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. For more information on informed ...