HHS sets clinical trial safety initiatives

The Department of Health and Human Services has announced that it 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 by the department will include:

• 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.

• 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.

• Beginning a systematic evaluation of the informed consent process to ensure that the process safeguards the rights of trial participants.

• Expanding human safety training requirements for researchers.

• Taking initial steps to address potential financial conflict-of-interest issues.

According to HHS, 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.

The steps come at a time when public attention has been focused on the recent shortcomings in gene therapy clinical trials and are meant to ease public fears about the safety of clinical trials in general. "Public uncertainty about the safety of clinical trials could discourage participation in these critical studies and undermine the critical progress science has made toward developing new methods to detect, treat and prevent diseases once thought to be deadly," said President Clinton.

Monetary penalties

The president also announced that the administration will send legislation to Congress that would provide the Food and Drug Association with new authority to levy civil monetary penalties of up to $250,000 for researchers and up to $1 million in penalties for institutions for repeated violations of current federal regulations.

While the 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.

"We are on the brink of discoveries that are astonishing in their complexity and implications for human life in the decades ahead," said Clinton. "But as committed as we are to further progress, we must be as committed to ensuring that we enter this new age of discovery in a manner that protects the safety of those making these new discoveries possible. These new actions are a critical first step toward meeting that goal." PR