This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.
IDEA: The Journal of Law and Technology
Thomas G. Field, Jr. and Dominic Piacenza, "Informed Consent and the Investigational Use of Medical Devices: A Comparison of Common Law Duties with Those Imposed on Researchers Under Section 520(g) of the Medical Device Amendments of 1976," 19 IDEA 171 (1977).
Copyright 1977 by Commerce Clearing House, Inc.