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Institutional Authority

Overview

The Chancellor of the Urbana-Champaign campus has designated the Vice Chancellor for Research as the Institutional Official (IO) for carrying out the University’s human research protections program.

The IO is responsible for ensuring that the Office for the Protection of Research Subjects (OPRS) has the resources and support necessary to comply with all institutional policies and with federal regulations and guidelines that govern human subjects research.  The IO is legally authorized to represent the campus.  He/she is the signatory of the FWA and assumes the obligations of the FWA.  The IO also has the authority to review and sign the Department of Defense Addendum for DoD sponsored research. The IO is the point of contact for correspondence addressing human research with the DHHS Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).  In the performance of these duties, the Institutional Official has the authority to delegate such activities as may be necessary in order to fulfill these duties.

The OPRS has jurisdiction over all human subject research (as defined above) conducted under the auspices of the institution.  Research under the auspices of the institution includes research conducted at this institution, conducted by or under the direction of any employee or agent of this institution (including students) in connection with his or her institutional responsibilities, conducted by or under the direction of any employee or agent of this institution using any property or facility of this institution, or involving the use of this institution's non-public information to identify or contact human subjects.

Assurance of Compliance

The University of Illinois at Urbana-Champaign holds a Federalwide Assurance (FWA), FWA 00008584. The Federalwide Assurance (FWA) is an assurance of compliance with the federal regulations for the protection of human subjects in research that is federally funded. The FWA is also approved by OHRP for Federalwide use, which means that other departments and agencies that have adopted the Common Rule may rely upon the FWA for the research that they conduct or support.

In its FWA, the campus has opted to apply only the Common Rule to all of its human subjects research regardless of the source of support.  The subparts of 45 CFR 46 only apply to research funded by DHHS. See Section 10 for a more detailed discussion of the application of the subparts.

Office for the Protection of Research Subjects (OPRS)

The Illinois OPRS reports to the Associate Vice Chancellor (Compliance) for Research who reports to the Vice Chancellor of Research (who also serves as the Institutional Official and the Signatory Official on the Federalwide Assurance) and is supervised by the Director of the OPRS (Director). The Director has expert knowledge in regulatory issues regarding human subjects, and is the primary contact at the campus level for the Office for Human Research Protections, Department of Health and Human Services.

The Director of OPRS is a member of the staff of the Vice Chancellor for Research and is responsible for the overall operation of the OPRS. The Director meets regularly with the Associated Vice Chancellor (Compliance) for Research and communicates regularly with the Office of Sponsored Programs and other University business administrators as needed. Persons in these offices are not involved in the day-to-day operations of the IRB review or approval process and may not serve on the IRB in any capacity.

The Director responds regularly to faculty, student, and staff questions about human subjects research as well as organizes and documents the review process. The Director works closely with the Chairs of the IRB in the development of policy and procedures and she/he is a voting member of the IRB. The OPRS is staffed by one Human Subjects Coordinator, three Human Subjects Research Specialists, one Assistant Human Subject Research Specialist, one Office Support Specialist and multiple student workers as Office Support Staff.

The Human Subjects Coordinators, Human Subjects Research Specialists and the Office Support Staff are members of the staff of the Vice Chancellor for Research and provide administrative support, services and resources to the IRB and the Illinois research community.  This includes organizing and reviewing submissions, consulting with the Director to identify issues in need of attention, and working with investigators to improve and clarify protocols (IRB applications) and related documentation. The Office Support Specialist and Office Support Associate prepare IRB meeting packets, maintain IRB databases and correspondence, and assist the Director and academic staff in the OPRS.

Interpretation and Application of Illinois Law

The University and the campus OPRS rely on the counsel of the General Counsel of the University for the interpretation and application of Illinois law and the laws of any other jurisdiction where research is conducted as they apply to human subjects research.