The Subcommittee on Oversight and Investigations held a hearing titled, “Institutional Review Boards that Oversee Experimental Human Testing for Profit” at 10:00 a.m. on Thursday, March 26, 2009, in 2123 Rayburn House Office Building. The hearing examined whether institutional review boards (IRBs) and the federal government are adequately protecting human subjects of biomedical research.

Witness List

• Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accountability Office
• Dr. Jerry Menikoff, Director, Office for Human Research Protections, Department of Health and Human Services
• Dr. Joanne Less, Director, Good Clinical Practice Program, Food and Drug Administration
• Daniel Dueber, Chief Executive Officer, Coast IRB, LLC

Documents

• Chair Stupak's Opening Statement
• Chair Waxman's Opening Statement
• Testimony of Gregory Kutz
• Testimony of Dr. Jerry Menikoff
• Testimony of Dr. Joanne Less
• Testimony of Daniel Dueber
• Email from Lisa Bean to information, January 13, 2009
• Coast IRB Board Meeting Minutes
• Coast Coupon
• Email chain from Dueber to Emord, March 6, 2009
• Email from Morrow to Dueber, March 17, 2009
• Email chain from Strasser to Gorey, October 30, 2008
• Coast IRB Press Release
• Coast IRB Revenue Chart
• Device Med-Systems Protocol
• Informed Consent form approved by Coast IRB
• Jonathan Q. Kruger VA Med License
• Warning Letter from HHS to Coast IRB
• GAO Slides
• Preliminary Transcript

Video

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