Types of Review and Turnaround Time
There are three major types of review paths for an IRB application: Exempt, Expedited, and Full Board. The review path is determined by many factors, including the level of risk to subjects, the sensitivity of the research questions or complexity of the research design, and the involvement of vulnerable populations as research subjects. Generally,
- Exempt review path applies to studies that present no greater than minimal risk and fall into one or more exempt categories. At NYU Shanghai, the Research Compliance Office is the reviewing body that makes exempt determinations, except for research for which limited IRB review is a condition of exemption. The turnaround time for an exempt determination is about 2-3 weeks.
- Expedited review path applies to studies that involve no more than minimal risk and fall into one or more OHRP Expedited Review Categories (1998). Applications qualifying for expedited review are accepted and reviewed on a rolling basis by experienced IRB members appointed to the role by the IRB Chair. An expedited review may take about 2-3 weeks.
- Full Board review path applies to research that is greater than minimal risk and/or does not qualify for an expedited review, as defined by the list of expedited review categories. Studies requiring full board review may take three or more weeks.
Submission Process
NYU Shanghai IRB accepts protocol submissions electronically through the IRBManager. Regardless of the level of review, a submission typically follows the submission process and review workflow as demonstrated below.
