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Alterations to Informed Consent

Alterations to the Informed Consent Procedure:

Federal regulations on informed consent do allow for modifications in the consent procedures and, under certain circumstances, informed consent may be waived entirely if the research meets certain conditions (as noted above) [see 45 CFR 46.116(c)(d)]. Note that such modifications and waivers are not allowed under FDA regulations.  See 45 CFR 46.116(c)(d).

Alterations in the Documentation of Informed Consent:

Typically, informed consent must be documented through the use of a written informed consent form that has been approved by the IRB and signed by the subject or the subject’s legally authorized representative.  A copy should be given to the individual signing the form.  However, documentation of informed consent may be waived in some circumstances.  See 45 CFR 46.117(c) and the above exceptions for more information.