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 ...

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 ...

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 ...

What if I told you that there was a plant that could be used to treat diabetes, liver problems, ulcers, leukemia, and malaria? Understandably, you would want that plant to be studied and turned into ...

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).

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 ...

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 ...

The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to ...

UConn Health has acknowledged that it had a lapse in an approved research protocol involving use of animals in the research process and that it was reported to federal regulators. A spokeswoman for ...