Office of Human Research Protections
(OHRP) Letters of Determination:
Office of Protection from Research Risks* (OPRR) List
of Compliance Oversight
Investigations Resulting in Restrictions or Actions to federally licensed
Institutions between 1990 - 2000.
*Reorganized in 2000 as OHRP
Aug 26: David Healy's response (502K pdf file) to a slanderous personal attack by Pfizer, posted by the FDA on FDA's website, August 20
Jun 27, 04: NIH Under Fire: Longtime Favorite of Congress - Wash Post / WSJ
Jun 12: Bad Medicine - Editorial - Guardian UK
June 8: Glaxo chief executive angry over NYS AG lawsuit - Telegraph
Jun 5: "Black Hole" of medical research--Negative Results Don't get Published - JAMA, WSJ
Jan 19, 2004: Critics of NIH Studies Prompt Senate Hearing - WashPost
Jan 15, 2004: NIH ethics review
Jan 9, 2004: Zolft pediatric study in JAMA challenged by peers - JAMA letters
Dec 2, 2003: Integrity of Scientific Findings Marred
Nov 14, 2003: Frontline: Dangerous Prescription
Nov 8, 2003: Chromium 6_Carcinogen tested in 5 humans in the US
Nov 5, 2003: FDA Advisor: "Ignore breast implant vote"
Oct 25, 2003: Why did OHRP SHRED informed consent documents?
Oct 17, 2003: Is it Cloning? U.S. experiment in China - Baltimore Sun
Oct 17, 2003: Nazi euthanasia files are made public - BMJ
Oct 14, 2003: WSJ: Court Revives Suit Against Pfizer On Nigeria Study
Oct 7, 2003: Ethics of U Penn surgical "drug implant" experiment
Sept 29, 2003: Doctor's Misconduct Left Trail of Broken Lives--A Broken Marriage and a 'Life Destroyed' - WashPost
Aug 19, 2003: Gene Therapy Experiment Called "Crazy"
Aug 6, 2003: A Come Back for Psychosurgery?
July 11, 2003: AHRP Letter to Editor re: ARDS published NEJM
June 10, 2003: AHRP Testimonies re: Fatal ARDS lung experiment
June 4, 2003: Auditing Standards in Accounting and Medicine
April 30, 2003: Artificial Heart experiment without informed consent?
February 2003: Remember Saddam's human guinea pigs by Jonathan Moreno, (Center for Biomedical Ethics, University of Virginia) in The American Journal of Bioethics 3(2): InFocus. http://bioethics.net/in_focus/moreno.pdf
February 9, 2003: UK Patients Used as Drug 'Guinea Pigs"_Guardian
February 6, 2003: VA Drug Study Deaths under Criminal Investigation in NY_BNA
January 8, 2003: "Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science
December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee
December 16, 2002: Former President of Amer Heart Assoc Caught in Fraud
December 10, 2002: Patient vs. Portfolio: ImClone_Salon
October 8, 2002: Last Journey of Artificial Heart Recipient - NYT
September 27, 2002: Is This Permissible Medical Research?
September 4, 2002: AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study).
August 28, 2002: "A Metaanalysis of ALI and ARDS Trials Testing Low Tidal Volumes." Eichacker, et al, American Journal of Respiratory and Critical Care Medicine (a critique of the ARDS Study).
July 26, 2002: Stop California AB 2328 (unauthorized consent to research)
July 25, 2002: AHRP Questions Ethics of ARDS Study
May 15, 2002:
Harvard's president admits Chinese experiments were " wrong"
AHRP Infomail, May 15 2002
2002: Children's Hospital Pittsburgh
2002: Mount Sinai Medical Center NYC
23, 2002: University of Chicago
April 16, 2002: University of California Los Angeles. Moratorium on IRB Approval of Surrogate or Proxy Informed Consent for Human Subjects Research http://www.oprs.ucla.edu/human/NewsLetters/041602.htm
4, 2002: Cornell Medical Center NYC.
March 28, 2002:
Mass. Mental Health Center (pdf file):
March 28, 2002:
Brigham & Women's Hospital (pdf file):
March 28, 2002:
Harvard University School of Public Health (pdf file):
Feb. 8, 2002: Federal investigation finding: informed consent requirements viotated. University of California, San Francisco. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/feb02l.pdf
2002: University of Maryland School of Medicine.
2002: Johns Hopkins University School of Medicine.
2002. University of Colorado Health Science Center.
2001: University of Cincinnati. University Hospital.
1990 to Aug 2001: Government Investigations
July 21, 2001: Government Agency Caves in to Johns Hopkins pressure
July 17, 2001: Johns Hopkins Admits Fault in Fatal Experiment
March 11, 2001:
Seattle Times Series,
"Investigation of Fred Hutchinson Cancer Center"
2001: Philadelphia Veterans Affairs Medical Center.
Dec 17-21, 2000. THE WASHINGTON POST. The Body Hunters. Six part investigative series.
As Drug Testing Spreads, Profits and Lives Hang in Balance. First of six articles By Joe Stephens. http://www.washingtonpost.com/ac2/wp-dyn/A11939-2000Dec15?language=printer
Overwhelming the Watchdogs. By Mary Pat Flaherty, Deborah Nelson and Joe Stephens. http://www.washingtonpost.com/ac2/wp-dyn/A11976-2000Dec15?language=printer
Dilemma: Submit or Suffer. By Sharon LaFraniere, Mary Pat Flaherty
and Joe Stephens
Page A01 Third of six articles
Isolated Region's Genetic Mother Lode. Fourth of six articles.
By John Pomfret and Deborah Nelson
Thursday, December 21, 2000;
Page A01 Fifth of six articles
Latin America Is Ripe For Trials, and Fraud By Karen DeYoung and Deborah Nelson
Feb 2, 2000:
Congressional Testimony submitted by Vera Sharav:
"Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research"
November 15 - 18, 1998: The Boston Globe. Doing Harm: Research on the Mentally Ill. Four part investigative series.
Testing Takes Human Toll by Robert Whitaker and Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/day1.htm
Debatable Forms of Consent by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/day2.htm
Lure of Riches Fuels Testing by Robert Whitaker. http://www.boston.com/globe/nation/packages/doing_harm/day3.htm
Still No Solution in the Struggle on Safeguards by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/
November 18, 1998: Panel Urges Review of Patient Studies by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/review111898.htm