Informed Consent Form
If you are offered an investigational stem cell treatment as part of a clinical trial or an unproven stem cell “treatment” outside of a clinical trial you should receive an Informed Consent Form or Treatment Consent Form. This document outlines your role as a patient and the possible implications of proceeding with the investigational or unproven treatment. It should provide a clear and detailed description of the treatment or procedure in language that you can easily understand. It should explain your options for treatment, the risks and potential benefit, and your and their responsibilities.
You should receive a consent form for any investigational stem cell treatment or procedure. It should emphasize the experimental nature of the treatment and outline the specific risks associated. A consent form is a good way to get the information you need to determine if you want to move forward with the treatment or procedure.
You are encouraged to have an open dialogue with your provider and make sure that all of your questions are answered. Once you have read and understood the consent form and had your questions answered through meaningful discussion with the provider, the form should be signed by you (or your legal representative) and the person providing the information. You should receive a copy of this form. The consent form should also clarify your right to withdraw at any time without consequences and a disclosure of any relevant conflicts of interest. The documents should not include language that releases the investigator, the institution, the sponsor, or their agents from liability for negligence.
The informed consent or treatment consent form for a clinical trial should include answers to the following questions:
How is participating in this clinical trial different from receiving the current standard of care?
What is the investigational treatment or procedure that is being tested?
What is the research question being tested and why is this research being done?
What are the risks of the investigational treatment?
What are your chances of receiving a different treatment (placebo or alternative treatment)?
Is the clinical trial a randomized trial?
How long will the trial last?
