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 ...

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 ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...

For more information, contact Janet Cline, Director of Research Integrity and Compliance, at 606-783-2541. NOTE: All researchers/investigators who submit a research ...

UConn Health has acknowledged that it had a lapse in an approved research protocol involving use of animals in the research process and that it was reported to federal regulators. A spokeswoman for ...