Informed Consent

Informed consent is the process used by researchers to explain the clinical trials to potential volunteers and their caregivers. The goal of informed consent is to protect the volunteer by ensuring they have complete and ongoing information to make an educated decision about becoming a participant or to continue participating in the clinical trial. This protection begins when they enter the trial and continues until they stop taking part or the trial ends.

To obtain valid informed consent for research, the following conditions must be met:

  1. Competency of the subject to make decisions or the presence of a legal guardian
  2. Disclosure of information from the researcher
  3. Confirmation of understanding of the information- they must have the opportunity to read the consent document and ask questions
  4. Voluntary nature of the decision, without coercion or duress

Informed consent is required to be documented and is usually written, signed, and dated as an informed consent form.

Source: Informed Consent for Clinical Trials. (2018, January 4). U.S. Food and Drug Administration. Retrieved January 8, 2022, from