Informed Consent for Clinical Trials

The term informed consent is mistakenly viewed as the same as getting a research participant’s signature on the consent form. FDA believes that obtaining a research participant’s verbal or written informed consent is only part of the process.

Informed Consent Involves Providing a Potential Participant With:

• Adequate information to allow for an informed decision about participation in the clinical investigation.
• Facilitating the potential participant’s understanding of the information.
• An appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.
• Obtaining the potential participant’s voluntary agreement to participate.
• Continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

More on Clinical Trial Education:
Phases of Clinical Trials
Finding a Clinical Trial
Clinical Trials: Benefits, Risks, and Safety