Coast IRB Heeds Call of Congress; Pledges Comprehensive Reforms

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Mon Mar 30, 2009 9:00am EDT

WASHINGTON--(Business Wire)--
Following yesterday`s hearing of the House Subcommittee on Oversight and
Investigations, Coast IRB CEO Dan Dueber announced that his company would
institute immediate and sweeping reforms. "We share Congress`s objective of
ensuring maximum protection for human subjects in clinical trials," said Dueber.
"We are instituting comprehensive reforms to prevent recurrence of the
vulnerabilities the Subcommittee brought to light," he said. "Our number one
priority is the protection of human subjects." 

Today, Coast is sending a written post-hearing statement to the Subcommittee for
inclusion in the record. That statement lists twelve specific reforms from
background checks on every sponsor of a clinical trial to the hiring of an
expert consultant to revamp Coast`s IRB reviews. In addition, Coast is replacing
the current chair of its IRB with a new chair and explains that the reform
process will be continuing in nature even after the twelve specific reforms are
instituted. 

The reforms Coast now institutes may one day be required by law for all IRBs if
Congress enacts legislation based on the Subcommittee`s deliberations. "For
Coast, this process of reform is not going to end," said Dueber. "We mean for it
to be continuous, making reexamination and improvement a dynamic, not a static
condition," he said. "Coast intends to exceed the requirements of the law, not
just meet them." 

Copies of the Post-Hearing Statement of Daniel S. Dueber are available upon
request. 





The B&B Media Group, Inc.
Diane Morrow, 800-927-1517
Cell: 817-319-9805
dmorrow@tbbmedia.com



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