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Public Citizen Report Documents Lack of Informed Consent for Risky Study on Premature Babies

View as PDF.

View press release.

View consent forms for SUPPORT study

View the protocol for SUPPORT study.

In a report submitted to Secretary of Health and Human Services Kathleen Sebelius, Public Citizen presents an independent analysis of the complete protocol and informed consent documents for the SUPPORT study, which involved extremely premature babies. The key finding in the report is that parents of babies enrolled in the study were not told the dangers of the study’s experimental procedures.

June 4, 2013, Letter from the Office for Human Research Protections to the University of Alabama at Birmingham

July 23, 2013: Letter from the Secretary of Health and Human Services