medical illustration of the function of stem cells in the human body

The informed consent form for a clinical trial should include:

• that the trial involves research and why research is being done
• what the study treatment is; if a randomized trial
• what the chance of you receiving different treatments is (placebo or alternative treatment)
• what other medical options there are
• what is involved in the research study before, during and after treatment including procedures like blood-draws
• who will perform the study
• how long the study will last
• the risk of the treatment
• contact details of the point person and contact details of an independent organization that protects patient rights
• your responsibilities as a subject and information on who may see your research/medical data and your rights to confidentiality
• your right to be informed of any new information that may effect your decision to continue participating in the research study
• the circumstances under which you may be withdrawn from the trial
• your right to withdraw at any time without consequence
• how many patients are involved in the study