What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:

  • Why the research is being done.
  • What the researchers want to accomplish.
  • What will be done during the trial and for how long.
  • What risks are involved in the trial.
  • What benefits can be expected from the trial.
  • What other treatments are available.
  • The fact that you have the right to leave the trial at any time.

If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. If English is not your native language, you can ask for the consent documents in languages other than English. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.

It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time.

Remember informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study. Informed consent continues as long as you are in the study.

For more information on this or other clinical trials, please contact us.