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This level (previously labeled as Exempt Research) is reserved for research that represents no more than minimal risks to participants and does not involve special populations (such as the cognitively impaired, some types of studies with children, prisoners, etc.). The purpose of this review is to determine if research is in keeping with the exempt categories as defined by regulation and thus exempt from Expedited or Full Review. Research that falls into one of the categories below may be reviewed at College Level:
It should be noted that only members of the IRB may determine that a study is exempt from Expedited or Full Review. Any member of the IRB reviewing a study at the College Level may consult with the Chair of the IRB or other members of the Board in needed.
In some circumstances, if there is no more than minimal risk, expedited review can be conducted even on studies involving minors. In the following circumstances, the College Representative and the IRB chair (or another IRB member that the chair designates) may review the study. The categories for expedited review are the same as in adult studies, but the blood collection limits differ. Research involving collection of PHI that is approved by both the parents and child with appropriate consent/assent forms can use expedited review. The categories for expedited review are:
Additionally, Expedited Review may be used when there are minor changes in previously approved research during the period (one year or less) for which approval is authorized.
The IRB is responsible for determining what does or does not meet the criteria for Expedited Review, and the IRB may always require a study to go on for Full Review even though it may initially qualify for Expedited Review. Expedited Review may be carried out by the IRB Chair or by one or more reviewers designated by the Chair from among members of the IRB Board. When conducting an Expedited Review, IRB members may exercise all of the authorities of the IRB, except that the reviewer(s) may not disapprove the research. A research activity may be disapproved only after a full IRB review has been conducted. All IRB members must be advised of research proposals that have been approved using expedited procedures at the next regularly scheduled meeting.
Full review by the entire IRB Board is reserved for studies that have potential risk to human subjects. This may include but is not limited to: