Version
1.0
Date Updated
Thursday, June 25, 2009
Descripton

Approved by: Interim Vice Chancellor for Research
AAHRPP REF#: 213
AAHRPP Elements: I.1.A


POLICY


  1. 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:
    1. When the UIC IRB is geographically removed from the site(s) at which the
      research will be conducted; and/or
    2. 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).
  2. 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.
  3. 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.
  4. 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.
  5. 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.