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Vulnerable Subjects

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benefits associated with participation, or of a retaliatory
response from senior members of hierarchy for refusing to
participate. Looking more closely at the informed consent
process for enrolling children into a clinical trial, there are
specific regulations that address this population. ICH
4.8.12 states that when a clinical trial includes subjects         [00:16:53] Delegation of Informed Consent Administration
who can be enrolled in the trial only with the consent of the
                                                                   [00:18:24] 'Special' Informed Consent Procedures
subject's legally acceptable
                                                                   [00:20:06] IC-Emergency Situations
                                                                   [00:21:35] Vulnerable Subjects
                                                                   [00:23:10] Sign & Date IC
                                                                   [00:24:54] Protocol Compliance

				
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posted:4/26/2010
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