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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.
Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.
Unless the HSRO or IRB approved a waiver or alteration of informed consent, the following information must be ... and a line for the date. A copy of the form must be available to the subject. Online ...
The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed ... in the form of a letter signed by the sponsor(s) with the same ...
Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ... requirements of research with human subjects as it reflects the basic principle from ...
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