No protocol, informed consent process, or informed consent document may be modified without prior approval from the IRB unless it is necessary to eliminate an apparent and immediate hazard to one or ...
The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...
Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed. In a healthcare setting ...
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