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 protection safeguards.

• 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 responsibilities.

• 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 responsible IRB.

• 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.

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