Key Information
Source
U.S Food & Drug Administration
Year
2018
summary/abstract
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.
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Abstract Source
https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials