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Coast Institutional Review Board

Quick Index

Committee Hearing and GAO Report

Committee on Energy and Commerce, Subcommittee on Oversight and Investigation Hearing: Institutional Review Boards that Oversee Experimental Human Testing for Profit. 2009-03-26. (Includes links to testimony, exhibit binder, and videocast.) Accessed on 2009-03-27 at: http://democrats.energycommerce.house.gov/index.php?q=hearing/institutional-review-boards-that-oversee-experimental-human-testing-for-profit

Subcommittee on Oversight and Investigation Hearing: Institutional Review Boards that Oversee Experimental Human Testing for Profit, Preliminary hearing transcript. Accessed on 2009-12-04 at: http://democrats.energycommerce.house.gov/Press_111/20090326/transcript_20090326_oi.pdf

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation GAO-09-448T, March 26, 2009. Accessed on 2009-03-27 at: http://www.gao.gov/new.items/d09448t.pdf

Related Information

Maryland Hause Institutional Review Board (IRB): http://marylandhauseirb.com/
Maryland Hause Institutional Review Board CEO Skipper Dawg (deceased): http://www.circare.org/images/skipper_dawg.jpg
Maryland Hause IRB HHS Office for Human Research Protections IRB registration (link dead as of 2009-12-04): http://ohrp.cit.nih.gov/search/irbdtl.asp?IRBID=6374

Device Med-Systems: http://devicemedsystems.com/
Device Med-Systems HHS Office for Human Research Protections Federal Wide Assurance (FWA) Registration (link dead as of 2009-12-04): http://ohrp.cit.nih.gov/search/asurdtl.asp?ASURID=15658

Additional Fictive Entity Registered with HHS-OHRP by GAO:
Phaké Med Devices, Inc. (Paynesville, SC) (link dead as of 2009-12-04): http://ohrp.cit.nih.gov/search/asurdtl.asp?ASURID=16653

Coast IRB website: http://www.coastirb.com/

Archive of Coast IRB website: http://web.archive.org/web/*/http://www.coastirb.com/

FDA Actions and Correspondence Related to Coast IRB

FDA Warning Letter to Coast Institutional Review Board 2008-03-11: http://www.circare.org/fdawls/coastirb_20080311.pdf

FDA Warning Letter to Coast Institutional Review Board 2009-04-14: http://www.circare.org/fdawls/coastirb_20090414.pdf

FDA Imposes Restrictions on Coast IRB due to Violations. FDA News Release. 2009-04-14: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149565.htm

FDA: Questions and Answers on Coast IRB April 14, 2009 Warning Letter. 2009-04-14: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm135468.htm

FDA Correspondence to Coast IRB, LLC. 2009-06-04: http://www.circare.org/fdawls/coastirb_20090604.pdf

FDA: Coast IRB Update. 2009-06-22: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168520.htm

FDA's HSP/BIMO Initiative Accomplishments — Update. 2009-03-25. Accessed on 2009-03-30 at: http://www.fda.gov/oc/gcp/hsp_bimo.html


News Stories

An Overseer of Trials in Medicine Draws Fire. Barry Meier. The New York Times. 2009-03-26.
URL: http://www.nytimes.com/2009/03/27/business/27clinic.html (Requires free registration)

Coast CEO is chided by congressional panel. Andrew Wineke. The Colorado Gazette. 2009-03-26.
URL: http://www.gazette.com/articles/coast_50672___article.html/dueber_review.html

Sting Operation Exposes Gaps in Oversight of Human Experiments. Alicia Mundy. The Wall Street Journal. 2009-03-26.
URL: http://online.wsj.com/article/SB123811179572353181.html

Investigators win approval of fake medical product. Jim Abrams. AP. 2009-03-26.
URL: http://www.google.com/hostednews/ap/article/ALeqM5jS05NrOriTuDXEIj3I4amzySYCIQD975T8K80

Trial safety lacking, says GAO. Alana Katsnelson. The Scientist. 2009-03-26.
URL: http://www.the-scientist.com/blog/display/55546/

UPDATE: Regulators Under Fire For Oversight Of Human Trials. Jared Favole. Dow Jones Newswire. 2009-03-26.
URL: http://online.wsj.com/article/BT-CO-20090326-711930.html

Was a Three-Legged Dog Head of a Review Board? Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
URL: http://blogs.wsj.com/health/2009/03/26/was-a-three-legged-dog-head-of-a-review-board/

Lawmakers Detail Medical Research Sting: Company Was a Real Dog. Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
URL: http://blogs.wsj.com/washwire/2009/03/26/lawmakers-detail-medical-research-sting-ceo-was-a-real-dog/

Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful. Coast IRB Press Release. 2009-03-26.
URL: http://sev.prnewswire.com/health-care-hospitals/20090326/DA8940226032009-1.html


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