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 ...
Institutional Biosafety Committee – recombinant DNA, materials of human or non-human primate origin, toxins, select agents, etc. Radiation Safety Committee – radioactive materials Institutional Review ...
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 ...
Researchers may use the "Protocol Template" below to type out and draft their protocol submission. Final versions of the protocols must be submitted via SPARCS. PROTOCOL Template All protocols are ...
High-quality evidence is what we use to guide medical practice. The standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single ...
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 prepare and submit a protocol to the IRB. Instructions below include information about single IRBs, student involvement in human subject ...
If it’s possible a project will fall under the category of “research involving human subjects,” a great deal of preliminary planning will be required. It’s never too early to learn about the ethical ...
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 ...