Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
Situations may occur during implementation of a research study, after a participant withdraws or completes their participation, or after study completion that warrant assessment by Research Integrity ...
When you work in a consulting role, there’s an urge to dive into solutions the moment you’re presented with a problem. After all, that’s what you’re there for, right? Clients come to you with ...
To understand what is meant by "human subjects research" under the regulations, it is helpful to begin by reviewing the definitions provided by the regulations. After reviewing these definitions, if ...
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