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- the circumstances under which you may be withdrawn from the trial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