The guidelines for the clinical transplantation of stem cells part 9

stem cells

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  • the circumstances under which you may be withdrawn from the trial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
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