Informed Consent- What is Informed Consent?
Updated April 03, 2015.
Definition:
This is the process where the investigator, or person in charge of a clinical trial, informs you of all the key facts pertinent to the trial. It is both a written document and a conversation with the investigator to make sure you understand risks, benefits, and what is expected of you and the investigator. The written document and your conversation should include:
You must give your informed consent before participating in a clinical trial. You usually signify this by signing an informed consent document.
Source:
U.S. National Institutes of Health. Consumer Information. Accessed March 15, 2009. Understanding Clinical Trials
Definition:
This is the process where the investigator, or person in charge of a clinical trial, informs you of all the key facts pertinent to the trial. It is both a written document and a conversation with the investigator to make sure you understand risks, benefits, and what is expected of you and the investigator. The written document and your conversation should include:
- Details about the study like number of visits, blood draws, and compensation
- The purpose of the study
- The length of the study
- Any study specific procedures you may need to preform like pulmonary function testing
- Potential risks and benefits
- Contact information in case you develop problems
- Time for you to ask and get answers to questions
You must give your informed consent before participating in a clinical trial. You usually signify this by signing an informed consent document.
Source:
U.S. National Institutes of Health. Consumer Information. Accessed March 15, 2009. Understanding Clinical Trials
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