OPRS SOP 104: IRB Authority and Signatory Authority
Approved Date
Revised Date
Full Details
PURPOSE
This SOP outlines the specific authority granted to the University of Illinois Urbana-Champaign Institutional Review Board (IRB) and Office for the Protection of Research Subjects (OPRS) to review, approve, and monitor research involving human subjects as a component of the Human Research Protection Program at the University of Illinois Urbana-Champaign.
SCOPE
This SOP applies to the University of Illinois Urbana-Champaign IRB, OPRS, and those with signatory authority for the IRB.
DEFINITIONS
- Affiliated institutions (i.e., affiliates) have a Memorandum of Understanding (MOU) with the University of Illinois Urbana-Champaign designating the University of Illinois Urbana-Champaign IRB as the IRB of record. The University of Illinois Urbana-Champaign IRB has oversight of research conducted at affiliated institutions.
- The Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.
- The Institutional Official is ultimately responsible for the oversight and conduct of the Human Research Protection Program of which the IRB is a component.
POLICY
The Vice Chancellor for Research and Innovation has been designated by the Board of Trustees and the University of Illinois Urbana-Champaign Chancellor to serve as the Institutional Official on the University of Illinois Urbana-Champaign’s Federalwide Assurance with the Office of Human Research Protection (OHRP) which also serves as the Food and Drug Administration (FDA) registration for IRBs.
The University of Illinois Urbana-Champaign Administration through the Vice Chancellor for Research and Innovation grants the University of Illinois Urbana-Champaign IRB and OPRS authority to approve research activity, specify modifications required to secure IRB approval of the research activity, or disapprove any research activity overseen and conducted by the University of Illinois Urbana-Champaign and its affiliates. The University of Illinois Urbana-Champaign IRB may suspend or terminate approval of research that is not being conducted in accordance with the IRB’s policies, is not in compliance with federal regulations, or that is associated with unexpected, serious harm to participants. The University of Illinois Urbana-Champaign IRB and OPRS also has the authority to observe or have a third party observe the consent process, and the conduct of the research.
Research that has been approved by the University of Illinois Urbana-Champaign IRB may be subject to further review and approval or disapproval by officials of the University of Illinois Urbana-Champaign, as appropriate. However, University of Illinois Urbana-Champaign officials may not approve the research if it has not been approved by the University of Illinois Urbana-Champaign IRB.
The OPRS Director, IRB Chair(s), and IRB Vice Chair(s) are authorized to sign any documents in connection with the review and approval of research projects involving the humans subjects, which have been reviewed and approved pursuant to University of Illinois Urbana-Champaign IRB policies and procedures. The IRB Chair may designate signatory authority to qualified IRB members and OPRS staff members, as appropriate. In all cases, individuals must sign their own name and indicate their title under their signature.
The results of IRB review, actions, and decisions are issued via email and are further described in OPRS SOP 305: Documentation.
Any action, letters, memos, or emails between the IRB, and/or members of the faculty or staff of the University of Illinois Urbana-Champaign that provides information concerning the review of research protocols by the IRB or OPRS staff which do not imply or appear to imply approval of the research protocol, may be signed by designated OPRS staff members.
Any letters or memos sent to agencies of the federal government, funding agencies (whether private or public) or their agents on behalf of the University of Illinois Urbana-Champaign IRB are signed by the Institutional Official, OPRS Director, IRB Chair or designee. Letters or memos may be signed with an electronic signature.
Any letters, memos or email sent representing the decision or opinions of the IRB Chair or designee, may be signed by the IRB Chair or designee, as long as such correspondence does not imply review and approval of research projects.