Frequently Asked Questions
What activities qualify for expedited review?
Under federal regulations, the following qualify for expedited review:
· Clinical studies of drugs and medical devices
· Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
· Prospective collection of biological specimens for research purposes by noninvasive means
· Collection of data through noninvasive procedures
· Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
· Collection of data from voice, video, digital, or image recordings made for research purposes
· Research on individual or group characteristics or behavior.
· Continuing review of research previously approved by the convened IRB.
· Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified