Ethics and Clinical Trials

Looking for our work on the unethical CLOVERS trial involving patients with sepsis?
Looking for our work on the unethical iCOMPARE and FIRST trials testing medical resident work-hour schedules without informed consent?
Looking for our work on the SUPPORT study, an unethical trial involving premature infants?

More Information on Ethics and Clinical Trials

• Press Statement: FDA Refuses to Impose Serious Sanctions Against Researchers at Minnesota Hospital Who Conducted Unethical High-Risk Experiments, May 2, 2022
• Petition to the FDA to Initiate Disqualification Procedures Against Hennepin County Medical Center Researchers and IRB for Unethical High-Risk Clinical Trials, November 17, 2021
• Letter to the NIH Regarding Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by the Agency, June 8, 2021
• Letter to the OHRP and FDA Calling for Investigations into Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by NIH, June 8, 2021
• Letter to the Secretary of Health and Human Services, FDA Commissioner and NIH Director Regarding Coronavirus Human Challenge Studies, July 6, 2020
• Letter to the FDA Calling for Investigation Into an Apparent Illegal Clinical Trial That Tested Unapproved Naltrexone Implants in Prison Inmates, November 20, 2019
• Comments on the FDA’s Proposed Rule for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, February 13, 2019
• Second Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation, October 29, 2018
• Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation, July 30, 2018
• Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the Hennepin County Medical Center’s Human Subjects Protection Program, July 26, 2018
• Letter to the FDA and OHRP Calling for Investigations of Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation, July 25, 2018
• Testimony before the HHS Secretary’s Advisory Committee on Human Research Protections Regarding the July 2017 HHS Office of Inspector General Report on OHRP’s Compliance Activities, July 10, 2018
• Follow-up Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding a Potentially Unethical Clinical Trial Involving Heart Attack Patients, July 5, 2018
• Press Release: Public Citizen Complaint Prompts Changes to Potentially Unethical Clinical Trial Involving Heart Attack Patients, June 12, 2018
• Research Group Study Examines Use of Placebos in Clinical Trials Testing New Drugs for Life-Threatening Diseases, April 24, 2018
• Follow-up Letter to the HHS Office of Inspector General Regarding the Need for an Independent Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study, March 22, 2018
• Letter to the HHS Office of Inspector General Requesting an Investigation Into NIH’s Solicitation of Donations From the Alcoholic Beverage Industry for Alcohol Research Study, March 19, 2018
• Letter Calling on Senator Chuck Grassley to Examine OHRP’s Failure to Adequately Protect Human Research Subjects, February 1, 2018
• Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects, September 22, 2017
• Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding an Unethical Clinical Trial Involving Heart Attack Patients, August 1, 2017
• Presentation at the Meeting of the Committee on Issues in Organ Donor Intervention Research, National Academies of Sciences • Engineering • Medicine, December 14, 2016
• Complaint Letter to the Office for Human Research Protections and the Department of Veterans Affairs Regarding an Unethical Kidney Transplant Experiment, April 20, 2016
• Complaint Letters to the Department of Veterans Affairs Regarding the Unethical CHAMPION PHOENIX Clinical Trial, January 7, 2016
• Comments on the Proposed Revisions to the Federal Regulations for the Protection of Human Subjects, January  6, 2016
• Testimony Before the FDA Pediatric Ethics Subcommittee of the Pediatric Advisory Committee, September 9, 2013
• Comments to HHS Responding to Questions About Informed Consent for Human Subjects Research, September 6, 2013
• Testimony before HHS Panel on Informed Consent for Human Subjects Research, August 28, 2013
• Letter to HHS Secretary Sebelius on a New NIH-Funded Premature Infant Study Lacking Compliance with Ethical Consent Standards, August 22, 2013
• Letter to OHRP Alleging Inadequate Informed Consent for Study Involving Diabetic Children, February 27, 2013
• Letter to the Secretary of Health and Human Services Criticizing Recent Action Taken by the Office for Human Research Protections, January 9, 2013
• Letter to the Presidential Commission for the Study of Bioethical Issues Opposing Unethical Anthrax Vaccine Studies in Children, August 27, 2012
• Letter to OHRP Criticizing the Agency’s Position Allowing CMS to Require Medicare Beneficiaries Undergoing Transthoracic Aortic Valve Replacement to Participate in Research, August 27, 2012
