This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not ...
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 ...
The Initial Protocol Application, like all of the HRPP webforms, is an interactive form with built-in logic. That means that the answers to some questions will reveal other questions. Only the ...
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 HRPP policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...