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More Information on Ethics and Clinical Trials
- Public Citizen Report Documents Lack of Informed Consent for Risky Study on Premature Babies, May 8, 2013
- Letter to the Assistant Secretary for Health and the OHRP Director Regarding Neonatal Research Network Trials, April 18, 2013
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Letter to Secretary of Health and Human Services Regarding Ongoing Clinical Trials Conducted by the Neonatal Research Network, April 15, 2013
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Letter to Dr. Richard Marchase at the University of Alabama at Birmingham Criticizing His Misleading Statements to the Media Regarding the Unethical SUPPORT Study, April 11, 2013
- Letter to Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants, April 10, 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- Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research,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 Pregnany Women in Developing Countries, October 23, 1997
- Letter Concerning Funding of Unethical Trials Which Administer Placebos to HIV-infected Pregnant Women, April 22, 1997