DeGette Introduces Research Participants Protection Act

Press Release

Today, U.S. Rep. Diana DeGette (CO-1) introduced the Research Participants Protection Act, a bill designed to modernize and improve our nation's system for safeguarding the volunteers who participate in research trials to find cures and treatments for diseases. Patients in these trials have lost their lives, or become injured or severely ill, due to inadequate protections to keep them safe, discouraging some people from participating in research studies.

"It is the volunteers facing difficult diseases and conditions who, by their agreement to participate in research trials, make scientific research and the discovery of cures possible for millions of Americans," said DeGette. "Sadly, families have lost loved ones because for too long volunteers participating in research haven't been adequately protected. Institutional review boards are overloaded, and current federal standards have simply not kept pace with the advances and complexity of research today. It is long past time to modernize the U.S. system for protecting human research participants so it is focused on approving investigations that are done more safely and ethically.

"The Research Participants Protection Act I introduced today will take significant steps to protect those individuals, by ensuring they are better informed of the risks of the trial they are considering, and by improving federal standards and review procedures for every phase of the research process. As the U.S. economy increases its dependence upon valuable data and the participation of research volunteers to help find cures for our most serious health issues, we must ensure we are doing everything we can to improve safety and efficacy."

The Research Participants Protection Act instructs the Secretary of Health and Human Services to review and harmonize federal policy on protecting research participants, including:

* Employing the most effective processes for informing participants of the risks of research and ensuring that they are able to make voluntary decisions about participating.
* Improving standards to guard against financial conflicts of interest by investigators.
* Ensuring efficient, ethical review and oversight of multisite research, which accounts for an increasingly large portion of biomedical research.
* Improving procedures for reporting and addressing unanticipated problems in research that could pose a danger to participants (such as serious negative reactions to a drug by clinical trial volunteers).

· Identifying types of research that should be eligible for expedited review procedures.

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