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Types of Reviews and Selection Process
Routine reviews include a sampling of human subject research selected and conducted in departments across the University. The selection process is based on such factors as study risk, enrollment of vulnerable populations, and the degree of external oversight.
Directed(For Cause) reviews are those studies identified by the IRB and requested to provide an assessment of compliance with the approval requirements and may be focused on one aspect of the research (such as the consent process) or a broader review.
Requested reviews are those that are not routine or directed and may include but are not limited to:
- A request by any member of the research team in support and preparation for an external audit by a federal agency (NIH, FDA, OHRP) or sponsor, or
- A request in support of a PI (new or experienced), study team, or department.