DeGette Introduces Research Participants Protection Act

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

"It is thevolunteers facing difficult diseases and conditions who, by their agreement toparticipate in research trials, make scientific research and the discovery ofcures possible for millions of Americans," said DeGette. "Sadly, families havelost loved ones because for too long volunteers participating in research haven'tbeen adequately protected. Institutional review boards are overloaded, and currentfederal standards have simply not kept pace with the advances and complexity ofresearch today. It is long past time tomodernize the U.S. system for protecting human research participants so it isfocused on approving investigations that are done more safely and ethically.

"TheResearch Participants Protection Act I introduced today will take significantsteps to protect those individuals, by ensuring they are better informed of therisks of the trial they are considering, and by improving federal standards andreview procedures for every phase of the research process. As the U.S. economyincreases its dependence upon valuable data and the participation of researchvolunteers to help find cures for our most serious health issues, we mustensure we are doing everything we can to improve safety and efficacy."

The Research Participants Protection Act instructs theSecretary of Health and Human Services to review and harmonize federal policyon protecting research participants, including:

• Employing the most effective processesfor informing participants of the risks of research and ensuring that they areable to make voluntary decisions about participating.
• Improving standards to guard againstfinancial conflicts of interest by investigators.
• Ensuring efficient, ethical review andoversight of multisite research, which accounts for an increasingly largeportion of biomedical research.
• Improving procedures for reporting andaddressing unanticipated problems in research that could pose a danger toparticipants (such as serious negative reactions to a drug by clinical trialvolunteers).

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

###