Approved by: Interim Vice Chancellor for Research
AAHRPP REF#: 213
AAHRPP Elements: I.1.A
POLICY
- If a UIC IRB becomes the IRB of Record for a protocol that raises a local research
context issue, the appropriate UIC IRB must demonstrate that it has obtained
sufficient information, and will be able to maintain sufficient oversight, regarding the
local research context in the following instances:- When the UIC IRB is geographically removed from the site(s) at which the
research will be conducted; and/or - When the research involves a distinct participant population with respect to
elements including, but not limited to, primary language and/or culture, subculture,
ethnicity, and/or religion. (Refer to UIC HSPP tip sheet Involvement of
Non-English Speaking Subjects in Research for additional information).
- When the UIC IRB is geographically removed from the site(s) at which the
- The UIC IRB must review the adequacy of local research context at initial review as
well as at each subsequent continuing review and when applicable amendments are
submitted for both minimal risk and greater than minimal risk research studies. - The UIC PI applying to conduct a research activity in another jurisdiction must first
become familiar, and provide evidence of compliance, with all applicable legal,
professional, and ethical requirements of each jurisdiction where the research will be
conducted. National, state, and local requirements may be implicated. - The UIC PI is responsible for promptly reporting any changes in the local research
context that may influence or alter the risk/benefit analysis for both minimal risk and
greater than minimal risk research studies. - Studies that involve vulnerable populations and are greater than minimal risk that are
not conducted in Illinois must be reviewed and approved by an IRB in the
appropriate jurisdiction, as well as the UIC IRB.
REFERENCES