Transcript Slide 1

Research Related Injury Language
Jean R. Gabeau
Page 1
Overview
• Why is this issue important?
• What an Informed Consent Form (ICF) and Clinical Trial
Agreement (CTA) should state with respect to Research
Related Injuries.
• Two related topics.
Page 2
Why is this issue important?
• To protect patients and prevent lawsuits.
Page 3
What should an Informed Consent Form and Clinical Trial
Agreement state with respect to Research Related Injury?
• Who will pay
•
Standard Sponsor initiated study
•
Investigator initiated study
•
Non-profit institution
•
Approved drug or device
• Exclusions
•
Negligence
•
Natural progression of disease
•
Patient non-compliance
•
Insurance
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Two related topics
• Ensuring consistency between the Informed Consent Form
and the Clinical Trial Agreement.
• Abney v. Amgen, Inc., 443 F.3d 540 (6th Cir. 2006).
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Jean R. Gabeau
Manager of Contracts
Clinical Trials Office
Columbia University Medical Center
(212) 305-4891
[email protected]
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