In order to address the specific details and regulatory requirements present in a retrospective medical chart review, the UB IRB recently created a new Protocol template: the HRP-503R. In order to ...

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 ...

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 ...

All submissions requiring IACUC review are assigned for review as they are received. Most protocols are reviewed and approved via designated member review (DMR), which allows approval once all review ...

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 ...

The purpose of this guidance is to explain the roles and responsibilities of both undergraduate and graduate students when submitting protocols to be reviewed by the Institutional Review Board (IRB).

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 ...

Ensuring the quality and intergrity of the data obtained. Assist with regulatory guidance and research management. Give faculty confidence that research is being conducted in accordance with ...

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