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 ...
The primary purpose of informed consent is to protect the prospective human subject. Informed consent provides the individual with the pertinent information regarding the research in which s/he is ...
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, 1 which allows an ...
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