» 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 OHRP Regarding Testing the Drug Canakinumab in Diabetic Children Without Adequate Informed Consent/Parental Permission

February 28, 2012

View as PDF

In a follow-up letter to the Office for Human Research Protections regarding a clinical study testing the drug canakinumab in children with type I diabetes, Public Citizen reported that its review of the research protocol and informed consent document for this study reaffirms and provides evidence for Public Citizen’s initial allegation that this research was not conducted in compliance with the requirements of HHS human subjects protection. Furthermore, Public Citizen’s review of the sample informed consent/parental permission form for the study reveals that the description of the risks and benefits of the research failed to satisfy the requirements of HHS regulations regarding informed consent for research.

July 19, 2011, Initial Letter to OHRP Regarding Canakinumab (Ilaris)

July 9, 2013, Response from the Office for Human Research Protections

Copyright © 2015 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


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.