Informed Consent Standard for Stem Cell-Based Interventions
This document outlines a professional standard for the information that needs to be provided to patients (or their legally valid surrogates) to help position them to make an informed decision if offered stem cell-based interventions outside of a formal clinical trial. Stem cell-based interventions are complex and come with unique risks. The Consent Standard specifies the information that must be disclosed during the informed consent process, prior to administering any stem-cell based intervention outside of a clinical trial. Anyone offering stem cell-based interventions outside of a formal clinical trial should include these elements, along with anything else required by applicable laws, policies, practices, and regulations for informed consent.