A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

In research, the terms "anonymous" and "confidential" are often confused and treated as interchangeable. They have, however, very distinct meanings, and it is important for an investigator to ...

Important Note: All IRB protocols for research to be conducted in a foreign country — including survey-only research — must include a completed international research addendum. The international ...

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 ...