What is informed consent?  

The process of learning key facts about a clinical trial before deciding whether or not to participate is called informed consent. This process is ongoing throughout an individual's participation in the study. In order to help a person decide whether or not to participate, doctors and nurses involved with the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Risks and potential benefits are explained in the informed consent document. A person then decides whether or not to sign the document and participate in the trial. Signing a consent form acknowledges that the trial was explained and is understood. Informed consent is not a contract however, and any participant may withdraw from a trial at any time. Informed consents should include the following information:

  • Trial title
  • Purpose
  • Description of the procedures
  • Duration 
  • Risks
  • Benefits
  • Alternatives to participation
  • Confidentiality
  • Costs and any additional expenses
  • Participant’s rights
  • Contact information
  • Supplemental information
  • Patient signature