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 ...

Download the template(s) of your choice. The template documents open as Word files; save as a Word file to begin drafting your protocol. All instructions in the template are highlighted in blue.

These collected resources can help when you're developing IRB protocols and related materials. If you have further questions after reviewing these materials, please contact our office. We also ...

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 ...

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 ...

All research involving human subjects that does not qualify for Exempt or Expedited review is reviewed by the convened IRB. For example, convened review is required for all research that involves ...