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Coast IRB Heeds Call of Congress; Pledges Comprehensive Reforms

WASHINGTON, March 30 /PRNewswire/ -- 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.

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