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 ...

Institutional Biosafety Committee – recombinant DNA, materials of human or non-human primate origin, toxins, select agents, etc. Radiation Safety Committee – radioactive materials Institutional 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 ...

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 ...

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

A qualitative case series research study sponsored by the American College of Lifestyle Medicine and published in Clinical Diabetes provides the first published examples of protocols to help guide ...