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

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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