» Drug, Devices, and Supplements

» Physician Accountability

» Consumer Product Safety

» Worker Safety

» Health Care Delivery

» Auto and Truck Safety

» Global Access to Medicines

» Infant Formula Marketing


More Information on Ethics and Clinical Trials

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

August 22, 2013

View as PDF.

TOP trial protocol and sample consent form

IRB-approved TOP trial consent forms

View press release

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

February 19, 2015, interim response letter from the Office for Human Research Protections

Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.