Informed Consent for Clinical Trials Form

Summary

This basic template can be used when drafting an informed consent for clinical trials. It is intended as a general drafting aid and will require modification for the specific clinical trial. This template includes practical guidance, drafting notes, and an optional clause. Informed consent involves providing a potential subject with enough information to allow for an informed decision about the subject's participation in the clinical trial, facilitating the potential subject's understanding of the information, providing opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject's voluntary agreement to take part in the clinical trial, and continuing to provide information as the clinical investigation moves forward. For a full listing of related content about clinical trials, see Clinical Trials Resource Kit. For more on healthcare generally, see Healthcare Fundamentals Resource Kit and Summer Associate Resource Kit: Healthcare. For more information on informed consent templates for various subjects, see Informed Assent for Clinical Trials for Children/Minors, and Informed Consent for Clinical Trials for People with Disabilities. To compare state laws on data breach notifications, see the Life Sciences section of the State Law Comparison Tool. For more information see FDA Guide to Good Clinical Practice (Thompson FDA). For additional guidance, please see Informed Consent for Clinical Trials (State Variations), Master Clinical Trial Agreement and Clinical Trial Agreement Key Considerations Checklist. For caselaw on this topic see 42 CFR § 11.60, 21 USCS § 355, 38 USCS § 7331, 21 CFR §§ 50.20 and 50.25.