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1. Access an informed consent document . for a clinical trial and locate the following items in the
informed consent document: The Required Elements of Informed Consent from ICH E6 The Basic
Elements of Informed Consent from 21 CFR 50.25) The Additional Elements of Informed Consent
from 21 CFR 50.25 HIPAA Authorization Language
2.Please review the links in the required reading as they will offer additional information on the
elements of informed consent.
3. Open the sample informed consent and locate the 20 required elements of informed consent
(ICH E6), the basic elements of consent (21 CFR 50.25), the additional elements of consent (21
CFR 50.25) and the HIPAA authorization language in the document. In a separate word
document, list each element of consent and include a the title of the section from the informed
consent and the text from the section.
Ex. Required Elements of Informed Consent (ICH E6) The trial involves research: WHY IS THIS
STUDY BEING DONE? [Include the title of the section of the informed consent where the
information is found AND include the text of the section.]

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1 Access an informed consent document for a clinical tria.pdf

  • 1. 1. Access an informed consent document . for a clinical trial and locate the following items in the informed consent document: The Required Elements of Informed Consent from ICH E6 The Basic Elements of Informed Consent from 21 CFR 50.25) The Additional Elements of Informed Consent from 21 CFR 50.25 HIPAA Authorization Language 2.Please review the links in the required reading as they will offer additional information on the elements of informed consent. 3. Open the sample informed consent and locate the 20 required elements of informed consent (ICH E6), the basic elements of consent (21 CFR 50.25), the additional elements of consent (21 CFR 50.25) and the HIPAA authorization language in the document. In a separate word document, list each element of consent and include a the title of the section from the informed consent and the text from the section. Ex. Required Elements of Informed Consent (ICH E6) The trial involves research: WHY IS THIS STUDY BEING DONE? [Include the title of the section of the informed consent where the information is found AND include the text of the section.]