What is informed consent?

Question: What is informed consent?

Answer: Informed consent is the process of learning the key facts about a clinical trial in order to decide whether or not to participate. Members of the research team explain the details of the clinical trial to someone interested in participating. Information will be translated if needed to make sure participants understand everything.

The research team provides you with an informed consent document, which contains information in writing about the clinical trial, such as:

• the purpose of the clinical trial
• how long it will last
• the number of doctor visits required
• what treatments and medications are included
• what the possible benefits of participating in the clinical trial are
• what the possible risks of participating in the clinical trial are
• who to contact for more information

After everything has been explained, and you read the informed consent document, you can decide whether to participate. If you agree, you can sign the informed consent document. Your signature means you understand what's involved in the clinical trial and that you are volunteering to participate. The informed consent document is not a contract, though, so you can withdraw from the study completely or refuse any medications or treatments.

_Sources:

_{"Are Clinical Studies for You?" Participate in Clinical Studies. NIH Clinical Center. 3 Aug 2009}

_{"Understanding Clinical Trials." ClinicalTrials.gov. 20 Sep 2007. 7 Aug 2009}