[00:37:26] IRB/IEC Documents (1)
[00:39:42] IRB/IEC Documents (2)
[00:41:39] Expedited Reviews
[00:43:31] Exemption from Requirements
[00:44:26] Essential Documents for the Conduct of a Trial
[00:45:11] Essential Documents - Time and Location
treatment is not available or helpful. The exceptions for
informed consent are that the patient is unable to give
consent due to the medical condition. The nature of the
medical condition is such that the investigator can't wait
until the patient's legal representative is available, the
research must hold the possibility of helping the patient,
there is no other reasonable alternative available, or there
is no way to get consent in advance of the
00:43:49 / 00:51:11