of Medicine highlights distressing concerns about the impact
these financial relationships have on research results.
Lack of public confidence in clinical trial safety threatens
participation in medical research. Recent reports of shortcomings in
clinical trial subject safety undermines public confidence that could
discourage greater participation in research, which has the great potential to
reduce medical breakthroughs.
PRESIDENT CLINTON ANNOUNCES NEW STEPS TO PROTECT PARTICIPANTS IN
CLINICAL TRIALS. Today, President Clinton will announce new action to:
Issue new guidelines stating that IRBs are expected to conduct
an annual audit of safety protocols to ensure that informed consent has been
obtained and is being maintained appropriately. HHS will release guidance
this June stating that all IRBs are expected to conduct an audit of participant
records and safety protocols to determine that informed consent has been
obtained and is being maintained in accordance with Federal regulations as part
of the IRBs' annual review of the clinical trials under their supervision.
For particularly risky or complex clinical trials, such as those using
particularly toxic substances or being performed on vulnerable populations such
as children, IRBs will be expected to take additional measures, such as
directly observing the informed consent process.
Explicitly require investigators to obtain new informed consent
from participants after any unexpected death or serious adverse health event
related to their clinical trial. This June, HHS will direct investigators
to reconfirm informed consent of participants after a significant event that
may have implications for the safety of participants, such as the unexpected
death or serious illness of a trial participant or a patient in a clinical
trial using similar scientific techniques that is determined to be related to
their participation in the trial. This re-confirmation of informed consent must
be obtained in writing and documented in subject records.
Initiate a systematic public review of the informed consent
process. This summer, HHS will conduct a widespread review, including
consumer advocates, members of the research community, industry
representatives, and other interested parties, of the informed consent process
with the goal of taking prompt action to strengthen current protections. This
process will explore the best way to ensure that subjects are informed of the
potential risks and benefits of study participation.
New penalties for non-compliance with Federal regulations.
The President also announced that the Administration will send legislation to
the Congress providing FDA with new authority to levy civil monetary penalties
of up to $250,000 for researchers and up to $1 million for institutions for
repeated violation of current Federal regulations. While FDA can currently
issue warning letters or impose regulatory sanctions that halt research until
problems are rectified, financial penalties give the agency additional tools to
sanction those who do not follow federal regulations.
Expand training requirements for researchers. In June, NIH
will announce that beginning this fall, it will expand its training
requirements by requiring all clinical researchers receiving Federal funds to
complete standard research ethics and human subject research training before
their research grants are renewed. To build on this first step taken by NIH,
FDA and OPRR will work together in the coming months to develop a set of
aggressive educational standards for required training that ensure all of the
researchers under their jurisdiction are properly informed of their roles and
Improve the ability of IRBs to monitor ongoing clinical
trials. This June, HHS will issue guidance requiring smaller-scale early
research trials (Phase I and Phase II) to inform the responsible IRB of adverse
events observed during the trials. NIH already requires that the Data Safety
Monitoring Boards required for all large-scale (Phase III) trials formally
share their analysis of adverse events observed during the trials with the
Address issues related to financial conflict of interest.
HHS will hold public discussions this summer to find new ways to manage
conflicts of interest so that research subjects are neither misled nor coerced,
and to further ensure that research results are analyzed and presented
objectively. Based on these public forums, NIH and FDA will work together to
develop new guidance for the broader medical research community, which will
require at a minimum that any researchers' financial interest in a
clinical trial be disclosed to potential participants, officials of the
research institution, and to federal officials.