Version
1.4
Date Updated
Monday, February 6, 2017
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 102
AAHRPP Elements:  I.1. B, I.1.C., I.1.D., III.2.A.


POLICY


  1. No UIC official has the authority to approve research that has not been approved by a UIC Institutional Review Board.    
  2. UIC holds a Federalwide Assurance (FWA) (#00000083) from the Office for Human Research Protections in the Department of Health and Human Services (DHHS).  The FWA is maintained at the Office for the Protection of Research Subjects (OPRS) and is established in accordance with the following guidelines:
    1. UIC’s institutional authority for the Human Subjects Protection Program (HSPP) rests with the Chancellor of UIC who, by example and mandate, sets the tone that supports the primacy of human subjects protections through the principles embodied in The Belmont Report.  The Chancellor has delegated this authority to the Vice Chancellor for Research (VCR), who serves as the Institutional Official (IO).  The VCR is generally responsible for the UIC HSPP.  The VCR has assigned the role of the Human Protections Administrator (HPA) to the Director of OPRS. The HPA is the primary contact person for human subject protection issues, including the investigation and reporting of non-compliance matters, and plays a key role in ensuring that the institution fulfills its responsibilities under the FWA.

    2. The FWA is an agreement between DHHS and UIC that UIC will review and approve federally funded research involving human subjects in accordance with the ethical principles outlined in The Belmont Report and the DHHS regulations [45 CFR 46]. 
    3. UIC is subject to this FWA, including but not limited to faculty, adjunct faculty, staff, students, certain consultants, departments and facilities.  In the event that another FWA or agreement, such as a Memorandum of Understanding (MOU), indicates a UIC IRB as an IRB of record, this research is also subject to the principles of this FWA.
    4. The UIC IRBs also meet the membership requirements of the U.S. Food and Drug Administration regulations [21 CFR Parts 50 and 56] and the U.S. Department of Education regulations [34 CFR Parts 350 and 356].  The Chicago Area IRB (CHAIRb) also meets the requirements of VA regulation 38 CFR 16, VHA Handbook 1200.05, and other applicable VA directives and guidance.
    5. Where applicable, the UIC IRBs meet the requirements of the International Conference for Harmonization in so far as they are consistent with FDA regulations.    
    6. In its FWA, UIC has elected to not extend OHRP’s authority to all human subjects research conducted at UIC; however, the general protections of the Belmont Report and the Common Rule [45 CFR 46] will be applied to all research reviewed and approved at UIC either in the same way or in a variation.
    7. UIC applies Illinois State law.  The appropriate state law applies to research conducted in a different state.  In the event that two laws govern a matter, the more specific of the two and/or the higher standard will govern.
    8. IRB members or OPRS staff who feel they may be experiencing undue influence should report this behavior to their respective IRB Chair or the OPRS Director, who will act as a mediator and consult the IO as necessary.  The IO may form an investigative committee of impartial UIC employees as necessary to evaluate the allegation. An IRB Chair who experiences undue influence should report this behavior to the OPRS Director or IO.  The IO may form an investigative committee of impartial UIC employees as necessary to evaluate the allegation. (Refer to UIC HSPP policy Undue Influence of IRB Members and OPRS Staff).