Protecting Participants in Research

WASHINGTON – As the Energy and Commerce Subcommittee on Oversight andInvestigations prepares to examine the role of independentinstitutional review boards that oversee research on humanparticipants, U.S. Rep. Diana DeGette (D-CO), Vice Chair of theCommittee on Energy and Commerce, today introduced the Protection for Participants in Research Act.This legislation will strengthen federal regulation and oversight toprotect people who participate in research such as clinical trials.

"Research is the key to innovation and discovery, including findingcures for deadly diseases," said DeGette. "We must ensure that ethicalprotections are in place so that researchers can do their importantwork while individuals who participate in research are adequatelyinformed and protected."

The Protection for Participants in Research Act will:

· Harmonize FDA regulations and the Common Rule, the two major setsof federal regulations governing research participant protection

· Make federal regulations applicable to all research that is in or that affects interstate commerce

· Strengthen education and monitoring of institutional review boards

· Strengthen protections against conflicts of interest by investigators or institutional review board members

· Improve monitoring of research risks and reporting of adverse events and unanticipated problems

Tomorrow, the Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled, "Institutional Review Boards that Oversee Experimental Human Testing for Profit," at10:00AM EDT in 2123 Rayburn House Office Building. The hearing willexamine whether institutional review boards and the federal governmentare adequately protecting individuals who participate in research. U.S.Rep. DeGette will participate in the hearing.

The hearing will be webcast at www.energycommerce.house.gov.