To qualify for Expedited Review, the research must meet all of the following criteria:
Research that requires full committee review may include one or more of the following:
This list is not exhaustive. The final decision as to whether an application is reviewed by the Board at a convened meeting is that of the IRB Chair and/or Board.
Individuals whose willingness to volunteer in a study or clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces (i.e., ROTC or Corps of Cadets), and persons kept in prison or detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
Revised September 2018