Text :: Skip Nav ::
Part of Study Testing Trauma Treatments Is Shut Down. Rob Stein. The Washington Post. 2009-03-27.
3 Researchers at Harvard Are Named in Subpoena. Gardiner Harris. The New York Times. 2009-03-27.
URL: http://www.nytimes.com/2009/03/28/health/policy/28subpoena.html (Requires free registration)
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)
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://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552&Itemid=95
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
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: 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: 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): http://ohrp.cit.nih.gov/search/asurdtl.asp?ASURID=16653
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
More information about Coast Institutional Review Board: http://www.circare.org/info/coastirb.htm
Coast CEO is chided by congressional panel. Andrew Wineke. The Colorado Gazette. 2009-03-26.
Sting Operation Exposes Gaps in Oversight of Human Experiments. Alicia Mundy. The Wall Street Journal. 2009-03-26.
Investigators win approval of fake medical product. Jim Abrams. AP. 2009-03-26.
Trial safety lacking, says GAO. Alana Katsnelson. The Scientist. 2009-03-26.
UPDATE: Regulators Under Fire For Oversight Of Human Trials. Jared Favole. Dow Jones Newswire. 2009-03-26.
Was a Three-Legged Dog Head of a Review Board? Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
Lawmakers Detail Medical Research Sting: Company Was a Real Dog. Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful. Coast IRB Press Release. 2009-03-26.
Porton Down 'Not a Death Sentence.' BBC News. 2009-03-25.
Safety of Drug Trials Tested. Barbara Basler. AARP Bulletin Today. 2009-03-19.
Once-secret drug-company records put U on the spot. Maura Lerner and Janet Moore. Minneapolis Star-Tribune. 2009-03-19.
U doctor scrutinized over drug research. Jeremy Olson. The Pioneer Press. 2009-03-18.
A Silenced Drug Study Creates An Uproar. The Washington Post. Shankar Vedantam. 2009-03-18.
Springs firm will testify to D.C. panel. Wayne Heilman. The Colorado Gazette. 2009-03-18.
Critics Object to 'Pseudoscience' Center. David Brown. The Washington Post. 2009-03-17.
Medical clinical research slows for lack of patients. The Los Angeles Times. 2009-03-14.
Testing Firm Finds Itself Being Tested. Barry Meier. The New York Times. 2009-03-13.
URL: http://www.nytimes.com/2009/03/13/business/13sting.html (Requires free registration)
Clinical Trial Fraud Detected by Independent Review Board, part of a congressionalstingoperation. Coast IRB Press Releases. 2009-03-10 and 11: http://www.circare.org/info/coastirb_pressreleases_20090311.pdf Originally accessed on 2009-03-13 at: http://www.coastirb.com/press-releases
FDA Warning Letter to Coast Institutional Review Board. 2008-03-01: http://www.fda.gov/cder/warn/2008/08-HFD-45-1101.pdf
Hyperbaric Autism Treatment Shows Possible Promise. Joseph Brownstein. ABC News. 2009-03-13.
Google Co-Founder Backs Vast Parkinson's Study. Andrew Pollack. The New York Times. 2009-03-11.
URL: http://www.nytimes.com/2009/03/12/business/12gene.html (Requires free registration)
Painkiller Trial Raises Questions for FDA, Pfizer. Shannon Brownlee and Jeanne Lenzer. The Center for Public Integrity. 2009-03-11.
Ex-New York Health Commissioner Is F.D.A. Pick. Gardiner Harris. The New York Times. 2009-03-11.
URL: http://www.nytimes.com/2009/03/12/us/politics/12hamburg.html (Requires free registration)
Carl Elliott: Create counterweights to the influence of money on drug studies. Carl Elliot. St. Paul Pioneer Press. 2009-03-11.
Doctor Admits Pain Studies Were Frauds, Hospital Says. Gardiner Harris. The New York Times. 2009-03-10.
URL: http://www.nytimes.com/2009/03/11/health/research/11pain.html (Requires free registration)
Obama's Order on Stem Cells Leaves Key Questions to NIH. Rob Stein. The Washington Post. 2009-03-10.
Obama Aims to Shield Science From Politics. Rob Stein. The Washington Post. 2009-03-09.
Political Lobbying Drove FDA Process. Alicia Mundy. The Wall Street Journal. 2009-03-06.
Goode, John S. FDA Center for Devices and Radiological Health, 510k Memo re: ReGen Biologics Collagen Scaffold (CS). 2008-08-14: http://www.circare.org/foia5/goode_20080814.pdf (courtesy of The Wall Street Journal)
Senger, Jeffrey. FDA re: ReGen Biologics Collagen Scaffold (CS) 510k. 2008-11-03: http://www.circare.org/foia5/senger_20081103.pdf (courtesy of The Wall Street Journal)
FDA Warning Letter to ReGen Biologics, Franklin Lakes, NJ. 2005-09-15: http://www.fda.gov/foi/warning_letters/archive/g5481d.pdf
FDA Warning Letter to Vail Valley Medical Center Institutional Review Board, Vail, CO. 2006-06-22: http://www.fda.gov/foi/warning_letters/archive/g5903d.pdf
FDA Center for Devices and Radiological Health, Orthopedic and Rehabilitation Devices Panel, Meeting of 2008-11-14. Accessed on 2009-03-09 at: http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#orthopaedic
Hines J, Lurie P. Testimony before FDA on Collagen Scaffold Medical Device. Public Citizen Health Research Group. Accessed on 2009-03-10 at: http://www.citizen.org/publications/release.cfm?ID=7620
Obama Reversing Stem Cell Limits Bush Imposed. David Stout and Gardiner Harris. The New York Times. 2009-03-06.
URL: http://www.nytimes.com/2009/03/07/us/politics/07stem.html (Requires free registration)
Med school pares rules on conflicts of interest. Janet Moore. Minneapolis Star-Tribune. 2009-03-03.
South Florida doctors, hospitals named in fraud lawsuit. John Dorschner. The Miami Herald. 2009-03-02.
EXCLUSIVE: Sen. Hatch's secret drug firm links. Jim McElhatton. The Washington Times. 2009-03-02.
Harvard Medical School in Ethics Quandary. Duff Wilson. The New York Times. 2009-03-02.
URL: http://www.nytimes.com/2009/03/03/business/03medschool.html (Requires free registration)
What I Learned as a Subject. Robin Whitsell. Applied Clinical Trials. 2009-03-01.
Last Updated: 2009-12-03
If you find the information on this page helpful please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating online with PayPal is quick and easy. Find out more on our Support page
All material on this site © CIRCARE Incorporated (2002-2005) or as indicated. Single copies can be downloaded for personal education. Adobe® Reader :: ::