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 ...

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 ...

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

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 ...

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 ...

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 ...

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 ...