Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...
A lot has been written about ensuring that the language of informed consent forms is at a level that is easily understandable, and for good reason. The Food and Drug Administration requires all ...
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