Version
1.2
Date Updated
Sunday, April 29, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  174
AAHRPP Elements:  I. 4.A., I.5.C.


POLICY


  1. The UIC OPRS handles complaints or concerns received from subjects or all other
    individuals related to research involving human subjects in a timely and vigilant
    manner. This policy and procedure outlines the steps in the receipt, investigation
    and resolution of any complaints.
  2. Individuals lodging complaints may include: subjects (past, present, or potential),
    family members, investigators, research staff or any person with a concern about a
    human subject research proposal.
  3. Federal regulations require as a basic element of informed consent “an explanation
    of whom to contact for answers to pertinent questions about the research and
    research subjects' rights, and whom to contact in the event of a research-related
    injury to the subject.” (45 CFR 46.116(a)(7); 21 CFR 50.25(a)(7); 38 CFR
    16.116(a)(7)).
  4. In accordance with these regulations, the informed consent templates contain for:
    1. UIC: a local and toll-free telephone number and e-mail address for contacting
      OPRS with any concerns, complaints or questions.
    2. JBVAMC: a local and toll-free telephone number and e-mail address for
      contacting the UIC OPRS and local telephone number for contacting the
      JBVAMC R&D Office with any concerns, complaints or questions.
      Additionally, the phone number for the Patient Advocate Office at JBVAMC is
      provided for the subject to talk with someone concerning their rights as a
      JBVAMC patient.
  5. The “Contact Us” section of the OPRS website provides a local telephone number
    for general questions and a toll-free telephone number and e-mail address for
    subjects or others to use for complaints or concerns. The telephone numbers and email
    addresses for the OPRS staff, OPRS Director, and VCR are also listed.
  6. Complaints representing minor issues that do not involve potential risks to subjects
    or others are investigated and resolved at an administrative level by the Assistant
    Director of the relevant IRB. The OPRS Director and IRB Chair are consulted as
    necessary.
  7. Complaints that are determined by the Assistant Director in consultation with the
    OPRS Director and IRB Chair to represent potential risks to subjects or others are
    referred to either the IRB Chair or convened IRB for review and determination of
    further action based on the seriousness of the issue and level and immediacy of the
    risks.
  8. The Assistant Director, OPRS Director, and IRB Chair (or designee) may consult
    with University legal counsel, the Associate Director of External Relations and Quality
    Improvement, and/or the Associate Director of Research Compliance for assistance
    in handling any complaint or concern.