• Letter to the FDA Opposing Resumption of Clinical Trials Testing Anti-Nerve Growth Factor Drugs, April 16, 2012
• Testimony to the FDA’s Arthritis Advisory Committee on Safety Issues Related to Anti-Nerve Growth Factor Agents, March 12, 2012
• Letter to OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consent/Parental Permission, February 28, 2012
• Letter to CMS and OHRP Opposing Proposal to Require Medicare Beneficiaries Undergoing an Aortic Valve Replacement Procedure to Participate in Research Without Their Informed Consent, February 28, 2012
• Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research, November 7, 2011
• Letter Opposing Unethical Anthrax Vaccine Studies on Children, November 1, 2011
• Comments on Proposals to Revise the Regulations for Protecting Human Research Subjects, October 26, 2011
• Letter Requesting Extension of ANPRM Comment Period, July 26, 2011
• Letter to HHS Regarding OHRP Failure to Investigate Unethical Placebo-Controlled Trials of Indacaterol Maleate (Arcapta Neohaler), April 28, 2011
• Letter on Unethical Trials of Indacaterol Maleate (Arcapta Neohaler), March 16, 2011
• Testimony to IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, November 9, 2010
• Statement: Foreign Clinical Trials for U.S. Drugs Present Significant Threat, June 22, 2010
• Letter Urging FDA to Halt Rosiglitazone (Avandia) Trial, May 11, 2010
• Letter Regarding the Draft Document Special Ethical Considerations for Epidemiological Research, April 9, 2007
• Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America, February 17, 2007
• Testimony Concerning Protocol for Biopure’s Blood Sub HBOC-201, December 14, 2006
• Letter in Obstetrics & Gynecology: Trials of Prophylaxis to Prevent Recurrent Herpes Should Not Utilize a Placebo Arm,  December 1, 2006
• Letter Opposing U.S. Government Efforts to Declare Some Foreign Ethics Approval Procedures Equivalent to Those in the U.S., May 31, 2005
• Comment in the Lancet: U.S. Exceptionalism Comes to Research Ethics, March 26, 2005
• Letter Urging FDA Not to Undermine the Declaration of Helsinki, September 1, 2004
• Letter Concerning Continuing Efforts to Amend Declaration of Helsinki, March 1, 2004
• Federal Failure in Psychiatric Research: Continuing NIMH Negligence in Funding Research on Serious Mental Illnesses, November 19, 2003
• Letter Opposing Proposed Changes to Declaration of Helsinki, August 28, 2003
• Letter Urging an Investigation of Medical Schools Conducting Unethical Research, July 22, 2003
• Testimony on Clinical Research Involving Children, July 9, 2003
• Letter on Ethical Concerns with the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT), April 15, 2003
• Letter on Ethical Concerns with the “Alzheimer’s Disease Anti-Inflammatory Prevention Trial” (ADAPT), September 4, 2002
• Article in GCPJ: Clinical Research Paradox, October 2001
• Letter on CIOMS’s Draft Ethical Guidelines, July 13, 2001
• Comments on Draft HHS Report on the Globalization of Clinical Trials, July 5, 2001
• Letter in JAMA on Problems with HIV-1 Vaccine Study, May 2, 2001
• Statement on National Bioethics Advisory Commission’s Endorsement of Unacceptable Ethical Standards, April 30, 2001
• Press Release: Placebo-Controlled Drug Trial in Latin America Redesigned, April 4, 2001
• Letter Requesting That HHS Halt Plans for Unethical Placebo-Controlled Study of Drug for Respiratory Distress Syndrome, February 22, 2001
• Comments on National Bioethics Advisory Commission Report on Research Issues Involving Human Participants, February 17, 2001
• Letter Criticizing Draft Report on Ethics of Research in Developing Countries, December 6, 2000
• Letter Regarding Challenges Conducting Research in Developing Countries, November 13, 2000
• Letter in the Washington Post on Modifications to the Declaration of Helsinki, October 17, 2000
• Statement Concerning an Ethical NEJM Study, October 4, 2000
• Letter on New Draft of Declaration of Helsinki, September 29, 2000
• Letter on New Version of Declaration of Helsinki, July 31, 2000
• Letter in AJPH Regarding Inclusion of Condoms and Counseling in Anti-HIV Microbicide Trials, July 2000
• Comments on HHS Study on Recruiting Human Subjects, June 13, 2000
• Letter in the Washington Post on Death of Jesse Gelsinger in Study, February 14, 2000
• Letter on UNAIDS Guidance Document on HIV Preventive Vaccine Research, February 11, 2000
• Letter Concerning Unethical Studies Which Used Placebos on HIV-Positive Pregnant Women in Developing Countries, October 23, 1997
• Letter Concerning Funding of Unethical Trials Which Administer Placebos to HIV-infected Pregnant Women, April 22, 1997