Letter to HHS Secretary Sebelius on a New NIH-Funded Premature Infant Study Lacking Compliance with Ethical Consent Standards

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TOP trial protocol and sample consent form

IRB-approved TOP trial consent forms

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Only months after exposing an unethical, federally funded experiment conducted on premature infants, Public Citizen has learned of a similar trial also posing known risks to premature babies without fully informing the parents about those risks. In a letter to Health and Human Services (HHS) Secretary Sebelius, Public Citizen urges that recruitment for the trial, which started only recently, be halted, and that the parents of babies already enrolled in the study be contacted regarding the consent-form deficiencies.

Institutions Conducting TOP Trial:

Brown University, Women & Infants Hospital of Rhode Island*§
Case Western Reserve University, Rainbow Babies and Children’s Hospital*§
Children’s Mercy Hospital*
Cincinnati Children’s Medical Center*§
Duke University Health System*§
Emory University*§
Indiana University*§
Mercy Medical Center*§
Research Institute at Nationwide Children’s Hospital*§
Stanford University§
University of Alabama at Birmingham
University of Buffalo§
University of California, Los Angeles*§
University of Iowa*§
University of North Carolina at Chapel Hill§
University of New Mexico*§
University of Pennsylvania, Children’s Hospital of Philadelphia*§
University of Rochester*§
University of Texas Health Science Center, Houston
University of Texas Southwestern Medical Center at Dallas*
Wayne State University*§

*Institutions actively recruiting as of July 19, 2013
§Institutions with IRB- approved consent forms released by NIH in response to a Freedom of Information Act request

September 20, 2013, response letter from the NIH Office of Management Assessment

November 13, 2013, response letter from Secretary of Health Services Kathleen Sebelius