SUPPORT Study
On April 10, 2013, Public Citizen drew attention to an unethical clinical trial funded by the National Institutes of Health (NIH) that exposed 1,316 premature infants to increased risk of blindness and death as part of a clinical trial without parents of the babies being informed of the risks to their babies or the true nature and purpose of the research.
The trial, known as the SUPPORT study, tested two experimental strategies for managing oxygen treatment in premature babies, with one group maintained at a low blood oxygen level and the other at a high level.
More Information on the SUPPORT Study
- Letter to the OHRP Regarding Major Ethical and Regulatory Lapses in the Conduct of the SUPPORT Trial, June 14, 2017
- New Study Shows NIH-Funded Oxygen Experiment on Premature Babies Was Unethical, Parents of Babies Were Misled, May 19, 2016
- Press Statement: The New England Journal of Medicine Continues to Defend Unethical Clinical Trial Involving Premature Babies, September 3, 2015
- Follow-up Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study, March 10, 2015
- Comments Before the Institute of Medicine Workshop: Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions, December 2, 2014
- Testimony Before the Secretary’s Advisory Committee on Human Research Protections Regarding OHRP’s Draft Guidance on Disclosing Risks in Research Evaluating Standards of Care and the SUPPORT Trial, October 29, 2014
- Government Agency Confirms: Parents Were Not Given Adequate Information About the Risks Posed to Their Premature Babies in NIH Trial, October 24, 2014
- Statement: Whitewash: Inspector General Review of Agency Misconduct Ignores Serious Ethical Lapses by Senior HHS Officials; Congress Should Act, September 16, 2014
- Statement: HHS Response to Public Citizen’s Finding of Agency Misconduct Doesn’t Add Up, May 20, 2014
- Letter to the HHS Inspector General Calling for an Investigation Into Inappropriate Conduct by Senior HHS Officials Related to the SUPPORT Study, May 20, 2014
- Letter to U.S. Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants, January 27, 2014
- 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
- Press release: In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward, August 21, 2013
- Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study, August 2, 2013
- Letter to HHS Secretary Sebelius Regarding the SUPPORT Study and Censorship of an NIH Expert, June 13, 2013
- Statement: The Office for Human Research Protections Reaffirms Main Findings of Inadequate Informed Consent for Premature Baby Study, But Bows to Political Pressure and Puts Enforcement Actions on Hold, June 5, 2013
- Public Citizen Commentary on the SUPPORT Study Involving Premature Babies, May 21, 2013
- Medical Study Put Premature Babies at Risk, May-June, 2013
- 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
- Letter to Secretary of Health and Human Services Regarding Ongoing Clinical Trials Conducted by the Neonatal Research Network, April 15, 2013
- 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