Informed consent for clinical evaluations of investigational implantable medical devices.
A basic element in the protection of human subjects in clinical trials is the requirement for informed consent. Informed consent, and the particular minimum information that must be provided to subjects, is regulated in the United States by the FDA and by regulatory authorities in other countries. The informed consent document (ICD) provides a basis for assuring that appropriate information is provided to potential subjects. This paper discusses problems that may be encountered in two specific aspects of the ICD, namely, readability and adequacy of content to comply with regulations. Specific issues related to trials involving long-term implantable medical devices are considered. Suggestions for improving informed consent in such trials are provided.
Sharp
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Regulatory and Clinical Affairs, ConforMIS, Inc., Burlington, MA 01803, USA. michael.sharp@conformis.com
D032962:Consent Forms; D006801:Humans; D007258:Informed Consent; D019736:Prostheses and Implants; D035703:Therapies, Investigational