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.

The ISSCR does not endorse the administration of unproven stem cell-based interventions outside of formal clinical trials.

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