For ADULTS and CHILDREN, a waiver or alteration of the requirements for obtaining informed consent can occur under any of the following three provisions set forth by HHS: 1. Research in general: an ...

Potential subjects or the parents of children who are subjects are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the ...

Informed consent must be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the participant or the participant’s legally ...